Registration Dossier: LORSTAT-20 (Atorvastatin Calcium Tablets USP 20 mg)

3.2. P.1. Description and Composition of the Pharmaceutical Product

Drug Product:
LORSTAT-20
Atorvastatin Calcium Tablets USP 20 mg

Description:
White to off white color, circular shaped, biconvex film coated tablet plain on both side.

Composition:
Each film coated tablet contains:
Atorvastatin calcium USP eq. to Atorvastatin ……….……………20.0 mg
Excipients…………………………….q.s

QUALITATIVE AND QUANTITATIVE COMPOSITION

B.size :1,00, 000 tablets
Sr.No. Ingredients Grade Function Quantity per Std.qty/ Quantity
tablet (mg) batch (kg) per tablet
(% w/w)
Dry mixing
1 Atorvastatin USP Active 21.70 2.17 7.04
Calcium*
2 Calcium carbonate BP Stabilizer 72.00 7.20 23.37
precipitate
3 Lactose Monohydrate BP Diluent 130.30 13.03 42.30
4 Micro crystalline BP Diluent 60.00 6.00 19.48
cellulose PH 102*
Binder
5 Polyvinyl BP Binder 6.00 0.60 1.94
Pyrrolidone K30
6 Polysorbate 80 BP Solubilizer 0.80 0.08 0.25
7 Purified water$ BP Vehicle 90.00 9.00 ………
Lubrication
8 Magnesium stearate BP Lubricant 1.20 0.12 0.38
9 Croscarmellose BP Disintegrant 8.00 0.80 2.59
sodium
Film coating
10 HPMC 5 CPS USP Film 6.00 0.60 1.94
polymer

BHPL/CTD/TAT20/ET/22/01 Page 1 of 2
Registration Dossier: LORSTAT-20 (Atorvastatin Calcium Tablets USP 20 mg)

11 Polyethylene glycol BP Plasticizer 0.64 0.064 0.20

12 Lactose Monohydrate BP Filler 0.96 0.096 0.31
13 Titanium Dioxide BP Opacifier 0.40 0.040 0.12
14 Purified water$ BP Vehicle 92.00 9.20 ………….
Total 308.00 mg 30.80 kg 100.00 %

*any increase in quantity of atorvastatin calcium should be compensate with Microcrystalline

cellulose (PH102)
$it is a not part of unit composition. As it disappears in the course of processing.

Packing
3 x 10 Alu pvc blister in one Mônocarton with leaflet.

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