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WO2005097079A3 - Controlled release dosage for gaba receptor agonist - Google Patents

Controlled release dosage for gaba receptor agonist Download PDF

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Publication number
WO2005097079A3
WO2005097079A3 PCT/US2005/011032 US2005011032W WO2005097079A3 WO 2005097079 A3 WO2005097079 A3 WO 2005097079A3 US 2005011032 W US2005011032 W US 2005011032W WO 2005097079 A3 WO2005097079 A3 WO 2005097079A3
Authority
WO
WIPO (PCT)
Prior art keywords
receptor agonist
controlled release
release dosage
gaba receptor
gabab
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/US2005/011032
Other languages
French (fr)
Other versions
WO2005097079A2 (en
Inventor
Chien-Hsuan Han
Ann Hsu
Larry Hsu
Charles Hsiao
Ching-Ling Diana Teng
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.)
Impax Laboratories LLC
Original Assignee
Impax Laboratories LLC
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
Priority claimed from US10/815,926 external-priority patent/US20050220873A1/en
Priority claimed from US10/815,930 external-priority patent/US20050220874A1/en
Priority claimed from US10/815,924 external-priority patent/US20050220863A1/en
Priority claimed from US10/815,929 external-priority patent/US20050220864A1/en
Priority to AU2005231433A priority Critical patent/AU2005231433A1/en
Priority to EP05733181A priority patent/EP1729740A2/en
Priority to MXPA06011322A priority patent/MXPA06011322A/en
Application filed by Impax Laboratories LLC filed Critical Impax Laboratories LLC
Priority to BRPI0509399-6A priority patent/BRPI0509399A/en
Priority to CA002560995A priority patent/CA2560995A1/en
Priority to JP2007506301A priority patent/JP2007531727A/en
Publication of WO2005097079A2 publication Critical patent/WO2005097079A2/en
Publication of WO2005097079A3 publication Critical patent/WO2005097079A3/en
Priority to IL178296A priority patent/IL178296A0/en
Anticipated expiration legal-status Critical
Priority to NO20065013A priority patent/NO20065013L/en
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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/06—Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Transplantation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (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 generally to pharmaceutical dosage forms having immediate release and controlled release properties that contain a Ϝ-aminobutyric acid (GABAB) receptor agonist, e.g., baclofen, for the treatment of medical conditions, which includes spasms, cramping, and tightness of muscles, associated with ailments such as multiple sclerosis or certain spinal injuries.
PCT/US2005/011032 2004-04-02 2005-04-01 Controlled release dosage for gaba receptor agonist Ceased WO2005097079A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
JP2007506301A JP2007531727A (en) 2004-04-02 2005-04-01 Pharmaceutical dosage form with immediate and / or controlled release properties containing a GABAB receptor agonist
CA002560995A CA2560995A1 (en) 2004-04-02 2005-04-01 Controlled release dosage for gaba receptor agonist
BRPI0509399-6A BRPI0509399A (en) 2004-04-02 2005-04-01 pharmaceutical dosage form
AU2005231433A AU2005231433A1 (en) 2004-04-02 2005-04-01 Controlled release dosage for GABA receptor agonist
EP05733181A EP1729740A2 (en) 2004-04-02 2005-04-01 PHARMACEUTICAL DOSAGE FORMS HAVING IMMEDIATE RELEASE AND/OR CONTROLLED RELEASE PROPERTIES THAT CONTAIN A GABA<SB>B</SB> RECEPTOR AGONIST
MXPA06011322A MXPA06011322A (en) 2004-04-02 2005-04-01 Pharmaceutical dosage forms having immediate release and/or controlled release properties that contain a gabab.
IL178296A IL178296A0 (en) 2004-04-02 2006-09-26 Pharmaceutical compositions containing a gaba?? receptor agonist
NO20065013A NO20065013L (en) 2004-04-02 2006-11-01 Controlled release dosage for GABA receptor agonist

