FormualtionHandbook 12-2007

A Guide for R+D
FORMULATION
HANDBOOK
Rev. December/2007
FORMULATION
HANDBOOK
Table of Contents
JRS PHARMA LP
Customer Service:
JRS PHARMA GMBH+CO.KG
2981 Route 22, Suite 1
Patterson, NY 12563-2359
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
E-mail: info@jrspharma.com
www.jrspharma.com
Holzmhle 1
D-73494 Rosenberg (Germany)
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
E-mail: info@jrspharma.de
www.jrspharma.de
www.jrs.de
WORLDWIDE HEADQUARTERS
Customer Service: +49 (0) 7967 / 152-312
USA + CANADA
+1 (845) 878-3414
Page 1/2
Table of Contents Page 02
Introduction Page 04
Excipients Page 05
Table of Contents Guide Formulations Page 08
Acetylsalicylic Acid (High Dosage) [No. 4282-001] Page 11
Acetylsalicylic Acid (Effervescent) [No. 4282-023] Page 13
Acetylsalicylic Acid (OD Tablets) [No. 4282-029] Page 15
Allopurinol [No. 4282-002] Page 16
Ambroxol Hcl [No. 4282-003] Page 18
Amoxicillin [No. 4282-024] Page 20
Atenolol [No. 4282-030] Page 22
Azitrhomycin 1000 mg Direct Compression [No. 4282-033] Page 24
Boswellia Serrata [No. 4282-004] Page 25
Calcium + Vitamin D3 [No. 4282-034] Page 26
Cefalexin [No. 4282-040] Page 28
Chromium Picoliante [No. 4282-005] Page 29
Cimetidin [No. 4282-025] Page 30
Ciprofloxacin Hcl [No. 4282-006] Page 32
Citramon Chewable Tablet [No. 4282-041] Page 34
Citramon Direct Compression [No. 4282-042] Page 35
Creatine Monohydrate [No. 4282-028] Page 36
Diazepam [No. 4282-022] Page 37
Enalapril [No. 4282-007] Page 39
Enalapril Hydrochlorothiazide [No. 4282-043] Page 40
Extract of Cartilage [4282-008] Page 41
Ginkgo Biloba [No. 4282-009] Page 42
Glucosamine [No. 4282-010] Page 43
Glucosamine-Chondroitin [No. 4282-035] Page 44
Guafenesin [No. 4282-011] Page 45
Ibuprofen (Direct Compression) [No. 4282-012] Page 47
Ibuprofen (Direct Compression) [No. 4282-013] Page 49
Ibuprofen (Wet Granulation) [No. 4282-014] Page 50
Lecithin [No. 4282-031] Page 51
Liuweidihuang TCM Fluid Bed Drying + Direct Compression [No. 4282-027] Page 52
Metformin [No. 4282-015] Page 54
Metformin [No. 4282-026] Page 56
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FORMULATION
HANDBOOK
Table of Contents
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Page 2/2
Metoprolol (Direct Compression) [No. 4282-016] Page 58
Metoprolol (Direct Compression) [No. 4282-017] Page 60
Multivitamin Chewable Tablets [No. 4282-032] Page 62
Multivitamin Effervescent Tablet [4282-039] Page 63
Natural Herbal Laxative Cassia Senna + Melissa off. [No. 4282-018] Page 64
Paracetamol 500 mg [No. 4282-038] Page 66
Peppermint Oil (Direct Compression) [No. 4282-037] Page 68
Piroxicam [No. 4282-019] Page 69
Ranitidine Hcl [No. 4282-020] Page 71
Silymarin [No. 4282-036] Page 73
Simethicone [No. 4282-021] Page 74
Simethicone Direct Compression [No. 4282-045] Page 75
Vitamin C + Zink [No. 4282-044] Page 76
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Dear Customer,
-
summarizes our commitment to the full range of technical services and support that
we provide for formulation development.
Take advantage of the experience and application know-how available from our
JRS PHARMA's Technical Competence Centers in all questions relating to solid
dosage forms.
This Formulation Handbook provides you with practical examples and ideas together
with an understanding of, and guides for diverse applications.
Use our suggestions and examples as the first steps (creative ideas) for your own
solutions.
Further technical details and product information can be found on the Internet under
www.jrspharma.com.
Our experts will be happy to answer any questions. We look forward to a co-operative
discussion with you.
JRS PHARMA
Technical Competence and Service Centers
"LEADING THE WORLD IN EXCIPIENTS"
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
FORMULATION
HANDBOOK
Introduction
JRS PHARMA LP JRS PHARMA GMBH+CO.KG
Patterson, NY 12563-2359 D-73494 Rosenberg (Germany)
WORLDWIDE HEADQUARTERS USA + CANADA
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FORMULATION
HANDBOOK
PROSOLV SMCC
Silicified Microcrystalline Cellulose (Microcrystalline
Cellulose, Ph.Eur., NF, JP & Silica, Colloidal Anhydrous,
Ph.Eur. & Colloidal Silicon Dioxide NF & Light
Anhydrous Silicic Acid JP)
PROSOLV SMCC is the most significant innovation in high

functionality excipients today. Used with simple direct com-
pression, it emulates the outcome of alternative granula-
tions while significantly reducing the number and quantity
of excipients.
PROSOLV SMCC is the high functionality ingredient that

offers significant benefits in terms of tablet size, production
yield and overall cost. Early use in formulation development
can result in early market entry, direct compression formulas
and smaller tablets that consumers prefer.

PROSOLV SMCC s characteristics are high compactibility,
high intrinsic flow, enhanced lubrication efficiency and im-
proved blending properties. Its benefits are proven in formu-
lation, manufacturing, marketing and regulatory approval.
Regulatory approvals have been simplified by the recognition

that PROSOLV SMCC is comprised of compendial excipients.
Submissions have been approved in the USA, Europe and
Japan. It is listed in the Inactive Ingredients Guide (IIG) of the
US Food and Drug Administration (FDA) website.

VIVAPUR and EMCOCEL

EMCOMPRESS
Microcrystalline Cellulose, Ph.Eur., NF, JP
These brands of MCC are preferred excipients in tablet manu-
facturing due to their high compactibility, inherent flow and
ability to initiate disintegration. JRS Pharma has the benefit
of multiple manufacturing plants for worldwide availability.
Calcium Hydrogen Phosphate Dihydrate, Ph.Eur.,
Dibasic Calcium Phosphate, Dihydrate, USP
The first direct compression excipient. Its particles are of a
size, shape, and density to maximize flow in high-speed
tablet production and to reduce tablet weight variation.
ANHYDROUS EMCOMPRESS : In addition to excellent flow

enhancement in direct compression. It does not contain
water of crystallization and can be used with moisture
sensitive actives. It is very often used in capsule formulations
and to accelerate formulation development.
Insoluble Tablet Binders:
EMDEX
Dextrates, NF
Ideal for chewable products, it is the only compendial
spherical dextrate available for direct compression that
delivers the required flow, compaction and flavor carrying
capacity for consumer products.

EMDEX has a great taste masking effect.
Soluble Tablet Binders:
The High Functionality Excipient
JRS Excipients
A synergistic co-processing platform resulting in a co-processed
API which becomes directly compressible, becomes a highly
effective binder/carrier, has maximized flow and content

uniformity, stabilizes hygroscopic actives. PROSOLV SMCC
co-processing provides the ultimate deaggregation and
dispersion of the API.
PROSOLV TECHNOLOGY:
Product Overview
Page 1/3
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
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ARBOCEL
VIVAPRESS
Powdered Cellulose, Ph.Eur., NF, JP
Plant derived unique functional filler for capsules and tablets
that shows excellent synergistic effect in hardness when used
in combination with lactose and starch.
Calcium Carbonate, Ph.Eur., USP
Precipitated Calcium Carbonate, JP
A direct compressible, calcium containing filler. VIVAPRESS

meets Proposition 65 for lead content.
FORMULATION
HANDBOOK
Functional Fillers:
CANDEX
SUGARTAB
COMPACTROL
Dextrates
A plant sourced tablet and capsule dextrate.
Compressible Sucrose
Excellent for chewable products, particularly vitamin formu-
lations. It offers good flow, excellent compressibility and flavor
masking.
Calcium Sulfate Dihydrate, Ph.Eur., NF
A non-hygroscopic and free-flowing product that offers
excellent and long-term stability. It can be used as a binder
in wet granulation, especially in combination with starch or
powdered cellulose. Due to its high bulk density and flowing
characteristics, it imparts a high degree of fluidity which is
essential for high-speed compaction and capsule filling.
JRS Excipients
Disintegrants:
EXPLOTAB
VIVASTAR
VIVASOL
EMCOSOY

SATIALGINE
Sodium Starch Glycolate, Type (A) Ph.Eur., NF
Sodium Carboxymethyl Starch, JPE
The classical Super Disintegrant based on starch. The
material shows excellent swelling properties and gives fast
disintegration times in combination with water insoluble
excipients. EXPLOTAB corresponds to type A (Ph.Eur.),

other types are available as well.
Sodium Starch Glycolate, Type (A) Ph.Eur., NF
Sodium Carboxymethyl Starch, JPE
Super disintegrant having great disintegration power and
cost savings.

VIVASTAR PSF is innovative in improving stability of certain

drugs by removing residual solvents.
Croscarmellose Sodium, Ph.Eur., NF, JPE
Starch-free super disintegrant that adds excellent results at
low use levels.
Soy Polysaccharides
An all natural super disintegrant, which does not contain
starch or sugar. Being a dietary fiber, it has excellent appli-
cation in nutritional products.
Alginic Acid, NF
A pharmaceutical grade alginic acid that offers rapid swelling
in an aqueous medium. It can be moistened and dried
without significant loss in disintegration and combines both
a wicking and swelling mechanism to promote
disintegration in either wet or dry granulations.
Product Overview
Page 2/3
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FORMULATION
HANDBOOK
Coating and Sustained Release:
VIVAPHARM
Hydroxylpropyl Methylcellulose, Hypromellose,
Ph.Eur., USP
Low viscosity types - the economical coating polymer for
protecting tablets against moisture, light oxydation, and
increased patients compliance.
PRUV
LUBRITAB
Sodium Stearyl Fumarate, Ph.Eur., NF, JPE
PRUV is a unique tablet lubricant that is more hydrophilic

than traditional lubricants, less sensitive to blending and rela-
tively inert. This results in tablets with improved disintegration
and dissolution, harder tablets and better drug stability. It
can be used in all tablet formulations including chewables
and effervescent tablets.
Hydrogenated Vegetable Oil, NF, BP
Hydrogenated Oil, JP
Less chemically reactive than most common lubricants, it
can also be used as an auxiliary dry binder and controlled
release matrix.
VIVAPUR MCG
Microcrystalline Cellulose and Carboxymethylcellulose
Sodium, NF
An excellent thixotropic gelling agent to stabilize suspensions
and emulsions. It is pH stable and could be used in hot
and cold medium.
Thickener and Stabilizer: Lubricants and Modified Release:
Carriers:
Disclaimer: The information provided is based on thorough
research and is believed to be completely reliable. Appli-
cation suggestions are given to assist our customers, but
are for guidance only. Circumstances in which our material
is used vary and are beyond our control. Therefore, we cannot
assume any responsibility for risks or liabilities, which may
result from the use of this technical advice.
JRS Excipients
NON-PAREIL SEEDS
Sugar Spheres, NF
Sugar spheres are used in multiple drug units for improved
content uniformity, consistent and controlled drug release
and high drug stability.
Product Overview
Page 3/3
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FORMULATION
HANDBOOK
No.
Acetylsalicylic Acid (Effervescent) 4282-001
Acetylsalicylic Acid (High Dosage) 4282-023
Acetylsalicylic Acid (OD Tablets) 4282-029
Allopurinol 4282-002
Ambroxol HCl 4282-003
Amoxicillin 4282-024
Atenolol 4282-030
Azitrhomycin 4282-033
Boswellia Serrata 4282-004
Calcium + Vitamin D3 4282-034
Cefalexin 4282-040
Chromium Picoliante 4282-005
Cimetidin 4282-025
Ciprofloxacin HCl 4282-006
Citramon Chewable Tablet 4282-041
Citramon Direct Compression 4282-042
Creatine Monohydrate 4282-028
Diazepam 4282-022
Enalapril 4282-007
Enalapril Hydrochlorothiazide 4282-043
Extract of Cartilage 4282-008
Table of Contents
Guide Formulations
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Page 1/3

