II.B.

1 Manufacturing Formula:

Labelled claim: Each film coated tablet contains:

Amoxicillin Trihydrate equivalent to Amoxicillin: 250 mg.

Batch size : 1, 00,000 Tablets

Practical Yield : 98,000 Tablets

Usual Packing : Blister of 10 Tablets

Shelf Life : 2 years

FORMULATION

S. No. Ingredients Quantity Overages

1. Amoxicillin Trihydrate 30.2 kg. 5%

2. Microcrystalline Cellulose 5.00 kg.
3. Starch 5.00 kg.
4. Lactose 5.00 kg.
5. Polyvinylpyrrolidone 0.50 kg.
6. Isopropyl Alcohol 15.0 lit.
7. Sodium Starch Glycolate 2.00 kg.
8. Aerosil 1.50 kg.
9. Talcum 0.30 kg.
10. Magnesium Stearate 0.50 kg.

Manufacturing Specifications:

Punch Size : 15/32 inch.

Hardness : 3 t0 4 Kg/ cm

Weight per tablet : 500 mg. +/- 25mg.

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Disintegration Time : N.M.T. 15 minutes

Friability : N.M.T. 0.5%

II.B.2 Manufacturing Process:

Granulation

1. Mix sifted Amoxicillin Trihydrate, Microcrystalline Cellulose,

Starch, and Lactose in a mass mixer and mix for 50
minutes.

2. Dissolve Polyvinylpyrrolidone in Isopropyl Alcohol.

3. Granulate the dry mix with the granulating solution.

4. Pass the wet mass through no.8 mesh and collect sieved
material.

5. Dry the wet granules in a Fluid Bed Drier without heating at

room temperature till the granules are dried.

6. Pass the dried granules through 12 mesh sieve.

Lubrication

1. Lubricate the dried granules with sifted Aerosil, Magnesium

Stearate, Talcum and Sodium Starch Glycolate in a Drum
mixer for 185 minutes.

2. The granules are ready for compression.

Compression

1. Compress 875 mg tablets using 20x9-mm bisected ovaloid

punches (thickness 9.6 to 10.6 mm; hardness not less than
15)
 2. Compress 500 mg tablets using 18x8.5-mm ovaloid punches
(thickness 6.5 to 6.7 mm; hardness 12 to 18)

3. Compress 250 mg tablets using 10.3-mm diameter punches

(thickness 5.1 to 5.3mm; hardness 12)
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Film Coating

Prepare the film coating dispersion using the following

formulation:

S.No Raw material Qty.__kg.

.

1. Hydrogen Propyl Methyl Cellulose E- BP 1.50

5
2. Talc BP 0.15
3. Titanium Dioxide BP 0.35
4. Iso Propyl Alcohol BP 9.00
5. Methylene Chloride BP 34.00
6. Carnauba Wax(100mesh) BP 0.015
7. Talc BP 0.065
8. Propylene glycol BP 0.45

Process:

A] Preparation of suspension:

1. Transfer Isopropyl alcohol to an S. S. Vessel and to this HPMC

E-5 soak for 30 minutes. Then stir under
K.D.Mill for 5 minutes.

2. Transfer Methylene Chloride to step 1 under stirring and add

Propylene Glycol, Talc and Titanium Dioxide. Stir for 30
minutes, Filter the suspension through 200 mesh.
3. Weigh the suspension .It should not be less than 40.0 kg. and
if necessary make up with same proportion of solvent.

B] Suspension Coating:

1. Keep the rotation of pan 8 to 9 RPM. Load the core tabs in

coating pan and switch on the pan. Start the Exhaust. Warm
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the tablets by maintaining temperature of hot air blower between

100C to 125C so that temperature of the bed is 40C+5C.

2. The suspension in pressure vessel and adjust the spraying gun

with 1.5 mm nozzle at a distance of 16 to 18 cm. from tablet bed,
by adjusting air pressure to 50 lb/in to 60 lb/in

to delivery solution 180 to 200 ml/min. Solution adjust the Inlet

air temperature at 100 to 125C. Film Coat the tablets by spraying
the coating solution on entire bed of tablet.

Packaging

Packaging to be started after approval of Batch by Q.C. Line

clearance must be taken from QA personnel prior to all packaging
operations.

Pack Size: 10 tablets/strip

Pack Amoxicillin tablets in a strip of 10 tablets. Run foil over the

heating rollers to check over printing of Batch nos., Mfg. date,
Exp. Date, and price of the product. Pack such 10 strip in printed
outer carton.

During packing, check leak test as per SOP every 30 min. and/or
at the time of changing Alu Foil. Remove and keep aside control
samples. After completion of packing intimate QA to draw
samples of finished goods for analysis.
All information provided in above manufacturing process section
follows ICH guidelines.

Guidelines: Q8: Pharmaceutical Development