JPH03503764A - ヒト成長ホルモン製剤 - Google Patents
ヒト成長ホルモン製剤Info
- Publication number
- JPH03503764A JPH03503764A JP1504344A JP50434489A JPH03503764A JP H03503764 A JPH03503764 A JP H03503764A JP 1504344 A JP1504344 A JP 1504344A JP 50434489 A JP50434489 A JP 50434489A JP H03503764 A JPH03503764 A JP H03503764A
- Authority
- JP
- Japan
- Prior art keywords
- growth hormone
- human growth
- hgh
- formulation
- buffer
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
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
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/27—Growth hormone [GH] (Somatotropin)
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/06—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
Abstract
Description
Claims (24)
- 1.a)ヒト成長ホルモン、 b)グリシン、 c)マンニトール、および d)緩衝液 を含有し、ヒト成長ホルモン:グリシンのモル比が1:50−200である安定 化された、薬学的に許容し得るヒト成長ホルモン製剤。
- 2.4−8のpHを有する請求項1に記載の製剤。
- 3.該緩衝液がリン酸緩衝液である請求項1に記載の製剤。
- 4.該緩衝液がトリス緩衝液である請求項1に記載の製剤。
- 5.hGH:マンニトールのモル比が1:700−3000である請求項1に記 載の製剤。
- 6.hGH:リン酸緩衝液のモル比が1:50−250である請求項3に記載の 製剤。
- 7.該ヒト成長ホルモンがmet−hGHである請求項1に記載の製剤。
- 8.更に薬学的に許容し得る希釈剤を含有する請求項1に記載の製剤。
- 9.二量体を含有していない請求項1に記載の製剤。
- 10.更に薬学的に許容し得る非イオン性界面活性剤を含有する請求項1に記載 の製剤。
- 11.非イオン性界面活性剤がポリソルベート80である請求項10に記載の製 剤。
- 12.hGH:ポリソルベート80のモル比が1:0.7−30である請求項1 1に記載の製剤。
- 13.ヒト成長ホルモンをグリシン、マンニトールおよび緩衝液と混合し、ヒト 成長ホルモン:グリシンのモル比が1:50−200である薬学的に許容し得る 製剤を製造する工程からなるヒト成長ホルモン製剤の安定化法。
- 14.該混合工程が更に、薬学的に許容し得る非イオン性界面活性剤を含有させ ることを含む請求項13に記載の方法。
- 15.該界面活性剤がポリソルベート80である請求項14に記載の方法。
- 16.該製剤が4−8のpHを有する請求項13に記載の方法。
- 17.hGH:マンニトールのモル比が1:700−3000である請求項13 に記載の方法。
- 18.該ヒト成長ホルモンがmet−hGHである請求項13に記載の方法。
- 19.該緩衝液がリン酸緩衝液である請求項13に記載の方法。
- 20.薬学的有効量のヒト成長ホルモン、グリシン、マンニトール、緩衝液、お よび非イオン性界面活性剤を含有し、実質上二量体を生成することなく製造およ び貯蔵し得る、安定化された、薬学的に許容し得るヒト成長ホルモン製剤。
- 21.該緩衝液がリン酸緩衝液である請求項20に記載の製剤。
- 22.該非イオン性界面活性剤がポリソルベート80である請求項20に記載の 製剤。
- 23.a)ヒト成長ホルモン、 b)マンニトール、 c)グリシン、 d)緩衝液、および e)非イオン性界面活性剤 を含有してなる製剤を、エアロゾル装置またはニードレスインジェクターガンを 用いて投与することからなる、ヒト成長ホルモンの投与方法。
- 24.該非イオン性界面活性剤がポリソルベートまたはポロキサマーである請求 項23に記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/182,262 US5096885A (en) | 1988-04-15 | 1988-04-15 | Human growth hormone formulation |
US182,262 | 1988-04-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH03503764A true JPH03503764A (ja) | 1991-08-22 |
JP2747073B2 JP2747073B2 (ja) | 1998-05-06 |
Family
ID=22667706
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP1504344A Expired - Lifetime JP2747073B2 (ja) | 1988-04-15 | 1989-03-28 | ヒト成長ホルモン製剤 |
Country Status (9)
Country | Link |
---|---|
US (1) | US5096885A (ja) |
EP (2) | EP0409870B1 (ja) |
JP (1) | JP2747073B2 (ja) |
AT (1) | ATE112685T1 (ja) |
AU (1) | AU627174B2 (ja) |
CA (1) | CA1329543C (ja) |
DE (1) | DE68918853T2 (ja) |
NZ (1) | NZ228747A (ja) |
