BRPI0311701B8 - formulação farmacêutica de dosagem multiparticulada revestida com liberação controlada de lamotrigina - Google Patents

formulação farmacêutica de dosagem multiparticulada revestida com liberação controlada de lamotrigina

Info

Publication number
BRPI0311701B8
BRPI0311701B8 BRPI0311701A BR0311701A BRPI0311701B8 BR PI0311701 B8 BRPI0311701 B8 BR PI0311701B8 BR PI0311701 A BRPI0311701 A BR PI0311701A BR 0311701 A BR0311701 A BR 0311701A BR PI0311701 B8 BRPI0311701 B8 BR PI0311701B8
Authority
BR
Brazil
Prior art keywords
lamotrigine
controlled release
pharmaceutical formulation
multiparticulate dosage
dosage pharmaceutical
Prior art date
Application number
BRPI0311701A
Other languages
English (en)
Other versions
BR0311701A (pt
BRPI0311701B1 (pt
Inventor
Sadanand Nadkarni Sunil
Original Assignee
Torrent 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 Torrent Pharmaceuticals Ltd filed Critical Torrent Pharmaceuticals Ltd
Publication of BR0311701A publication Critical patent/BR0311701A/pt
Publication of BRPI0311701B1 publication Critical patent/BRPI0311701B1/pt
Publication of BRPI0311701B8 publication Critical patent/BRPI0311701B8/pt

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
    • A61K9/20—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Abstract

"formulação de dosagem multiparticulada com liberação controlada de lamotrigina, composição farmacêutica, processo para a preparação de uma composição farmacêutica de lamotrigina, método para a redução da flutuação no pico e no depósito da concentração da droga no plasma do sangue de um paciente, método para melhorar a complacência de um paciente pela redução da freqüência de dosagem para uma vez por dia, método para a ministração mais segura de lamotrigina, método para proporcionar uma concentração terapêutica de plasma de sangue de lamotrigina e uso da formulação". a presente invenção refere-se a formulações com liberação controlada de múltiplas partículas de rápida desintegração de lamotrigina tendo um perfil farmacocinético melhorado e uma melhor complacência por parte do paciente e a um processo para a preparação das formulações. a invenção proporciona um melhor controle dos níveis de plasma no sangue que as formulações de tabletes convencionais que são ministradas uma vez ao dia.
BRPI0311701A 2002-06-07 2003-06-06 formulação farmacêutica de dosagem multiparticulada revestida com liberação controlada de lamotrigina BRPI0311701B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US38679502P 2002-06-07 2002-06-07
US60/386,795 2002-06-07
PCT/IN2003/000213 WO2003104192A2 (en) 2002-06-07 2003-06-06 Controlled release formulation of lamotrigine

Publications (3)

Publication Number Publication Date
BR0311701A BR0311701A (pt) 2005-03-08
BRPI0311701B1 BRPI0311701B1 (pt) 2018-05-29
BRPI0311701B8 true BRPI0311701B8 (pt) 2021-05-25

Family

ID=29736213

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0311701A BRPI0311701B8 (pt) 2002-06-07 2003-06-06 formulação farmacêutica de dosagem multiparticulada revestida com liberação controlada de lamotrigina

Country Status (12)

Country Link
US (2) US7939102B2 (pt)
EP (1) EP1513535B1 (pt)
AT (1) ATE401890T1 (pt)
AU (1) AU2003267808A1 (pt)
BR (1) BRPI0311701B8 (pt)
CA (1) CA2488868C (pt)
DE (1) DE60322389D1 (pt)
DK (1) DK1513535T3 (pt)
ES (1) ES2311108T3 (pt)
PT (1) PT1513535E (pt)
RU (1) RU2328274C2 (pt)
WO (1) WO2003104192A2 (pt)

