JP2012051894A - 修飾glp−1の安定な処方剤 - Google Patents
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Abstract
【解決手段】ある特定の修飾GLP−1またはその類縁体を、緩衝液と一緒に水溶液中で配合し、約7〜約10のpH範囲で保持された高濃度の修飾GLP−1またはその類縁体の水溶液または懸濁液。
【効果】本処方剤は、推奨保管温度で所定の貯蔵寿命期間(通常2〜8℃で2〜3年)内で、さらに、一般の使用期間(通常、加速温度、例えば25℃または37℃で1ヶ月)は物理的に安定である。また、処方剤は化学的にも安定であり、それらを貯蔵安定性で且つ侵襲性(例えば、注射、皮下注射、筋内、静脈内または注入)ならびに非侵襲性(例えば、鼻内または肺内、経皮または経粘膜、例えば頬)の投与手段に適切なものにしている。
【選択図】なし
Description
His−Ala−Glu−Gly−Thr−Phe−Thr−Ser−Asp−Val−Ser−Ser−Tyr−Leu−Glu−Gly−Gln−Ala−Ala−Lys−Glu−Phe−Ile−Ala−Trp−Leu−Val−Lys−Gly−Arg−Gly。
(a)N末端アミノ酸のα炭素に結合されるアミノ基、
(b)C末端アミノ酸のα炭素に結合されるカルボキシ基、
(c)任意のLys残基のε−アミノ基、
(d)任意のAspおよびGlu残基のR基のカルボキシ基、
(e)任意のTyr、SerおよびThr残基のR基のヒドロキシ基、
(f)任意のTrp、Asn、Gln、ArgおよびHis残基のR基のアミノ基、または
(g)任意のCys残基のR基のチオール基。
Claims (32)
- GLP−1化合物および緩衝液を含む薬学的処方剤であって、前記GLP−1化合物はGLP−1(7−37)またはその類縁体(ここで、親ペプチドのアミノ酸残基は任意にスペーサーを介して結合された親油性置換基を有する)であり、前記GLP−1化合物は0.1mg/mL〜100mg/mLの濃度で存在し、前記処方剤は7.0〜10のpHを有する薬学的処方剤;但し、等張剤が存在し且つpHが7.4である場合、該等張剤はマンニトールまたはNaClではない。
- 前記GLP−1化合物は1mg/mL〜100mg/mLの濃度で存在する、請求項1に記載の薬学的処方剤。
- 水をさらに含む、請求項1に記載の薬学的処方剤。
- 水をさらに含む、請求項2に記載の薬学的処方剤。
- GLP−1化合物および緩衝液の水溶液を含む薬学的処方剤であって、前記GLP−1化合物はGLP−1(7−37)またはその類縁体(ここで、親ペプチドのアミノ酸残基は任意にスペーサーを介して結合された親油性置換基を有する)であり、前記GLP−1化合物は0.1mg/mL〜100mg/mLの濃度で存在し、前記処方剤は7.0〜10のpHを有する薬学的処方剤;但し、等張剤が存在し且つpHが7.4である場合、該等張剤はマンニトールまたはNaClはではない。
- 前記GLP−1化合物は1mg/mL〜100mg/mLの濃度で存在する、請求項5に記載の薬学的処方剤。
- 前記処方剤は7.5〜10のpHを有する、請求項3及び請求項5のいずれか1項に記載の薬学的処方剤。
- 前記処方剤は7.5〜10のpHを有する、請求項4及び請求項6のいずれか1項に記載の薬学的処方剤。
- 前記GLP−1化合物は0.1mg/mL〜80mg/mL、0.1mg/mL〜50mg/mL、0.1mg/mL〜20mg/mL、0.1mg/mL〜10mg/mL、概しては0.1〜5mg/mLの濃度で存在する、請求項1、3、5及び7のいずれか1項に記載の薬学的処方剤。
- 前記GLP−1化合物は1mg/mL〜80mg/mL、1mg/mL〜50mg/mL、1mg/mL〜20mg/mL、1mg/mL〜10mg/mL、概しては1〜5mg/mLの濃度で存在する、請求項2、4、6及び8のいずれか1項に記載の薬学的処方剤。
- 防腐剤をさらに含む、請求項1ないし10のいずれか1項に記載の薬学的処方剤。
- 前記防腐剤は0.1mg/mL〜20mg/mLの濃度で存在する、請求項11に記載の薬学的処方剤。
- 等張剤をさらに含む、請求項1ないし12のいずれか1項に記載の薬学的処方剤。
- 前記等張剤は1mg/mL〜50mg/mLの濃度で存在する、請求項13に記載の薬学的処方剤。
- キレート剤をさらに含む、請求項1ないし14のいずれか1項に記載の薬学的処方剤。
- 前記キレート剤は0.1mg/mL〜5mg/mLの濃度で存在する、請求項15に記載の薬学的処方剤。
- 安定剤をさらに含む、請求項1ないし16のいずれか1項に記載の薬学的処方剤。
- 前記安定剤は、L−ヒスチジン、イミダゾールおよびアルギニンからなる群から選択される、請求項17に記載の薬学的処方剤。
- 前記安定剤は、高分子量ポリマーおよび/または低分子量化合物であり、かつ0.1mg/mL〜50mg/mLの濃度で存在する、請求項17に記載の薬学的処方剤。
- 界面活性剤をさらに含む、請求項1ないし19のいずれか1項に記載の薬学的処方剤。
- 前記GLP−1化合物は、リシン残基(例えば、1個のリシン)を有するGLP−1(7−36)、GLP−1(7−37)またはGLP−1(7−38)類縁体から選択され、任意にスペーサーを介した親油性置換基が前記リシンのε−アミノ基に結合されている、請求項1ないし20のいずれか1項に記載の薬学的処方剤。
- 前記GLP−1(7−36)、GLP−1(7−37)またはGLP−1(7−38)類縁体は、Arg34GLP−1(7−37)、Arg26,34,Lys36GLP−1(7−36)、Arg26GLP−1(7−37)、またはGly8,Arg26,34,Glu37,Lys38GLP−1(7−38)から選択される、請求項21に記載の薬学的処方剤。
- 前記親油性置換基は、8〜40個、好ましくは12〜24個、例えば14〜18個の炭素原子を有する、請求項1ないし22のいずれか1項に記載の薬学的処方剤。
- 前記スペーサーが存在し、かつアミノ酸、例えば、β−Ala、L−Glu、アミノブチロイルから選択される、請求項1ないし23のいずれか1項に記載の薬学的処方剤。
