JP6039157B2 - 膀胱癌の治療のための組成物及び治療法 - Google Patents
膀胱癌の治療のための組成物及び治療法 Download PDFInfo
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- JP6039157B2 JP6039157B2 JP2010536170A JP2010536170A JP6039157B2 JP 6039157 B2 JP6039157 B2 JP 6039157B2 JP 2010536170 A JP2010536170 A JP 2010536170A JP 2010536170 A JP2010536170 A JP 2010536170A JP 6039157 B2 JP6039157 B2 JP 6039157B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
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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
- A61K47/08—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
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- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- 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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- 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
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- 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
- A61K9/08—Solutions
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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
- A61K9/127—Liposomes
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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
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- 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
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
Description
本願は、2007年11月30日に提出された米国仮特許出願No.60/991,596の優先権を主張するものであり、その全内容は、ありとあらゆる目的のために参照することにより、本明細書の一部を構成する。
本発明は、一般に、癌治療の分野に関する。とりわけ治療は、例えば、膀胱、結腸、口腔及び胃などの患者の中空体構造内に発現した癌に施される。
抗癌剤としての活性を有する医薬組成物及び膀胱癌患者の治療法が提供される。1態様では、医薬組成物は、抗腫瘍薬(NA)及び浸透促進剤を含む。1実施形態では、組成物は、有効量のバルルビシン及び浸透促進剤ジメチルスルホキシド(DMSO)を含む。他の実施形態では、組成物は、有効量のバルルビシン、浸透促進剤DMSO及び添加剤を含む。
本例では、上下の表に特定される種々の製剤をラットの膀胱に注入した。次いでラットは所定の間隔で犠牲にし、血液と膀胱を採取した。血液は、バルルビシンの全身への浸透について分析した。5つのパラメータで各膀胱のスコアをつけることにより、炎症について膀胱を分析した。5つのパラメータは、静脈性鬱血、浮腫、上皮損傷、出血と細胞浸潤であり、10段階評価でスコアをつけ、その間の数値は、測定パラメータの様々な度合いを表示する。浮腫に関して、0は、浮腫がないことに相当し、他方10は、膀胱全体を含む大規模な巣状の浮腫に相当する。静脈性鬱血に関して、0は、静脈性鬱血がないことに相当し、他方10は、目に見える、著しく拡張された全ての静脈血管に相当する。細胞浸潤に関して、0は、細胞浸潤がないことに相当し、他方10は、感染(好中球の存在)を示唆する非常に重度の細胞浸潤に相当する。上皮損傷に関して、0は、上皮損傷がないことに相当し、他方10は、上皮の大領域の著しい損失に相当する。出血に関して、0は、出血がないことに相当し、他方10は、全ての深く広範囲に及ぶ出血に相当する。次いで、この5個の各スコアを合計して、各動物について合計炎症スコアを提供する。次いで、何か特定の製剤について使用された動物数を加えて、その製剤についての平均炎症スコアを決定した。より低い炎症スコアは、膀胱への刺激のより低い量に関連すると信じることができる。
Claims (14)
- (i)生理食塩水と、(ii)5mg/mL〜100mg/mLのバルルビシン、ジメチルスルホキシド及びポリエトキシル化ヒマシ油からなるバルルビシン製剤とを含む、膀胱内投薬用の医薬組成物であって、前記バルルビシン製剤の前記生理食塩水に対する容積比が1:1または1:2.75であり、前記ポリエトキシル化ヒマシ油及びジメチルスルホキシドが等容積で備わる、医薬組成物。
- エタノール、イソプロパノール、ジメチルアセトアミド、ジメチルホルムアミド、デシルメチルスルホキシド、2−ピロリドン、N−エチル−2−ピロリドン、カプリン酸、リノール酸、尿素、ドデシル硫酸ナトリウム、ラウリル硫酸ナトリウム及びこれらの任意のもの2つ以上の混合物からなる群から選択される化学的浸透促進剤1種以上を更に含む請求項1に記載の医薬組成物。
- 結合開口剤を含む請求項1に記載の医薬組成物。
- 前記結合開口剤が、トリメチル−キトサン、モノ−N−カルボキシメチルキトサン、N−ジエチルメチルキトサン、カプリン酸ナトリウム、シトカラシンB、IL−1、ポリカルボフィル、カルボポール934P、N−スルフェート−N,O−カルボキシメチルキトサン、Zounla occludens毒素、1−パルミトイル−2−グルタロイル−sn−グリセロ−3−ホスホコリン及びこれらの任意のもの2つ以上の混合物からなる群から選択される請求項3に記載の医薬組成物。
- 前記結合開口剤の量が、1〜15重量%/医薬組成物容積である請求項3に記載の医薬組成物。
- ムチン分解化合物を更に含む請求項1に記載の医薬組成物。
- 前記ムチン分解化合物が、トリプシン、ヒアルロニダーゼ、硫酸プロタミン及びノルエピネフリンからなる群から選択される請求項6に記載の医薬組成物。
