Abstract: The present invention relates to improved pharmaceutical compositions of Pirfenidone comprising Pirfenidone and one or more pharmaceutically acceptable excipients, wherein the said composition is free of binding agent. The present invention also relates to process for preparing pharmaceutical composition of Pirfenidone, where in the process comprises direct blending, dry granulation or wet granulation process without using any binding agent
1. A pharmaceutical composition comprising Pirfenidone and one or more pharmaceutically acceptable excipients, wherein the said composition is free of binding agent.
2. A pharmaceutical composition according to claim 1, where in one or more pharmaceutically acceptable excipients are selected from diluents, disintegrants and lubricants.
3. A pharmaceutical composition according to claim 2, where in the diluents are selected from lactose, starch, corn starch, pregelatinized starch, maize starch, potato starch, sorbitol and xylitol.
4. A pharmaceutical composition according to claim 2, where in the disintegrants are selected from sodium starch glycolate, croscarmellose sodium, polacrilin potassium, crospovidone, pregelatinized starch
5. A pharmaceutical composition according to claim 2, where in the lubricants are selected from glyceryl dislearate, talc, magnesium stearate, stearic acid, fumaric acid, palmitic acid and sodium stearyl fumarate.
6. A pharmaceutical composition according to claim 1 is prepared by direct blending, dry granulation or wet granulation process.
7. A pharmaceutical composition according to claim 1 is in the form of powders, tablets, capsules and tablets filled in capsule.
8. A pharmaceutical composition comprising Pirfenidone and one or more pharmaceutically acceptable excipients, wherein the said composition is free of binding agent resulted in T/R ratio of Cmax 99.7 in Fasting and 104.7 in Fed conditions.
9. A pharmaceutical compOSition comprising Pirfenidone and one or more pharmaceutically acceptable excipients, wherein the said composition is free of binding
agent resulted in T/R ratio of AUC (M and AU(1 (H„rof 100.0 in fasting and 95.0 in Fed conditions.
10. A pharmaceutical composition comprising Pirfenidone and one or more pharmaceutical^ acceptable excipicnts, wherein the said composition is free of binding agent resulted in bioequivalent to that of marketed product Ksbriet.
| # | Name | Date |
|---|---|---|
| 1 | 201841045925-STATEMENT OF UNDERTAKING (FORM 3) [05-12-2018(online)].pdf | 2018-12-05 |
| 2 | 201841045925-POWER OF AUTHORITY [05-12-2018(online)].pdf | 2018-12-05 |
| 3 | 201841045925-FORM 1 [05-12-2018(online)].pdf | 2018-12-05 |
| 4 | 201841045925-FIGURE OF ABSTRACT [05-12-2018(online)].pdf | 2018-12-05 |
| 5 | 201841045925-DECLARATION OF INVENTORSHIP (FORM 5) [05-12-2018(online)].pdf | 2018-12-05 |
| 6 | 201841045925-COMPLETE SPECIFICATION [05-12-2018(online)].pdf | 2018-12-05 |
| 7 | 201841045925-CLAIMS UNDER RULE 1 (PROVISIO) OF RULE 20 [05-12-2018(online)].pdf | 2018-12-05 |