BRPI0514682A - composição de liberação rápida incluindo gránulos de derretimento de um medicamento sensìvel à umidade e processos para manufatura deste - Google Patents

composição de liberação rápida incluindo gránulos de derretimento de um medicamento sensìvel à umidade e processos para manufatura deste

Info

Publication number
BRPI0514682A
BRPI0514682A BRPI0514682-8A BRPI0514682A BRPI0514682A BR PI0514682 A BRPI0514682 A BR PI0514682A BR PI0514682 A BRPI0514682 A BR PI0514682A BR PI0514682 A BRPI0514682 A BR PI0514682A
Authority
BR
Brazil
Prior art keywords
moisture sensitive
composition including
release composition
processes
including melt
Prior art date
Application number
BRPI0514682-8A
Other languages
English (en)
Inventor
James Kowalski
Oskar Kalb
Abu T M Serajuddin
Yatindra Joshi
Original Assignee
Novartis Ag
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=35447883&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0514682(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of BRPI0514682A publication Critical patent/BRPI0514682A/pt
Publication of BRPI0514682B1 publication Critical patent/BRPI0514682B1/pt
Publication of BRPI0514682B8 publication Critical patent/BRPI0514682B8/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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

COMPOSIçãO DE LIBERAçãO RáPIDA INCLUINDO GRáNULOS DE DERRETIMENTO DE UM MEDICAMENTO SENSìVEL à UMIDADE E PROCESSOS PARA MANUFATURA DESTE Formas de dosagem oral sólidas que incluem grânulos de derretimento de um composto terapêutico sensível á umidade e um componente de derretimento hidrofóbico. Os grânulos de derretimento protegem melhor o composto terapêutico de degradação hidrolítica. Tais formas de dosagem oral sólidas também possuem características de liberação imediata ao invés de aquela associada com produtos de medicamentos de liberação extensa ou liberação controlada.
BRPI0514682A 2004-08-27 2005-08-26 processo para fabricar grânulos de composto terapêutico sensível à umidade e inibidor de dpp-iv, bem como composição farmacêutica de liberação imediata para administração oral compreendendo grânulos assim obtidos BRPI0514682B8 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US60532704P 2004-08-27 2004-08-27
US60/605,327 2004-08-27
US61682804P 2004-10-07 2004-10-07
US60/616,828 2004-10-07
PCT/EP2005/009252 WO2006021455A1 (en) 2004-08-27 2005-08-26 Fast release composition including melt granules of a moisture sensitive drug and process for manufacturing thereof

Publications (3)

Publication Number Publication Date
BRPI0514682A true BRPI0514682A (pt) 2008-06-17
BRPI0514682B1 BRPI0514682B1 (pt) 2019-06-04
BRPI0514682B8 BRPI0514682B8 (pt) 2021-05-25

Family

ID=35447883

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0514682A BRPI0514682B8 (pt) 2004-08-27 2005-08-26 processo para fabricar grânulos de composto terapêutico sensível à umidade e inibidor de dpp-iv, bem como composição farmacêutica de liberação imediata para administração oral compreendendo grânulos assim obtidos

Country Status (21)