- 前記GLP−1化合物はArg34,Lys26(N−ε−(γ−Glu(N−α−ヘキサデカノイル)))−GLP−1(7−37)である、請求項1ないし24のいずれか1項に記載の薬学的処方剤。
- GLP−1(7−37)またはその類縁体(ここで、親ペプチドのアミノ酸残基は任意にスペーサーを介して結合された親油性置換基を有する)であるGLP−1化合物の、物理的に安定な薬学的処方剤を調製する方法であって、前記GLP−1化合物および緩衝液を含有する処方剤を調製することを含み、前記GLP−1化合物は0.1mg/mL〜100mg/mLの濃度で存在し、前記処方剤は7.0〜10のpHを有する方法。
- 前記GLP−1化合物は1mg/mL〜100mg/mLの濃度で存在する、請求項26に記載の方法。
- GLP−1(7−37)またはその類縁体(ここで、親ペプチドのアミノ酸残基は任意にスペーサーを介して結合された親油性置換基を有する)であるGLP−1化合物の、物理的に安定な薬学的処方剤を調製する方法であって、前記GLP−1化合物、水、および緩衝液を含有する処方剤を調製することを含み、前記GLP−1化合物は0.1mg/mL〜100mg/mLの濃度で存在し、前記処方剤は7.0〜10のpHを有する方法。
- 前記GLP−1化合物は1mg/mL〜100mg/mLの濃度で存在する、請求項28に記載の方法。
- GLP−1(7−37)またはその類縁体(ここで、親ペプチドのアミノ酸残基は任意にスペーサーを介して結合された親油性置換基を有する)であるGLP−1化合物の、物理的に安定な薬学的処方剤を調製する方法であって、前記GLP−1化合物および緩衝液を含有する水溶液を調製することを含み、前記GLP−1化合物は0.1mg/mL〜100mg/mLの濃度で存在し、前記処方剤は7.0〜10のpHを有する方法。
- 前記GLP−1化合物は1mg/mL〜100mg/mLの濃度で存在する、請求項30に記載の方法。
- 前記処方剤は7.5〜10のpHを有する、請求項26ないし31のいずれか1項に記載の方法。
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Application Number | Priority Date | Filing Date | Title |
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DKPA200101011 | 2001-06-28 | ||
DKPA200101010 | 2001-06-28 | ||
DKPA200101010 | 2001-06-28 | ||
DKPA200101011 | 2001-06-28 | ||
DKPA200101052 | 2001-07-04 | ||
DKPA200101052 | 2001-07-04 | ||
DKPA200101053 | 2001-07-04 | ||
DKPA200101053 | 2001-07-04 | ||
DKPA200200092 | 2002-01-18 | ||
DKPA200200093 | 2002-01-18 | ||
DKPA200200092 | 2002-01-18 | ||
DKPA200200093 | 2002-01-18 |
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JP2011209396A Withdrawn JP2012051894A (ja) | 2001-06-28 | 2011-09-26 | 修飾glp−1の安定な処方剤 |
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DK (1) | DK1412384T3 (ja) |
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US6558952B1 (en) * | 1992-12-14 | 2003-05-06 | Waratah Pharmaceuticals, Inc. | Treatment for diabetes |
US20040037818A1 (en) * | 1998-07-30 | 2004-02-26 | Brand Stephen J. | Treatment for diabetes |
ATE382057T1 (de) * | 2001-06-28 | 2008-01-15 | Novo Nordisk As | Stabile formulierung von modifiziertem glp-1 |
ES2545090T3 (es) | 2001-12-21 | 2015-09-08 | Human Genome Sciences, Inc. | Proteínas de fusión de albúmina y GCSF |
DE60335608D1 (de) * | 2002-02-27 | 2011-02-17 | Pharmain Corp | Zusammensetzungen zur abgabe von therapeutika und anderen materialien und verfahren zu ihrer herstellung und verwendung |
US20050260259A1 (en) * | 2004-04-23 | 2005-11-24 | Bolotin Elijah M | Compositions for treatment with glucagon-like peptide, and methods of making and using the same |
US7635463B2 (en) * | 2002-02-27 | 2009-12-22 | Pharmain Corporation | Compositions for delivery of therapeutics and other materials |
EP1506786B1 (en) | 2002-05-21 | 2016-11-23 | Daiichi Sankyo Company, Limited | Medicinal compositions containing ghrelin |
