AR062647A1 - PHARMACEUTICAL FORMULATIONS AND METHODS OF USE - Google Patents

PHARMACEUTICAL FORMULATIONS AND METHODS OF USE

Info

Publication number
AR062647A1
AR062647A1 ARP060100226A ARP060100226A AR062647A1 AR 062647 A1 AR062647 A1 AR 062647A1 AR P060100226 A ARP060100226 A AR P060100226A AR P060100226 A ARP060100226 A AR P060100226A AR 062647 A1 AR062647 A1 AR 062647A1
Authority
AR
Argentina
Prior art keywords
pregabalin
gabapentin
active ingredient
group
ingredient selected
Prior art date
Application number
ARP060100226A
Other languages
Spanish (es)
Original Assignee
Pharmanova Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36692870&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR062647(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pharmanova Inc filed Critical Pharmanova Inc
Publication of AR062647A1 publication Critical patent/AR062647A1/en

Links

Classifications

    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Ophthalmology & Optometry (AREA)
  • Addiction (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Hospice & Palliative Care (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Psychology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Formulaciones farmacéuticas, y con nuevos usos médicos de la gabapentina y la pregabalina. Las formulaciones pueden contener hasta tres componentes, incluyendo un componente de liberacion inmediata, un componente de liberacion sostenida y un componente de liberacion retardada. La proporcion de cada componente presente en la formulacion puede ser ajustada para obtener una AUC y efectos terapéuticos deseados después de la administracion oral en sujetos humanos. Reivindicacion 1: Una composicion que comprende: (a) un ingrediente activo seleccionado del grupo formado por gabapentina y pregabalina con una cubierta de excipiente polimérico soluble independiente del pH. (b) un ingrediente activo seleccionado del grupo formado por gabapentina y pregabalina con una cubierta de excipiente polimérico insoluble independiente del pH, (c) un ingrediente activo seleccionado del grupo formado por gabapentina y pregabalina con una cubierta de excipiente polimérico soluble dependiente del pH.Pharmaceutical formulations, and with new medical uses of gabapentin and pregabalin. The formulations may contain up to three components, including an immediate release component, a sustained release component and a delayed release component. The proportion of each component present in the formulation can be adjusted to obtain an AUC and desired therapeutic effects after oral administration in human subjects. Claim 1: A composition comprising: (a) an active ingredient selected from the group consisting of gabapentin and pregabalin with a soluble polymer excipient shell independent of pH. (b) an active ingredient selected from the group consisting of gabapentin and pregabalin with a pH-insoluble polymeric excipient shell, (c) an active ingredient selected from the group consisting of gabapentin and pregabalin with a pH-dependent soluble polymeric excipient shell.

ARP060100226A 2005-01-21 2006-01-20 PHARMACEUTICAL FORMULATIONS AND METHODS OF USE AR062647A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US64585705P 2005-01-21 2005-01-21

Publications (1)

Publication Number Publication Date
AR062647A1 true AR062647A1 (en) 2008-11-26

Family

ID=36692870

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP060100226A AR062647A1 (en) 2005-01-21 2006-01-20 PHARMACEUTICAL FORMULATIONS AND METHODS OF USE

Country Status (12)

Country Link
EP (1) EP1838291A4 (en)
JP (1) JP2008528494A (en)
KR (1) KR20070116588A (en)
CN (1) CN101137352A (en)
AR (1) AR062647A1 (en)
AU (1) AU2006206423A1 (en)
BR (1) BRPI0614021A2 (en)
CA (1) CA2595470A1 (en)
IL (1) IL184735A0 (en)
MX (1) MX2007008833A (en)
TW (1) TW200640497A (en)
WO (1) WO2006078811A2 (en)