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US10/815,926 US20050220873A1 (en) 2004-04-02 2004-04-02 Pharmaceutical dosage forms having immediate and controlled release properties that contain a GABAB receptor agonist
US10/815,930 2004-04-02
US10/815,924 2004-04-02
US10/815,926 2004-04-02
US10/815,929 US20050220864A1 (en) 2004-04-02 2004-04-02 Pharmaceutical dosage forms having controlled release properties that contain a GABAB receptor agonist
US10/815,924 US20050220863A1 (en) 2004-04-02 2004-04-02 Pharmaceutical dosage forms having controlled release properties that contain a GABAB receptor agonist
US10/815,929 2004-04-02
US10/815,930 US20050220874A1 (en) 2004-04-02 2004-04-02 Pharmaceutical dosage forms having immediate release and controlled release properties that contain a GABAB receptor agonist

Publications (2)

Publication Number Publication Date
WO2005097079A2 WO2005097079A2 (en) 2005-10-20
WO2005097079A3 true WO2005097079A3 (en) 2006-01-05

Family

ID=35060819

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/011032 Ceased WO2005097079A2 (en) 2004-04-02 2005-04-01 Controlled release dosage for gaba receptor agonist

Country Status (11)

Country Link
EP (1) EP1729740A2 (en)
JP (1) JP2007531727A (en)
KR (1) KR20070020022A (en)
AU (1) AU2005231433A1 (en)
BR (1) BRPI0509399A (en)
CA (1) CA2560995A1 (en)
IL (1) IL178296A0 (en)
MX (1) MXPA06011322A (en)
NO (1) NO20065013L (en)
TW (1) TW200536523A (en)
WO (1) WO2005097079A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2836778C1 (en) * 2024-04-04 2025-03-21 Акционерное общество "Органика" Modified release pharmaceutical composition based on clozapine polymorphs

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010515754A (en) * 2007-01-11 2010-05-13 ゼノポート，インコーポレイティド Sustained release oral dosage form of prodrug of R-baclofen and method of treatment
WO2009096985A1 (en) * 2008-02-01 2009-08-06 Xenoport, Inc. Sustained release particulate oral dosage forms of (r)-baclofen prodrugs and methods of treatment
WO2010102071A1 (en) 2009-03-03 2010-09-10 Xenoport, Inc. Sustained release oral dosage forms of an r-baclofen prodrug
RU2672884C1 (en) * 2017-11-07 2018-11-20 Федеральное государственное бюджетное образовательное учреждение высшего образования "Российский государственный педагогический университет им. А.И. Герцена" (РГПУ им. А.И. Герцена) Agent for preserving population of gaba-ergic neurons after acute perinatal hypoxia
JP7138666B2 (en) * 2018-01-24 2022-09-16 大原薬品工業株式会社 METHOD FOR IMPROVING CHEMICAL STABILITY OF TABLETS CONTAINING γ-AMINOBUTYRIC ACID DERIVATIVES
TW202228665A (en) * 2020-10-05 2022-08-01 凱瑞康寧生技股份有限公司 Modified release compositions of a gamma-hydroxybutyric acid derivative
CN115919806A (en) * 2022-12-22 2023-04-07 南京乐韬生物科技有限公司 A kind of preparation method of GABA sustained release capsule

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5719185A (en) * 1993-04-23 1998-02-17 Glaxo Group Limited Use for GABA agonists for treating emesis
US6544998B2 (en) * 2000-11-30 2003-04-08 Pfizer Inc Combination of gaba agonists and sorbitol dehydrogenase inhibitors

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5719185A (en) * 1993-04-23 1998-02-17 Glaxo Group Limited Use for GABA agonists for treating emesis
US6544998B2 (en) * 2000-11-30 2003-04-08 Pfizer Inc Combination of gaba agonists and sorbitol dehydrogenase inhibitors

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2836778C1 (en) * 2024-04-04 2025-03-21 Акционерное общество "Органика" Modified release pharmaceutical composition based on clozapine polymorphs

Also Published As

Publication number Publication date
WO2005097079A2 (en) 2005-10-20
NO20065013L (en) 2007-01-02
IL178296A0 (en) 2007-02-11
JP2007531727A (en) 2007-11-08
MXPA06011322A (en) 2007-02-21
AU2005231433A1 (en) 2005-10-20
EP1729740A2 (en) 2006-12-13
KR20070020022A (en) 2007-02-16
TW200536523A (en) 2005-11-16
BRPI0509399A (en) 2007-09-18
CA2560995A1 (en) 2005-10-20

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