JP5841333B2 - 安定化されたカリスバメートの小児用懸濁液 - Google Patents
安定化されたカリスバメートの小児用懸濁液 Download PDFInfo
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- JP5841333B2 JP5841333B2 JP2010531607A JP2010531607A JP5841333B2 JP 5841333 B2 JP5841333 B2 JP 5841333B2 JP 2010531607 A JP2010531607 A JP 2010531607A JP 2010531607 A JP2010531607 A JP 2010531607A JP 5841333 B2 JP5841333 B2 JP 5841333B2
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- charisbamate
- pharmaceutical composition
- suspension
- hypromellose
- epilepsy
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- 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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- 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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Description
本出願は、2007年10月31日に出願された米国特許仮出願第60/984,144号の優先権の利益を主張する。前記の関連する米国特許出願の全開示は、これによりすべての目的のために参照として編入する。
本発明は、小児および成人が使用するためのカリスバメートの安定化された製薬学的懸濁液を提供する。より詳細にはこの懸濁液は、懸濁した粒子の結晶成長を防止し、そして多形状態が変化する薬物製品の再結晶を防止するために安定化される。さらに、この製剤は味が遮蔽されて、錠剤またはカプセルを飲み込むことが困難な患者、例えば小児患者に容易に投与することができる製剤を提供する。
本発明は、懸濁液を安定化するための湿潤剤として作用するために、しかも結晶の成長および再形成を制御し、そして結晶構造を安定化するために、ヒプロメロースを約1.8〜約2.0mg/mlで添加したカリスバメート粒子の水中懸濁液を含んでなる製薬学的製剤を対象とする。
Bossingerらへの米国特許第3,265,728号明細書に記載された様々な置換フェニルアルキルカルバメート化合物は、哺乳動物で鎮痙性を有し、すなわちヒトにおいて癲癇のような疾患の処置に有用性を有する。
スバメートの水性懸濁液を提供する。
0mg/ml、好ましくは0.3%〜3.0mg/ml、そして最も好ましくは1.5〜2.5mg/mlの範囲でよい。
う行動障害、精神遅滞および自閉における行動障害、双極躁病、鬱および不安に罹患しているヒトの処置法に関し、該方法は治療に有効な量のこれまでに記載した水性懸濁液の投与を含んでなる。治療に有効な量のカリスバメートは、50〜1200mgの毎日の総用量を、1から4回の等用量で投与される。
Claims (6)
- a)20mg/mlのカリスバメート;および
b)10mg/mlのヒプロメロース
を含んでなる水性懸濁液状態の製薬学的組成物。 - 組成物がさらに懸濁剤および湿潤剤を含んでなる請求項1に記載の製薬学的組成物。
- 1もしくは複数の、保存剤、バッファー、甘味料、風味料および等張剤を含んでなる請求項2に記載の製薬学的組成物。
- 保存剤がベンジルアルコールであり、そして等張剤がマンニトールまたはリン酸バッファーである、請求項3に記載の組成物。
- a)20mg/mlのカリスバメート;および
b)10mg/mlのヒプロメロース
を含んでなる、哺乳動物の癲癇の処置のための水性懸濁液状態の製薬学的組成物。 - a)20mg/mlのカリスバメート;および
b)10mg/mlのヒプロメロース
を含んでなる、癲癇、神経障害性疼痛、振せん、癲癇誘発、神経保護、統合失調症、非***的精神病、認知症、精神遅滞および自閉における行動障害、双極躁病、鬱および不安からなる群から選択される障害の処置のための水性懸濁液状態の製薬学的組成物。
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US98414407P | 2007-10-31 | 2007-10-31 | |
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PCT/IB2008/003331 WO2009056980A1 (en) | 2007-10-31 | 2008-10-31 | Stabilized pediatric suspension of carisbamate |
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JP2011500870A JP2011500870A (ja) | 2011-01-06 |
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JP2016136713A Active JP6273589B2 (ja) | 2007-10-31 | 2016-07-11 | 安定化されたカリスバメートの小児用懸濁液 |
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US8263652B2 (en) | 2007-10-31 | 2012-09-11 | Sk Biopharmaceuticals Co., Ltd. | Stabilized pediatric suspension of carisbamate |