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FORMULATION
HANDBOOK
Ginkgo Biloba 4282-009
Glucosamine 4282-010
Glucosamine-Chondroitin 4282-035
Guafenesin 4282-011
Ibuprofen (Direct Compression) 4282-012
Ibuprofen (Direct Compression) 4282-013
Ibuprofen (Wet Granulation) 4282-014
Lecithin 4282-031
Liuweidihuang TCM Fluid Bed Drying + Direct Compression 4282-027
Metformin 4282-015
Metformin 4282-026
Metoprolol (Direct Compression) 4282-016
Metoprolol (Direct Compression) 4282-017
Multivitamin Chewable Tablet V1 4282-032
Multivitamin Chewable Tablet V2 4282-039
Natural Herbal Laxative Cassia Senna + Melissa off. 4282-018
Paracetamol 500 mg 4282-038
Peppermint Oil (Direct Compression) 4282-037
Piroxicam 4282-019
Table of Contents
Guide Formulations
Page 2/3
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414

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FORMULATION
HANDBOOK
Ranitidine HCl 4282-020
Simethicone 4282-021
Simethicone (Direct Compression) 4282-045
Silymarin 4282-036
Vitamin C + Zink 4282-044
Disclaimer: The information provided is based on thorough research and is believed to be completely reliable. Application suggestions are
given to assist our customers, but are for guidance only. Circumstances in which our material is used vary and are beyond our control.
Therefore, we cannot assume any responsibility for risks or liabilities, which may result from the use of this technical advice.
Table of Contents
Guide Formulations
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Page 3/3
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414

No.
Acetylsalicylic Acid
Direct Compression
Key Words: High Dosage, Direct Compression

JRS Products: VIVAPUR 102, VIVASTAR P
FORMULATION
HANDBOOK
Comments:
Formulation
Procedure
Tablet Weight: 670 mg
Tablet Diameter: 13 mm
Compaction Force: 27 - 28 kN
Hardness: 79.1 N
Disintegration Time: 40 sec

Acetylsalicylic Acid (ASA), VIVAPUR 102 and VIVASTAR P were blended to homogeneity for 15 minutes. Then a sieved
mixture of magnesium stearate and Aerosil were added and mixed for another 5 minutes. The powder mix is ready for
direct compression.
Active content (mg) mg/tablet Contribution (%)
Acetylsalicylic Acid (ASA) 500.0 500.0 74.6
VIVAPUR 102 (Microcrystalline Cellulose) 140.0 20.9
VIVASTAR P (Sodium Starch Glycolate) 23.4 3.5

Magnesium Stearate 3.3 0.5
Fumed Silica (Aerosil ) 3.3 0.5

Blending:
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Tablet Characteristics
# 4282-001
Page 1/2
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Acetylsalicylic acid (ASA) is an old, very well known active
substance with analgesic and antipyretic properties. It is a
non-steroidal anti-inflammatory drug which also inhibits
platelet aggregation.
The common acetylsalicylic acid (ASA) dosage is 500 mg. In
the following formulation VIVAPUR 102 is used as filler and
binder, and VIVASTAR P as disintegrant.

Back to Table of Contents
Dissolution Medium: 900 ml 0.1 N HCl, 37C, n=6
Samples are taken after 5, 10, 20, 30, 45 and 60 minutes. The sample volume is 3 ml.
The determination of the active ingredient is done by an UV-spectrophotometer at = 280 nm.
Dissolution Test:
Diagram 1:
Typical Dissolution Profile Diagram of an Acetylsalicylic Acid 500 mg Tablet, Produced According to the Above Given
Formulation.
FORMULATION
HANDBOOK
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Time (min)
120
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Tablet Press: Korsch EK 0, instrumented
Turbula Mixer: Type T2A
Hardness Tester: Pharmatest PTB 311, n=6
Friability Tester: ERWEKA TAP
Disintegration Tester: ERWEKA ZT 3
Dissolution Tester: Pharmatest PTW II, with 6 vessels, flat blade paddle
Spectrophotometer: Shimadzu UV-2101 PC
Equipment:
15 10 30 45 60

# 4282-001
Page 2/2
Direct Compression
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Effervescent Tablet
Direct Compression
Key Words: Acetylsalicylic Acid, Direct
Compression, Effervescent Tablet

JRS Products: EMDEX , PRUV
FORMULATION
HANDBOOK
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# 4282-023
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
The acetylsalicylic acid is an old and very well known active with
analgesic, antipyretic, antiinflammatory and antiaggregant
Procedure
Compression Force 20 kN
Hardness 10.0 kp
Diameter 25 mm
Disintegration Time 176 sec.
All ingredients except were blended for 15 minutes. The was added and the tabletting powder was mixed for
another 3 min. Ready for direct compression.

PRUV PRUV
Blending:
Equipment:
properties. Its lipophility and low water solubility make the
development of an effervescent formulation a big challenge.
Tablet Diameter: 25 mm, biplane,
Hardness Tester: Schleuniger 2E
Disintegration Tester: Pharmatest Standard PTZ
Dissolution Tester: Pharmatest PTW 2
Spectrophotometer: Cecil Spektralphotometer, Series 1000
Comments:
Formulation
mg/Tablet Contribution (%)
Acetylsalicylic Acid (ASA) 500.0 12.5
PRUV (Sodium Stearyl Fumarate) 12.0 0.3

Citric Acid 348.0 8.7
NaHCO 400.0 10.0
3
Glycine HCl 128.0 3.2
Aspartame 76.0 1.9
Flavour 36.0 0.9
EMDEX (Dextrates) 2500.0 62.5

Total 4000.0 100.0
Dissolutuion Medium: 900 ml 0.1 N HCl, 37 C, n=6
Samples are taken after 5, 10, 15, 30, 60, 120, 180 and 300 minutes. The sample volume is 3 ml. The probes were
diluted if necessary. The determination of the acetylsalicylic acid was done by an UV-spectrophotometer at = 232.0 nm.
Dissolution Test:
Diagram 1:
Dissolution Profile of Acetylsalicylic Acid Effervescent Tablet, Produced According to the Above Given Formulation.
FORMULATION
HANDBOOK
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JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Compression, Effervescent Tablet

Page 2/2
# 4282-023
Time (min)
120
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Effervescent Tablet
Direct Compression
Back to Table of Contents Back to Table of Contents
OD Tablets;
DC Formulations
Compression, Fast Disintegration

JRS Products: PROSOLV SMCC 90, PURV , EXPLOTAB ,

VIVASOL , EMCOMPRESS
FORMULATION
HANDBOOK
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# 4282-029
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
The acetylsalicylic acid is an old and very well known active with
analgesic, antipyretic, antiinflammatory and antiaggregant
properties. The permanently growing interest on ODT (Orally
Disintegrating Tablets) in the last few years stimulate us to
create these formulations.
Formulation
Substance (%)
Formulation 1 2 3 4
Acetylsalicylic Acid 71.43 70.43 70.43 70.43
PROSOLV SMCC 90 (Silicified Microcrystalline Cellulose) 20.00 20.00 14.00 14.00

Adipic Acid 4.00 4.00 - -
Citric Acid - - 4.00 7.50
Sodium Hydrogencarbonate 2.86 2.86 2.86 6.36
EMCOMPRESS (Calcium Hydrogen Phosphate) - - 1.00 -
EXPLOTAB (Sodium Starch Glycolate) - - 5.00 -
VIVASOL ( ) 1.00 2.00 2.00 1.00
PRUV (Sodium Stearyl Fumarate) 0.71 0.71 0.71 0.71

Total 100 100 100 100
Croscarmellose Sodium
Procedure
All ingredients except PRUV were blended for 15 minutes. The
PRUV was added and the tabletting powder was mixed for
Note: The mentioned above formulations do not contain
taste masking substances!
Disintegration Time (sec) 29 27 28 40
Friability (%) 0.68 0.61 0.87 1.18
Compression Force (kN) 13.40 14.30 20.00 22.10
Hardness (kp) 7.10 6.80 7.10 8.10
Comments:
Allopurinol
Direct Compression
Key Words: Poor Flowability, Direct Compression

FORMULATION
HANDBOOK
Allopurinol is used to treat chronic gout (gouty arthritis). This
condition is caused by too much uric acid in the blood. It is also
used to prevent or treat other medical problems that may
occur if too much uric acid is present in the body.
Comments:
Formulation
Procedure
Hardness: 91.3 N

Allopurinol, VIVAPUR 102 and VIVASTAR P were mixed in a Turbula mixer for 15 minutes. Then a sieved mixture of
magnesium stearate and Aerosil were added and mixed for another 3 minutes. The powder mix was ready for direct
compression.
Blending:
These include certain kinds of kidney stones or other kidney
problems.
Allopurinol can be directly compressed using VIVAPUR

Microcrystalline Cellulose as a binder.
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Tablet Press: Korsch EK 0 eccentric press, 9 mm punch,biplane
Friability Tester: Erweka TAP
Disintegration Tester: Erweka ZT 3
Equipment:
Allopurinol 100.0 100.0 55.5
72.0 40.0

(Sodium Starch Glycolate) 6.2 3.5
Fumed Silica (Aerosil 200) 0.9 0.5

VIVAPUR 102 (Microcrystalline Cellulose)

VIVASTAR P
# 4282-002
Page 1/2
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
FORMULATION
HANDBOOK
120
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Diagram 1:
Typical Dissolution Profile Diagram of a Allopurinol Tablet, Produced According to the Above Given Formulation.
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Samples are taken after 5, 10, 20, 30, 45 and 60 minutes. The sample volume is 3 ml. Samples were diluted if necessa-
ry. The determination of the active ingredient is done by an UV-spectrophotometer at = 248.8 nm.
Dissolution Test:
Allopurinol
Direct Compression
# 4282-002
Page 2/2
Key Words: Poor Flowability, Direct Compression

JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Ambroxol HCl
Direct Compression
Key Words: Poorly Soluble, Low Dosage,
Direct Compression

JRS Products: VIVAPUR 12, ARBOCEL A 300,
VIVASOL
FORMULATION
HANDBOOK
Ambroxol Hydrochloride is an example for a poorly soluble
active substance used in low concentrations. It can be com-
pressed directly by using VIVAPUR Microcrystalline Cellulose
as a dry binder and ARBOCEL Powdered Cellulose as a plant-

derived filler.
Comments:
Formulation
Procedure
Compaction Force: 12.5 kN
Hardness: 64.0 N
Friability: <0.1 %
All ingredients were mixed for 4 minutes and compressed at a compaction force of approx. 12.5 kN.
Ambroxol HCl 30.0 30.00 20.0
ARBOCEL A 300 (Powdered Cellulose) 46.20 30.8
VIVASOL (Croscarmellose Sodium) 3.00 2.0


