JP2000508345A - 持続した薬物送達のための水不溶性複合体を含む薬学的処方物 - Google Patents
持続した薬物送達のための水不溶性複合体を含む薬学的処方物Info
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- JP2000508345A JP2000508345A JP10527002A JP52700298A JP2000508345A JP 2000508345 A JP2000508345 A JP 2000508345A JP 10527002 A JP10527002 A JP 10527002A JP 52700298 A JP52700298 A JP 52700298A JP 2000508345 A JP2000508345 A JP 2000508345A
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
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- 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
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/61—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
-
- 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
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.薬学的に活性なペプチドとキャリア巨大分子との固体イオン性複合体を含む 薬学的組成物であって、ここで該複合体のペプチド含有量が少なくとも57重量% である、組成物。 2.薬学的に活性なペプチドとキャリア巨大分子との固体イオン性複合体を含む 薬学的組成物であって、ここで該複合体のペプチド含有量が57重量%〜79重量% である、組成物。 3.薬学的に活性なペプチドとキャリア巨大分子との固体イオン性複合体から実 質的になる薬学的組成物であって、ここで該複合体のペプチド含有量が少なくと も57重量%である、組成物。 4.薬学的に活性なペプチドとキャリア巨大分子との固体イオン性複合体から実 質的になる薬学的組成物であって、ここで該複合体のペプチド含有量が57重量% 〜79重量%である、組成物。 5.LHRHアナログとキャリア巨大分子との固体イオン性複合体を含む薬学的組成 物であって、ここで該複合体を形成するために使用される該キャリアおよびアナ ログが、0.5:1〜0.1:1のキャリア:アナログの重量比で合わされており、か つここで該複合体がマイクロカプセルではない、組成物。 6.薬学的に活性なペプチドとキャリア巨大分子との固体イオン性複合体から実 質的になる薬学的組成物であって、ここで該複合体を形成するために使用される 該キャリアおよびペプチドが、0.5:1〜0.1:1のキャリア:アナログの重量比 で合わされており、かつここで該複合体がマイクロカプセルではない、組成物。 7.薬学的に活性なペプチドとキャリア巨大分子との滅菌固体イオン性複合体を 含む薬学的組成物であって、ここで該複合体がγ線照射による滅菌後も安定なま まであり得る、組成物。 8.前記薬学的に活性なペプチドがLHRHアナログである、請求項1、2、3、4 、6、または7のいずれか1つに記載の薬学的組成物。 9.前記薬学的に活性なペプチドがLHRHアンタゴニストである、請求項8に記載 の薬学的組成物。 10.前記薬学的に活性なペプチドが、ブラジキニンアナログ、副甲状腺ホルモ ン、副腎皮質刺激ホルモン、カルシトニン、およびバソプレッシンアナログから なる群より選択される、請求項1、2、3、4、6、または7のいずれか1つに 記載の薬学的組成物。 11.前記薬学的に活性なペプチドがカチオン性であり、そして前記キャリア巨 大分子がアニオン性である、請求項1、2、3、4、6、または7のいずれか1 つに記載の薬学的組成物。 12.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも1週間 、該被験体に前記薬学的に活性なペプチドの持続した送達を提供する、請求項1 、2、3、4、5、6、または7のいずれか1つに記載の薬学的組成物。 13.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも2週間 、該被験体に前記薬学的に活性なペプチドの持続した送達を提供する、請求項1 、2、3、4、5、6、または7のいずれか1つに記載の薬学的組成物。 14.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも3週間 、該被験体に前記薬学的に活性なペプチドの持続した送達を提供する、請求項1 、2、3、4、5、6、または7のいずれか1つに記載の薬学的組成物。 15.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも4週間 、該被験体に前記薬学的に活性なペプチドの持続した送達を提供する、請求項1 、2、3、4、5、6、または7のいずれか1つに記載の薬学的組成物。 16.前記薬学的に活性なペプチドが多価カチオン性またはアニオン性ペプチド である、請求項1、2、3、4、5、6、または7のいずれか1つに記載の薬学 的組成物。 17.前記ペプチドが5〜20アミノ酸長である、請求項1、2、3、4、5、6 、または7のいずれか1つに記載の薬学的組成物。 18.前記ペプチドが8〜15アミノ酸長である、請求項1、2、3、4、5、6 、または7のいずれか1つに記載の薬学的組成物。 