|
Generic Name |
Atorvastatin
Calcium 10mg and Fenofibrate 160mg Tablets |
|
Composition |
Each film coated
tablet contains: Atorvastatin
Calcium Equivalent to
Atorvastatin 10mg Fenofibrate 160mg Colour:
Yellow Oxide of Iron |
|
Shelf Life |
24 Months |
|
Standard
Batch Size |
1 Lakh
Tablets |
MANUFACTURING
FORMULA:
|
Sl. No. |
Name of the material |
Std. |
Qty Required / Batch (kg) |
|
|
Dry Mixing |
|
|
|
1 |
Atorvastatin Calcium |
I.P. |
1.120 |
|
2 |
Fenofibrate |
I.P. |
16.000 |
|
3 |
Starch |
I.P. |
5.000 |
|
4 |
Lactose |
I.P. |
7.500 |
|
5 |
Microcrystalline cellulose Powder |
I.P. |
17.500 |
|
6 |
Sodium Lauryl Sulphate |
I.P. |
0.075 |
|
|
Granulation |
|
|
|
7 |
Polyvinyl Pyrolidone K30 |
I.P |
0.500 |
|
8 |
Isopropyl Alcohol |
I.P |
8.000 |
|
|
Lubrication |
|
|
|
9 |
Talc |
I.P |
0.350 |
|
10 |
Magnesium stearate |
I.P |
0.250 |
|
11 |
Sodium Starch Glycolate |
I.P |
1.000 |
|
12 |
Colloidal Silicon Dioxide |
I.P. |
0.250 |
|
13 |
Starch |
I.P. |
0.455 |
|
Total weight |
50.000 kg |
||
* - Starch Qty
may vary based on drying loss.
FOR FILM COATING:
|
Sl. No. |
Ingredients |
Specs |
Qty Required / Batch (kg) |
|
1 |
Hydroxypropyl
Methyl Cellulose (HPMC E-15) |
IP |
1.200 |
|
2 |
Iso Propyl
Alcohol |
IP |
14.400 |
|
3 |
Methylene
Chloride |
USP |
23.400 |
|
4 |
Talc |
IP |
0.325 |
|
5 |
Titanium
Dioxide |
IP |
0.255 |
|
6 |
Castor Oil |
IP |
0.415 |
|
7 |
PEG 6000 |
IP |
0.180 |
|
8 |
Yellow Oxide of Iron |
I.H.S |
0.120 |
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