Blending:
Ambroxol HCl is a mucolytic agent which is widely used in
chronic bronchitis in Europe. Ambroxol HCl is very popular as
an Active Pharmaceutical Ingredient (API) for children.
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Tablet Press: Korsch EK 0 eccentric press, 8 mm punch
Hardness Tester: Pharmatest PTB 311
Equipment:
# 4282-003
Page 1/2
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Samples are taken after 1, 5, 10, 15, 20, 30, 45, 60, 75 and 90 minutes. The sample volume is 3 ml. Samples were
diluted if necessary. The determination of the active ingredient is done by an UV-spectrophotometer at = 223 nm.
Dissolution Test:
Diagram 1:
Typical Dissolution Profile Diagram of a Ambroxol Tablet, Produced According to the Above Given Formulation.
120
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90
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FORMULATION
HANDBOOK
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Ambroxol HCl
Direct Compression
Key Words: Poorly Soluble, Low Dosage,
Direct Compression

JRS Products: VIVAPUR 12, ARBOCEL A 300,
VIVASOL
# 4282-003
Page 2/2
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Amoxicillin
Direct Compression
Key Words: High Dosage, Crystalline Active
Ingredient, Direct Compression

JRS Products: VIVAPUR , VIVASTAR , PRUV
FORMULATION
HANDBOOK
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# 4282-024
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Amoxicillin is a bactericidal antibiotic with a relatively broad
spectrum of activity. It belongs to the penicillin group. Amoxicillin
mainly acts against infections caused by amoxicillin-sensitive
Formulation
Procedure
Diameter of Tablet: 20 mm
Compression Force: 25 - 26 kN
Hardness: 8.8 kp
Friability: 2.02 %
Disintegration Time (in 200 ml Water): 98 sec
Mixing of all ingredients (10 min), compressing at a compaction force of approx. 25 kN
Blending:
Equipment:
micro organisms, i.e. respiratory tract infections, urogenital
infections or gastrointestinal infections. It is an example for
an easy to compress crystalline substance.
Amoxicillin Trihydrate 574.0 58.6

Tablet Press: Korsch EKO, Nr. 6087/64 , 20 mm punch
Hardness Tester: Schleuniger, Type 2 E
Dissolution Tester: Pharmatest, Type PTW 2 , Nr. 6276
Disintegration Tester: Pharmatest Standard, Type PTZ , Nr. 6454
Friability Tester: Pharmatest, Typ PTF 1, Nr. 6453
Spectrophotometer: Cecil Spektralphotometer, Series 1000 (CE 1021)
Comments:
FORMULATION
HANDBOOK
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Amoxicillin
Direct Compression
Key Words: High Dosage, Crystallin Active
Ingredient, Direct Compression

JRS Products: VIVAPUR , VIVASTAR , PRUV
Page 2/2
# 4282-024
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Dissolution Medium: 900 ml 0,1 N HCl, 37C, n=3.
Samples were taken after 1, 5, 10, 20, 30, 60, 90 and 120 minutes.
The determination of the active ingredient was done by an U.V. spektrophotometer at Lambda =230 nm.
Dissolution Test:
120
110
100
90
80
70
60
50
40
30
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0 20 40 60 80 100 120 140
Time (min)
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Atenolol
Direct Compression
Key Words: Atenolol, Direct Compression,
Dissolution Profile

JRS Products: VIVAPUR 102, PURV , EXPLOTAB
FORMULATION
HANDBOOK
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Page 1/2
# 4282-030
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Atenolol is a drug belonging to the group of beta blockers, a
class of drugs used primarily in cardiovascular diseases.
Atenolol (trade name Tenormin) can be used to treat
cardiovascular diseases such as hypertension, coronary heart
Comments:
disease, arrhythmias, and treatment of myocardial infarction
after the acute event. The drug is also used to treat other
conditions, including dysautonomia, anxiety and
hyperthyroidism (overfunction of the thyroid gland).
Formulation
active content/tablet (mg) Contribution (%)
VIVAPUR 102 (Microcrystalline Cellulose)
EXPLOTAB (Sodium Starch Glycolate)
PRUV (Sodium Stearyl Fumarate)

Atenolol 50.0 16.7
238.0 79.3
9.0 3.0
3.0 1.0
Total 300.0 100.0
Tablet Weight: 300.0 mg
Tablet Height: 3.4 mm
Compaction Force: 4.7-4.9 kN
Hardness: 7.1 kp
Disintegration 14 sec
Friability 0.22 %
Procedure

The Atenolol, VIVAPUR 102 and the EXPLOTAB were blended
for 15 minutes. The PRUV was added and the tabletting

powder was mixed for another 3 min. Ready for direct
compression.
FORMULATION
HANDBOOK
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Atenolol
Direct Compression
Key Words: Atenolol, Direct Compression,
Dissolution Profile

JRS Products: VIVAPUR 102, PURV , EXPLOTAB
Page 2/2
# 4282-030
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Dissolution Medium: 900 ml 0.1 N HCl, 37 C, n=6
Samples are taken after 5, 10, 15, 30, 60 and 120 minutes. The sample volume is 3 ml. The probes were dilueted if
necessary. The determination of the atenolol was done by an UV-spectrophotometer at l = 220 nm.
Dissolution Test:
120
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90
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Time (min)
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Diagram 1:
Dissolution Profile of Atenolol Tablet, Produced According to the Above Given Formulation.
Azithromycin 1000 mg
Direct Compression
Key Words: Azithromycin, Direct Compression

JRS Products: PROSOLV SMCC 50, PRUV , VIVASOL
FORMULATION
HANDBOOK
Azithromycin is an antibiotic acting API, which belongs to the
class of macrolides. Chemical it is similar to erythromycin.
Today, Azithromycin is one of the best selling antibiotics world-
wide. It is used against certain bacterial infections, mainly
bronchitis, pneumonia, rhinitis and some throat infections.
Formulation
Procedure
Tablet Diameter: 14 mm, oblong
Compaction Force: 16-18 kN
Hardness: 10.3 kp
Friability: 2.3 %
The Azithromycin, and the were blended intensive for 15 minutes. The was added
and the tabletting powder was mixed for another 3 min. Press with compression force 16-18 kN!! A higher compression
forces may cause capping.

PROSOLV SMCC 5o VIVASOL PRUV
Azithromycin 1000 1000.0 77.22
PROSOLV SMCC 5o (Silicified Microcrystalline Cellulose) 256.0 19.77

Total 1295.0 100
Blending:
The formulation of 1.000 mg Azithromycin per tablet is a
major challenge. The substance is very good flowing but poor
compressible. The monohydrate gives better compression
results than the dihydrate.
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# 4282-033
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Tablet Press: Kilian Pressima, 14 mm punch oblong
Friability Tester: Pharmatest PTF
Equipment:
Boswellia Serrata
Direct Compression
Key Words: Botanical Extract, Sticky Active,
High Dosage, Direct Compression

JRS Products: PROSOLV SMCC HD 90, PRUV
FORMULATION
HANDBOOK
Boswellia has been used historically for various conditions, in-
cluding arthritis and other inflammation. It is a gum resin, co-
hesive in nature and, consequently, poorly flowing. Since
Boswellia extract is a gum resin, it is also very poorly compac-
table. Due to its physical characteristics, Boswellia is gene-
rally granulated prior to tablet manufacture.
Comments:
Formulation
Procedure

PROSOLV SMCC HD 90
V-blender. Boswellia was
minutes.
and PRUV were dispensed to the correct masses and transferred to a Patterson-Kelly twin-shell
sieved through a twenty mesh and transferred into the V-blender. The powders were blended for five
Boswellia extract 200.0 200.0 49.75
PROSOLV SMCC HD 90 (Silicified Microcrystalline Cellulose) 200.0 49.75

Blending:
Blender: Patterson-Kelly twin-shell V-blender
Flowability Apparatus: Hanson Research Flodex
Tablet Press: Korsch PH-106 instrumented rotary tablet press
Hardness Tester: Erweka TBH-30
Disintegration Tester: Erweka ZT-62
Friability Tester: Erweka TA-3
Equipment:
Using PROSOLV SMCC HD 90, Boswellia was formulated into

a directly compressible tablet.
PROSOLV SMCC HD 90 not only provided the necessary bin-

ding properties required for direct compression tableting, but
also served as the tablet disintegrant.
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Tablet Mass: 402 mg
Hardness: 14. kp
Tablet Weight Variation: 2.3%
Tablet Disintegration Time: 225 sec
4
Page 1/1
# 4282-004
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Calcium+Vit. D3 Effervescent
Direct Compression
Key Words: Calcium, Vitamin D3,
Effervescent Tablet, Direct Compression

JRS Products: EMDEX , VIVAPRESS , PRUV
FORMULATION
HANDBOOK
Vitamin D is a group of fat-soluble prohormones, the two major
forms of which are vitamin D2 (ergocalciferol) and vitamin D3
(cholecalciferol). Vitamin D regulates the calcium and phosphorus
levels in the blood by promoting their absorption from food in
the intestines, and by promoting re-absorption of calcium in
the kidneys. It promotes bone formation and mineralization
and is essential in the development of an intact and strong
skeleton. The combination of calcium supplement and
vitamin D3 ist very popular for the prevention and treatment
of osteoporosis.
4
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Page 1/2
# 4282-034
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Formulation
VIVAPRESS (CaCO ) (Calcium Carbonate) 670 670 16.75

3
Vitamin C 500 500 12.50
Vitamin D3 400 IU (10 mcg) 0.00025
Vitamin B6 10 10 0.25
Sodium Hydrogenphosphate 650 16.25
Citric Acid 575 14.37
Aspartam 70 1.75
Flavour (orange) 100 2.50
Beta Carotine 1 % CWS 25 0.63
Sodium Chloride 10 0.25
1310 32.75
PEG 6000 40 1.00

(Sodium Stearyl Fumarate) 40 1.00
Total 4000 100
CA 800
EMDEX (Dextrate)
PRUV
Compaction Force: 18 kN
Hardness: 7.5 kp
Disintegration < 2 min
Calcium+Vit. D3 Effervescent
Direct Compression
Key Words: Calcium, Vitamin D3,
Effervescent Tablet, Direct Compression

JRS Products: EMDEX , VIVAPRESS , PRUV
FORMULATION
HANDBOOK
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Page 2/2
# 4282-034
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Procedure
The vitamin mixture was preblended. All substances without the lubricant were mixed for 20 min. Than PRUV Sodium
Stearyl Fumarate was added and the powder was mixed for another 3 min. DC ready.
Blending:
Equipment:
Cefalexin 1000 mg
Direct Compression
Key Words : Cefalexin, High Dosage,
Direct Compression

JRS Products: PROSOLV SMCC 90, PRUV
FORMULATION
HANDBOOK
Cefalexin (INN) belolongs to the group of cephalosporins,
member of the big family of the -lactam antibiotics. It shows
bactericidal activity caused by disruption the synthesis of the
peptidoglycan layer of the bacterial cell walls. Cefalexin is so
called first generation cephalosporin antibiotic with
Comments:
Formulation
Procedure
The Cefalexin and the were blended for 15 minutes. The was added and the powder was mixed
for another 3 min. Ready for direct compression.

PROSOLV SMCC 90 PRUV
Cefalexin 1000.0 1000.0 73.26
PROSOLV SMCC 50 (Silicified Microcrystalline Cellulose) 345.0 25.27

Total 1365.0 100.00
Blending:
Tablet Press Korsch EK 0, instrumented
Hardness Tester Schleuniger 6D
Disintegration Tester Pharmatest Standard PTZ
Equipment:
predominantly activity against Gram-positive bacterias. Its
stability toward hydrochloric acid make this -lactam
antibiotic suitable for oral administration. We developed a
direct compression formulation with PROSOLV as a binder
and PRUV as a lubricant.

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Tablet Weight 1365.0 mg
Tablet Diameter 20 mm
Compaction Force 9.5-10.5 kN
Tablet Hardness 8.5-9.0 kp
Disintegration Time 123 sec
Page 1/1
# 4282-040
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Chromium Picolinate
Direct Compression
Key Words : Sticky Active, Low Dosage,
Direct Compression

JRS Products: PROSOLV SMCC , PRUV
FORMULATION
HANDBOOK
Chromium Picolinate is a poorly flowing, low dose substance.
Chromium is an essential trace element. It is reported to play
an important role in blood sugar regulation and acts as a
cofactor to a number of enzymes involved in energy produc-
Comments:
Formulation
Procedure
Chromium Picolinate,
PRUV was added to the blender and blended for additional three minutes.

