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Improved Pharmaceutical Compositions Of Pirfenidone And Its Manufacturing Process Thereof

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

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Patent Information

Application #
Filing Date
05 December 2018
Publication Number
24/2020
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
prasad.vure@granulesindia.com
Parent Application

Applicants

GRANULES INDIA LIMITED
My Home Hub, 2nd Floor, 3rd Block, Madhapur, Hyderabad, Telangana, India. -500 081.

Inventors

1. KRISHNA PRASAD CHIGURUPATI
GRANULES INDIA LIMITED My Home Hub, 2nd Floor, 3rd Block, Madhapur, Hyderabad, Telangana, India. -500 081.
2. MALLIKARJUN GUNDLAPALLI
GRANULES INDIA LIMITED My Home Hub, 2nd Floor, 3rd Block, Madhapur, Hyderabad, Telangana, India. -500 081.
3. MANIKANDAN RAMALINGAM
GRANULES INDIA LIMITED My Home Hub, 2nd Floor, 3rd Block, Madhapur, Hyderabad, Telangana, India. -500 081.
4. PRASAD VURE
GRANULES INDIA LIMITED My Home Hub, 2nd Floor, 3rd Block, Madhapur, Hyderabad, Telangana, India. -500 081.

Specification

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.

Documents

Application Documents

# 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