DK2164467T3 - Farmaceutisk sammensætning med langsom frigivelse bestående af mikropartikler - Google Patents
Farmaceutisk sammensætning med langsom frigivelse bestående af mikropartikler Download PDFInfo
- Publication number
- DK2164467T3 DK2164467T3 DK08763237.8T DK08763237T DK2164467T3 DK 2164467 T3 DK2164467 T3 DK 2164467T3 DK 08763237 T DK08763237 T DK 08763237T DK 2164467 T3 DK2164467 T3 DK 2164467T3
- Authority
- DK
- Denmark
- Prior art keywords
- microparticles
- pharmaceutical composition
- group
- micrometers
- copolymer
- Prior art date
Links
Classifications
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- 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)
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- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Reproductive Health (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Inorganic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (10)
1. Farmaceutisk sammensætning bestående af mikropartikler til langsom frigivelse af en LHRH-agonist triptorelin, kendetegnet ved at sammensætningen omfatter en første gruppe af mikropartikler og en anden gruppe af mikropartikler, hvor a) mikropartiklerne af den første gruppe består af en copolymer af PLGA-typen som inkorporerer LHRH-agonisten i form af et vanduopløseligt peptidsalt; idet copolymeren omfatter mindst 85 % (molær) mælkesyre og har en iboende viskositet mellem 0,5 og 0,9 dl/g, som målt i kloroform ved 25 °C og ved en polymerkoncentration på 0,5 g/dL; b) mikropartiklerne i den anden gruppe består af en copolymer af PLGA-typen som inkorporerer LHRH-agonisten i form af et vanduopløseligt peptidsalt og som omfatter en mængde mælkesyre på mellem 70 % og 80 % (molær); idet mikropartiklerne af de første og anden grupper endvidere har en størrelsesfordeling defineret som følger: - D (v,0,l) er mellem 10 og 30 mikrometer, - D (v,0,5) er mellem 30 og 70 mikrometer, - D (v,0,9) er mellem 50 og 110 mikrometer, idet den farmaceutiske sammensætning frigiver LHRH-agonisten triptorelin mindst i løbet af et tidsrum der dækker den 5. måned efter indsprøjtning af sammensætningen.
2. Farmaceutisk sammensætning ifølge krav 1, hvor copolymeren i den første gruppe omfatter mindst 85 % (molær) mælkesyre og har en iboende viskositet mellem 0,55 og 0,75 dl/g.
3. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor mikropartiklerne af den første gruppe, eller af den anden gruppe, eller af begge grupper, er mikrosfærer.
4. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor mikropartiklerne af den første gruppe, eller af den anden gruppe, eller af begge grupper, er mikrogranulater.
5. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 4, hvor den iboende viskositet af copolymeren i den anden gruppe er mellem 0,5 og 0,9, fortrinsvis mellem 0,60 og 0,70 dl/g.
6. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 5, hvor begge grupper af mikropartikler er i et dosisforhold, udtrykt i peptidindhold, på 50:50.
7. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor mindst en af grupperne af mikropartikler er opnået ved blanding, i en opløsnings-fri proces, af PLGA'en med set vanduopløselige peptidsalt.
8. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 7, hvor det vanduopløselige peptidsalt er triptorelinpamoat.
9. Anvendelse afen sammensætning ifølge et hvilket som helst af kravene 1 til 8 ved fremstillingen af et lægemiddel til behandling af prostatacancer, kendetegnet ved det forhold at sammensætningen indgives en gang hver 6 måned.
10. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 8 til anvendelse til behandling af prostatacancer, hvor sammensætningen indgives en gang hver 6 måned.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07109767 | 2007-06-06 | ||
IB2007054372 | 2007-10-27 | ||
PCT/IB2008/052241 WO2008149320A2 (en) | 2007-06-06 | 2008-06-06 | Slow release pharmaceutical composition made of microparticles |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2164467T3 true DK2164467T3 (da) | 2017-01-30 |
Family
ID=40032512
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK08763237.8T DK2164467T3 (da) | 2007-06-06 | 2008-06-06 | Farmaceutisk sammensætning med langsom frigivelse bestående af mikropartikler |
DK12172232.6T DK2500014T3 (da) | 2007-06-06 | 2008-06-06 | Farmaceutisk sammensætning med langsom frigivelse lavet af mikropartikler |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12172232.6T DK2500014T3 (da) | 2007-06-06 | 2008-06-06 | Farmaceutisk sammensætning med langsom frigivelse lavet af mikropartikler |
Country Status (32)
Country | Link |
---|---|
US (3) | US10166181B2 (da) |
EP (3) | EP2500014B1 (da) |
JP (1) | JP5419169B2 (da) |
KR (1) | KR101631475B1 (da) |
CN (1) | CN101677959B (da) |
AP (1) | AP3000A (da) |
AU (1) | AU2008259411B2 (da) |
BR (1) | BRPI0812250B8 (da) |
CA (1) | CA2688478C (da) |
CO (1) | CO6251234A2 (da) |
CY (2) | CY1118434T1 (da) |
DK (2) | DK2164467T3 (da) |
EA (1) | EA019284B1 (da) |
ES (2) | ES2611020T3 (da) |
HK (1) | HK1141737A1 (da) |
HR (2) | HRP20161785T1 (da) |
HU (2) | HUE040391T2 (da) |
IL (1) | IL202501A (da) |
LT (2) | LT2164467T (da) |
MA (1) | MA31422B1 (da) |
ME (1) | ME00959B (da) |
MX (1) | MX2009012856A (da) |
MY (1) | MY150450A (da) |
NZ (1) | NZ582423A (da) |
PL (2) | PL2500014T3 (da) |
PT (2) | PT2500014T (da) |
RS (2) | RS58248B1 (da) |
SI (2) | SI2500014T1 (da) |
TN (1) | TN2009000476A1 (da) |
UA (1) | UA99830C2 (da) |
WO (1) | WO2008149320A2 (da) |
ZA (1) | ZA200907940B (da) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
NZ582423A (en) | 2007-06-06 | 2011-10-28 | Debio Rech Pharma Sa | Slow release pharmaceutical composition made of microparticles comprising plga, lhrh and lactic acid |
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 |
EP3535297B1 (en) | 2016-11-02 | 2022-08-10 | Debiopharm International, S.A. | Methods for improving anti-cd37 immunoconjugate therapy |
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)
Publication number | Priority date | Publication date | Assignee | Title |
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DE3678308D1 (de) | 1985-02-07 | 1991-05-02 | Takeda Chemical Industries Ltd | Verfahren zur herstellung von mikrokapseln. |
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 |
CH679207A5 (da) | 1989-07-28 | 1992-01-15 | Debiopharm Sa | |
US5225205A (en) | 1989-07-28 | 1993-07-06 | Debiopharm S.A. | Pharmaceutical composition in the form of microparticles |
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 |
ES2182850T3 (es) * | 1993-10-22 | 2003-03-16 | Genentech Inc | Procedimientos y composiciones para la microencapsulacion de adyuvantes. |
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 |
EP1028746B1 (en) * | 1997-11-07 | 2003-02-26 | Chiron Corporation | Method for producing igf-i sustained-release formulations |
TWI284048B (en) * | 2000-01-27 | 2007-07-21 | Zentaris Ag | Compressed microparticles for dry injection |
US20040170665A1 (en) * | 2000-06-02 | 2004-09-02 | Allergan, Inc. | Intravitreal botulinum toxin implant |
ES2541908T3 (es) * | 2001-10-10 | 2015-07-28 | Pierre Fabre Medicament | Microesferas biodegradables de liberación prolongada y su procedimiento de preparación |
JP2006525306A (ja) * | 2003-04-30 | 2006-11-09 | デビオファーム ソシエテ アノニム | ゴナドトロピン・ホルモン放出ホルモンを使用する方法及び組成物 |
