Aceclofenac 100 mg Tablet | Formulation & Manufacturing Process

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It relieves pain and inflammation in rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It was patented in 1983 and approved for medical use in 1992.

There are several dosage forms and strengths available with Aceclofenac. The most common of which is Aceclofenac 100 mg Tablet.

Each film-coated tablet contains Aceclofenac BP 100 mg. The formulation & manufacturing process of Aceclofenac 100 mg Tablet is as follows:

Formulation-1:

Each tablet contains:

SL	NAME OF INGREDIENT(S)	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient(s)
1	Aceclofenac	BP	100.000 mg	Active
Excipient(s)
2	Microcrystalline Cellulose 101	BP	25.101 mg	Binder/Disintegrant
3	Lactose Monohydrate	BP	13.360 mg
4	Maize Starch	BP	46.964 mg	Diluent/Binder
5	Sodium Starch Glycolate	BP	8.502 mg	Disintegrant
6	Polyvinylpyrrolidone K-30	BP	2.105 mg	Binder
7	Magnesium Stearate	BP	1.619 mg	Lubricant
8	Purified Talc	BP	3.239 mg	Lubricant
Coating Material(s)
9	Hydroxypropyl Methylcellulose 15 CPS	BP	2.105 mg	Coating Material
10	Polyethylene Glycol 6000	BP	0.296 mg	Coating Material
11	Titanium Dioxide	BP	0.085 mg	Coating Material
12	Purified Talc	BP	0.296 mg	Coating Material
13	Carnauba Wax	BP	0.021 mg	Coating Material
14	Methylene Chloride*	BP	28.745 mg	Coating Material
15	Methanol*	BP	15.061 mg	Coating Material

*Does not appear in the final product.

* The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Formulation-2:

Each Tablet Contains:

SL	NAME OF INGREDIENT(S)	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient(s)
1	Aceclofenac	BP	100.000 mg
Excipient(s)
2	Microcrystalline Cellulose 101	BP	30.000 mg
3	Maize Starch	BP	30.000 mg
4	Polyvinylpyrrolidone K-30	BP	15.000 mg
5	Sodium Starch Glycolate	BP	05.000 mg
6	Purified Talc	BP	03.000 mg
7	Magnesium Stearate	BP	02.000 mg
Coating Material(s)
8	Hydroxypropyl Methylcellulose	BP	4.000 mg
9	Polyethylene Glycol 6000	BP	1.000 mg
10	Polyethylene Glycol 400	BP	0.500 mg
11	Propylene Glycol	BP	0.900 mg
12	Purified Talc	BP	0.753 mg
13	Titanium Dioxide	BP	1.000 mg
14	FD & C Blue No.01	Pharma Grade	0.002 mg
15	*Carnauba Wax	BP	1.333 mg
16	*Chloroform	BP	02.50 mg
17	*Purified Water	BP	55.00 mg
*Does not appear in the final product.
* The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process:

The process consists of sieving the active ingredient & excipients through a Vibration Shifter and granules preparation by rapid mixture/granulator & blending that a Drum Blender follows. Tablets will be compressed by compression machine and coating will be carried out by Auto coater. The Blister machine will blister tablets.