WO2009087682A3 - Stabilized injectable formulation of pregabalin - Google Patents

Stabilized injectable formulation of pregabalin Download PDF

Info

Publication number
WO2009087682A3
WO2009087682A3 PCT/IN2008/000869 IN2008000869W WO2009087682A3 WO 2009087682 A3 WO2009087682 A3 WO 2009087682A3 IN 2008000869 W IN2008000869 W IN 2008000869W WO 2009087682 A3 WO2009087682 A3 WO 2009087682A3
Authority
WO
WIPO (PCT)
Prior art keywords
pregabalin
injectable formulation
formulation
injectable
stabilized injectable
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IN2008/000869
Other languages
French (fr)
Other versions
WO2009087682A2 (en
Inventor
Sehgal Ashish
Vallabhabhai Patel Bhavesh
Patel Aditya
Kumar Mandal Jayanta
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intas Pharmaceuticals Ltd
Original Assignee
Intas Pharmaceuticals Ltd
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 Intas Pharmaceuticals Ltd filed Critical Intas Pharmaceuticals Ltd
Priority to EP08869815A priority Critical patent/EP2240158A2/en
Publication of WO2009087682A2 publication Critical patent/WO2009087682A2/en
Publication of WO2009087682A3 publication Critical patent/WO2009087682A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/325—Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to an injectable pregabalin formulation which is stable in between pH 4.0 to 8.0. Further, the present invention relates to a process for manufacturing the said injectable pregabalin formulation. The injectable formulation of pregabalin according to the present invention is administered intravenously to the patients requiring pregabalin treatment.
PCT/IN2008/000869 2007-12-28 2008-12-26 Stabilized injectable formulation of pregabalin Ceased WO2009087682A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08869815A EP2240158A2 (en) 2007-12-28 2008-12-26 Stabilized injectable formulation of pregabalin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2596/MUM/2007 2007-12-28
IN2596MU2007 2007-12-28

Publications (2)

Publication Number Publication Date
WO2009087682A2 WO2009087682A2 (en) 2009-07-16
WO2009087682A3 true WO2009087682A3 (en) 2009-09-11

Family

ID=40801860

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2008/000869 Ceased WO2009087682A2 (en) 2007-12-28 2008-12-26 Stabilized injectable formulation of pregabalin

Country Status (2)

Country Link
EP (1) EP2240158A2 (en)
WO (1) WO2009087682A2 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109498611B (en) * 2019-01-15 2020-09-01 张惊宇 Medicine for treating diabetic peripheral neuralgia and application thereof
DK3946260T3 (en) * 2019-03-26 2026-03-23 Orion Corp Pregabalin formulations and use thereof
WO2022043227A1 (en) * 2020-08-28 2022-03-03 Small Pharma Ltd Injectable formulation
US11406619B2 (en) 2020-08-28 2022-08-09 Small Pharma Ltd Injectable formulations
CN112353767A (en) * 2020-11-16 2021-02-12 海南锦瑞制药有限公司 Diltiazem hydrochloride and pregabalin composition, and preparation method and application thereof
CN113069411B (en) * 2021-04-02 2022-08-09 石家庄四药有限公司 Pentoxifylline injection and preparation method thereof
WO2022256545A1 (en) * 2021-06-04 2022-12-08 Nevakar Injectables Inc. Injectable pregabalin formulations
US12318477B2 (en) 2021-11-18 2025-06-03 Cybin Uk Ltd Injectable and inhalable formulations
GB2624861A (en) 2022-11-28 2024-06-05 Orbit Pharma Ltd Sustained release pharmaceutical compositions comprising pregabalin or pharmaceutically acceptable salts thereof
GB2639602A (en) 2024-03-19 2025-10-01 Novumgen Ltd An orodispersible tablet of pregabalin and its process of preparation

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998058641A1 (en) * 1997-06-25 1998-12-30 Warner-Lambert Company Use of gaba analogs such as gabapentin in the manufacture of a medicament for treating inflammatory diseases
WO2000061135A1 (en) * 1999-04-08 2000-10-19 Warner-Lambert Company Method for the treatment of incontinence
WO2003061656A1 (en) * 2002-01-16 2003-07-31 Endo Pharmaceuticals Inc. Pharmaceutical composition and method for treating disorders of the central nervous system
US20050090550A1 (en) * 2003-09-11 2005-04-28 Barrett Ronald W. Treating and/or preventing urinary incontinence using prodrugs of GABA analogs
US20060229361A1 (en) * 2005-04-06 2006-10-12 Xenoport, Inc. Prodrugs of GABA analogs, compositions and uses thereof
US20060281816A1 (en) * 2005-04-11 2006-12-14 Lilach Hedvati Pregabalin free of lactam and a process for preparation thereof
EP1992609A1 (en) * 2007-05-14 2008-11-19 Dipharma Francis S.r.l. A process for the preparation of a (S)(+)-3-(aminomethyl)-5-methylhexanoic acid

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998058641A1 (en) * 1997-06-25 1998-12-30 Warner-Lambert Company Use of gaba analogs such as gabapentin in the manufacture of a medicament for treating inflammatory diseases
WO2000061135A1 (en) * 1999-04-08 2000-10-19 Warner-Lambert Company Method for the treatment of incontinence
WO2003061656A1 (en) * 2002-01-16 2003-07-31 Endo Pharmaceuticals Inc. Pharmaceutical composition and method for treating disorders of the central nervous system
US20050090550A1 (en) * 2003-09-11 2005-04-28 Barrett Ronald W. Treating and/or preventing urinary incontinence using prodrugs of GABA analogs
US20060229361A1 (en) * 2005-04-06 2006-10-12 Xenoport, Inc. Prodrugs of GABA analogs, compositions and uses thereof
US20060281816A1 (en) * 2005-04-11 2006-12-14 Lilach Hedvati Pregabalin free of lactam and a process for preparation thereof
EP1992609A1 (en) * 2007-05-14 2008-11-19 Dipharma Francis S.r.l. A process for the preparation of a (S)(+)-3-(aminomethyl)-5-methylhexanoic acid

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SHI W ET AL: "DESIGN, SYNTHESIS, AND PRELIMINARY EVALUATION OF GABAPENTIN-PREGABALIN MUTUAL PRODRUGS IN RELIEVING NEUROPATHIC PAIN", ARCHIV DER PHARMAZIE, VCH VERLAGSGESELLSCHAFT MBH, WEINHEIM, DE, vol. 338, no. 8, 1 January 2005 (2005-01-01), pages 358 - 364, XP008067446, ISSN: 0365-6233 *

Also Published As

Publication number Publication date
EP2240158A2 (en) 2010-10-20
WO2009087682A2 (en) 2009-07-16

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