PROSOLV SMCC 90 and PROSOLV SMCC 50 added to the V-blender and blended for 30 minutes.
Chromium Picolinate 0.4 0.4 0.27

Blending:
Blender: Patterson-Kelly 2 qt. twin-shell V-blender
Tablet Press: Korsch PH-106 rotary tablet press
Friability Tester: Erweka TA-3
Equipment:
tion as well as reducing lipid levels. It can be directly com-
pressed using a combination of PROSOLV SMCC 50 and
PROSOLV SMCC 90.

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Tablet Mass: 150.7 mg
Hardness: 20 kp
Page 1/1
# 4282-005
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Cimetidin 400 mg
Direct Compression

JRS Products: VIVAPUR 12, VIVASTAR P, PRUV
FORMULATION
HANDBOOK
4
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Page 1/2
# 4282-025
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Cimetidin is a histamine H2-receptor antagonist for treatment
of ulcus duodeni and ulcus ventriculi. Normally, this active is
wet granulated to achieve a better water solubility, because the
Formulation
Procedure
Compression Force: 14 - 15 kN
Hardness: 9.8 kp
Friability: 0.79 %
Disintegration Time (in 200 ml Water): 47 sec
Mixing of all ingredients (10 min), compressing at a compaction force of approx. 14 - 15 kN
Blending:
Equipment:
cimetidin is only slightly water soluble. But it is not a problem
to make tablets by direct compression using VIVAPUR 12 as

a binder, getting good dissolution profiles as well.

Cimetidin 400.0 57.1
3.5 0.5
Comments:
FORMULATION
HANDBOOK
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Cimetidin 400 mg
Direct Compression

JRS Products: VIVAPUR 12, VIVASTAR P, PRUV
Page 2/2
# 4282-025
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Samples were taken after 1, 5, 10, 20, 30, 60 and 120 minutes.
The determination of the active ingredient was done by an U.V. spektrophotometer at Lambda = 220 nm.
Dissolution Test:
120
110
100
90
80
70
60
50
40
30
20
10
0
0 20 40 60 80 100 120 140
Time (min)
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(
%
)
Ciprofloxacin HCl
Dry Compaction
Key Words: Very Low Bulk Density,
Dry Compaction
JRS Products: VIVAPUR 12

FORMULATION
HANDBOOK
Ciprofloxacin HCl is a material of very low bulk density and has
to be precompacted. This can be done with a dry compactor or
by re-processing.
Ciprofloxacin is an antimicrobial agent that stops multiplication
of bacteria by inhibiting the reproduction and repair of their
genetic material (DNA).
Comments:
Formulation
Step 1 (Granules)
Procedure
Hardness: 109.7 N
Friability: 0.36 %
In the first step tablets were made of 20 mm insize and in the second step the tablets have been crushed by passing
them through a dry granulator with a screen size of 19 mesh (800 m). The resulting granules have been compressed to
the final tablet by m and ixing of all ingredients for 4 minutes compressing at a compaction force of approx. 8.5 kN.
Ciprofloxacin HCl 500.0 500.0 85.1


Blending:
Ciprofloxacin is used to treat infections of the skin, lungs,
airways, bones, and joints caused by susceptible bacteria.
Ciprofloxacin is also frequently used to treat urinary infections
caused by bacteria such as E. Coli.
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mg/tablet Contribution (%)
Ciprofloxacin Granules 587.5 85.1


Step 2 (Tablets)
Page 1/2
# 4282-006
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
FORMULATION
HANDBOOK
4
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120
110
100
90
80
70
60
50
40
30
20
10
0
0 50 100 150 200 250 300 350
Time (min)
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A
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(
%
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Diagram 1:
Typical Dissolution Profile Diagram of a Ciprofloxacin Tablet, Produced According to the Above Given Formulation.
Granulator: Erweka 20240
Hardness Tester: Schleuniger Type 2 E
Friability Tester: Pharmatest Type PTF 1, Nr. 6453
Disintegration Tester: Pharmatest Standard, Type PTZ, Nr. 6454
Spectrophotometer: Cecil Spectrophotometer, Series 1000 (CE 1021)
Equipment:
Ciprofloxacin HCl
Dry Compaction
Key Words: Very Low Bulk Density,
Dry Compaction
JRS Products: VIVAPUR 12

Page 2/2
# 4282-006
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Samples are taken after 1, 5, 10, 20, 30, 60, 90, 120, 180, 240 and 300 minutes. The determination of the active
ingredient is done by an UV-spectrophotometer at l= 278.7 nm.
Dissolution Test:
Citramon
Chewable Tablet
Key Words : Acetylsalicylic Acid, Paracetamol,
Caffein, Direct Compression

FORMULATION
HANDBOOK
The acetylsalicylic acid and the paracetamol are two of the
widest used pain relief actives world-wide. The combination
with caffein is often found in many headache and cold
medicinal compositions. A common problem with this
Comments:
Formulation
Procedure
All substances were blended for 20 minutes. Ready for direct compression.
Acetylsalicylic Acid 240.0 240 12.06
Paracetamol 200.0 200 10.05
Caffein 30.0 30 1.51
Milk Powder 199 10.00
1150 57.79
Cacao Powder 129 6.48
Citric Acid 12 0.60
Aspartame 10 0.50
PRUV (Sodium Stearyl Fumarate) 20 1.01

Total 1990.0 100.00
EMDEX (Dextrates)
Blending:
Equipment:
formulation is the unpleasant bitter taste of the paracetamol
and the caffein. We developed a direct compression
formulation with EMDEX as a binder and taste improver, and
PRUV as a lubricant.
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Hardness: 8-9 kp
Page 1/1
# 4282-041
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Citramon
Direct Compression
Chewable Tablet
Key Words : Acetylsalicylic Acid, Paracetamol,
Caffein, Direct Compression

FORMULATION
HANDBOOK
The acetylsalicylic acid and the paracetamol are two of the
widest used pain relief actives world-wide. The combination
with caffein is often found in many headache and cold
medicinal compositions. The most of the formulations on the
Comments:
Formulation
Procedure
All substances except were blended for 15 minutes. The was added and the powder was mixed for another
3 min. Ready for direct compression.

PRUV PRUV
Acetylsalicylic acid 240.0 240.0 30.19
Paracetamol 200.0 200.0 25.16
Caffein 30.0 30.0 3.77
292.0 36.73
Cacao Powder 20.0 2.52

Total 795.0 100.00
EMDEX (Dextrates)
Blending:
Hardness Tester Scleuniger 6D
Friability Tester Pharmatest Standard PTF
Equipment:
market are made with microcrystalline cellulose. We
developed a direct compression formulation with water

soluble matrix using EMDEX as a binder and PRUV as a
lubricant.
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Hardness: 8-9 kp
Friability 0.8 %
Page 1/1
# 4282-042
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Creatine Monohydrate
Direct Compression
Key Words: Creatine Monohydrate, Direct
Compression, High Dosage

JRS Products: EMDEX PRUV
FORMULATION
HANDBOOK
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Page 1
# 4282-028
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Creatine is a nitrogenous organic acid that naturally occurs in
vertebrates and helps to supply energy to muscle cells. Its
functions as part of a system based on arginine/
phosphoarginine that operates in many invertebrates. The
presence of this energy shuttle keeps the ATP/ADP ratio high
which ensures that the free energy of ATP remains high and
minimizes the loss of adenosine nucleotides, which would
cause cellular dysfunction. Such high energy phosphate
buffers are known as phosphagens. Creatine supple-
mentation has been, and continues to be, investigated as a
possible therapeutic approach for the treatment of muscular,
neurological and neuromuscular diseases (arthritis,
congestive heart failure, disuse atrophy, gyrate atrophy,
McArdle's disease, Huntington's disease, miscellaneous
neuromuscular diseases, mitochondrial diseases, muscular
dystrophy, neuroprotection, etc.).
Formulation
(Dextrates)

Creatine Monohydrate 1000.0 83.33
EMDEX 190.0 15.83
10.0 0.84
Total 1200.0 100.00
Compression Force: 32 kN
Hardness: 6 kp
Procedure
The creatine mohohydrate and EMDEX were blended for 18
minutes. The PRUV was added and the tabletting powder was
mixed for another 3 min. Ready for direct compression.
Comments:
Diazepam
Key Words: Low Dosage, Direct Compression

JRS Products: VIVAPUR 12, EMCOMPRESS ,

EXPLOTAB /VIVASTAR
FORMULATION
HANDBOOK
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Page 1/2
# 4282-022
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Diazepam, better known under the original name Valium, is a
benzodiazepine derivative.
It is for short-term management of moderate degrees of
anxiety, tension, agitation, fear or aggressiveness. It is often
used in certain medical procedures (e.g. surgery ) to reduce
Formulation
Procedure
Hardness: 7,3 kp
Friability: 0,1 %

Mix all ingredients except PRUV for 10 minutes. Add PRUV and mix another 3 minutes. The powder is for direct compression.
Blending:
Equipment:
tension and anxiety. Normally the dosage in tablets is
between 2 and 10 mg.
This formulation is an example for a low dosage active
ingredient, workable in direct compression.
Diazepam 10,0 7,1
VIVAPUR 12 (Microcrystalline Cellulose) 59,0 42,1
EMCOMPRESS (Calcium Hydrogen Phosphate) 65,5 46,8
VIVASTAR (Sodium Starch Glycolate) 4,0 2,9
PRUV (Sodium Stearyl Fumarate) 0,8 0,6

Fumed Silica (Aerosil 200) 0,7 0,5
Comments:
FORMULATION
HANDBOOK
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Diazepam
Key Words: Low Dosage, Direct Compression

JRS Products: VIVAPUR 12, EMCOMPRESS ,

EXPLOTAB /VIVASTAR
Page 2/2
# 4282-022
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Dissolution Medium: 900 ml 0,1 N HCl, 37C, n = 6
Samples were taken after 1, 5, 10, 20, 30, 60 and 120 minutes. The determination of the active ingredient was done by
an UV spectrometer at = 242 nm.
Dissolution Test:
120
110
100
90
80
70
60
50
40
30
20
10
0
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70
Time (min)
D
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(
%
)
Enalapril
Direct Compression
Key Words: Poor Flowability, Low Dosage,
Direct Compression

JRS Products: PROSOLV SMCC 90, EMCOMPRESS ,

VIVASTAR P, PRUV
FORMULATION
HANDBOOK
Enalapril is an angiotensin converting enzyme (ACE) inhibitor
used in the treatment of hypertension and some types of
chronic heart failure.
Comments:
Formulation
Procedure
Hardness: 10.8 kp
Friability: 0.03 %
Enalapril maleate, 90, EMCOMPRESS and P were blended to homogeneity for 10 minutes.
Then PRUV was added and mixed for another 3 minutes. The powder-mix was ready for direct compression.

