|
Generic Name |
Montelukast 10mg,
Levocetirizine Hydrochloride 5mg Tablets |
|
Composition |
Each film
coated tablet contains: Montelukast
Sodium Equivalent to
Montelukast 10mg Levocetirizine Hydrochloride 5mg 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) |
|
|
BINDER
PREPARATION - LEVOCETIRIZINE |
|
|
|
1 |
Ethyl Cellulose N-20 |
USP |
0.075
Kgs. |
|
2 |
Acetone |
BP |
0.500
Lts. |
|
|
GRANULATION -
LEVOCETIRIZINE |
|
|
|
3 |
Levocetrizine Hydrochloride |
IP |
0.500
Kgs. |
|
4 |
Microcrystalline Cellulose
Powder |
IP |
1.478
Kgs. |
|
|
BINDER PREPARATION -
MONTELUKAST |
|
|
|
5 |
Polyvinyl Pyrollidone (PVP
K 30) |
IP |
0.350
Kgs. |
|
6 |
Isopropyl Alcohol |
IP |
6.000
Lts. |
|
|
GRANULATION |
|
|
|
7 |
Montelukast Sodium |
IP |
1.092
Kgs. |
|
8 |
Microcrystalline Cellulose
Powder |
IP |
5.980
Kgs. |
|
9 |
Lactose |
IP |
3.500
Kgs. |
|
10 |
Starch |
IP |
2.500
Kgs. |
|
11 |
Croscarmellose Sodium |
IP |
0.300
Kgs. |
|
|
LUBRICATION |
|
|
|
12 |
Talc |
IP |
0.150
Kgs. |
|
13 |
Colloidal Silicon Dioxide
(Aerosil) |
IP |
0.150
Kgs. |
|
14 |
Cross Povidone XL 10 |
IP |
0.740
Kgs. |
|
15 |
Croscarmellose Sodium |
BP |
0.480
Kgs. |
|
16 |
Sodium Starch Glycolate |
IP |
0.600
Kgs. |
|
17 |
Magnesium Stearate |
IP |
0.200
Kgs. |
|
Total weight |
18.000 kgs. |
||
* - Starch Qty
may vary based on drying loss.
FOR FILM COATING:
|
Sl. No. |
Ingredients |
Specs |
Qty Required / Batch (kg) |
|
|
1 |
Hydroxy Propyl Methyl
Cellulose E-15 |
IP |
0.540
Kgs. |
|
|
2 |
Talc |
IP |
0.060
Kgs. |
|
|
3 |
Titanium Dioxide |
IP |
0.060
Kgs. |
|
|
4 |
Poly Ethylene Glycol 6000 |
IP |
0.040
Kgs. |
|
|
5 |
Ferric Oxide (Yellow) |
USP |
9.060
Gms |
|
|
6 |
Ferric Oxide (Red) |
USP |
9.689
Gms |
|
|
7 |
Isopropyl Alcohol |
IP |
5.400
Lts |
|
|
8 |
Methylene Chloride |
BP |
7.000
Lts |
|
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