BR112019000636A2 - formas de dosagem de liberação prolongada de pregabalina - Google Patents

formas de dosagem de liberação prolongada de pregabalina

Info

Publication number
BR112019000636A2
BR112019000636A2 BR112019000636-2A BR112019000636A BR112019000636A2 BR 112019000636 A2 BR112019000636 A2 BR 112019000636A2 BR 112019000636 A BR112019000636 A BR 112019000636A BR 112019000636 A2 BR112019000636 A2 BR 112019000636A2
Authority
BR
Brazil
Prior art keywords
pregabalin
release
hours
pharmaceutical compositions
prolonged release
Prior art date
Application number
BR112019000636-2A
Other languages
English (en)
Inventor
Sela Yoram
Rubnov Shai
Original Assignee
Mapi Pharma Ltd.
Jiangsu Nhwa Pharmaceutical Co., 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 Mapi Pharma Ltd., Jiangsu Nhwa Pharmaceutical Co., Ltd. filed Critical Mapi Pharma Ltd.
Publication of BR112019000636A2 publication Critical patent/BR112019000636A2/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C1/00—Preparation of hydrocarbons from one or more compounds, none of them being a hydrocarbon
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—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
    • A61K9/48—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
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/5073—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

a presente invenção se refere a composições farmacêuticas de liberação prolongada compreendendo pregabalina ou um sal do mesmo, que são adaptados à liberação do ingrediente ativo pregabalina de acordo com um perfil de liberação duplo. as formulações compreendem dois componentes, o primeiro (er rápida) fornecendo liberação prolongada do ingrediente ativo em um modo controlado curto durante de cerca de 4 a cerca de 6 horas, e o segundo (er lenta ou de manutenção) fornecendo a liberação prolongada do ingrediente ativo durante um período de 24 horas. a proporção de cada componente na formulação pode ser ajustada para conseguir a auc e o efeito terapêutico desejado após a administração oral a um sujeito. a invenção ainda se refere aos métodos de uso de composições farmacêuticas para o tratamento de condições e distúrbios que respondem ao tratamento com pregabalina, tais como dor neuropática associada com neuropatia diabética periférica (dpn), neuralgia pós-herpética (phn), epilepsia, convulsões e fibromialgia.
BR112019000636-2A 2016-07-17 2017-07-16 formas de dosagem de liberação prolongada de pregabalina BR112019000636A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662363267P 2016-07-17 2016-07-17
US62/363,267 2016-07-17
PCT/IL2017/050802 WO2018015946A1 (en) 2016-07-17 2017-07-16 Extended release dosage forms of pregabalin

Publications (1)

Publication Number Publication Date
BR112019000636A2 true BR112019000636A2 (pt) 2019-04-30

Family

ID=60992289

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019000636-2A BR112019000636A2 (pt) 2016-07-17 2017-07-16 formas de dosagem de liberação prolongada de pregabalina

Country Status (8)

Country Link
US (2) US11026908B2 (pt)
EP (1) EP3484456A4 (pt)
CN (1) CN109475510B (pt)
AU (1) AU2017300185B2 (pt)
BR (1) BR112019000636A2 (pt)
CA (1) CA3030105A1 (pt)
IL (1) IL263941B (pt)
WO (1) WO2018015946A1 (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112019000636A2 (pt) * 2016-07-17 2019-04-30 Mapi Pharma Ltd. formas de dosagem de liberação prolongada de pregabalina
KR102631399B1 (ko) * 2018-03-30 2024-02-01 씨지인바이츠 주식회사 폴마콕시브 및 프레가발린을 포함하는 통증 치료용 약제학적 조성물
US11938222B2 (en) * 2018-06-13 2024-03-26 Beijing Tide Pharmaceutical Co., Ltd. Pregabalin sustained release composition and method for preparing the same
US20210251906A1 (en) * 2018-06-28 2021-08-19 Mylan Inc. Pregabalin extended-release formulations
MX2022011196A (es) * 2020-03-09 2022-09-19 Sushma Paul Berlia Formulaciones de liberacion controlada que comprenden drotaverina o una sal de la misma.
WO2022119430A1 (es) 2020-12-04 2022-06-09 Laboratorios Silanes S.A. De C.V. Composición farmacéutica sólida recubierta y estable de un analgésico opioide y un antiepiléptico para el dolor
WO2022256545A1 (en) * 2021-06-04 2022-12-08 Nevakar Injectables Inc. Injectable pregabalin formulations
CN114983951B (zh) * 2021-12-24 2023-11-07 微研优仿医药科技(江苏)有限公司 一种胃漂浮片组合物及其制备方法
CN116850153B (zh) * 2023-06-12 2024-02-06 则正(上海)生物科技有限公司 一种普瑞巴林药物组合物及其制备方法

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US5133974A (en) * 1989-05-05 1992-07-28 Kv Pharmaceutical Company Extended release pharmaceutical formulations
ATE359068T1 (de) 1999-07-22 2007-05-15 Univ Rochester Methode zur behandlung der symptome hormoneller veränderungen, einschliesslich hitzewallungen
CA2363902C (en) 2000-12-07 2005-07-26 Warner-Lambert Company Process and system for controlled-release drug delivery
TWI312285B (en) 2001-10-25 2009-07-21 Depomed Inc Methods of treatment using a gastric retained gabapentin dosage
US20050163841A1 (en) 2003-10-31 2005-07-28 Wong Patrick S. Compositions and dosage forms for enhanced absorption of 3-amino-n-butyl-phosphinic acid
US20060159233A1 (en) * 2005-01-19 2006-07-20 Cotton John M Re-arrangeable analog electrical cross connect
TW200640497A (en) * 2005-01-21 2006-12-01 Pharmanova Inc Pharmaceutical formulations and methods of use
NL2000281C2 (nl) * 2005-11-02 2007-08-07 Pfizer Prod Inc Vaste farmaceutische samenstellingen die pregabaline bevatten.
CN1857244A (zh) 2006-03-06 2006-11-08 重庆医药工业研究院有限责任公司 普瑞巴林缓释药物组合物
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US20100159001A1 (en) * 2008-12-19 2010-06-24 Cardinal John R Extended-Release Pharmaceutical Formulations
JP5827952B2 (ja) 2009-10-09 2015-12-02 ユンジン・ファーム・カンパニー・リミテッドＹｕｎｇｊｉｎ Ｐｈａｒｍ． Ｃｏ． Ｌｔｄ． 速効性と持続性を同時に有する薬剤学的組成物
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Also Published As

Publication number Publication date
WO2018015946A1 (en) 2018-01-25
CA3030105A1 (en) 2018-01-25
US20190298675A1 (en) 2019-10-03
EP3484456A4 (en) 2020-03-18
CN109475510B (zh) 2023-03-10
IL263941A (en) 2019-02-28
AU2017300185A1 (en) 2019-01-24
AU2017300185B2 (en) 2023-02-02
EP3484456A1 (en) 2019-05-22
IL263941B (en) 2022-01-01
US11026908B2 (en) 2021-06-08
US20210260006A1 (en) 2021-08-26
CN109475510A (zh) 2019-03-15

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B25A Requested transfer of rights approved

Owner name: MAPI PHARMA LTD. (IL)