Aceclofenac Sustained Release Tablets 200mg

 

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