PROSOLV SMCC VIVASTAR

Enalapril Maleate 10.0 10.0 5.1
EMCOMPRESS (Calcium Hydrogen Phosphate) 85.4 43.6

(Sodium Stearyl Fumarate) 1.0 0.5

PRUV
Blending:
Friability Tester: Pharmatest PFT
Equipment:
Enalapril which is a poor flowing API can be directly com-

pressed using PROSOLV SMCC 90 and EMCOMPRESS as
binders.
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Page 1/1
# 4282-007
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Enalapril Hydrochlorothiazide
Direct Compression
Key Words : Enalapril, Hydrochlorothiazide,
Direct Compression

JRS Products: PROSOLV SMCC 50, VIVASTAR P,
PRUV
FORMULATION
HANDBOOK
Enalapril and Hyrochlorothiazide are two actives, used in
combination to treate high blood pressure. The syergistic effect
of an ACE-inhibitor (Enalapril) and a diuretic (Hydrochlor-
othiazide) for the treatment of the hypertension was observed
years ago and applied successful in many drug compositions.
Comments:
Formulation
Procedure

PRUV PRUV
Enalapril 10.0 10.0 6.71
Hydrochlorothiazide 25.0 25.0 16.78

Sodium Hydrogencarbonate 3.0 2.01
Total 149.0 100.00
Blending:
Equipment:
JRS PHARMA developed a direct compression formulation
using silicified microcrystalline cellulose (PROSOLV SMCC 50)
as a filler and binder, VIVASTAR P as superdisintegrant and
PRUV as a lubricant.
4
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Compaction Force: 6-6.5 kN
Hardness: 11-12 kp
Friability 0.2 %
Disintegration 12 sec
Page 1/1
# 4282-043
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Extract of Cartilage
Direct Compression
Key Words: Very Hygroscopic, Sticky,
Direct Compression

JRS Products: PROSOLV SMCC 90, EMCOMPRESS ,

ARBOCEL P 290, VIVASOL , PRUV
FORMULATION
HANDBOOK
The extract of Cartilage is a hygroscopic substance with a very
high water content. The substance is very sticky. The extract
is a product made from the cartilage of the common dogfish
shark. There are several diseases which can affect the
Comments:
Formulation
Procedure
Compaction Force: 9.1 kN / 18.4 KN / 22 KN
Hardness: 2.5 kp / 7.3 kp / 9.7 kp
Friability: 0.26 %
Disintegration Time: 15 min
Extract of Cartilage 186.9 186.9 35.6
Ascorbic Acid Crystalline 43.5 8.3

ARBOCEL P290 (Powdered Cellulose) 5.25 1.0
Talcum 9.45 1.8
(Sodium Stearyl Fumarate) 2.6 0.5 PRUV

Blending:
Equipment:
cartilage, for example arthritis. It was possible to develop a
simple formulation with PROSOLV SMCC in direct com-

pression.
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Extract of Cartilage, ascorbic acid, and EMCOMPRESS were blended for 15 minutes. ARBOCEL P 290,
talcum and VIVASOL were added and blended for another 10 minutes. After that PRUV was added and mixed for 3 minutes.
PROSOLV SMCC 90
Page 1/1
# 4282-008
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Ginkgo Biloba
Direct Compression
Key Words: Sticky Active, Direct Compression

JRS Products: PROSOLV SMCC 90, EMCOSOY ,
PRUV
FORMULATION
HANDBOOK
Ginkgo Biloba extract is a poorly flowing, poorly compressible
herbal extract used as a short-term memory enhancing
natural herbal remedy. It can be directly compressed using
PROSOLV SMCC 90 due to its enhanced flow, compaction,

Comments:
Formulation
Procedure
Tablet Mass: 130 mg
Hardness: 19.65 kp

Add Ginkgo Biloba extract and PROSOLV SMCC 90 to the blender and mix for 10 minutes. Add EMCOSOY and talcum to the
blender and blend for 10 minutes. Add PRUV to the blender and mix for additional five minutes.
Ginkgo Biloba Extract 60.0 60.0 46.2
EMCOSOY (Soy Polysaccharides) 6.0 4.6

Talcum 3.0 2.3

Blending:
Blender: Patterson-Kelly 2 qt. twin-shell V-blender
Equipment:
and excellent active loading properties. Tablet disintegration
is achieved using EMCOSOY , a naturally derived soy poly-

saccharide disintegrant.
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Page 1/1
# 4282-009
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Glucosamine
Direct Compression
Key Words: Very Hygroscopic, Sticky,
Direct Compression

JRS Products: PROSOLV SMCC 90
FORMULATION
HANDBOOK
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Page 1/1
# 4282-010
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Glucosamine sulfate is a very hygroscopic and sticky sub-
stance. This amino sugar is found naturally in the human
body and it is believed to play a role in cartilage formation and
repair.
Comments:
Formulation
Procedure
Hardness: 7.8 kp
The glucosamine sulfate and the 90 were blended to homogeneity for 15 minutes. Then magnesium
stearate was added and mixed for another 3 minutes. The powder mix was ready for direct compression.
PROSOLV SMCC
Active Content (mg) mg/Tablet Contribution (%)
Glucosamine Sulfate 250.0 250.0 65.0

Blending:
Equipment:
The glucosamine is extracted from animal tissue (carb,
lobster or shrimp shells) and is promoted as a treatment of
arthritis. It was possible to develop a simple formulation with
PROSOLV SMCC in direct compression.

Glucosamine-Chondroitin
Direct Compression
Key Words: Glucosamine HCl, Chondroitin Sulfate,
High Dosage, Direct Compression

JRS Products: PROSOLV SMCC 50, PRUV
FORMULATION
HANDBOOK
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Page 1/1
# 4282-035
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Formulation
Glucosamine HCl 1000 1000.0 58.8
Chondroitin Sulfate 400 400.0 23.5

Total 1700.0 100
Tablet Diameter: 16 mm oblong
Hardness: 7.0 kp
Disintegration 5-6 min
Friability 3.5 %
Procedure
The glucosamine HCl, the chondroitin sulfate and the were blended with V-blender for 20 minutes.
The was added and the powder was mixed for another 3 min. Ready for direct compression.
PROSOLV SMCC 5o
PRUV
Blending:
Tablet Press: Kilian Pressima, 16 mm oblong punch
Equipment:
Glucosamine is the name of an Amino-glucopyranose, which
differs from glucose only by the aminogroup at the C2. It is
part of the hyaluronic acid, which is a component of cartilage
and synovial fluid. Chondroitin sulfate is a glucosamino-
glycan, composed of a chain of alternating sugars. The
chondroitin sulfate shows sulfategroups at C4 and C6 of the
galactosamine.
The combination glucosamine + chondroitin is a very
common food addtive for treatment of osteoarthritis. The
problem in formulation work is the high dosage of both
actives.
Guafenesin
Direct Compression
Key Words: Sticky Active, High Dosage,
Direct Compression

JRS Products: PROSOLV SMCC HD 90
FORMULATION
HANDBOOK
Guafenesin is a flocculated, low melting point expectorant. It
is poorly flowing and poorly compressible and is typically granu-
lated prior to solid dosage form manufacture.
PROSOLV SMCC HD 90 delivered a directly compressible,

Comments:
Formulation
Procedure
Tablet Mass: 500 mg
Hardness: 12 kp
PROSOLV SMCC HD 90 a
V-blender. Guafenesin was sieved through a twenty sieve and transferred into the V-blender. The powders were blended for five
minutes.
nd talcum were dispensed to the correct masses and transferred to a Patterson-Kelly twin-shell
Guafenesin 200.0 200.0 40.0
PROSOLV SMCC HD 90 (Silicified Microcrystalline Cellulose) 295.0 59.0

Talcum 5.0 1.0
Blending:
Blender: Patterson-Kelly twin-shell V-blender
Tablet Press: Riva Piccola instrumented rotary tablet press
Hardness Tester: Key HT-500
Disintegration Tester: GlobePharma ED-2L
Friability Tester: GlobePharma FT-400
Equipment:
disintegrating tablet with excellent formulation and tableting
characteristics. By comparison, PROSOLV SMCC HD 90

provided harder, smaller tablets at lower compaction forces
than comparable high density microcrystalline cellulose
formulations.
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Page 1/2
# 4282-011
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
FORMULATION
HANDBOOK
Diagram 1:
Tablet Weight Variation as a Function of Die Table Tangential
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Diagram 2:
Tablet Hardness as a Function of Compaction Force
200 mg Guafenesin Tablet Formulation Compaction Profiles
High density
Microcrystalline
Cellulose formulation
PROSOLV SMCC HD 90
formulation
280
240
200
160
120
80
40
0
0 2 4 6 8 10 12 14 16 18 20
Compression Force (kN)
B
r
e
a
k
i
n
g

F
o
r
c
e

(
N
)
295 mg of PROSOLV SMCC HD 90 / Tablet

295 mg of MCC PH-302 / Tablet
295 mg of MCC 102 / Tablet
8
7
6
5
4
3
2
1
0
167 215 322 386 558 644 703
Tangential Velocity, mm/sec
T
a
b
l
e
t

W
e
i
g
h
t

V
a
r
i
a
t
i
o
n
,

PROSOLV HD 90 Formulation SMCC

MCC 102 Formulation
Guafenesin
Direct Compression
Key Words: Sticky Active, High Dosage
Direct Compression

JRS Products: PROSOLV SMCC HD 90
Page 2/2
# 4282-011
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Ibuprofen
Direct Compression
Direct Compression

FORMULATION
HANDBOOK
Ibuprofen is a poorly flowing, poorly compacting, low melting
point, waxy API used to relieve minor pain, tenderness and
inflammation. Ibuprofen belongs to the group Non-Steroidal
Anti-Inflammatory Drug (NSAIDs).
Comments:
Formulation
Procedure
Hardness: 83.6 N

Ibuprofen, VIVAPUR 102 and VIVASTAR P were blended to homogeneity for 15 minutes. Then a sieved mixture of
magnesium stearate and Aerosil were added and mixed for another 5 minutes. The powder mix is ready for direct
compression.
Blending:
Ibuprofen can be directly compressed using VIVAPUR
Microcrystalline Cellulose as a binder and VIVASTAR P

Sodium Starch Glycolate as a disintegrant.
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Ibuprofen 200.7 200.7 47.5


Page 1/2
# 4282-012
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Dissolution Medium: 900 ml buffer pH 7.4, 37C, n=6
Samples are taken after 5, 10, 20, 30, 45 and 60 minutes. The sample volume is 3 ml. The determination of the active
ingredient is done by an UV-spectrophotometer at = 222 nm (diluted 1:9).
Dissolution Test:
Diagram 1:
Typical Dissolution Profile Diagram of a Ibuprofen 200 mg Tablet, Produced According to the Above Given Formulation.
FORMULATION
HANDBOOK
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120
110
100
90
80
70
60
50
40
30
20
10
0
5
Time (min)
D
i
s
s
o
l
v
e
d

A
c
t
i
v
e

I
n
g
r
e
d
i
e
n
t

(
%
)
0 15 10 30 45 60
Ibuprofen
Direct Compression
Direct Compression

Page 2/2
# 4282-012
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Tablet Press: Korsch EK 0 eccentric press, 7 mm punch, biplane
Equipment:
FORMULATION
HANDBOOK
inflammation. PROSOLV SMCC 90, due to its excellent rheo-

logical properties and high inherent compactibility, provided a
Formulation
Procedure
Tablet Mass: 360 mg
Hardness: 4.8 kp
Friability: 0.47 %
Each ingredient, excluding the lubricant, was dispensed to the correct mass and transferred to the V-blender and mixed for 10

minutes. PRUV was dispensed to the correct mass, transferred to the V-blender and mixed for additional fiveminutes.
Ibuprofen 200.0 200.0 55.5
EXPLOTAB (Sodium Starch Glycolate) 6.0 1.6

Talcum 4.0 1.1

Blending:
Blender: Twin-shell V-blender
Flowability: Ph. Eur. Method 2.9.16
Tablet Press: Korsch instrumented tablet press
Equipment:
directly compressible tablet with improved mechanical cha-
racteristics, where other conventional tableting ingredients
failed in direct compression applications.
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Ibuprofen
Direct Compression
Direct Compression

JRS Products: PROSOLV SMCC 90, EXPLOTAB ,
PRUV
Page 1/1
# 4282-013
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Ibuprofen
Wet Granulation
Wet Granulation

JRS Products: PROSOLV SMCC 50, EXPLOTAB ,
PRUV
FORMULATION
HANDBOOK
inflammation. PROSOLV SMCC 50, due to its excellent high

