|
Generic Name |
Aceclofenac Sustained
Release Tablets 200mg |
|
Composition |
Each filmcoated
sustained release tablet contains: Aceclofenac I.P 200 mg Colour:
Ponceau 4R |
|
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 |
Aceclofenac |
I.P. |
17.000 |
|
2 |
Lactose |
I.P. |
2.580 |
|
3 |
Starch |
I.P. |
1.200 |
|
4 |
Fumaric Acid |
|
1.000 |
|
5 |
Methocel K 100M |
|
1.800 |
|
|
Granulation |
|
|
|
4 |
Starch |
I.P. |
1.000 |
|
5 |
Propylparaben
Sodium |
I.P. |
0.160 |
|
6 |
Polyvinyl Pyrolidone K30 |
I.P. |
0.500 |
|
7 |
Purified Water |
I.P. |
9.00 |
|
|
Lubrication |
|
|
|
9 |
Aceclofenac |
I.P. |
3.000 |
|
10 |
Talc |
I.P. |
0.500 |
|
11 |
Magnesium stearate |
I.P. |
0.260 |
|
Total weight |
29.000 |
||
* - 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) |
I.P. |
0.750 |
|
2 |
Iso Propyl
Alcohol |
I.P. |
9.000 |
|
3 |
Methylene
Chloride |
U.S.P. |
14.700 |
|
4 |
Talc |
I.P. |
0.190 |
|
5 |
Titanium
Dioxide |
I.P. |
0.160 |
|
6 |
Castor Oil |
I.P. |
0.250 |
|
7 |
PEG 6000 |
I.P. |
0.085 |
|
8 |
Lake Ponceau 4R |
I.H.S |
0.060 |
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