GRANULES  Oral Penicillin V Potassium

 Provides faster and higher blood levels than

 Prepared agglomerates of smaller particle size phenoxymethylpeniclllin
 Irregularly shaped and behaved as single
particle CGMP Requirement: Penicillin must be manufactured in
 Makes use of sieve #4-12 a separated area from non-penicillin

GRANULATION FORMULA:

 Pharmaceutical process which attempts to RAW MATERIAL AMOUNT

convert Phenoxymethylpenicillin 25.0 g
 powdered materials into aggregates called Potassium 25.0 g
Carboxymethylcellulose 12.5 g
 granules
Sucrose 1.0 g
TWO WAYS OF GRANULATION: Sodium Benzoate 5.0 g
Citric Acid 1.0 g
1. Granulating Machine or Granulator - Allows Strawberry Powder 1.0 g
granulation with or without moisture Lactose, qs ad 300.0 g
2. Wet Granulation - Involves wetting powder
mixture, sieving and drying in preparation of
granules MANUFACTURING PROCEDURES:

1. Mix the powders and blend for 15 minutes

Powder Mix Moist Mass
Dry Granules
ADVANTAGES OF GRANULES OVER POWDER:
 Faster to dissolve
 Physically and chemically stable
 Flow properties
 Seldom form a cake
ESSENTIAL ELEMENTS IN LABELING POWDER
GRANULES:
Wet Granules using trituration.
2. Prepare 20 mL colorant solution and spray onto
powder mixture with continuous trituration
Oven Drying until a moist mass is formed.
3. Pass the moist mass through sieve number 12
and receive wet granules in tray.
4. Over dry granules at a temperature not
exceeding 40 degrees.
5. Dry the granules not more than 2% moisture is
present. Check moisture content every 30
minutes.
6. Weigh and pack the dried granules.
SUSPENSIONS

 Directions for reconstitution  Liquid preparation containing undissolved finely

 Shelf-life of reconstitution
 Label-shake well before use
PHENOXYMETHYLPENICILLIN POTASSIUM
GRANULES FOR ORAL SUSPENSION
 Penicillin G - Benzylpenicillin
 Penicillin V - Phenoxymethylpenicllin
 Relatively stable In the presence of gastric
acidity, soluble in duodenal fluids, orally
effective without buffers
divided particles evenly distributed in a vehicle.
CHARACTERISTICS OF SUSPENSION:
 Pourable, settle slowly, redispersable,
chemically stable
REASONS OR ADVANTAGES OF SUSPENSION:
 Sustaining effect, stability, taste, basic solubility
 Availability
 Ready to use

Dry powder or granules for suspension in a liquid

vehicle (requires reconstitution)
COMPONENTS OF SUSPENSION: MANUFACTURING PROCEDURE:

 Active ingredient 1. Place magnesium hydroxideIn a blender

 Wetting agent 2. Add sorbitol
 Displaces the air from hydrophobic material 3. Add 100 ml purified water
 Allows liquid to surround the particles and 4. Blend the mixture for 5 minutes
provide proper dispersion 5. Add aluminum hydroxide gel. Blend for 5
 Surfactant in nature 0.05-0.5% minutes
 HLB value 7-9 6. Place CMC in a mortar and triturate with 50 ml
 Examples: Glycerin, sorbitol of water until a paste ls formed. Add the
 Flocculating agent CMCpaste is formed. Add the CMC paste to the
 Added if desired blender
 Low concentration of electrolytes (<1%) 7. In a separate container, heat 200 ml of water to
 NaCl & KCl –induce flocculation 5.ooc and dissolve saccharin sodium and
 Viscosity agent sodium benzoate. Cool the solution to 4ooc.
 Suspending agents or thickeners Charge blender and blend for 10 minutes.
 Natural - acacia, Tragacanth 8. Add peppermint oil
 Synthetic - derivatives of methylcellulose 9. Homogenize the suspension for 5 minutes
10. Add enough purified water to make the
FOR INTERNAL PREPARATIONS: required volume
Tragacanth and acacia – 1.25 % OINTMENTS
CMC – 2.5 %  Semisolid preparations Intended for external
Carbopol 934 –0.3 % application
 Easily applied
BUFFERS:  Absence of grittiness
 Drug has ionizable group to maintain low USES
solubility of drugs
 Preservative, tolerant, flavorant 1. Emollient
 Vehicle - water, glycerin, sorbitol  To make skin more pliable
 Smoothening effect
ALUMINUM HYDROXIDE SUSPENSION  Protective barrier
 Prevent harmful substances from coming
 Weak bases that react with gastric HC.L
into contact with skin
 Alkali adsorbent that neutralizes or counteracts
 Closure of wound
acidity
2. Vehicle
 Al(OH)3 + HCl = AlCl3 + H2O
 Active ingredient ls incorporated
FORMULA:  Ointment bases [non-medicated ointments]