19.前記ペプチドが8〜12アミノ酸長である、請求項1、2、3、4、5、6 、または7のいずれか1つに記載の薬学的組成物。 20.前記キャリア巨大分子がアニオン性ポリマーである、請求項1、2、3、 4、5、6、または7のいずれか1つに記載の薬学的組成物。 21.前記キャリア巨大分子がアニオン性ポリアルコール誘導体またはそのフラ グメントである、請求項1、2、3、4、5、6、または7のいずれか1つに記 載の薬学的組成物。 22.前記キャリア巨大分子がアニオン性ポリサッカリド誘導体またはそのフラ グメントである、請求項1、2、3、4、5、6、または7のいずれか1つに記 載の薬学的組成物。 23.前記キャリア巨大分子がカルボキシメチルセルロース、またはそのフラグ メントあるいは誘導体である、請求項1、2、3、4、5、6、または7のいず れか1つに記載の薬学的組成物。 24.前記キャリア巨大分子が、アルギン、アルギネート、アニオン性アセテー トポリマー、アニオン性アクリル酸ポリマー、キサンタンガム、アニオン性カラ ギーナン誘導体、アニオン性ポリガラクツロン酸誘導体、グリコール酸ナトリウ ムスターチ、ならびにそのフラグメント、誘導体、および薬学的に受容可能な塩 からなる群より選択される、請求項1、2、3、4、5、6、または7のいずれ か1つに記載の薬学的組成物。 25.凍結乾燥された固体である、請求項1、2、3、4、5、6、または7の いずれか1つに記載の薬学的組成物。 26.前記固体イオン性複合体が液体懸濁物として懸濁されているか、または半 固体分散体として分散されている、請求項1、2、3、4、5、6、または7の いずれか1つに記載の薬学的組成物。 27.前記LHRHアナログがペプチド化合物を含むLHRHアンタゴニストであり、こ こで天然の哺乳動物LHRHの6位におけるアミノ酸に対応する該ペプチド化合物の 残基がD-アスパラギン構造を含む、請求項8に記載の薬学的組成物。 28.前記LHRHアナログが、以下の構造を含むペプチド化合物を含むLHRHアンタ ゴニストまたはその薬学的に受容可能な塩である、請求項8に記載の薬学的組成 物: A-B-C-D-E-F-G-H-I-J ここで Aは、ピロ-Glu、Ac-D-Nal、Ac-D-Qal、Ac-Sar、またはAc-D-Palであり Bは、His、または4-Cl-D-Pheであり Cは、Trp、D-PaL、D-Nal、L-NaL、D-Pal(N-0)、またはD-Trpであり Dは、Serであり Eは、N-Me-Ala、Tyr、N-Me-TyL、Ser、Lys(iPr)、4-Cl-Phe、His、Asn、Met、Al a、Arg、またはIleであり; Fは、D-Asn、D-Gln、またはD-Thrであり; Gは、Leu、またはTrpであり; Hは、Lys(iPr)、Gln、Met、またはArgであり Iは、Proであり;そして Jは、Gly-NH2、またはD-Ala-NH2である。 29.前記LHRHアナログが、以下の構造:Ac-D-Nal-4-Cl-D-Phe-D-Pal-Ser-N-Me -Tyr-D-Asn-Leu-Lys(iPr)-Pro-D-Alaを有するLHRHアンタゴニストである、請求 項8に記載の薬学的組成物。 30.LHRHアナログで処置可能な状態の被験体を処置するためのパッケージ化処 方物であって、以下: LHRHアナログで処置可能な状態の被験体を処置するための複合体の使用説明書 と合わせてパッケージ化された、LHRHアナログとキャリア巨大分子との固体イオ ン性複合体であって、ここで該複合体のペプチド含有量が少なくとも57重量%で ある、固体イオン性複合体 を含む、パッケージ化処方物。 31.前記LHRHアナログが、以下の構造:Ac-D-Nal-4-Cl-D-Phe-D-Pal-Ser-N-Me -Tyr-D-Asn-Leu-Lys(iPr)-Pro-D-Alaを有し、そして前記キャリア巨大分子がカ ルボキシメチルセルロースである、請求項30に記載のパッケージ化処方物。 32.管腔を有するシリンジにおいて、改良が、該管腔に、LHRHアナログとキャ リア巨大分子との固体イオン性複合体の液体懸濁液を含み、ここで該複合体のペ プチド含有量が少なくとも57重量%であることを含む、シリンジ。 33.前記LHRHアナログが、以下の構造:Ac-D-Nal-4-Cl-D-Phe-D-Pal-Ser-N-Me -Tyr-D-Asn-Leu-Lys(iPr)-Pro-D-Alaを有し、そして前記キャリア巨大分子がカ ルボキシメチルセルロースである、請求項32に記載のシリンジ。 34.LHRHアナログで処置可能な状態を処置するための薬物の製造における、請 求項1、2、3、4、5、6、または7のいずれか1つに記載の薬学的組成物の 使用。 35.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも1週間 、該被験体にLHRHアナログの持続した送達を提供する、請求項34に記載の使用 。 36.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも2週間 、該被験体にLHRHアナログの持続した送達を提供する、請求項34に記載の使用 。 37.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも3週間 、該被験体にLHRHアナログの持続した送達を提供する、請求項34に記載の使用 。 38.前記複合体が、前記薬学的組成物を被験体に投与した後少なくとも4週間 、該被験体にLHRHアナログの持続した送達を提供する、請求項34に記載の使用 。 39.前記LHRHアナログがLHRHアンタゴニストである、請求項34に記載の使用 。 40.