KR100818904B1 - 서방형 미세결정성 펩타이드 현탁액 - Google Patents
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- KR100818904B1 KR100818904B1 KR1020047003371A KR20047003371A KR100818904B1 KR 100818904 B1 KR100818904 B1 KR 100818904B1 KR 1020047003371 A KR1020047003371 A KR 1020047003371A KR 20047003371 A KR20047003371 A KR 20047003371A KR 100818904 B1 KR100818904 B1 KR 100818904B1
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- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
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- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
- A61P5/04—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin for decreasing, blocking or antagonising the activity of the hypothalamic hormones
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K9/10—Dispersions; Emulsions
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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
- A61K9/14—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
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Abstract
Description
Claims (49)
- 트리플루오로아세트산 또는 황산으로부터 유도된 트리플루오로아세테이트 이온 또는 설페이트 이온과 Ac-D-Nal-D-pClPhe-D-Pal-Ser-Tyr-D-Hci-Leu-Lys(iPr)-Pro-D-Ala-NH2의 펩타이드 (테베렐릭스(teverelix®))를, 겔을 형성시키지 않으면서 당해 테베렐릭스의 유동성 유백색 미세결정성 수성 현탁액을 제공하도록 1.6:1 이상의 산:테베렐릭스의 몰 비로 접촉시킴을 포함하여, 테베렐릭스의 겔 형성을 방지하는 방법.
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- 제1항에 있어서, 테베렐릭스 염이 수성 매질에 25mg/㎖ 이상의 농도로 현탁되는 방법.
- 제1항 또는 제8항에 있어서, 수성 현탁액이 등장제를 함유하는 방법.
- 제9항에 있어서, 등장제가 만니톨인 방법.
- 제1항 또는 제8항에 있어서, 수성 현탁액이 약제학적으로 허용되는 부형제를 함유하는 방법.
- 제1항 또는 제8항에 있어서, 수성 현탁액이 동결건조된 테베렐릭스 염으로부터 즉석으로 수득되는 방법.
- 트리플루오로아세트산 또는 황산으로부터 유도된 트리플루오로아세테이트 이온 또는 설페이트 이온과 Ac-D-Nal-D-pClPhe-D-Pal-Ser-Tyr-D-Hci-Leu-Lys(iPr)-Pro-D-Ala-NH2의 펩타이드 (테베렐릭스)가, 혼합시 겔을 형성시키지 않으면서 유동성 유백색 미세결정성 수성 현탁액을 형성하도록 1.6:1 이상의 산:테베렐릭스의 몰 비로 존재하는, 상기 트리플루오로아세테이트 이온 또는 설페이트 이온과 테베렐릭스의 유동성 유백색 미세결정성 수성 현탁액.
- 삭제
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- 제13항에 있어서, 테베렐릭스 염이 수성 매질에 25mg/㎖ 이상의 농도로 현탁되는 현탁액.
- 제13항 또는 제20항에 있어서, 등장제를 함유하는 현탁액.
- 제21항에 있어서, 등장제가 만니톨인 현탁액.
- 제13항 또는 제20항에 있어서, 약제학적으로 허용되는 부형제를 추가로 포함하는 현탁액.
- 제13항 또는 제20항에 있어서, 미세결정이 입자 크기가 5 내지 150㎛인 침상형인 현탁액.
- 제13항의 건조된 현탁액을 포함하는 동결건조된 조성물.
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- 트리플루오로아세트산 또는 황산으로부터 유도된 트리플루오로아세테이트 이온 또는 설페이트 이온을 Ac-D-Nal-D-pClPhe-D-Pal-Ser-Tyr-D-Hci-Leu-Lys(iPr)-Pro-D-Ala-NH2의 펩타이드 (테베렐릭스)와 접촉시키고, 이때 상기 산으로부터 유도된 이온과 테베렐릭스가, 혼합시 겔을 형성시키지 않으면서 현탁액을 형성하기에 충분하도록 1.6:1 이상의 산:테베렐릭스의 몰 비로 존재하는, 테베렐릭스의 서방형 제형의 제조방법.
- 삭제
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- 제28항에 있어서, 테베렐릭스 염이 수성 매질에 25mg/㎖ 이상의 농도로 현탁되는 방법.