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 |
BR122019027412B8 (pt) | 2005-12-22 | 2021-07-27 | Novartis Ag | composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administração |
NZ582423A (en) | 2007-06-06 | 2011-10-28 | Debio Rech Pharma Sa | Slow release pharmaceutical composition made of microparticles comprising plga, lhrh and lactic acid |
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2008
- 2008-06-06 NZ NZ582423A patent/NZ582423A/en unknown
- 2008-06-06 PT PT12172232T patent/PT2500014T/pt unknown
- 2008-06-06 PT PT87632378T patent/PT2164467T/pt unknown
- 2008-06-06 KR KR1020107000176A patent/KR101631475B1/ko active IP Right Grant
- 2008-06-06 CA CA2688478A patent/CA2688478C/en active Active
- 2008-06-06 EP EP12172232.6A patent/EP2500014B1/en active Active
- 2008-06-06 SI SI200832014T patent/SI2500014T1/sl unknown
- 2008-06-06 LT LTEP08763237.8T patent/LT2164467T/lt unknown
- 2008-06-06 AP AP2009005088A patent/AP3000A/xx active
- 2008-06-06 EP EP18186642.7A patent/EP3431077A1/en active Pending
- 2008-06-06 RS RS20181349A patent/RS58248B1/sr unknown
- 2008-06-06 SI SI200831754A patent/SI2164467T1/sl unknown
- 2008-06-06 MY MYPI20094886 patent/MY150450A/en unknown
- 2008-06-06 EA EA200971132A patent/EA019284B1/ru unknown
- 2008-06-06 ES ES08763237.8T patent/ES2611020T3/es active Active
- 2008-06-06 PL PL12172232T patent/PL2500014T3/pl unknown
- 2008-06-06 US US12/601,649 patent/US10166181B2/en active Active
- 2008-06-06 RS RS20170032A patent/RS55591B1/sr unknown
- 2008-06-06 WO PCT/IB2008/052241 patent/WO2008149320A2/en active Application Filing
- 2008-06-06 ME MEP-2009-341A patent/ME00959B/me unknown
- 2008-06-06 JP JP2010510946A patent/JP5419169B2/ja active Active
- 2008-06-06 ES ES12172232.6T patent/ES2694401T3/es active Active
- 2008-06-06 DK DK08763237.8T patent/DK2164467T3/da active
- 2008-06-06 BR BRPI0812250A patent/BRPI0812250B8/pt active IP Right Grant
- 2008-06-06 MX MX2009012856A patent/MX2009012856A/es active IP Right Grant
- 2008-06-06 UA UAA200913838A patent/UA99830C2/uk unknown
- 2008-06-06 DK DK12172232.6T patent/DK2500014T3/da active
- 2008-06-06 HU HUE12172232A patent/HUE040391T2/hu unknown
- 2008-06-06 HU HUE08763237A patent/HUE031550T2/en unknown
- 2008-06-06 EP EP08763237.8A patent/EP2164467B1/en not_active Revoked
- 2008-06-06 PL PL08763237T patent/PL2164467T3/pl unknown
- 2008-06-06 AU AU2008259411A patent/AU2008259411B2/en active Active
- 2008-06-06 CN CN200880018833.3A patent/CN101677959B/zh active Active
- 2008-06-06 LT LTEP12172232.6T patent/LT2500014T/lt unknown
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2009
- 2009-11-09 TN TNP2009000476A patent/TN2009000476A1/fr unknown
- 2009-11-11 ZA ZA200907940A patent/ZA200907940B/xx unknown
- 2009-12-01 MA MA32391A patent/MA31422B1/fr unknown
- 2009-12-02 CO CO09137855A patent/CO6251234A2/es not_active Application Discontinuation
- 2009-12-03 IL IL202501A patent/IL202501A/en active IP Right Grant
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2010
- 2010-09-02 HK HK10108338.2A patent/HK1141737A1/xx unknown
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2016
- 2016-12-27 HR HRP20161785TT patent/HRP20161785T1/hr unknown
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2017
- 2017-01-17 CY CY20171100060T patent/CY1118434T1/el unknown
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2018
- 2018-11-07 HR HRP20181854TT patent/HRP20181854T1/hr unknown
- 2018-11-07 CY CY181101171T patent/CY1120891T1/el unknown
- 2018-11-15 US US16/192,674 patent/US20190192423A1/en not_active Abandoned
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2022
- 2022-09-15 US US17/932,621 patent/US20230082575A1/en active Pending
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