Formulation
Procedure
Tablet Mass: 259.5 mg
Hardness: 12.2 kp

Ibuprofen, PROSOLV SMCC 50, EXPLOTAB , and PVP were dispensed to the correct mass, screened, and transferred to the
high shear mixer-granulator. The impeller and chopper were energized and the water added slowly to the powder bed. The
granulation continued for several minutes beyond the water addition to ensure uniform granulation.
The final granulation was passed through a 16 mesh screen and transferred into trays for drying in a convection oven at 60C.
The dried granulation was transferred to a twin-shell V-blender. PRUV was dispensed to the correct mass, transferred to the
blender and mixed for five minutes.
Ibuprofen 220.0 220.0 84.8 (60.59 %)
PROSOLV SMCC 50 (Silicified Microcrystalline Cellulose) 32.4 12.5 (8.91 %)

Polyvinylpirrolidone (PVP K-30) 2.6 1.0 (0.71 %)
EXPLOTAB (Sodium Starch Glycolate) 3.9 1.5 (1.07 %)
PRUV (Sodium Stearyl Fumarate) 0.5 0.2 (0.14 %)

DI Water (104.0) (28.57 %)
Blending:
High Shear Granulator: Bakker-Perkins 10 L mixer-granulator
Blender: Twin-shell V-blender
Tablet Press: Korsch instrumented tablet press
Equipment:
inherent compactibility after wet granulation, provided a
tablet formulation with improved mechanical characteristics.
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Page 1/1
# 4282-014
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Lecithin
Direct Compression
Key Words: Lecithin, Direct Compression, Fatty
Active
JRS Products: EMDEX

FORMULATION
HANDBOOK
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Page 1
# 4282-031
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Lecithin is mostly a mixture of glycolipids, triglycerides, and
phospholipids (e.g. phosphatidylcholine, phosphatidy-
lethanolamine, and phosphatidylinositol). However, in
biochemistry, lecithin is usually used as a synonym for pure
phosphatidylcholine, a phospholipid which is the major
component of a phosphatide fraction which may be isolated
Comments:
from either egg yolk or soy beans from which it is
mechanically or chemically extracted using hexane. Lecithin
is found in every cell or organ in the body. It is also necessary
to every cell and organ. Lecithin has been found to reduce
cholesterol levels in the blood. It helps dissolve the plaques
already laid down in the arteries.
Formulation
(Dextrates)
Lecithin 220.0 27.50
EMDEX 580.0 72.50
Total 800.0 100
Tablet High 5 mm
Hardness: 7.8 kp
Procedure
The lecithin and the EMDEX were blended for 20 minutes.The

mixture is ready for direct compression.
Liu'wei'di'huang TCM
Fluid Bed Drying and
Direct Compression
Key Words: Herbal Extract, Traditional Chinese
Medicine, Fluid Bed Drying

JRS Products: PROSOLV SMCC 90, VIVAPUR 102,
VIVASOL
FORMULATION
HANDBOOK
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Page 1/2
# 4282-027
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
The Liu'wei'di'huang is a very popular mixture of herbal
materials used in the Traditional Chinese Medicine ( TCM ). In a
conventional tablet production process of Liu'wei'di'huang
extract, two drying steps are necessary: The drying of the fluid
The Liu'wei'di'huang herbal raw material:
Liu'wei'di'huang fluid extract 2.143 mg *
PROSOLV SMCC 90 (Silicified Microcrystalline Cellulose) 300 mg
VIVASOL ( ) 150 mg
VIVAPUR 102 (Microcrystalline Cellulose) 285 mg

Magnesiumstearate 15 mg
Total weight (after drying ) 1.500 mg
Croscarmellose Sodium
herbal extract and the drying of the wetted mass after
granulation. This formulation combines drying and
granulating of the extract.
Radix Rehmanniae 32 %
Cornus officinalis 16 %
Dioscorea villosa 16 %
Rhizoma alismatis 12 %
Poria sclerotum 12 %
Paeonia suffructicosa 12 %
The herbal raw material is extracted by an ethanol/water
system.
The indication of Liu'wei'di'huang mixture is improving blood
circulation, removing blood stasis and relieving pain.
The dried extract is very sticky, hygroscopic and shows a poor
flowability. So, Liu'wei'di'huang normally is offered as a liquid,
only very few solid forms are available.
* The content of dry substance in the fluid extract is about 35%.
Formulation:
Comments:
FORMULATION
HANDBOOK
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Liu'wei'di'huang TCM
Fluid Bed Drying and
Direct Compression
Key Words: Herbal Extract, Traditional Chinese
Medicine, Fluid Bed Drying

JRS Products: PROSOLV SMCC 90, VIVAPUR 102,
VIVASOL
Page 2/2
# 4282-027
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Procedure
Equipment:
High Shear blender SHL-3,
Fluid bed dryer FGL-01,
Blender HSJ-5,
Tablet press ZP-8
all from Shanghai Meiyang
The initial fluid herbal extract is blended with PROSOLV SMCC 90,
VIVASOL and dried in a fluid bed dryer. The dried powder could
be used for direct compression.
Adjustments of the fluid bed dryer:
Inlet air temperature 60C
Product temperature 28 - 30C
Atomizing pressure 2,0 bar
Air flow 80 - 100 m/h
To the dried powder VIVAPUR 102 is added and mixed for

10 minutes. After adding the magnesiumstearate, another
3 minutes mixing time is essential. The mix is ready for Direct
Compression.
Properties of the powder:
Bulk density 0,42 g/ml
Angle of repose 40
Properties of the tablets:
Tablet weight 1.500 mg
Tablet size 16 mm
Compression force 21,6 kN
Hardness 17,2 kp
Friability 0,09 %
Disintegration time 37 sec
Hardness : Schleuniger Tablet Tester 6D
Disintegration : Pharmatest Standard PTZ
Friability : Pharmatest type PTF
Metformin
Direct Compression
Direct Compression

JRS Products: PROSOLV SMCC 90, VIVASOL ,
PRUV
FORMULATION
HANDBOOK
Metformin is a very popular pharmaceutical active ingredient.
Because of the high dosages of this active, metformin nor-
mally is wet granulated. This formulation is for direct com-
pression with PROSOLV SMCC .

Formulation
Procedure
Powder Mix:
Angle of Repose: 37
Bulk Density: 0.59 g/ml
Tablet:
Hardness: 5.2 - 5.5 kp
Metformin, 90 and were blended to homogeneity. Then was added and mixed for
another 3 minutes. The powder-mix was ready for direct compression.

PROSOLV SMCC VIVASOL PRUV
Metformin (Biesterfeld) 850.0 850.0 70.8

Blending:
Equipment:
Metformin is used to regulate blood glucose (sugar) levels. It
is mainly to treat non-insulin-dependent diabetes mellitus
(Type II diabetes).
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Page 1/2
# 4282-015
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
FORMULATION
HANDBOOK
4
2
8
2
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0
1
5
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G
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0
0
7
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Diagram 1:
Typical Compression Diagram of a Metformin Tablet, Produced According to the Above Given Formulation.
Diagram 2:
Typical Dissolution Profile Diagram of a Metformin Tablet, Produced According to the Above Given Formulation.
9
8
7
6
5
4
3
2
1
0
10 15 20 25 30
Compression Force (kN)
T
a
b
l
e
t

H
a
r
d
n
e
s
s

(
k
p
)

Metformin Biesterfeld
120
100
80
60
40
20
0
0 10 20 30 40 50 60 70
Time (min)
%

R
e
l
e
a
s
e
d
Metformin Biesterfeld
Metformin
Direct Compression
Direct Compression

JRS Products: PROSOLV SMCC 90, VIVASOL ,
PRUV
Page 2/2
# 4282-015
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Metformin 500 mg
Direct Compression
Key Words: High Dosage, Poor Flowing Active,
Hygroscopic Active, Direct Compression

JRS Products: VIVAPUR 12, VIVASOL , PRUV
FORMULATION
HANDBOOK
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Page 1/2
# 4282-026
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Metformin is used to regulate blood glucose levels, mainly to
treat non-insulin-dependent diabetes mellitus (Type II diabetes).
This formulation is an example for a crystalline active
Formulation
Procedure
Compression Force: 24 kN
Hardness: 9.9 kp
Friability: 4.0 %
Disintegration Time (in 200 ml water): 28 sec
Mixing of all ingredients (5 min), compressing at a compaction force of approx. 24 kN
Blending:
Equipment:
ingredient used in high concentration. Normally, the dosage
is 850 mg, but for better patient compliance, tablets with 500
mg are very common.

Metformin Hydrochloride 500.0 55.6
VIVASOL P (Croscarmellose Sodium) 18.0 2.0

Comments:
FORMULATION
HANDBOOK
4
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7
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Metformin 500 mg
Direct Compression
Key Words: High Dosage, Poor Flowing Active,
Hygroscopic Active, Direct Compression

JRS Products: VIVAPUR 12, VIVASOL , PRUV
Page 2/2
# 4282-026
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Samples were taken after 1, 3, 5, 10, 20 and 30 minutes.
The determination of the active ingredient was done by an U.V. spektrophotometer at Lambda =233 nm.
Dissolution Test:
120
110
100
90
80
70
60
50
40
30
20
10
0
0 5 10 15 20 25 30 35
Time (min)
D
i
s
s
o
l
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d

A
c
t
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v
e

I
n
g
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d
i
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n
t

(
%
)
FORMULATION
HANDBOOK
Metoprolol tartrate is an example for a highly soluble active
used in medium concentrations.
Metoprolol is a selective b-adrenoreceptor blocking agent to
1
treat hypertension and to prevent angina pectoris.
Formulation
Procedure
Hardness: 81.9 N
Metoprolol tartrate, , and were mixed in a urbula mixer for 15 minutes. Then a
sieved mixture of agnesium tearate and w added and mixed for another 3 minutes. The powder mix w ready
for irect ompression.

EMCOMPRESS VIVAPUR 12 VIVASTAR P t

m s Aerosil as as
d c
Metoprolol Tartrate 50.88 50.88 27.5


Blending:
It can be directly compressed using VIVAPUR Microcrysta-
lline Cellulose and EMCOMPRESS Calcium Hydrogen Phos-

pate as a combination of binders.
4
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Equipment:
Metoprolol
Direct Compression
Key Words: Highly Soluble, Medium Concentration,
Direct Compression

JRS Products: VIVAPUR 12, VIVASTAR P,
EMCOMPRESS
Page 1/2
# 4282-016
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
FORMULATION
HANDBOOK
4
2
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2
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6
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0
0
7
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Metoprolol
Direct Compression
Direct Compression

JRS Products: VIVAPUR 12, VIVASTAR P,
EMCOMPRESS
Samples are taken after 5, 10, 20, 30, 45 and 60 minutes. The sample volume is 3 ml. Samples were diluted if necessa-
ry. The determination of the active ingredient is done by an UV-spectrophotometer at = 222 nm.
Dissolution Test:
120
100
90
80
70
60
50
40
30
20
10
0
0 5 10 15 20 25 30 35 40 45 50 55 60 65
Time (min)
D
i
s
s
o
l
v
e
d

A
c
t
i
v
e

I
n
g
r
e
d
i
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n
t

(
%
)
Diagram 1:
Typical Dissolution Profile Diagram of a Metoprolol Tartrate Tablet, Produced According to the Above Given Formulation.
Page 2/2
# 4282-016
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Metoprolol
Direct Compression
Direct Compression

JRS Products: VIVAPUR 12, ARBOCEL P 290,
VIVASOL
FORMULATION
HANDBOOK
Metoprolol is an example for a highly soluble active used in
medium concentrations. It can be compressed directly by using
VIVAPUR Microcrystalline Cellulose as a dry binder and

Formulation
Procedure
Hardness: 66.0 N
Friability: <0.10 %
All ingredients except magnesium stearate were mixed for 10 minutes. Magnesium stearate was added and was blended
for another 3 minutes.
Metoprolol tartrate 50.0 50.0 33.3
ARBOCEL P 290 (Powdered Cellulose) 38.2 25.5
VIVASOL (Croscaramellose Sodium) 3.00 2.0


Blending:
ARBOCEL Powdered Cellulose as a plant-derived filler.