- 제28항 또는 제35항에 있어서, 수성 현탁액이 등장제를 함유하는 방법.
- 제36항에 있어서, 등장제가 만니톨인 방법.
- 제28항 또는 제35항에 있어서, 수성 현탁액이 약제학적으로 허용되는 부형제를 함유하는 방법.
- 제28항 또는 제35항에 있어서, 수성 현탁액이 동결건조된 테베렐릭스 염으로부터 즉석으로 수득되는 방법.
- 제1항에 청구된 방법을 수행한 후, 냉동건조 또는 분무건조를 수행하여 조성물을 수득함을 포함하는, 제25항의 동결건조된 조성물의 제조방법.
- 제25항의 동결건조된 조성물을 물 또는 완충 용액을 사용하여 재구성함을 포함하는, 테베렐릭스의 주사 가능한 유동성 유백색 미세결정성 수성 현탁액의 제조방법.
- Ac-D-Nal-D-pClPhe-D-Pal-Ser-Tyr-D-Hci-Leu-Lys(iPr)-Pro-D-Ala-NH2 (테베렐릭스) 트리플루오로아세테이트의 미세결정성 수성 현탁액.
- Ac-D-Nal-D-pClPhe-D-Pal-Ser-Tyr-D-Hci-Leu-Lys(iPr)-Pro-D-Ala-NH2 (테베렐릭스) 설페이트의 미세결정성 수성 현탁액.
- 제42항 또는 제43항에 있어서, 피험체에게 투여되는 경우 생체내에서 펩타이드를 서방출시키는 현탁액.
- 제42항 또는 제43항에 있어서, 당해 염이 수성 매질에 25mg/㎖ 이상의 농도로 현탁된 현탁액.
- 제42항 또는 제43항에 있어서, 등장제를 함유하는 현탁액.
- 제46항에 있어서, 등장제가 만니톨인 현탁액.
- 제42항 또는 제43항에 있어서, 약제학적으로 허용되는 부형제를 추가로 포함하는 현탁액.
- 제42항 또는 제43항에 있어서, 미세결정이 입자 크기 5 내지 150㎛의 침상형인 현탁액.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US31761601P | 2001-09-06 | 2001-09-06 | |
US60/317,616 | 2001-09-06 | ||
PCT/EP2002/009537 WO2003022243A2 (en) | 2001-09-06 | 2002-08-27 | Sustained release of microcrystalline peptide suspensions |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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KR1020077021972A Division KR20070107161A (ko) | 2001-09-06 | 2002-08-27 | 서방형 미세결정성 펩타이드 현탁액 |
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Publication Number | Publication Date |
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KR20040037077A KR20040037077A (ko) | 2004-05-04 |
KR100818904B1 true KR100818904B1 (ko) | 2008-04-04 |
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Application Number | Title | Priority Date | Filing Date |
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KR1020047003371A KR100818904B1 (ko) | 2001-09-06 | 2002-08-27 | 서방형 미세결정성 펩타이드 현탁액 |
KR1020077021972A KR20070107161A (ko) | 2001-09-06 | 2002-08-27 | 서방형 미세결정성 펩타이드 현탁액 |
Family Applications After (1)
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KR1020077021972A KR20070107161A (ko) | 2001-09-06 | 2002-08-27 | 서방형 미세결정성 펩타이드 현탁액 |
Country Status (27)
Country | Link |
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US (5) | US7098305B2 (ko) |
EP (2) | EP2198888B1 (ko) |
JP (3) | JP2005504787A (ko) |
KR (2) | KR100818904B1 (ko) |
CN (1) | CN100386116C (ko) |
AR (1) | AR042592A1 (ko) |
AT (1) | ATE463258T1 (ko) |
AU (1) | AU2002337025B2 (ko) |
BR (1) | BR0212333A (ko) |
CA (1) | CA2459309C (ko) |
CY (1) | CY1118642T1 (ko) |
DE (1) | DE60235896D1 (ko) |
DK (1) | DK2198888T3 (ko) |
ES (2) | ES2362505T3 (ko) |
HK (1) | HK1062148A1 (ko) |
HU (1) | HUP0402099A2 (ko) |
IL (1) | IL160443A0 (ko) |
MX (1) | MXPA04002185A (ko) |
NO (1) | NO20040938L (ko) |
NZ (1) | NZ531734A (ko) |
PL (1) | PL368056A1 (ko) |
PT (1) | PT2198888T (ko) |
RU (1) | RU2311195C2 (ko) |
TW (1) | TWI249409B (ko) |
UA (1) | UA79435C2 (ko) |
WO (1) | WO2003022243A2 (ko) |
ZA (1) | ZA200401390B (ko) |
Families Citing this family (44)