WO (1) | WO1989009614A1 (ja) |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1997017991A1 (fr) * | 1995-11-15 | 1997-05-22 | Sumitomo Pharmaceuticals Company, Limited | Medicament contre l'insuffisance hepatique aigue |
JP2000504696A (ja) * | 1996-02-12 | 2000-04-18 | シーエスエル、リミテッド | 安定化された成長ホルモン処方物およびその製造方法 |
JP2005535651A (ja) * | 2002-07-09 | 2005-11-24 | サンド・アクチエンゲゼルシヤフト | グリシンを含有するヒト成長ホルモン(hGH)の高濃度液体製剤 |
JP2006219500A (ja) * | 1994-04-26 | 2006-08-24 | Genetics Inst Llc | 因子ix用処方 |
JP2007506683A (ja) * | 2003-09-25 | 2007-03-22 | カンジェーン コーポレイション | ヒト成長ホルモン剤およびその調整方法と使用方法 |
JP4711520B2 (ja) * | 2000-03-21 | 2011-06-29 | 日本ケミカルリサーチ株式会社 | 生理活性ペプチド含有粉末 |
JP2014516515A (ja) * | 2011-04-29 | 2014-07-17 | オンコリティクス バイオテク,インコーポレーテッド | ゲル浸透クロマトグラフィーを使用してウイルスを精製する方法 |
JP2014208656A (ja) * | 1999-07-12 | 2014-11-06 | サンド・アクチエンゲゼルシヤフト | 成長ホルモン製剤 |
JP2016520545A (ja) * | 2013-04-05 | 2016-07-14 | ノヴォ・ノルディスク・ヘルス・ケア・アーゲー | 成長ホルモン化合物製剤 |
Families Citing this family (89)
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CA1331133C (en) * | 1988-03-01 | 1994-08-02 | Michael Jon Pikal | Pharmaceutical growth hormone formulations |
US5763394A (en) * | 1988-04-15 | 1998-06-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
US5981485A (en) * | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
IL93986A0 (en) * | 1989-04-04 | 1991-01-31 | Lilly Co Eli | Improvements in and relating to pharmaceutical formulations |
DK372589D0 (da) * | 1989-07-28 | 1989-07-28 | Novo Nordisk As | Protein |
WO1991011196A1 (en) * | 1990-02-02 | 1991-08-08 | Novo Nordisk A/S | A method of treating a mammal with a biologically active compound |
WO1991011195A1 (en) * | 1990-02-02 | 1991-08-08 | Novo Nordisk A/S | A method of treating a mammal with a biologically active compound |
US6326154B1 (en) * | 1990-11-19 | 2001-12-04 | Genentech, Inc. | Ligand-mediated immunofunctional hormone binding protein assay method |
AU1757092A (en) * | 1991-03-28 | 1992-11-02 | Genentech Inc. | Stable growth hormone metal ion formulations |
US5492891A (en) * | 1991-09-05 | 1996-02-20 | Novo Nordisk A/S | Method for treatment of patients with chronic liver disease |
DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
US5849700A (en) * | 1991-12-20 | 1998-12-15 | Novo Nordisk A/S | Pharmaceutical formulation |
US5849704A (en) * | 1991-12-20 | 1998-12-15 | Novo Nordisk A/S | Pharmaceutical formulation |
US6022858A (en) * | 1991-12-20 | 2000-02-08 | Novo Nordisk A/S | Pharmaceutical formulation of human-growth hormone pretreated with zinc salt |
FR2686899B1 (fr) * | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
SE9201073D0 (sv) * | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
ATE359824T1 (de) * | 1992-07-31 | 2007-05-15 | Genentech Inc | Wässrige formulierung enthaltend menschliches wachstumshormon |