Metoprolol is a selective b-adrenoreceptor blocking agent to
1
treat hypertension and to prevent angina pectoris.
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Tablet Press: Korsch EK 0 eccentric press, 8 mm punch,biplane
Equipment:
Page 1/2
# 4282-017
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
FORMULATION
HANDBOOK
4
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Samples are taken after 1, 5, 10, 15, 20, 30, 45, 60, 75 and 90 minutes. The sample volume is 3 ml. Samples were
diluted if necessary. The determination of the active ingredient is done by an UV-spectrophotometer at = 215 nm.
Dissolution Test:
120
110
100
90
80
70
60
50
40
30
20
10
0
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90
Time (min)
D
i
s
s
o
l
v
e
d

A
c
t
i
v
e

I
n
g
r
e
d
i
e
n
t

(
%
)
Diagram 1:
Typical Dissolution Profile Diagram of a Metoprolol Tartrate Tablet, Produced According to the Above Given Formulation.
Metoprolol
Direct Compression
Direct Compression

VIVASOL
Page 2/2
# 4282-017
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Multivitamin
Chewable Tablets
Key Words: Vitamins, Direct Compression

FORMULATION
HANDBOOK
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Page 1
# 4282-032
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Vitamins are nutrients required in tiny amounts for essential
metabolic reactions in the body. They are bio-molecules that
act both as catalysts and substrates in chemical reactions.
Vitamins also act as coenzymes to carry chemical groups
Comments:
between enzymes and are essential for the normal growth
and development of a multicellular organism. Because
humans do not store most vitamins in their bodies, a human
must consume them regularly to avoid deficiency.
Formulation
(Dextrates)

Multivitamin Mix* 40.0 5.0
EMDEX 630.4 78.8
Gummi Arabicum 80.0 10.0
Xylitol 40.0 5.0
Orange-Lemon Flavour 5.6 0.7
4.0 0.5
Total 800.0 100.0
Tablet Diameter: 17 x 8 mm
Compaction Force: 7.0-8.4 kN
Hardness: 9-11 kp
Procedure
All substances except PRUV were blended for 18 minutes. The
PRUV was added and the powder was mixed for another 3 min.
Ready for direct compression.
*Ready mixture from Sternvitamin GmbH. 160 mg contain 100 % RDA vitamins.
Each tablet contains 25 % RDA vitamins: Vitamin C, Vitamin E, Vitamine B1 (thiamin), Vitamin B2 (riboflavin), Vitamin B6
(pyridoxin), Vitamine B12, Folic acid, Panthotenic acid, Niacin, Biotin, Vitamin A (retinol).
Multivitamin
Effervescent Tablet
Key Words: Vitamins, Direct Compression
Effervescent Tablet

JRS Products: EMDEX , PURV
FORMULATION
HANDBOOK
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Page 1
# 4282-039
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Formulation
(Dextrates)

Multivitamin Mix* 160.9 4.2
EMDEX 2162.1 68.2
Sodium Hydrogencarbonate 490.2 12.8
Aspartame 76.6 2.0
Flavour 34.5 0.9
11.5 0.3
Total 3830.0 100.0
Hardness: 10.0 kp
Procedure
All substances except PRUV were blended for 18 minutes. The
PRUV was added and the powder was mixed for another 3 min.
Ready for direct compression.
*100 % RDA
Each tablet contains the following vitamins: Vitamin C, Vitamin E, Vitamine B1 (thiamin), Vitamin B2 (riboflavin), Vitamin B6
(pyridoxin), Vitamine B12, Folic Acid, Panthotenic Acid, Niacin, Biotin, Vitamin A (retinol).
Vitamins are nutrients required in tiny amounts for essential
metabolic reactions in the body. They are bio-molecules that
act both as catalysts and substrates in chemical reactions.
Vitamins also act as coenzymes to carry chemical groups
between enzymes and are essential for the normal growth
and development of a multicellular organism. Because
humans do not store most vitamins in their bodies, a human
must consume them regularly to avoid deficiency.
FORMULATION
HANDBOOK
Cassia Senna and Melissa Officinalis are poorly flowing, poorly
compressible herbal extracts used as natural laxative herbal
remedy. It can be directly compressed easily in PROSOLV SMCC

Formulation
Procedure
Tablet Mass: 200 mg
Flow (Bridging Aperture): 14 mm
Hardness: 7.2 kp
Blend the Senna extract and Melissa Officinalis extract together for 10 minutes. Add PROSOLV SMCC 90 and blend for 10
minutes. Add EMCOSOY to the blender and blend for another 10 minutes. Next add talcum to the blend and blend for five

more minutes. Finally, add PRUV to the blend and blend for additional five minutes.
Senna Extract 75.0 75.0 37.5
Melissa Leaf Extract 50.0 50.0 25.0
EMCOSOY (Soy Polysaccharides) 8.0 4.0

Talcum 6.0 3.0

Blending:
Blender: Patterson-Kelly 2 qt. Twin-shell V-blender

Equipment:
due to its enhanced flow and compaction properties. Tablet

disintegration is achieved using EMCOSOY , naturally derived
soy polysaccharide.
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Cassia Senna &
Melissa Officinalis
Direct Compression
Key Words: Sticky Actives, Medium Concentration,
Direct Compression


PRUV
Page 1/2
# 4282-018
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Cassia Senna &
Melissa Officinalis
Direct Compression
Key Words: Sticky Actives, Medium Concentration,
Direct Compression


PRUV
FORMULATION
HANDBOOK
Diagram 1:
Tablet Hardness as a Function of Compaction Force
8
7
6
5
4
3
2
1
0
0 3 6 9 12 15 18
Compaction Force (kN)
T
a
b
l
e
t

H
a
r
d
n
e
s
s

(
k
p
)
4
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7
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Page 2/2
# 4282-018
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Paracetamol 500 mg
Effervescent Tablet
Direct Compression
Key Words: Paracetamol, Effervescent Tablet,
Direct Compression

FORMULATION
HANDBOOK
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Page 1/2
# 4282-038
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Paracetamol (Acetaminophen) is hailed as the best and safest
painkiller ever developed. Doctors feel so confident about the
effectiveness and safety of the drug, that it is not only
prescribed for all aches and pains, acute as well as chronic,
Procedure
Compression Force 23 kN
Hardness 8.0 kp
Diameter 25 mm
Disintegration Time 133 sec.
All ingredients except were blended for 15 minutes. The was added and the tabletting powder was mixed for

PRUV PRUV
Blending:
Equipment:
but that it is also made available to the public as an over the
counter drug. Despite its low water solubility, it is possible to
prepare an effervescent formulation using EMDEX as a filler

and binder.
Tablet Diameter: 25 mm, biplane,
Comments:
Formulation
Paracetamol 500.0 12.5
EMDEX (Dextrate) 2500.0 62.5

NaHCO 400.0 10.0
3
Glycine HCl 128.0 3.2
Aspartame 76.0 1.9
Flavour 36.0 0.9

Total 4000.0 100.0
Dissolutuion Medium: 900 ml 0.1 N HCl, 37 C, n=6
Samples are taken after 5, 10, 15, 30, 60, 120, 180 and 300 minutes. The sample volume is 3 ml. The probes were
diluted if necessary. The determination of the paracetamol was done by an UV-spectrophotometer at = 245.3 nm.
Dissolution Test:
Diagram 1:
Dissolution Profile of Paracetamol Effervescent Tablet, Produced According to the Above Given Formulation.
4
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JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Page 2/2
Paracetamol 500 mg
Effervescent Tablet
Direct Compression
Key Words: Paracetamol, Effervescent Tablet,
Direct Compression

FORMULATION
HANDBOOK # 4282-038
Time (min)
120
110
100
90
80
70
60
50
40
30
20
10
0
D
i
s
s
o
l
v
e
d

A
c
t
i
v
e

(
%
)
0 320 300 20 40 60 80 100 120 140 160 180 200 220 240 260 280
FORMULATION
HANDBOOK
In low dosages, peppermint oil is used a breath refreshener
without therapeutic effects. In higher dosages it helps against
pain, especially stomach pain.
Peppermint oil has a high menthol content. The porosity of
Formulation
Procedure
Tablet Mass: 200 mg
Diameter: 8 mm
Hardness: 7.2 N
The peppermint oil was dispersed onto the EMDEX and blended for about 15 minutes. Then the Sorbitol was added and
mixed for about 10 minutes. As the last step the PRUV was filled in and mixed for 3 minutes.
Peppermint oil (Casar & Loretz G 474-1) 6.58 6.58 3.29
EMDEX (Dextrates) 183.70 91.88

Sorbitol (Neosorb) 7.90 3.99

Blending:
EMDEX binds the oil and keeps it into the tablet.The following
formulation is a tablet for breath refreshment, there is no
therapeutic effect. The tablets can be used as a gift for
customers or demonstration tablets at an exhibition.
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Peppermint Oil
Direct Compression
Key Words: Chewable tablet, essential oil, low
dosage, pleasing product

Page 1
# 4282-037
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
The taste depends mainly of the quality of the peppermint oil. Variations in the dosage of peppermint oil are possible.
Moreover, a dosage of about 0,15 % of Vanillin gives a little softer taste.
Taste:
Tablet Press: Korsch EK 0.8 mm punch
Equipment:
FORMULATION
HANDBOOK
Piroxicam is an example for a very poorly soluble active sub-
stance used in low concentrations.
Piroxicam is in a class of drugs called Nonsteroidal Anti-
Inflammatory Drugs (NSAIDs). It acts as non-selective inhibitor
of the enzyme cyclooxygenase, inhibiting both COX-1 and COX-2.
Formulation
Procedure
Hardness: 58.0 N
Friability: <0.1 %

Piroxicam, VIVAPUR 101 and ARBOCEL P 290 were granulated with an ethanol solution of Kollidon 25. The mass was
dried and sieved through a 100 m sieve.

For the outer phase VIVASOL , Aerosil and magnesium stearate were added and mixed for 5 minutes. The mixture was
compressed at a compaction force of approx. 17.5 kN.
Piroxicam 10.0 10.00 6.7
ARBOCEL P 290 (Powdered Cellulose) 51.20 34.1
Polyviniylpyrrolidon (Kollidon 25) 7.50 5.0


Blending:
It is used to reduce pain, inflammation and stiffness caused
by rheumatoid arthritis and osteoarthritis.
Tablets can be produced by wet granulation using VIVAPUR
101 as a binder and ARBOCEL P 290 as a filler.