- 更に、生体接着剤又は粘膜接着剤を含む請求項1に記載の医薬組成物。
- 前記粘膜接着剤がポリアクリル酸である請求項8に記載の医薬組成物。
- 更に、イオン性又は非イオン性界面活性剤、ポリビニルピロリドン、アルギネート、ポリアクリル酸又はこれらの任意のもの2つ以上の混合物を含む請求項1に記載の医薬組成物。
- 前記イオン性及び非イオン性界面活性剤が、ポリオキシエチレンヒマシ油誘導体、エチレンオキシドとプロピレンオキシドのブロックコポリマー、ソルビタン脂肪酸エステル又はこれらの任意のもの2つ以上の混合物である請求項10に記載の医薬組成物。
- 前記ポリアクリル酸は、Carbomer934P、Carbomer940、Carbomer941、Carbomer974P、Carbomer980、Carbomer1342、ポリカルボフィル、ポリカルボフィルカルシウム又はこれらの任意のもの2つ以上の混合物である請求項11に記載の医薬組成物。
- 前記バルルビシン製剤の前記生理食塩水に対する容積比が1:1である請求項1に記載の医薬組成物。
- ポリエトキシル化ヒマシ油をさらに含み、前記ジメチルスルホキシドと前記ポリエトキシル化ヒマシ油が等容積で備わる請求項13に記載の医薬組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US99159607P | 2007-11-30 | 2007-11-30 | |
US60/991,596 | 2007-11-30 | ||
PCT/US2008/084870 WO2009073517A2 (en) | 2007-11-30 | 2008-11-26 | Intravesical compositions with valrubicin for the treatment of bladder cancer |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2011505370A JP2011505370A (ja) | 2011-02-24 |
JP6039157B2 true JP6039157B2 (ja) | 2016-12-07 |
Family
ID=40433882
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010536170A Expired - Fee Related JP6039157B2 (ja) | 2007-11-30 | 2008-11-26 | 膀胱癌の治療のための組成物及び治療法 |
Country Status (14)
Country | Link |
---|---|
US (2) | US20090214634A1 (ja) |
EP (1) | EP2224904A2 (ja) |
JP (1) | JP6039157B2 (ja) |
KR (1) | KR20100092016A (ja) |
CN (2) | CN101951884A (ja) |
AR (1) | AR069831A1 (ja) |
AU (1) | AU2008331500B2 (ja) |
BR (1) | BRPI0821100A2 (ja) |
CA (1) | CA2706923A1 (ja) |
CL (1) | CL2008003558A1 (ja) |
MX (1) | MX2010005862A (ja) |
RU (1) | RU2542449C2 (ja) |
TW (1) | TWI510243B (ja) |
WO (1) | WO2009073517A2 (ja) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2009111555A1 (en) * | 2008-03-05 | 2009-09-11 | Endo Pharmaceuticals Solutions Inc., | Combination treatment for bladder cancer comprisining valrubicin and trospium chloride |
CA2922627C (en) * | 2013-06-18 | 2022-03-08 | THERMOSOME GmbH | Stereospecific lipids for locoregional therapy with long-term circulating stimuli-sensitive nanocarrier systems |
CN105982910A (zh) * | 2015-01-29 | 2016-10-05 | 上海建华精细生物制品有限公司 | 膀胱保护液制剂及生产工艺 |
AU2017240074B2 (en) * | 2016-03-31 | 2020-01-02 | Jiangsu Yahong Meditech Co., Ltd. | Combinational uses of Nitroxoline and its analogues with chemotherapies and immunotherapies in the treatment of cancers |
CN108498454B (zh) * | 2018-04-03 | 2020-11-06 | 济川药业集团有限公司 | 一种蛋白琥珀酸铁口服液及其制备方法 |
AU2020265812A1 (en) * | 2019-04-30 | 2021-11-25 | Trigone Pharma Ltd. | Formulations and methods for drug instillation into the bladder and treatment of bladder ailments |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
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US4035566A (en) * | 1975-09-25 | 1977-07-12 | Sidney Farber Cancer Institute, Inc. | N-trifluoroacetyladriamycin-14-alkanoates and therapeutic compositions containing same |
CA1282405C (en) * | 1984-05-21 | 1991-04-02 | Michael R. Violante | Method for making uniformly sized particles from water-insoluble organic compounds |
IE58981B1 (en) * | 1985-10-15 | 1993-12-15 | Vestar Inc | Anthracycline antineoplastic agents encapsulated in phospholipid micellular particles |
