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 60 mg Tablet.
Each film-coated tablet contains Etoricoxib INN 60 mg. The formulation & manufacturing process of Etoricoxib 60 mg Tablet is as below:
Formulation:
Each tablet contains:
SN | COMPOSITION | SPECIFICATION | QUANTITY | FUNCTION |
Active Ingredient(s): | ||||
1 | Etoricoxib | INN | 60.000 mg | |
Excipient(s): | ||||
2 | Povidone K-30 | BP | 9.000 mg | |
3 | Microcrystalline Cellulose PH-101 | BP | 70.000 mg | |
4 | Sodium Starch Glycolate | BP | 10.000 mg | |
5 | Crospovidone | BP | 8.000 mg | |
6 | Purified Talc | BP | 3.000 mg | |
7 | Magnesium Stearate | BP | 2.000 mg | |
8 | Sodium Lauryl Sulphate | BP | 1.250 mg | |
9 | Purified Water | BP | 133.000 mg | |
Coating Material(s): | ||||
10 | Hypromellose 15 cps | BP | 3.289 mg | |
11 | Polyethylene Glycol-6000 | BP | 1.069 mg | |
12 | Propylene Glycol | BP | 0.822 mg | |
13 | Purified Talc | BP | 1.069 mg | |
14 | Titanium Dioxide | BP | 1.069 mg | |
15 | Carnauba Wax | BP | 0.250 mg | |
16 | Chloroform * | BP | 2.000 mg | |
17 | Purified Water * | BP | 59.227 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:
- Pass Etoricoxib, Microcrystalline Cellulose PH-101, Crospovidone, and Sodium Lauryl Sulphate through a 20-mesh sieve.
- Mix Etoricoxib, Microcrystalline Cellulose PH-101, Crospovidone, and Sodium Lauryl Sulphate in a Planetary/Mass Mixer for 20 minutes.
- Prepare Povidone K-30 solution with 10.0 Kg of Purified Water and add to step b with continuous mixing.
- 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.
- Dry this wet mass in a Fluidized Bed Dryer until a semi-dried mass is achieved by using a temperature not exceeding 60oC.
- Now grind this semidried mass by the Multimill using a 2.0 mm Screen.
- Again dry this ground mass in a Fluidized Bed Dryer using a temperature not exceeding 60oC to achieve an L.O.D. of 1.50 – 2.50 % at 80oC.
- Pass Primogel, Purified Talc, and magnesium Stearate through a 40-mesh sieve.
- Now blend this dried mass with Primogel and lubricate with Purified Talc and Magnesium Stearate.
- Send this blended mix to the Quality Control Department for necessary analysis.
- 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.
- Finally, send the sample of tablets to the Quality Control Department for the release for coating.
Preparation of Coating Solution:
- Blend Hypromellose, Polyethylene Glycol-6000, Propylene Glycol, Purified Talc, and titanium Dioxide.
- Take Purified Water in a suitable vessel and create a vortex by stirring.
- Pour the blended mix into the vortex without allowing it to float and stir until a homogeneous dispersion has been achieved.
- Now start coating according to the following instructions.
- After coating, polish the tablet with Carnauba Wax solution (Prepared by dissolving Carnauba Wax in Chloroform).
- Finally, send the sample of coated tablets to the Quality Control Department for the release of blistering.