4
2
8
2
_
0
1
9
.
G
B
0
.
0
0
7
0
9
p
d
f
Blending:
Piroxicam
Wet Granulation
Key Words: Very Poorly Soluble, Low Dosage,
Wet Granulation

VIVASOL
Page 1/2
# 4282-019
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
FORMULATION
HANDBOOK
Samples are taken after 5, 10, 15, 20, 30, 45, 60, 75 and 90 minutes. The sample volume is 3 ml. Samples were dilu-
ted if necessary. The determination of the active ingredient is done by an UV-spectrophotometer at = 334.7 nm.
Dissolution Test:
Diagram 1:
Typical Dissolution Profile Diagram of a Piroxicam Tablet, Produced According to the Above Given Formulation.
Equipment:
Piroxicam
Wet Granulation
Key Words: Very Poorly Soluble, Low Dosage,
Wet Granulation

VIVASOL
120
110
100
90
80
70
60
50
40
30
20
10
0
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90
Time (min)
D
i
s
s
o
l
v
e
d

A
c
t
i
v
e

I
n
g
r
e
d
i
e
n
t

(
%
)
4
2
8
2
_
0
1
9
.
G
B
0
.
0
0
7
0
9
p
d
f
Page 2/2
# 4282-019
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Ranitidine HCl
Direct Compression

FORMULATION
HANDBOOK
Formulation for Direct Compression with an active content of
more than 50 % of the tablet mass can be developed by

using VIVAPUR 102 in order to get a good hardness and

VIVASTAR P for a short disintegration time.
The following study gives an example and shows the
dissolution results of the active ingredient.
Formulation
Procedure
Hardness: 106.5 N
Friability: 0.9 %

Ranitidine HCl, VIVAPUR 102 and VIVASTAR P were blended to homogeneity for 15 minutes. Then a sieved mixture of
magnesium stearate and Aerosil were added and mixed for another 5 minutes. The powder mix is ready for direct
compression.
Ranitidine HCl 167.4 167.4 69.75
VIVAPUR 102 (Microcrystalline Cellulose) 60.0 25


Blending:
Ranitidine Hcl is a histamine receptor antagonist which de-
creases the amount of acid the stomach produces. It is used
to treat and prevent ulcers in the stomach and intestines.
Ranitidine is also used to treat conditions which the stomach
produces too much acid and conditions in which acid comes
up into the esophagus and causes heartburn.
4
2
8
2
_
0
2
0
.
G
B
0
.
0
0
7
0
9
p
d
f
Page 1/2
# 4282-020
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Samples are taken after 5, 10, 20, and 30 minutes. The sample volume is 3 ml.
The determination of the active ingredient is done by an UV-spectrophotometer at = 313 nm.
Dissolution Test:
Diagram 1:
Typical Dissolution Profile Diagram of a Ranitidine Tablet, Produced According to the Above Given Formulation.
FORMULATION
HANDBOOK
4
2
8
2
_
0
2
0
.
G
B
0
.
0
0
7
0
9
p
d
f
120
110
100
90
80
70
60
50
40
30
20
10
0
5
Time (min)
D
i
s
s
o
l
v
e
d

A
c
t
i
v
e

I
n
g
r
e
d
i
e
n
t

(
%
)
0 15 20 10 25 30
Ranitidine HCl
Direct Compression

Page 2/2
# 4282-020
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Equipment:
Silymarin
Direct Compression
Key Words: Silymarin, Poor Flowing Active,
Low Dosage, Direct Compression

JRS Products: PROSOLV SMCC 50, EXPLOTAB , PRUV
FORMULATION
HANDBOOK
Silymarin is a polyphenolic flavonoid derived from the milk
thistle (Silybum marianum) from the Asteraceae family.
Because of the high polyphenol content the extract acts as an
antioxidant and shows a higher potency than tocopherole. The
silymarin flavonoides prevents from liver destruction and
improves liver function. The mechanism of action is the
inhibitation of free radicals and leukotrienes.
The flowability of common silymarin extracts are poor. For
direct compression a flow improvement is necessary, which is
achieved by PROSOLV SMCC in the following formulation.

4
2
8
2
_
0
3
6
.
G
B
0
.
0
0
7
0
9
p
d
f
Page 1/1
# 4282-036
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Formulation
Silymarin 35 35.0 16.05
EXPLOTAB (Sodium Starch Glycolate) 3.0 1.38

Total 218.0 100
Hardness: 8.0 kp
Procedure
The Silymarin was blended for 15 min. with the from the . The other of the was mixed with the
EXPLOTAB for the same time. Finally the both mixtures were combined, the was added and the powder was mixed
for another 3 min. Ready for direct compression. The tablet has to be coated!

PROSOLV PROSOLV

PRUV
Blending:
Equipment:
Simethicone
Direct Compression
Key Words: Liquid Active, Poor Flowability,
Direct Compression, Chewable Tablets

JRS Products: EMDEX , EMCOMPRESS , PRUV
FORMULATION
HANDBOOK
Simethicone is an oral antifoaming agent used to reduce
bloating, discomfort and pain caused by excess gas in the
stomach or intestinal tract.
Formulation
Procedure
Hardness: 5.8 kp
Simethicone was dispersed in EMDEX and blended for 10 minutes. Then was added and blended again
for 5 minutes. After that PRUV Sodium Stearyl Fumarate was added and blended for another 3 minutes.
EMCOMPRESS
Simethicone 50.0 50.0 10.0
150.0 30.0

EMDEX (Dextrate)
PRUV
Blending:
Equipment:
It can be directly compressed using
EMDEX and EMCOM-

PRESS as binders. EMDEX is a water soluble binder for
chewable tablets.
4
2
8
2
_
0
2
1
.
G
B
0
.
0
0
7
0
9
p
d
f
Page 1/1
# 4282-021
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
Simethicone
Direct Compression
Key Words: Simethicone, Oily Active,
Direct Compression

FORMULATION
HANDBOOK
Simethicone is very popular anti-foaming and anti-bloating
agent. Its neutral taste make this API very suitable for
chewable parmaceutical formulations. We used this
Formulation
Procedure
Hardness: 7-8 kp

To the preliminary prepared simethicone mixture, EMDEX and PRUV were added in small portions until the formation of a
homogeneous, free flowing powder. The tablet mass was sieved and blended for 20 min. Ready for direct compression.
Simethicone Mix* 42.0 42.0 8.54
440.0 89.43

Total 492.0 100.00
EMDEX (Dextrate)
PRUV
Blending:
Equipment:
substance as a model active for the preparation of chewable
tablets with oily active on the base of (Dextrates).
EMDEX
4
2
8
2
_
0
4
5
.
G
B
0
.
0
0
7
0
9
p
d
f
Page 1/1
# 4282-045
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
Comments:
* The simethicone mixture: 150 g of Q7-9120 + 100 g of ANTIFOAM M Compound + 1 g Peppermint oil were mixed intensive;
the Dimethicone / Silicium ratio of the so prepared mixture is 97:3.
Vitamin C + Zink
Chewable Tablets
Key Words : Vitamin C, Zink, Direct Compression

FORMULATION
HANDBOOK
Zink (Zn) is essential trace element for the human organism.
Its deficiency can have marked effects on all components of
the immune system disturbing the body's vital defence forces.
The combination of Zn and vitamin C is widely used as an
Comments:
Formulation
Procedure

PRUV PRUV
Zink Lactate 5.0 18.6* 3.10
Ascorbic Acid 60.0 60.0 10.00
498.0 83.00
Aspartame 12.0 2.00
Lemomon / Orange Flavour 4.6 0.77
Riboflavine 0.8 0.13

Total 600.0 100.00
EMDEX (Dextrates)
Blending:
Equipment:
immune stimulator especially in the cold seasons. JRS
developed a chewable tablet containing a resorbable zink-
salt (zn-lactate) and ascorbic acid (vitamin C) using EMDEX
and PRUV as the only filler and binder in the formulation.

4
2
8
2
_
0
4
4
.
G
B
0
.
0
0
7
1
1
p
d
f
Tablet Hardness: 8-9 kp
Friability 0.51 %
Page 1/1
# 4282-044
JRS PHARMA LP
Customer Service:
Toll-Free: (800) 431-2457
Phone: +1 (845) 878-3414
Fax: +1 (845) 878-3484
www.jrspharma.com
Holzmhle 1
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
www.jrspharma.de
www.jrs.de
USA + CANADA
+1 (845) 878-3414
*Correspond to 5 mg of Zn.
Each tablet contains 100 % RDA vitamin C and Zink.

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Copyright:

Verfügbare Formate

A Guide for R+D

PROSOLV SMCC is the most significant innovation in high

PROSOLV SMCC is the high functionality ingredient that

ANHYDROUS EMCOMPRESS : In addition to excellent flow

A direct compressible, calcium containing filler. VIVAPRESS

excipients. EXPLOTAB corresponds to type A (Ph.Eur.),

VIVASTAR PSF is innovative in improving stability of certain

PRUV is a unique tablet lubricant that is more hydrophilic

VIVAPUR 102 (Microcrystalline Cellulose) 140.0 20.9

VIVASTAR P (Sodium Starch Glycolate) 23.4 3.5

Fumed Silica (Aerosil ) 3.3 0.5

the following formulation VIVAPUR 102 is used as filler and

binder, and VIVASTAR P as disintegrant.

PRUV (Sodium Stearyl Fumarate) 12.0 0.3

EMDEX (Dextrates) 2500.0 62.5

PROSOLV SMCC 90 (Silicified Microcrystalline Cellulose) 20.00 20.00 14.00 14.00

EMCOMPRESS (Calcium Hydrogen Phosphate) - - 1.00 -

EXPLOTAB (Sodium Starch Glycolate) - - 5.00 -

VIVASOL ( ) 1.00 2.00 2.00 1.00

PRUV (Sodium Stearyl Fumarate) 0.71 0.71 0.71 0.71

All ingredients except PRUV were blended for 15 minutes. The

Allopurinol can be directly compressed using VIVAPUR

Fumed Silica (Aerosil 200) 0.9 0.5

pressed directly by using VIVAPUR Microcrystalline Cellulose

as a dry binder and ARBOCEL Powdered Cellulose as a plant-

VIVAPUR 12 (Microcrystalline Cellulose) 69.30 46.2

ARBOCEL A 300 (Powdered Cellulose) 46.20 30.8

VIVASOL (Croscarmellose Sodium) 3.00 2.0

Fumed Silica (Aerosil 200) 0.75 0.5

Amoxicillin Trihydrate 574.0 58.6

VIVAPUR 102 (Microcrystalline Cellulose)

EXPLOTAB (Sodium Starch Glycolate)

PRUV (Sodium Stearyl Fumarate)

for 15 minutes. The PRUV was added and the tabletting

PROSOLV SMCC 5o (Silicified Microcrystalline Cellulose) 256.0 19.77

VIVASOL (Croscarmellose Sodium) 16.0 1.24

PRUV (Sodium Stearyl Fumarate) 23.0 1.77

PROSOLV SMCC HD 90 (Silicified Microcrystalline Cellulose) 200.0 49.75

PRUV (Sodium Stearyl Fumarate) 2.0 0.50

Using PROSOLV SMCC HD 90, Boswellia was formulated into

PROSOLV SMCC HD 90 not only provided the necessary bin-

VIVAPRESS (CaCO ) (Calcium Carbonate) 670 670 16.75

PROSOLV SMCC 50 (Silicified Microcrystalline Cellulose) 345.0 25.27

PRUV (Sodium Stearyl Fumarate) 20.0 1.47

direct compression formulation with PROSOLV as a binder

and PRUV as a lubricant.

PROSOLV SMCC 50 (Silicified Microcrystalline Cellulose) 15.0 9.95

PROSOLV SMCC 90 (Silicified Microcrystalline Cellulose) 135.0 89.58

PRUV (Sodium Stearyl Fumarate) 0.3 0.20

pressed using a combination of PROSOLV SMCC 50 and

PROSOLV SMCC 90.

to make tablets by direct compression using VIVAPUR 12 as

PRUV (Sodium Stearyl Fumarate)

JRS Products: VIVAPUR 12

VIVAPUR 12 (Microcrystalline Cellulose) 75.0 12.8

Fumed Silica (Aerosil 200) 5.0 0.8

VIVAPUR 12 (Microcrystalline Cellulose) 93.5 13.6

Fumed Silica (Aerosil 200) 4.0 0.6

JRS Products: VIVAPUR 12

PRUV (Sodium Stearyl Fumarate) 20 1.01

formulation with EMDEX as a binder and taste improver, and

PRUV (Sodium Stearyl Fumarate) 8.0 1.00

PRUV (Sodium Stearyl Fumarate)

The creatine mohohydrate and EMDEX were blended for 18