WO2011107855A2 (en) | 2010-03-04 | 2011-09-09 | Torrent Pharmaceuticals Limited | Sustained release oral liquid suspension dosage form |
WO2011137274A1 (en) * | 2010-04-30 | 2011-11-03 | Bristol-Myers Squibb Company | Pharmaceutical compositions comprising n-(4-(2-amino-3-chloropyridin-4-yloxy)-3-fluorophenyl)-4-ethoxy-l-(4-fluorophenyl)-2-oxo- 1,2-dihydropyridine-3 -carboxamide |
US8609849B1 (en) | 2010-11-30 | 2013-12-17 | Fox Chase Chemical Diversity Center, Inc. | Hydroxylated sulfamides exhibiting neuroprotective action and their method of use |
JO3190B1 (ar) * | 2011-10-19 | 2018-03-08 | Otsuka Pharma Co Ltd | محلول للتناول عن طريق الفم |
TWI660748B (zh) * | 2013-03-01 | 2019-06-01 | 日商大塚製藥股份有限公司 | 用於口服投藥之包含非晶型托伐普坦(Tolvaptan)的懸浮液 |
CN103966680A (zh) * | 2014-05-04 | 2014-08-06 | 东华大学 | 一种药物缓释纳米纤维的制备方法 |
WO2016190638A1 (ko) * | 2015-05-22 | 2016-12-01 | 에스케이바이오팜 주식회사 | 카리스바메이트를 포함하는 약제, 및 통증 또는 뇌전증을 예방, 경감 또는 치료하기 위한 그의 용도 |
ITUB20155193A1 (it) * | 2015-11-03 | 2017-05-03 | Italfarmaco Spa | Sospensioni orali di Givinostat fisicamente e chimicamente stabili |
CN105997866B (zh) * | 2016-07-13 | 2019-08-20 | 成都明慈医药科技有限公司 | 一种含***的混悬剂及其制备方法 |
US11369579B2 (en) | 2016-10-24 | 2022-06-28 | Syneurx International (Taiwan) Corp. | Polymorphic forms of sodium benzoate and uses thereof |
US10336679B2 (en) * | 2016-10-24 | 2019-07-02 | Syneurx International (Taiwan) Corp. | Polymorphic forms of sodium benzoate and uses thereof |
US10098861B1 (en) | 2017-10-24 | 2018-10-16 | Syneurx International (Taiwan) Corp. | Pharmaceutical composition comprising sodium benzoate compound and clozapine, and uses thereof |
KR102369827B1 (ko) | 2020-09-04 | 2022-03-04 | (주)피알지에스앤텍 | 프로게리닌을 포함하는 나노현탁액 및 이의 제조방법 |
US20220213802A1 (en) * | 2021-01-06 | 2022-07-07 | General Electric Company | System for controlling blade clearances within a gas turbine engine |
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MXPA02001820A (es) * | 1999-08-20 | 2003-07-14 | Johnson & Johnson | Composicion que comprende un material de tramadol y un farmaco anticonvulsivo. |
MXPA03007720A (es) * | 2001-02-27 | 2004-11-12 | Johnson & Johnson | Compuestos de carbamato para su uso en la prevencion o el tratamiento de transtornos de ansiedad. |
ES2305776T3 (es) * | 2003-06-17 | 2008-11-01 | Pfizer Inc. | Derivados de n-pirrolidin-3-il-amida como inhibidores de la re-captacion de serotonina y noradrenalina. |
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CN101663026A (zh) * | 2006-10-13 | 2010-03-03 | 詹森药业有限公司 | 氨基甲酸苯基烷基酯组合物 |
US8263652B2 (en) * | 2007-10-31 | 2012-09-11 | Sk Biopharmaceuticals Co., Ltd. | Stabilized pediatric suspension of carisbamate |
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