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ATE348618T1 (de) * 2001-05-09 2007-01-15 Bayer Healthcare Ag Neue verwendung von 2-(2-ethoxy-5-(4-methyl- piperazin-1-sulfonyl)-phenyl)-5-methyl-7-propyl 3h-imidazo(5,1-f)(1,2,4)triazin-4-on
GB0203296D0 (en) 2002-02-12 2002-03-27 Glaxo Group Ltd Novel composition
US7939102B2 (en) * 2002-06-07 2011-05-10 Torrent Pharmaceuticals Ltd. Controlled release formulation of lamotrigine
DE10232113A1 (de) * 2002-07-16 2004-01-29 Bayer Ag Vardenafil Hydrochlorid Trihydrat enthaltende Arzneimittel
US8637512B2 (en) * 2002-07-29 2014-01-28 Glaxo Group Limited Formulations and method of treatment
WO2004103340A1 (en) * 2003-05-20 2004-12-02 Ranbaxy Laboratories Limited Water dispersible tablets of lamotrigine
US20060165790A1 (en) * 2003-06-27 2006-07-27 Malcolm Walden Multiparticulates
WO2005051350A2 (en) * 2003-10-28 2005-06-09 Torrent Pharmaceuticals Limited Water dispersible tablet
AU2005244329A1 (en) * 2004-04-06 2005-11-24 Rpg Life Sciences Limited Mouth dissolvable and meltable, and water dispersable delivery formulation
DE102004023069A1 (de) * 2004-05-11 2005-12-08 Bayer Healthcare Ag Neue Darreichungsformen des PDE 5-Inhibitors Vardenafil
GB2418854B (en) 2004-08-31 2009-12-23 Euro Celtique Sa Multiparticulates
DE102005001989A1 (de) * 2005-01-15 2006-07-20 Bayer Healthcare Ag Intravenöse Formulierungen von PDE-Inhibitoren
WO2006088814A2 (en) * 2005-02-15 2006-08-24 Jazz Pharmaceuticals Dosage form and method for sustained release of a substituted pyrazine compound
DE102005009240A1 (de) * 2005-03-01 2006-09-07 Bayer Healthcare Ag Arzneiformen mit verbesserten pharmakokinetischen Eigenschaften
DE102005009241A1 (de) * 2005-03-01 2006-09-07 Bayer Healthcare Ag Arzneiformen mit kontrollierter Bioverfügbarkeit
WO2006092064A1 (en) * 2005-03-04 2006-09-08 Intelgenx Corporation Delayed release pharmaceutical oral dosage form and method of making same
EP1906937B1 (en) 2005-07-22 2016-10-19 Rubicon Research Pvt Ltd. Novel dispersible tablet composition
US20090186896A1 (en) * 2005-09-29 2009-07-23 Bayer Healthcare Ag PDE Inhibitors and Combinations Thereof for the Treatment of Urological Disorders
CA2689638A1 (en) * 2007-06-13 2008-12-18 Bayer Schering Pharma Aktiengesellschaft Pde inhibitors for the treatment of hearing impairment
TWI547282B (zh) * 2007-07-02 2016-09-01 愛戴爾製藥股份有限公司 樂命達之口服分解錠劑組合物
US20090022789A1 (en) * 2007-07-18 2009-01-22 Supernus Pharmaceuticals, Inc. Enhanced formulations of lamotrigine
US20090181084A1 (en) * 2008-01-15 2009-07-16 Ta-Ping Liao Oral fast-disintegrating tablet including particles of slowly-releaseable ascorbic acid
US20090196924A1 (en) * 2008-02-04 2009-08-06 Pramod Kharwade Controlled-release lamotrigine formulations
US8133506B2 (en) 2008-03-12 2012-03-13 Aptalis Pharmatech, Inc. Drug delivery systems comprising weakly basic drugs and organic acids
FR2930147B1 (fr) * 2008-04-18 2013-02-08 Flamel Tech Sa Forme orale solide dotee d'un double profil de liberation
AU2010211985A1 (en) * 2009-01-22 2011-08-11 Abbott Healthcare Private Limited Chronotherapeutic pharmaceutical composition
EP2263657B1 (en) 2009-05-20 2013-07-17 Ranbaxy Laboratories Limited Controlled release lamotrigine formulations
US20110052686A1 (en) 2009-09-03 2011-03-03 Ranbaxy Laboratories Limited Modified release lamotrigine tablets
EP2542243A2 (en) 2010-03-04 2013-01-09 Wockhardt Limited Modified release dosage form
RU2633655C1 (ru) * 2016-05-17 2017-10-16 Федеральное государственное бюджетное образовательное учреждение высшего образования "Саратовский национальный исследовательский государственный университет имени Н.Г. Чернышевского" Устройство для дозированного вскрытия микрокапсул
CN110545818A (zh) * 2017-02-03 2019-12-06 朱比兰特医药有限公司 拉莫三嗪悬浮剂剂型

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IE66933B1 (en) 1990-01-15 1996-02-07 Elan Corp Plc Controlled absorption naproxen formulation for once-daily administration
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US6559293B1 (en) * 2002-02-15 2003-05-06 Transform Pharmaceuticals, Inc. Topiramate sodium trihydrate
ES2282628T3 (es) * 2002-04-23 2007-10-16 Teva Pharmaceutical Industries Ltd. Composicon farmaceutica que contiene particulas de lamotrigina de morfologia definida.
US7939102B2 (en) * 2002-06-07 2011-05-10 Torrent Pharmaceuticals Ltd. Controlled release formulation of lamotrigine
US8637512B2 (en) 2002-07-29 2014-01-28 Glaxo Group Limited Formulations and method of treatment
WO2004012741A1 (en) 2002-07-29 2004-02-12 Glaxo Group Limited Sustained release formulations comprising lamotrigine

Also Published As

Publication number Publication date
WO2003104192A2 (en) 2003-12-18
RU2328274C2 (ru) 2008-07-10
CA2488868A1 (en) 2003-12-18
BR0311701A (pt) 2005-03-08
US20110123618A1 (en) 2011-05-26
US7939102B2 (en) 2011-05-10
EP1513535A2 (en) 2005-03-16
BRPI0311701B1 (pt) 2018-05-29
DK1513535T3 (da) 2008-11-17
EP1513535B1 (en) 2008-07-23
AU2003267808A1 (en) 2003-12-22
CA2488868C (en) 2010-05-11
PT1513535E (pt) 2008-10-31
ES2311108T3 (es) 2009-02-01
US20040043996A1 (en) 2004-03-04
AU2003267808A8 (en) 2003-12-22
WO2003104192A3 (en) 2004-03-11
DE60322389D1 (de) 2008-09-04
RU2004139088A (ru) 2005-11-20
ATE401890T1 (de) 2008-08-15

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: PARA.INT.CI. A61K 31/53, A61K 9/20, A61K 9/26, A61K 9/52, A61P 25/08

Ipc: A61K 31/53 (2011.01), A61K 9/20 (2011.01), A61K 9/

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 29/05/2018, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/06/2003 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 21A ANUIDADE.

B21H Decision of lapse of a patent or of a certificate of addition of invention cancelled [chapter 21.8 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 21.6 NA RPI NO 2778 DE 02/04/2024 POR TER SIDO INDEVIDA.