WO2009084041A4 - Pharmaceutical compositions of dexibuprofen - Google Patents

Pharmaceutical compositions of dexibuprofen Download PDF

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Publication number
WO2009084041A4
WO2009084041A4 PCT/IN2008/000876 IN2008000876W WO2009084041A4 WO 2009084041 A4 WO2009084041 A4 WO 2009084041A4 IN 2008000876 W IN2008000876 W IN 2008000876W WO 2009084041 A4 WO2009084041 A4 WO 2009084041A4
Authority
WO
WIPO (PCT)
Prior art keywords
composition according
pharmaceutical composition
derivatives
mixtures
dexibuprofen
Prior art date
Application number
PCT/IN2008/000876
Other languages
French (fr)
Other versions
WO2009084041A2 (en
WO2009084041A3 (en
Inventor
Milind Kesharlal Biyani
Vivekanandan Sundaramurthy
Devarajan Sampath Kumar
Original Assignee
Shasun Chemicals And Drugs Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shasun Chemicals And Drugs Limited filed Critical Shasun Chemicals And Drugs Limited
Publication of WO2009084041A2 publication Critical patent/WO2009084041A2/en
Publication of WO2009084041A3 publication Critical patent/WO2009084041A3/en
Publication of WO2009084041A4 publication Critical patent/WO2009084041A4/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to formulations of pharmaceutical compositions and in particular to a process of manufacture of such pharmaceutical compositions comprising dexibuprofen and/or salts in oral dosage form possessing high in-vitro dissolution and enhanced bioavailability in humans. Importantly, the invention is directed to high in-vitro dissolution of a poor water soluble drug dexibuprofen by controlling the particle size of the active ingredient of the invention such as dexibuprofen, to enable a significant improvement in the in-vivo performance of the active ingredient.

Claims

AMENDED CLAIMS received by the International Bureau on 03 November 2009 (03.11.2009)
1. A pharmaceutical composition comprising of dexibuprofen or its pharmaceutically acceptable salt having mean particle size equal to or less than 125 microns with in-vitro dissolution of more than about 90% at pH 7.2 in 5 minutes.
2. A pharmaceutical composition according to claim 1, wherein the mean particle size is between 10 to 125 microns.
3. A pharmaceutical composition according to claim 1, wherein the mean particle size is between 30 to 100 microns.
4. A pharmaceutical composition according to claim 1 , wherein the amount of dexibuprofen is between 50-1000 mg.
5. A pharmaceutical composition according to claim 1, wherein the amount of dexibuprofen is about 100-800 mg.
6. A pharmaceutical composition according to claim 1, wherein the process of preparation of oral dosage form consists of blending and direct compression, wet or dry granulation or combination thereof.
7. A pharmaceutical composition according to claim 1 , comprising one or more pharmaceutically acceptable fillers, binders, disintegrants, super disintegrants, lubricants, anti-adherents, glidants, stabilizers, solubility enhancers, surfactants, wetting agent and coating agents.
8. A pharmaceutical composition according to claim 7, wherein the fillers are used from the group comprising of starch and its derivatives, cellulose and its derivatives, lactose, mannitol, sorbitol, sucrose, dicalcium phosphate-tricalcium phosphate and mixtures thereof and the said fillers are used in between the range 5% and 50%.
9. A pharmaceutical composition according to claim 7, wherein the binders are used from the group comprising of starch paste, starch and its derivatives, hydroxypropyl methyl cellulose, hydroxyl propyl cellulose, gelatin alginate, sorbitol, glucose, polyvinylpyrrolidone, gum and mixtures thereof and the said binders are used in between the range 1% and 10%.
28
10. A pharmaceutical composition according to claim 7, wherein the disintegrants are used from the group comprising of starch and its derivatives, sodium starch glycolate, cellulose and its derivatives, croscarmellose sodium, calcium carboxymethyl cellulose, alginates, crospovidone and mixtures thereof and the said disintegrants are used in between the range 1% and 14%.
11. A pharmaceutical composition according to claim 7, wherein the antiadherents are used from the group comprising of starch, talc, colloidal silicon dioxide, stearic acid, magnesium stearate, calcium stearate, sodium stearyl fumarate, hydrogenated vegetable oil and mixtures thereof and the said antiadherents are used in between the range 0. i% and 10%.
12. A pharmaceutical composition according to claim 7, wherein the coating materials are used from the group comprising of hypromellose, hydorxypropyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, methyl cellulose, methacrylic acids, ethyl acrylates, saccharides and mixtures thereof and the said coating materials are used in between the range 1 % and 7%.
13. A pharmaceutical composition according to claim 7, wherein solubility enhancers are used from sodium lauryl sulphate, sorbitam monolaurate, docusate sodium, polysorbate 80/20, polyvinyl pyrrolidone, polyethylene glycol, propylene glycol, cyclodextrin and its derivatives, poloxamer, ethylene oxide- propylene oxide copolymer surfactants, polyalkylene glycol and their derivatives, polyoxyethylene alkyl ethers and polar solvezits and mixtures thereof and the said solubility enhancers are used in between the range 0.05% and 5.0%.
14. A phaπnaceutical composition according to claim 1, wherein the composition is administered as an oral solid dosage form.
15. A phaπnaceutical composition according to claim 14, wherein the solid oral dosage form is selected from a group consisting of capsule, pellet, granules, powder blends, orally disintegrating tablets, dispersible tablets, chewable tablets and effervescent tablets.
16. A pharmaceutical composition according to claim 15, wherein solid oral dosage form is uncoated, film coated or sugar coated.
PCT/IN2008/000876 2008-01-01 2008-12-31 Pharmaceutical compositions of dexibuprofen WO2009084041A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1CH2008 2008-01-01
IN1/CHE/2008 2008-01-01