Country Link
US (1) US20080050443A1 (pt)
EP (2) EP3087975A1 (pt)
JP (1) JP5147399B2 (pt)
KR (8) KR20200087870A (pt)
CN (1) CN101010068B (pt)
AR (1) AR050615A1 (pt)
AU (1) AU2005276583B2 (pt)
BR (1) BRPI0514682B8 (pt)
CA (1) CA2575499A1 (pt)
DK (1) DK1786401T3 (pt)
ES (1) ES2647671T3 (pt)
HU (1) HUE034653T2 (pt)
MX (1) MX2007002253A (pt)
MY (1) MY144297A (pt)
PE (1) PE20060652A1 (pt)
PL (1) PL1786401T3 (pt)
PT (1) PT1786401T (pt)
RU (1) RU2383332C2 (pt)
SI (1) SI1786401T1 (pt)
TW (1) TWI402082B (pt)
WO (1) WO2006021455A1 (pt)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005067976A2 (en) 2004-01-20 2005-07-28 Novartis Ag Direct compression formulation and process
US7754757B2 (en) * 2004-02-05 2010-07-13 Kyorin Pharmaceutical Co., Ltd. Bicycloester derivative
PE20060652A1 (es) 2004-08-27 2006-08-11 Novartis Ag Composiciones farmaceuticas de liberacion inmediata que comprenden granulos de fusion
US7915427B2 (en) * 2006-03-08 2011-03-29 Kyorin Pharmaceuticals Co., Ltd. Process for producing aminoacetyl pyrrolidine carbonitrile derivative and intermediate for production thereof
WO2007128801A1 (en) * 2006-05-08 2007-11-15 Novartis Ag Combination of organic compounds
EP2123636B1 (en) * 2007-03-22 2012-03-21 Kyorin Pharmaceutical Co., Ltd. Method for producing aminoacetylpyrrolidinecarbonitrile derivative
DE102008020701A1 (de) * 2008-04-24 2009-10-29 Bayer Technology Services Gmbh Formulierung mit reduzierter Hygroskopizität
EP2322499A4 (en) 2008-08-07 2011-12-21 Kyorin Seiyaku Kk PROCESS FOR PRODUCING A BICYCLOÝ2.2.2¨OCTYLAMINE DERIVATIVE
EP2327406A4 (en) * 2008-08-14 2014-04-09 Kyorin Seiyaku Kk STABILIZED PHARMACEUTICAL COMPOSITION
AR073651A1 (es) * 2008-09-24 2010-11-24 Novartis Ag Formulaciones galenicas de compuestos organicos
CA2756428A1 (en) 2009-03-27 2010-09-30 Mamoru Fukuda Matrix-type sustained release preparation containing basic additive
JP2011057586A (ja) * 2009-09-08 2011-03-24 Kyorin Pharmaceutical Co Ltd ｐＨ非依存性マトリックス型徐放性製剤
TR201002256A1 (tr) * 2010-03-24 2011-10-21 Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� Stabil aliskiren formülasyonları
US9071358B2 (en) 2012-06-21 2015-06-30 Qualcomm Incrorporated Repeater fiber-coax units
US8989577B2 (en) 2012-06-21 2015-03-24 Qualcomm Incorporated Methods and systems for implementing time-division duplexing in the physical layer
US9363017B2 (en) 2012-07-06 2016-06-07 Qualcomm Incorporated Methods and systems of specifying coaxial resource allocation across a MAC/PHY interface
JP6283316B2 (ja) * 2012-10-26 2018-02-21 株式会社三和化学研究所 アナグリプチン含有固形製剤
WO2014152207A1 (en) * 2013-03-15 2014-09-25 Mylan Laboratories, Inc. Hot melt granulation formulations of poorly water-soluble active agents
CN104274408A (zh) * 2013-07-10 2015-01-14 北京科信必成医药科技发展有限公司 一种熔融包衣的速释药物微粒及其制备方法
WO2015195990A1 (en) * 2014-06-20 2015-12-23 Banner Life Sciences Llc Liquid-filled immediate release soft gelatin capsules
WO2018050892A1 (en) 2016-09-16 2018-03-22 Galenicum Health S.L. Vildagliptin pharmaceutical compositions