前記LHRHアンタゴニストが、以下の構造:Ac-D-Nal-4-Cl-D-Phe-D-Pal-Se r-N-Me-Tyr-D-Asn-Leu-Lys(iPr)-Pro-D-Alaを有する、請求項39に記載の使用 。 41.前記キャリア巨大分子がアニオン性ポリマーである、請求項34に記載の 使用。 42.前記キャリア巨大分子がアニオン性ポリアルコール誘導体またはそのフラ グメントである、請求項34に記載の使用。 43.前記キャリア巨大分子がアニオン性ポリサッカリド誘導体またはそのフラ グメントである、請求項34に記載の使用。 44.前記キャリア巨大分子がカルボキシメチルセルロース、またはそのフラグ メントあるいは誘導体である、請求項34に記載の使用。 45.前記キャリア巨大分子が、アルギン、アルギネート、アニオン性アセテー トポリマー、アニオン性アクリル酸ポリマー、キサンタンガム、アニオン性カラ ギーナン誘導体、アニオン性ポリガラクツロン酸誘導体、グリコール酸ナトリウ ムスターチ、ならびにそのフラグメント、誘導体、および薬学的に受容可能な塩 からなる群より選択される、請求項34に記載の使用。 46.前記薬学的組成物が、非経口経路により前記被験体へ投与される、請求項 34に記載の使用。 47.前記薬学的組成物が、経口で前記被験体へ投与される、請求項34に記載 の使用。 48.前記薬学的組成物が、筋肉内注射または皮下/皮内注射により投与される 、請求項34に記載の使用。 49.前記LHRHアナログで処置可能な状態が、ホルモン依存性癌である、請求項 34に記載の使用。 50.前記ホルモン依存性癌が前立腺癌である、請求項49に記載の使用。 51.前記LHRHアナログで処置可能な状態が、良性前立腺肥大、性的早熟、子宮 内膜症、および子宮筋肺からなる群より選択される、請求項34に記載の使用。 52.前記LHRHアナログが、インビトロでの妊娠または避妊目的のために投与 される、請求項34に記載の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US08/762,747 | 1996-12-11 | ||
US08/762,747 US5968895A (en) | 1996-12-11 | 1996-12-11 | Pharmaceutical formulations for sustained drug delivery |
PCT/US1997/022881 WO1998025642A2 (en) | 1996-12-11 | 1997-12-11 | Pharmaceutical formulations comprising a water-insoluble complex for sustained drug delivery |
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JP2006272340A Division JP2007016049A (ja) | 1996-12-11 | 2006-10-03 | 持続した薬物送達のための水不溶性複合体を含む薬学的処方物 |
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JP2000508345A true JP2000508345A (ja) | 2000-07-04 |
JP4033498B2 JP4033498B2 (ja) | 2008-01-16 |
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JP52700298A Expired - Fee Related JP4033498B2 (ja) | 1996-12-11 | 1997-12-11 | 持続した薬物送達のための水不溶性複合体を含む薬学的処方物 |
JP2006272340A Withdrawn JP2007016049A (ja) | 1996-12-11 | 2006-10-03 | 持続した薬物送達のための水不溶性複合体を含む薬学的処方物 |
JP2011024133A Pending JP2011105760A (ja) | 1996-12-11 | 2011-02-07 | 持続した薬物送達のための水不溶性複合体を含む薬学的処方物 |
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JP2011024133A Pending JP2011105760A (ja) | 1996-12-11 | 2011-02-07 | 持続した薬物送達のための水不溶性複合体を含む薬学的処方物 |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2004508411A (ja) * | 2000-09-13 | 2004-03-18 | プラエシス ファーマシューティカルズ インコーポレーテッド | 持続的薬物送達のための医薬組成物 |
JP2011068670A (ja) * | 2002-06-25 | 2011-04-07 | Alza Corp | 短期間デポ調剤 |
JP2006501936A (ja) * | 2002-10-04 | 2006-01-19 | エラン ファーマ インターナショナル,リミティド | 固体ナノ粒子活性薬剤のガンマ線照射 |
JP2007521244A (ja) | 2003-11-10 | 2007-08-02 | ファイン、シーモア、エイチ. | 低用量デスモプレシンを含有する医薬組成物 |
JP2016516062A (ja) * | 2013-03-15 | 2016-06-02 | リズム・ファーマシューティカルズ・インコーポレイテッド | 医薬組成物 |
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