WO2003100024A2 (en) * | 2002-05-24 | 2003-12-04 | Waratah Pharmaceuticals, Inc. | Treatment for diabetes |
US7560425B2 (en) | 2002-06-07 | 2009-07-14 | Waratah Pharmaceuticals Inc. | Pharmaceutical composition consisting of rapamycine and gastrin 17(LEU15) and a method for treating diabetes |
CA2501677A1 (en) * | 2002-10-22 | 2004-05-06 | Waratah Pharmaceuticals, Inc. | Treatment of diabetes |
KR101198346B1 (ko) | 2003-04-08 | 2012-11-06 | 노보 노르디스크 에이/에스 | 크로마토그래피 고정상의 재생 |
WO2004089985A1 (en) | 2003-04-11 | 2004-10-21 | Novo Nordisk A/S | Stable pharmaceutical compositions |
ES2383752T3 (es) | 2003-05-15 | 2012-06-26 | Trustees Of Tufts College | Analogos estables de GLP-1 |
JP4936884B2 (ja) * | 2003-06-03 | 2012-05-23 | ノボ・ノルデイスク・エー/エス | 安定化された薬学的ペプチド組成物 |
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2002
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- 2002-06-27 DK DK02745182T patent/DK1412384T3/da active
- 2002-06-27 JP JP2003508375A patent/JP5562510B2/ja not_active Expired - Lifetime
- 2002-06-27 AU AU2002316811A patent/AU2002316811A1/en not_active Abandoned
- 2002-06-27 DE DE60224284T patent/DE60224284T2/de not_active Expired - Lifetime
- 2002-06-27 US US10/185,923 patent/US20030119734A1/en not_active Abandoned
- 2002-06-27 ES ES02745182T patent/ES2298378T3/es not_active Expired - Lifetime
- 2002-06-27 WO PCT/DK2002/000437 patent/WO2003002136A2/en active IP Right Grant
- 2002-06-27 EP EP02745182A patent/EP1412384B1/en not_active Expired - Lifetime
- 2002-06-27 PT PT02745182T patent/PT1412384E/pt unknown
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2007
- 2007-04-11 US US11/786,095 patent/US20080167226A1/en not_active Abandoned
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2008
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2010
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2011
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Also Published As
Publication number | Publication date |
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WO2003002136A2 (en) | 2003-01-09 |
JP5562510B2 (ja) | 2014-07-30 |
EP1412384B1 (en) | 2007-12-26 |
PT1412384E (pt) | 2008-03-28 |
WO2003002136A3 (en) | 2004-03-04 |
DE60224284T2 (de) | 2008-12-18 |
ES2298378T3 (es) | 2008-05-16 |
US8846618B2 (en) | 2014-09-30 |
DE60224284D1 (de) | 2008-02-07 |
US20080167226A1 (en) | 2008-07-10 |
EP1412384A2 (en) | 2004-04-28 |
US20030119734A1 (en) | 2003-06-26 |
ATE382057T1 (de) | 2008-01-15 |
AU2002316811A1 (en) | 2003-03-03 |
US20090111752A1 (en) | 2009-04-30 |
DK1412384T3 (da) | 2008-04-28 |
US20100234299A1 (en) | 2010-09-16 |
JP2004535442A (ja) | 2004-11-25 |
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