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US6828415B2 (en) * | 1993-02-19 | 2004-12-07 | Zentaris Gmbh | Oligopeptide lyophilisate, their preparation and use |
US7658938B2 (en) | 1999-02-22 | 2010-02-09 | Merrion Reasearch III Limited | Solid oral dosage form containing an enhancer |
US20070148228A1 (en) * | 1999-02-22 | 2007-06-28 | Merrion Research I Limited | Solid oral dosage form containing an enhancer |
US8119159B2 (en) * | 1999-02-22 | 2012-02-21 | Merrion Research Iii Limited | Solid oral dosage form containing an enhancer |
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US7098305B2 (en) * | 2001-09-06 | 2006-08-29 | Ardana Bioscience Limited | Sustained release of microcrystalline peptide suspensions |
AU2003263964C1 (en) * | 2002-07-31 | 2010-08-19 | Seagen Inc. | Drug conjugates and their use for treating cancer, an autoimmune disease or an infectious disease |
AR044852A1 (es) * | 2003-06-24 | 2005-10-05 | Novartis Ag | Una composicion farmaceutica para la administracion parenteral que comprende un analogo de somatostatina |
GB0320806D0 (en) | 2003-09-05 | 2003-10-08 | Astrazeneca Ab | Therapeutic treatment |
ES2579836T3 (es) | 2003-11-06 | 2016-08-17 | Seattle Genetics, Inc. | Compuestos de monometilvalina capaces de conjugación con ligandos |
GB0428151D0 (en) * | 2004-12-22 | 2005-01-26 | Novartis Ag | Organic compounds |
EP1674082A1 (de) | 2004-12-22 | 2006-06-28 | Zentaris GmbH | Verfahren zur Herstellung von sterilen Suspensionen oder Lyophilisaten schwerlöslicher basischer Peptidkomplexe, diese enthaltende pharmazeutische Formulierungen sowie ihre Verwendung als Arzneimittel |
GB0511269D0 (en) * | 2005-06-02 | 2005-07-13 | Creative Peptides Sweden Ab | Sustained release preparation of pro-insulin C-peptide |
RU2427383C2 (ru) * | 2006-01-18 | 2011-08-27 | КьюПиЭс, ЭлЭлСи | Фармацевтические композиции с повышенной стабильностью |
EP2526950A1 (en) * | 2006-04-07 | 2012-11-28 | Merrion Research III Limited | Solid oral dosage form containing an enhancer |
WO2008071984A1 (en) * | 2006-12-13 | 2008-06-19 | Ardana Bioscience Limited | Administration of the gonadotropin-releasing hormone antagonist teverelix |
CN101802012B (zh) | 2007-07-16 | 2014-08-06 | 健泰科生物技术公司 | 抗cd79b抗体和免疫偶联物及使用方法 |
CA2692819A1 (en) | 2007-07-16 | 2009-01-22 | Genentech, Inc. | Humanized anti-cd79b antibodies and immunoconjugates and methods of use |
CL2009000062A1 (es) | 2008-01-31 | 2010-05-14 | Genentech Inc | Anticuerpo humanizado anti cd79b; con modificaciones de cisterna libre; inmunoconjugado que contiene dicho anticuerpo y una droga; polinucleotido que codifica el anticuerpo; vector, celula huesped; composicion farmaceutica y uso de dicha composicion para tratar cancer, preferentemente linfomas. |
CA2723541A1 (en) * | 2008-05-07 | 2009-11-12 | Merrion Research Iii Limited | Compositions of peptides and processes of preparation thereof |
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