Etoricoxib 120 mg Tablet | Formulation & Manufacturing Process

Etoricoxib is a selective COX-2 inhibitor developed and commercialized by Merck. It is approved in 63 countries worldwide as of 2007, except the United States where the Food and Drug Administration sent a Non Approvable Letter to Merck and required them to provide additional data.

Etoricoxib is indicated for “the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. It was patented in 1996 and approved for medical use in 2002.

There are several dosage forms and strengths available with Etoricoxib. The most common of which is Etoricoxib 120 mg Tablet.

Each film-coated tablet contains Etoricoxib INN 120 mg. The formulation & manufacturing process of Etoricoxib 120 mg Tablet is as below:

Formulation:

Each tablet contains:

SN	COMPOSITION	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient(s):
1	Etoricoxib	INN	120.000 mg
Excipient(s):
2	Povidone K-30	BP	122.45 mg
3	Microcrystalline Cellulose PH-101	BP	11.00 mg
4	Sodium Starch Glycolate	BP	60.00 mg
5	Crospovidone	BP	15.00 mg
6	Purified Talc	BP	10.71 mg
7	Magnesium Stearate	BP	10.00 mg
8	Sodium Lauryl Sulphate	BP	2.00 mg
9	Purified Water	BP	1.70 mg
Coating Material(s):
10	Hypromellose 15 cps	BP	4.500 mg
11	Polyethylene Glycol-6000	BP	1.460 mg
12	Propylene Glycol	BP	1.120 mg
13	Purified Talc	BP	1.460 mg
14	Titanium Dioxide	BP	1.460 mg
15	Carnauba Wax	BP	0.250 mg
16	Chloroform *	BP	2.000 mg
17	Purified Water *	BP	80.954 mg
* Will 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:

1. Pass Etoricoxib, Microcrystalline Cellulose PH-101, Crospovidone, and Sodium Lauryl Sulphate through a 20-mesh sieve.
2. Mix Etoricoxib, Microcrystalline Cellulose PH-101, Crospovidone, and Sodium Lauryl Sulphate in a Planetary/Mass Mixer for 20 minutes.
3. Prepare Povidone K-30 solution with 10.0 Kg of Purified Water and add to step b with continuous mixing.
4. Add 15.0 Kg of Purified Water to step b in 4 (Four) consecutive steps with 5-minute intervals of each addition and then mix for 30 minutes.
5. Dry this wet mass in a Fluidized Bed Dryer until a semi-dried mass is achieved by using a temperature not exceeding 60^oC.
6. Now grind this semidried mass by the Multimill using a 2.0 mm Screen.
7. Again dry this ground mass in a Fluidized Bed Dryer using a temperature not exceeding 60^oC to achieve an L.O.D. of 1.50 – 2.50 % at 80^oC.
8. Pass Primogel, Purified Talc, and magnesium Stearate through a 40-mesh sieve.
9. Now blend this dried mass with Primogel and lubricate with Purified Talc and Magnesium Stearate.
10. Send this blended mix to the Quality Control Department for necessary analysis.
11. Upon clearance from the Quality Control Department, compress to form a tablet according to the specification by using 8.0 mm round, standard concave punches.
12. Finally, send the sample of tablets to the Quality Control Department for the release for coating.

Preparation of Coating Solution:

1. Blend Hypromellose, Polyethylene Glycol-6000, Propylene Glycol, Purified Talc, and titanium Dioxide.
2. Take Purified Water in a suitable vessel and create a vortex by stirring.
3. Pour the blended mix into the vortex without allowing it to float and stir until a homogeneous dispersion has been achieved.
4. Now start coating according to the following instructions.
5. After coating, polish the tablet with Carnauba Wax solution (Prepared by dissolving Carnauba Wax in Chloroform).
6. Finally, send the sample of coated tablets to the Quality Control Department for the release of blistering.