JP3905921B2 (ja) * | 1992-10-02 | 2007-04-18 | ジェネティクス インスチチュート リミテッド ライアビリティー カンパニー | 凝固第▲viii▼因子を含む組成物及びその製造方法並びに安定剤としての界面活性剤の使用方法 |
DE69428521T2 (de) * | 1993-02-02 | 2002-05-23 | Xoma Technology Ltd | Arzneizusammensetzungen enthaltend ein bakterizides permeabilität erhöhendes protein und ein tensid |
JP3698721B2 (ja) * | 1993-02-23 | 2005-09-21 | ジェネンテク・インコーポレイテッド | 有機溶媒を用いて処理したポリペプチドの賦形剤安定化 |
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-
1988
- 1988-04-15 US US07/182,262 patent/US5096885A/en not_active Expired - Lifetime
-
1989
- 1989-03-28 AT AT89904428T patent/ATE112685T1/de not_active IP Right Cessation
- 1989-03-28 DE DE68918853T patent/DE68918853T2/de not_active Expired - Lifetime
- 1989-03-28 JP JP1504344A patent/JP2747073B2/ja not_active Expired - Lifetime
- 1989-03-28 WO PCT/US1989/001272 patent/WO1989009614A1/en active IP Right Grant
- 1989-03-28 AU AU33687/89A patent/AU627174B2/en not_active Expired
- 1989-03-28 EP EP89904428A patent/EP0409870B1/en not_active Expired - Lifetime
- 1989-03-28 EP EP94102274A patent/EP0603159A3/en not_active Withdrawn
- 1989-04-14 NZ NZ228747A patent/NZ228747A/xx unknown
- 1989-04-17 CA CA000596921A patent/CA1329543C/en not_active Expired - Lifetime
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2006219500A (ja) * | 1994-04-26 | 2006-08-24 | Genetics Inst Llc | 因子ix用処方 |
JP2010077148A (ja) * | 1994-04-26 | 2010-04-08 | Genetics Inst Llc | 因子ix用処方 |
WO1997017991A1 (fr) * | 1995-11-15 | 1997-05-22 | Sumitomo Pharmaceuticals Company, Limited | Medicament contre l'insuffisance hepatique aigue |
JP2000504696A (ja) * | 1996-02-12 | 2000-04-18 | シーエスエル、リミテッド | 安定化された成長ホルモン処方物およびその製造方法 |
JP2014208656A (ja) * | 1999-07-12 | 2014-11-06 | サンド・アクチエンゲゼルシヤフト | 成長ホルモン製剤 |
JP4711520B2 (ja) * | 2000-03-21 | 2011-06-29 | 日本ケミカルリサーチ株式会社 | 生理活性ペプチド含有粉末 |
JP2005535651A (ja) * | 2002-07-09 | 2005-11-24 | サンド・アクチエンゲゼルシヤフト | グリシンを含有するヒト成長ホルモン(hGH)の高濃度液体製剤 |
JP2007506683A (ja) * | 2003-09-25 | 2007-03-22 | カンジェーン コーポレイション | ヒト成長ホルモン剤およびその調整方法と使用方法 |
JP2014516515A (ja) * | 2011-04-29 | 2014-07-17 | オンコリティクス バイオテク,インコーポレーテッド | ゲル浸透クロマトグラフィーを使用してウイルスを精製する方法 |
JP2016520545A (ja) * | 2013-04-05 | 2016-07-14 | ノヴォ・ノルディスク・ヘルス・ケア・アーゲー | 成長ホルモン化合物製剤 |
Also Published As
Publication number | Publication date |
---|---|
DE68918853T2 (de) | 1995-04-13 |
ATE112685T1 (de) | 1994-10-15 |
EP0603159A2 (en) | 1994-06-22 |
DE68918853D1 (de) | 1994-11-17 |
AU627174B2 (en) | 1992-08-20 |
EP0409870A1 (en) | 1991-01-30 |
WO1989009614A1 (en) | 1989-10-19 |
EP0603159A3 (en) | 1995-12-13 |
EP0409870B1 (en) | 1994-10-12 |
AU3368789A (en) | 1989-11-03 |
NZ228747A (en) | 1991-09-25 |
JP2747073B2 (ja) | 1998-05-06 |
CA1329543C (en) | 1994-05-17 |
US5096885A (en) | 1992-03-17 |
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