RAW MATERIALS AMOUNT TYPES

Aluminum Hydroxide Gel 7.0%
1. Medicated ointments
Magnesium Hydroxide 3.0%
 Ointment base + active Ingredient
Carboxymethylcellulose 2.5%
Saccharin Sodium 0.1%  Has therapeutic activity
Peppermint oil 0.1% 2. Non-medicated ointments
Sodium Benzoate 0.1%  Vehicles use to carry drug
Sorbitol Solution 70% 20.0%  Ointment bases
Purified water, qs ad 100.0%
CLASSIFICATION OF OINTMENT BASES 2. Levigaton
 Uniformly disperse active ingredient
1. Oleaginous Bases
throughout the vehicle
 Non-water washable, Hydrophobic, greasy
3. Fusion method
used as emollient and/or occlusive
 Heating and melting the base
 Hydrocarbon bases
 Components with high melting points
 Solid- paraffinwax
 Active medicament readily soluble with the
 Semi-solid- Petrolatum / vasellna
melted base
blanca
 Liquid mineral oil /liquid petrolatum ANALGESIC OINTMENT
 From animal sources
 Beeswax, spermaceti  Use: To relieve pain
 From vegetable origin  Mechanism: Sensation of coolness
 Fixed oil  Method of preparation: Mechanical
2. Absorption (Anhydrous Bases) Incorporation
 Ability to absorb water, greasy, non-water
FORMULA:
washable, emollient, occluslve
 Wool fat RAW MATERIALS AMOUNT
 Anhydrous lanolin, refined wool fat Menthol 2.4 g
 Hydrophilic petrolatum Camphor 2.4 g
3. Emulsion Bases Methyl Salicylate 12.0 mL
 Water-Ln-Oil Wool fat, qs ad 120.0g
 Can contain/absorb water, greasy non
water washable, emollient, occlusive MANUFACTURING PROCEDURE:
 Cold cream, lanolin
 Oil-In-Water 1. Triturate menthol with camphor.
 Water washable, greasy
2. Add ½ portion of total wool amount to the mixture
 Can be diluted with water, non - occlusive
and triturate until completely mixed.
 Hydrophilic ointment
4. Water Soluble Base 3. Add ½ part of methyl salicylate and ¼ portion of total
 Greaseless ointment base, lipid-free, water wool fat amount to the mixture and triturate until
washable, water soluble, usually anhydrous completely mixed
absorbs/contains
4. Add the remaining portion of methyl salicylate and
 water
wool fat to the mixture and triturate until completely
 Polyethylene glycol ointment
mixed.
FACTORS IN CHOOSING OINTMENT BASE
5. Weigh and pack
 Compatibility of the active Ingredient and other
BURN OINTMENT
ingredients
 Patient factor  Uses: Local anaesthetic, protective
 Wet wound (cream)  Method of preparation: Fusion
 Dry wound (ointment)
FORMULA:
PREPARATION OF OINTMENTS
RAW MATERIALS AMOUNT
1. Mechanical Incorporation Chlorobutanol 2.4 g
 Solid/liquid ingredient is incorporated in the Eucalyptus oil 1.68 g
ointment base Zinc oxide 8.76 g
 Reduced In Its finest form to prevent Bismuth subnitrate 4.44 g
grittiness White petrolatum 34.8 g
Wool fat 35.16 g
Purified water 32.76 g

MANUFACTURING PROCEDURE:

1. Heat white petrolatum and wool fat until

melted.
2. Blend zinc oxide and bismuth subnitrate by
trituration.
3. In a separate vessel, heat purified water to 80
degrees. Add powder mixture of zinc oxide and
bismuth subnitrate, and mix for 5 minutes
4. Add no. 3 to melted base In no. 1. Mix for 5
minutes and cool to 40 degrees,
5. In a separate vessel, dissolve chlorobutanol in
eucalyptus oil
6. Add chlorobutanol solution to melted base
mixture and mix for 5 minutes.
7. Fill Into ointment tubes.
8. Seal and crimp tubes.