Publications (3)

Publication Number Publication Date
WO2009084041A2 WO2009084041A2 (en) 2009-07-09
WO2009084041A3 WO2009084041A3 (en) 2009-10-29
WO2009084041A4 true WO2009084041A4 (en) 2009-12-23

Family

ID=40824854

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2008/000876 WO2009084041A2 (en) 2008-01-01 2008-12-31 Pharmaceutical compositions of dexibuprofen

Country Status (1)

Country Link
WO (1) WO2009084041A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101829064B (en) * 2010-04-27 2012-04-25 海南新中正制药有限公司 Dexibuprofen granule and preparation method thereof
WO2013154512A1 (en) * 2012-04-13 2013-10-17 Mahmut Bilgic Pharmaceutical formulations comprising dexibuprofen
CN104546732A (en) * 2013-10-24 2015-04-29 北京韩美药品有限公司 Dexibuprofen sustained-release tablet and preparation process thereof
CN111135146A (en) * 2018-11-05 2020-05-12 珠海润都制药股份有限公司 Ibuprofen sustained-release pellet and preparation method thereof
GB2581132B (en) * 2019-01-28 2022-06-01 Reckitt Benckiser Health Ltd Novel composition
CN110327309B (en) * 2019-07-17 2023-02-10 珠海润都制药股份有限公司 Ibuprofen sustained-release pellet without pill sticking

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8231899B2 (en) * 1998-09-10 2012-07-31 Nycomed Danmark Aps Quick release pharmaceutical compositions of drug substances
DE10024413A1 (en) * 2000-05-19 2001-12-06 Mika Pharma Gmbh Pharmaceutical and / or cosmetic preparation
US6551615B1 (en) * 2001-10-18 2003-04-22 M/S. Strides Arcolab Limited Dexibuprofen-containing soft gelatin capsules and process for preparing the same
AU2003259417A1 (en) * 2002-09-04 2004-03-29 Ranbaxy Laboratories Limited Taste masked dosage forms and processes for their preparation

Also Published As

Publication number Publication date
WO2009084041A2 (en) 2009-07-09
WO2009084041A3 (en) 2009-10-29

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