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* Cited by examiner, † Cited by third party
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UA94979C2 (en) 2006-12-22 2011-06-25 Рекордати Айеленд Лимитед Combination therapy for lower urinary tract disorders with α2δ AND NSAIDs
JP2011504491A (en) 2007-11-23 2011-02-10 ルピン・リミテッド Controlled release pharmaceutical composition of pregabalin
RS55769B1 (en) * 2007-11-23 2017-07-31 Gruenenthal Gmbh Tapentadol compositions
US9211263B2 (en) 2012-01-06 2015-12-15 Elcelyx Therapeutics, Inc. Compositions and methods of treating metabolic disorders
HUE051738T2 (en) 2011-01-07 2021-03-29 Anji Pharma Us Llc Chemosensory receptor ligand-based therapies
US8796338B2 (en) 2011-01-07 2014-08-05 Elcelyx Therapeutics, Inc Biguanide compositions and methods of treating metabolic disorders
US9572784B2 (en) 2011-01-07 2017-02-21 Elcelyx Therapeutics, Inc. Compositions comprising statins, biguanides and further agents for reducing cardiometabolic risk
US11974971B2 (en) 2011-01-07 2024-05-07 Anji Pharmaceuticals Inc. Compositions and methods for treating metabolic disorders
US11759441B2 (en) 2011-01-07 2023-09-19 Anji Pharmaceuticals Inc. Biguanide compositions and methods of treating metabolic disorders
WO2012150246A1 (en) * 2011-05-05 2012-11-08 Hennig Arzneimittel Gmbh & Co. Kg Dosage form for the controlled release of active ingredients
KR101438546B1 (en) * 2011-08-26 2014-09-17 근화제약주식회사 Controlled-release formulations comprising pregabalin
WO2013100873A1 (en) * 2011-12-19 2013-07-04 Mahmut Bilgic Pharmaceutical formulation of pregabalin (particle size 300-2500 micrometer)
CN104254325A (en) 2012-01-06 2014-12-31 埃尔舍利克斯治疗公司 Biguanide compositions and methods of treating metabolic disorders
MX2014008189A (en) 2012-01-06 2015-02-12 Elcelyx Therapeutics Inc Compositions and methods for treating metabolic disorders.
KR102221846B1 (en) * 2014-04-07 2021-02-26 영진약품 주식회사 Pharmaceutical composition of pregabalin with improved stability and method for preparing thereof
CN107073048B (en) * 2014-08-29 2021-09-10 若素制药株式会社 Composition containing lactic acid bacteria
CA3018328A1 (en) 2014-10-31 2016-04-30 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
US10561602B2 (en) 2015-05-26 2020-02-18 Isa Odidi Controlled extended release pregabalin
BR112018071363A2 (en) * 2016-04-19 2019-02-05 Ferring Bv oral nicotinamide pharmaceutical compositions
CA3030105A1 (en) * 2016-07-17 2018-01-25 Mapi Pharma Ltd. Extended release dosage forms of pregabalin
JP6919119B2 (en) * 2017-01-23 2021-08-18 日新製薬株式会社 A compressed solid pharmaceutical composition containing a γ-aminobutyric acid derivative substituted at the 3-position.
US10722473B2 (en) 2018-11-19 2020-07-28 Purdue Pharma L.P. Methods and compositions particularly for treatment of attention deficit disorder
CN112023032B (en) * 2020-09-14 2022-03-18 广东鼎信医药科技有限公司 Pharmaceutical composition containing digestive enzyme and preparation method thereof
KR20230117591A (en) 2020-12-04 2023-08-08 라보라토리오스 실레인즈, 에스.에이. 드 씨.브이. Stable coated, solid pharmaceutical composition containing an opioid analgesic and an anticonvulsant for pain relief
CN116898819B (en) * 2023-06-09 2024-02-06 则正(上海)生物科技有限公司 Pregabalin sustained release agent and preparation method thereof

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ZA953078B (en) * 1994-04-28 1996-01-05 Alza Corp Effective therapy for epilepsies
WO1998029095A2 (en) * 1997-01-03 1998-07-09 Elan Corporation, Plc Sustained release cisapride mini-tablet formulation
FR2781793B1 (en) * 1998-08-03 2001-07-20 Prographarm Lab PROCESS FOR PRODUCING COATED GABAPENTINE GRANULES
RU2004123792A (en) * 2002-01-04 2005-04-10 Ивэкс Рисеч, Инк. (Us) DEVICE DELIVERY DEVICE FOR PROLONGED GLIPYSIT DELIVERY
EP2316468A1 (en) * 2002-02-22 2011-05-04 Shire LLC Delivery system and methods for protecting and administering dextroamphetamine
NZ556562A (en) * 2005-02-15 2010-08-27 Jazz Pharmaceuticals Inc Dosage form and method for sustained release of a substituted pyrazine compound

Also Published As

Publication number Publication date
WO2006078811A3 (en) 2007-03-01
CN101137352A (en) 2008-03-05
IL184735A0 (en) 2007-12-03
EP1838291A4 (en) 2008-12-03
KR20070116588A (en) 2007-12-10
MX2007008833A (en) 2008-03-25
BRPI0614021A2 (en) 2011-03-01
JP2008528494A (en) 2008-07-31
TW200640497A (en) 2006-12-01
CA2595470A1 (en) 2006-07-27
EP1838291A2 (en) 2007-10-03
AU2006206423A1 (en) 2006-07-27
WO2006078811A2 (en) 2006-07-27

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