US5902604A (en) * | 1995-06-06 | 1999-05-11 | Board Of Regents, The University Of Texas System | Submicron liposome suspensions obtained from preliposome lyophilizates |
CA2302496C (en) * | 1997-08-28 | 2009-12-08 | Afferon Corporation | Urinary incontinence therapy |
WO2003015698A2 (en) * | 2001-08-13 | 2003-02-27 | University Of Pittsburgh | Application of lipid vehicles and use for drug delivery |
US7862834B2 (en) * | 2003-05-28 | 2011-01-04 | Novartis Pharma Ag | Pharmaceutical formulation comprising a water-insoluble active agent |
US20050059613A1 (en) * | 2003-07-08 | 2005-03-17 | Bahram Memarzadeh | Compositions and methods for the enhanced uptake of therapeutic agents through the bladder epithelium |
US20050129752A1 (en) * | 2003-12-15 | 2005-06-16 | Tty Biopharm Limited Company | Use and manufacturing process for liposomal doxorubicin pharmaceutical composition |
JP4658967B2 (ja) * | 2003-12-24 | 2011-03-23 | ジェネンテック, インコーポレイテッド | 造血系起源の腫瘍の治療のための組成物と方法 |
WO2005087221A1 (en) * | 2004-03-15 | 2005-09-22 | Christine Allen | Biodegradable biocompatible implant and method of manufacturing same |
-
2008
- 2008-11-26 JP JP2010536170A patent/JP6039157B2/ja not_active Expired - Fee Related
- 2008-11-26 CN CN2008801253861A patent/CN101951884A/zh active Pending
- 2008-11-26 CN CN201510385794.2A patent/CN105147594A/zh active Pending
- 2008-11-26 AU AU2008331500A patent/AU2008331500B2/en not_active Ceased
- 2008-11-26 RU RU2010126615/15A patent/RU2542449C2/ru not_active IP Right Cessation
- 2008-11-26 KR KR1020107013020A patent/KR20100092016A/ko active Search and Examination
- 2008-11-26 CA CA2706923A patent/CA2706923A1/en not_active Abandoned
- 2008-11-26 US US12/324,019 patent/US20090214634A1/en not_active Abandoned
- 2008-11-26 WO PCT/US2008/084870 patent/WO2009073517A2/en active Application Filing
- 2008-11-26 MX MX2010005862A patent/MX2010005862A/es active IP Right Grant
- 2008-11-26 BR BRPI0821100A patent/BRPI0821100A2/pt not_active IP Right Cessation
- 2008-11-26 EP EP08857915A patent/EP2224904A2/en not_active Withdrawn
- 2008-11-28 TW TW097146316A patent/TWI510243B/zh not_active IP Right Cessation
- 2008-11-28 CL CL2008003558A patent/CL2008003558A1/es unknown
- 2008-11-28 AR ARP080105215A patent/AR069831A1/es unknown
-
2015
- 2015-03-20 US US14/663,830 patent/US20150190413A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
AU2008331500A1 (en) | 2009-06-11 |
KR20100092016A (ko) | 2010-08-19 |
CL2008003558A1 (es) | 2009-12-18 |
CA2706923A1 (en) | 2009-06-11 |
MX2010005862A (es) | 2010-11-30 |
JP2011505370A (ja) | 2011-02-24 |
US20090214634A1 (en) | 2009-08-27 |
CN105147594A (zh) | 2015-12-16 |
WO2009073517A2 (en) | 2009-06-11 |
AR069831A1 (es) | 2010-02-24 |
RU2542449C2 (ru) | 2015-02-20 |
TWI510243B (zh) | 2015-12-01 |
AU2008331500B2 (en) | 2013-11-21 |
WO2009073517A3 (en) | 2009-08-13 |
BRPI0821100A2 (pt) | 2017-05-23 |
RU2010126615A (ru) | 2012-01-10 |
EP2224904A2 (en) | 2010-09-08 |
CN101951884A (zh) | 2011-01-19 |
TW200930381A (en) | 2009-07-16 |
US20150190413A1 (en) | 2015-07-09 |
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