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL109770A0 (en) 1993-05-29 1994-11-28 Smithkline Beecham Corp Thermal infusion process for preparing controlled release solid dosage forms of medicaments for oral administration and controlled release solid dosage forms of medicaments prepared thereby
WO1995005808A1 (en) * 1993-08-24 1995-03-02 Abbott Laboratories Oil-based tableting method
EP0654263B1 (en) * 1993-11-23 2002-01-23 Euro-Celtique S.A. Method for preparing a sustained release composition
IL111785A0 (en) 1993-12-03 1995-01-24 Ferring Bv Dp-iv inhibitors and pharmaceutical compositions containing them
US20020142037A1 (en) * 1996-10-01 2002-10-03 Nabil Farah Process for the manufacture of a pharmaceutical composition with modified release of active principle comprising a matrix
WO1998018763A1 (fr) 1996-10-25 1998-05-07 Tanabe Seiyaku Co., Ltd. Derives de tetrahydroisoquinoline
TW492957B (en) 1996-11-07 2002-07-01 Novartis Ag N-substituted 2-cyanopyrrolidnes
US6011155A (en) 1996-11-07 2000-01-04 Novartis Ag N-(substituted glycyl)-2-cyanopyrrolidines, pharmaceutical compositions containing them and their use in inhibiting dipeptidyl peptidase-IV
AU9496798A (en) 1997-09-19 1999-04-05 Shire Laboratories, Inc. Solid solution beadlet
DE19823831A1 (de) 1998-05-28 1999-12-02 Probiodrug Ges Fuer Arzneim Neue pharmazeutische Verwendung von Isoleucyl Thiazolidid und seinen Salzen
CO5150173A1 (es) * 1998-12-10 2002-04-29 Novartis Ag Compuestos n-(glicilo sustituido)-2-cianopirrolidinas inhibidores de peptidasa de dipeptidilo-iv (dpp-iv) los cuales son efectivos en el tratamiento de condiciones mediadas por la inhibicion de dpp-iv
US6107317A (en) 1999-06-24 2000-08-22 Novartis Ag N-(substituted glycyl)-thiazolidines, pharmaceutical compositions containing them and their use in inhibiting dipeptidyl peptidase-IV
US20020015730A1 (en) * 2000-03-09 2002-02-07 Torsten Hoffmann Pharmaceutical formulations and method for making
CA2437492A1 (en) 2001-02-02 2002-08-15 Yoshihiro Banno Fused heterocyclic compounds
UA74912C2 (en) 2001-07-06 2006-02-15 Merck & Co Inc Beta-aminotetrahydroimidazo-(1,2-a)-pyrazines and tetratriazolo-(4,3-a)-pyrazines as inhibitors of dipeptylpeptidase for the treatment or prevention of diabetes
US7985422B2 (en) * 2002-08-05 2011-07-26 Torrent Pharmaceuticals Limited Dosage form
AU2003262059A1 (en) 2002-09-11 2004-04-30 Takeda Pharmaceutical Company Limited Sustained release preparation
DE60320008T2 (de) 2002-10-18 2009-06-18 Merck & Co., Inc. Heterozyklische beta-aminoverbindungen als inhibitoren des dipeptidylpeptidase zur behandlung bzw. prevention von diabetes
ES2344057T3 (es) 2002-10-23 2010-08-17 Bristol-Myers Squibb Company Inhibidores de la dipeptidil peptidasa iv basados en nitrilos de glicina.
PE20060652A1 (es) 2004-08-27 2006-08-11 Novartis Ag Composiciones farmaceuticas de liberacion inmediata que comprenden granulos de fusion

Also Published As

Publication number Publication date
MX2007002253A (es) 2007-04-20
HUE034653T2 (hu) 2018-02-28
BRPI0514682B8 (pt) 2021-05-25
KR20220061249A (ko) 2022-05-12
PT1786401T (pt) 2017-11-22
KR20170103039A (ko) 2017-09-12
JP5147399B2 (ja) 2013-02-20
US20080050443A1 (en) 2008-02-28
RU2007110953A (ru) 2008-10-10
KR20160136465A (ko) 2016-11-29
ES2647671T3 (es) 2017-12-26
JP2008510764A (ja) 2008-04-10
WO2006021455A1 (en) 2006-03-02
AR050615A1 (es) 2006-11-08
PE20060652A1 (es) 2006-08-11
SI1786401T1 (sl) 2017-12-29
KR20130043697A (ko) 2013-04-30
KR20200087870A (ko) 2020-07-21
CN101010068A (zh) 2007-08-01
PL1786401T3 (pl) 2018-01-31
DK1786401T3 (da) 2017-11-27
TW200613005A (en) 2006-05-01
RU2383332C2 (ru) 2010-03-10
TWI402082B (zh) 2013-07-21
KR20070049646A (ko) 2007-05-11
KR101613775B1 (ko) 2016-04-19
AU2005276583B2 (en) 2009-12-03
EP1786401B1 (en) 2017-08-16
KR20160017123A (ko) 2016-02-15
AU2005276583A1 (en) 2006-03-02
CA2575499A1 (en) 2006-03-02
BRPI0514682B1 (pt) 2019-06-04
EP3087975A1 (en) 2016-11-02
MY144297A (en) 2011-08-29
EP1786401A1 (en) 2007-05-23
CN101010068B (zh) 2013-05-22
KR20190006612A (ko) 2019-01-18

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Legal Events

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
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

B07A Application suspended after technical examination (opinion) [chapter 7.1 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 04/06/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 04/06/2019, 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 26/08/2005 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF