BRPI0812250B8 - composição farmacêutica de liberação lenta de uma triptorelina agonista de lhrh feita de micropartículas e uso da mesma - Google Patents

composição farmacêutica de liberação lenta de uma triptorelina agonista de lhrh feita de micropartículas e uso da mesma

Info

Publication number
BRPI0812250B8
BRPI0812250B8 BRPI0812250A BRPI0812250A BRPI0812250B8 BR PI0812250 B8 BRPI0812250 B8 BR PI0812250B8 BR PI0812250 A BRPI0812250 A BR PI0812250A BR PI0812250 A BRPI0812250 A BR PI0812250A BR PI0812250 B8 BRPI0812250 B8 BR PI0812250B8
Authority
BR
Brazil
Prior art keywords
microparticles
pharmaceutical composition
slow release
same
micrometers
Prior art date
Application number
BRPI0812250A
Other languages
English (en)
Inventor
Ducrey Bertrand
Curdy Catherine
Lundstrom Eija
Heimgartner Frédéric
Porchet Hervé
Bardet Marie-Anne
Garrouste Patrick
Original Assignee
Debio Rech Pharmaceutique S A
Debiopharm Int Sa
Debiopharm Res & Manufacturing Sa
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=40032512&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0812250(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Debio Rech Pharmaceutique S A, Debiopharm Int Sa, Debiopharm Res & Manufacturing Sa filed Critical Debio Rech Pharmaceutique S A
Publication of BRPI0812250A2 publication Critical patent/BRPI0812250A2/pt
Publication of BRPI0812250B1 publication Critical patent/BRPI0812250B1/pt
Publication of BRPI0812250B8 publication Critical patent/BRPI0812250B8/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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Abstract

composição farmacêutica de liberação lenta feita de micropartículas. a presente invenção refere-se a composição farmacêutica feita de micropartículas para a liberação lenta de uma substância ativa pelo menos durante um período cobrindo o 6q mês após a injeção da referida composição, compreendendo a referida composição um grupo de micropartículas feitas de um copolímero do tipo plga que incorpora uma substância ativa na forma de um sal de peptídeo insolúvel em água; compreendendo o referido copolímero ainda pelo menos 75% de ácido lático e uma viscosidade inerente entre 0,1 e 0,9 dl/g, conforme determinado em clorofórmio a 25°c e em uma concentração de polímero de 0,5 dl/g; tendo ainda as referi- das micropartículas uma distribuição de tamanho definida como a seguir: - d (v,o,1) situa-se entre 10 e 30 micrômetros, - d (v,0,5) situa-se entre 10 e 70 . 15 micrômetros, - d (v,0,9) situa-se entre 50 e 110 micrômetros.
BRPI0812250A 2007-06-06 2008-06-06 composição farmacêutica de liberação lenta de uma triptorelina agonista de lhrh feita de micropartículas e uso da mesma BRPI0812250B8 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP07109767.9 2007-06-06
EP07109767 2007-06-06
IBPCT/IB2007/054372 2007-10-27
IB2007054372 2007-10-27
PCT/IB2008/052241 WO2008149320A2 (en) 2007-06-06 2008-06-06 Slow release pharmaceutical composition made of microparticles

Publications (3)

Publication Number Publication Date
BRPI0812250A2 BRPI0812250A2 (pt) 2014-12-23
BRPI0812250B1 BRPI0812250B1 (pt) 2020-03-03
BRPI0812250B8 true BRPI0812250B8 (pt) 2021-05-25

Family

ID=40032512

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0812250A BRPI0812250B8 (pt) 2007-06-06 2008-06-06 composição farmacêutica de liberação lenta de uma triptorelina agonista de lhrh feita de micropartículas e uso da mesma

Country Status (32)

Country Link
US (3) US10166181B2 (pt)
EP (3) EP3431077A1 (pt)
JP (1) JP5419169B2 (pt)
KR (1) KR101631475B1 (pt)
CN (1) CN101677959B (pt)
AP (1) AP3000A (pt)
AU (1) AU2008259411B2 (pt)
BR (1) BRPI0812250B8 (pt)
CA (1) CA2688478C (pt)
CO (1) CO6251234A2 (pt)
CY (2) CY1118434T1 (pt)
DK (2) DK2164467T3 (pt)
EA (1) EA019284B1 (pt)
ES (2) ES2611020T3 (pt)
HK (1) HK1141737A1 (pt)
HR (2) HRP20161785T1 (pt)
HU (2) HUE040391T2 (pt)
IL (1) IL202501A (pt)
LT (2) LT2500014T (pt)
MA (1) MA31422B1 (pt)
ME (1) ME00959B (pt)
MX (1) MX2009012856A (pt)
MY (1) MY150450A (pt)
NZ (1) NZ582423A (pt)
PL (2) PL2164467T3 (pt)
PT (2) PT2164467T (pt)
RS (2) RS58248B1 (pt)
SI (2) SI2164467T1 (pt)
TN (1) TN2009000476A1 (pt)
UA (1) UA99830C2 (pt)
WO (1) WO2008149320A2 (pt)
ZA (1) ZA200907940B (pt)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS58248B1 (sr) 2007-06-06 2019-03-29 Debiopharm Res & Manufacturing Sa Farmaceutska kompozicija sa sporim oslobađanjem pripremljena od mikročestica
PT105270B (pt) 2010-08-26 2012-05-31 Domino Ind Ceramicas S A Camada de sílica com libertação lenta de fragrância, telha cerâmica e respectivo processo de produção
CN105267153B (zh) * 2015-11-27 2018-05-11 上海苏豪逸明制药有限公司 一种曲普瑞林缓释微粒及其制备方法
CN105797134B (zh) * 2016-03-29 2019-06-14 浙江圣兆药物科技股份有限公司 一种难溶亮丙瑞林缓释制剂
JP2020510608A (ja) 2016-11-02 2020-04-09 デビオファーム インターナショナル， エス． アー． 抗ｃｄ３７イムノコンジュゲート療法を改善するための方法
KR102402639B1 (ko) 2017-11-24 2022-05-26 삼성전자주식회사 전자 장치 및 그의 통신 방법
CN111000798B (zh) * 2019-12-26 2021-11-23 四川恒博生物科技有限公司 一种采用原位凝胶技术的犬用非手术去势注射液
IT202000017191A1 (it) 2020-07-15 2022-01-15 Xbrane Biopharma Ab Procedimento senza acqua per preparare una composizione farmaceutica per un rilascio più prolungato e controllato di triptorelina o di un suo sale

Family Cites Families (21)

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Publication number Priority date Publication date Assignee Title
EP0190833B1 (en) 1985-02-07 1991-03-27 Takeda Chemical Industries, Ltd. Method for producing microcapsule
US4897268A (en) * 1987-08-03 1990-01-30 Southern Research Institute Drug delivery system and method of making the same
GB2209937B (en) * 1987-09-21 1991-07-03 Depiopharm S A Water insoluble polypeptides
US5225205A (en) * 1989-07-28 1993-07-06 Debiopharm S.A. Pharmaceutical composition in the form of microparticles
CH679207A5 (pt) 1989-07-28 1992-01-15 Debiopharm Sa
MY107937A (en) 1990-02-13 1996-06-29 Takeda Chemical Industries Ltd Prolonged release microcapsules.
CH683149A5 (fr) * 1991-07-22 1994-01-31 Debio Rech Pharma Sa Procédé pour la préparation de microsphères en matériau polymère biodégradable.
FR2693905B1 (fr) * 1992-07-27 1994-09-02 Rhone Merieux Procédé de préparation de microsphères pour la libération prolongée de l'hormone LHRH et ses analogues, microsphères et formulations obtenues.
JP3277342B2 (ja) 1992-09-02 2002-04-22 武田薬品工業株式会社 徐放性マイクロカプセルの製造法
CA2172507C (en) * 1993-10-22 2008-12-02 Jeffrey L. Cleland Methods and compositions for microencapsulation of antigens for use as vaccines
US5945128A (en) * 1996-09-04 1999-08-31 Romano Deghenghi Process to manufacture implants containing bioactive peptides
TW577759B (en) 1997-04-18 2004-03-01 Ipsen Pharma Biotech Sustained release compositions in the form of microcapsules or implants and the process for their preparation
JP2001522812A (ja) * 1997-11-07 2001-11-20 カイロン コーポレイション Ｉｇｆ−１持続放出性処方物の作製方法
TW200800298A (en) * 2000-01-27 2008-01-01 Zentaris Ag Compressed microparticles for dry injection
US20040170665A1 (en) * 2000-06-02 2004-09-02 Allergan, Inc. Intravitreal botulinum toxin implant
BRPI0213226B1 (pt) * 2001-10-10 2016-03-01 Pf Medicament processo de preparação de uma composição farmacêutica sob forma de microesferas com liberação prolongada de um princípio ativo hidrossolúvel, e, microesferas
MXPA05011299A (es) * 2003-04-30 2006-01-24 Debiopharm Sa Metodos y composiciones utilizando la hormona liberadora de la hormona gonadotropina.
KR100466637B1 (ko) * 2003-06-26 2005-01-13 주식회사 펩트론 서방성 미립구의 혼합 제형을 연속한 단일 공정으로제조하는 방법
FR2865938B1 (fr) * 2004-02-05 2006-06-02 Sod Conseils Rech Applic Formulation retard solide comprenant de l'acetate de triptoreline
CN103251929A (zh) 2005-12-22 2013-08-21 诺瓦提斯公司 包含奥曲肽和两种或更多种聚丙交酯-共-乙交酯聚合物的缓释制剂
RS58248B1 (sr) 2007-06-06 2019-03-29 Debiopharm Res & Manufacturing Sa Farmaceutska kompozicija sa sporim oslobađanjem pripremljena od mikročestica

Also Published As

Publication number Publication date
CY1118434T1 (el) 2017-06-28
AP2009005088A0 (en) 2009-12-31
LT2164467T (lt) 2017-01-25
MX2009012856A (es) 2009-12-15
US20190192423A1 (en) 2019-06-27
KR101631475B1 (ko) 2016-06-20
ES2611020T3 (es) 2017-05-04
RS55591B1 (sr) 2017-06-30
PT2164467T (pt) 2017-01-13
CA2688478C (en) 2015-10-27
DK2500014T3 (en) 2018-12-03
US10166181B2 (en) 2019-01-01
ZA200907940B (en) 2010-08-25
MY150450A (en) 2014-01-30
CN101677959B (zh) 2014-02-26
LT2500014T (lt) 2019-01-25
EP2500014B1 (en) 2018-08-08
US20110052717A1 (en) 2011-03-03
CO6251234A2 (es) 2011-02-21
IL202501A (en) 2015-11-30
SI2500014T1 (sl) 2019-02-28
EP3431077A1 (en) 2019-01-23
EP2500014A2 (en) 2012-09-19
BRPI0812250A2 (pt) 2014-12-23
SI2164467T1 (sl) 2017-05-31
AU2008259411A1 (en) 2008-12-11
CY1120891T1 (el) 2019-12-11
HUE031550T2 (en) 2017-07-28
AP3000A (en) 2014-10-31
ES2694401T3 (es) 2018-12-20
WO2008149320A3 (en) 2009-02-05
JP2010529106A (ja) 2010-08-26
EA200971132A1 (ru) 2010-04-30
PT2500014T (pt) 2018-11-21
AU2008259411B2 (en) 2013-10-17
DK2164467T3 (en) 2017-01-30
EA019284B1 (ru) 2014-02-28
RS58248B1 (sr) 2019-03-29
EP2500014A3 (en) 2012-11-07
CN101677959A (zh) 2010-03-24
NZ582423A (en) 2011-10-28
UA99830C2 (uk) 2012-10-10
TN2009000476A1 (en) 2011-03-31
HK1141737A1 (en) 2010-11-19
BRPI0812250B1 (pt) 2020-03-03
ME00959B (me) 2012-06-20
KR20100023950A (ko) 2010-03-04
WO2008149320A2 (en) 2008-12-11
HUE040391T2 (hu) 2019-03-28
US20230082575A1 (en) 2023-03-16
HRP20181854T1 (hr) 2019-02-08
HRP20161785T1 (hr) 2017-03-10
CA2688478A1 (en) 2008-12-11
EP2164467B1 (en) 2016-12-14
PL2500014T3 (pl) 2019-04-30
IL202501A0 (en) 2010-06-30
JP5419169B2 (ja) 2014-02-19
EP2164467A2 (en) 2010-03-24
PL2164467T3 (pl) 2017-07-31
MA31422B1 (fr) 2010-06-01

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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]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 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]
B25D Requested change of name of applicant approved

Owner name: DEBIOPHARM RESEARCH AND MANUFACTURING SA (CH)

B25A Requested transfer of rights approved

Owner name: DEBIOPHARM INTERNATIONAL SA (CH)

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 03/03/2020, 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 06/06/2008 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF