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1. (WO2010113840) SOLID PHARMACEUTICAL COMPOSITION CONTAINING AMORPHOUS BODY OF SOLIFENACIN
Latest bibliographic data on file with the International Bureau   

Pub. No.: WO/2010/113840 International Application No.: PCT/JP2010/055515
Publication Date: 07.10.2010 International Filing Date: 29.03.2010
IPC:
A61K 31/439 (2006.01) ,A61K 9/19 (2006.01) ,A61K 47/04 (2006.01) ,A61K 47/12 (2006.01) ,A61K 47/18 (2006.01) ,A61K 47/38 (2006.01) ,A61P 13/02 (2006.01) ,A61P 25/00 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
33
Heterocyclic compounds
395
having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
435
having six-membered rings with one nitrogen as the only ring hetero atom
439
the ring forming part of a bridged ring system, e.g. quinuclidine
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
14
Particulate form, e.g. powders
19
lyophilised
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
02
Inorganic compounds
04
Non-metals; Compounds thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
08
containing oxygen
12
Carboxylic acids; Salts or anhydrides thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
16
containing nitrogen
18
Amines; Quaternary ammonium compounds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
36
Polysaccharides; Derivatives thereof
38
Cellulose; Derivatives thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
13
Drugs for disorders of the urinary system
02
of urine or of the urinary tract, e.g. urine acidifiers
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
25
Drugs for disorders of the nervous system
Applicants:
若生 佑子 WAKO Yuko [JP/JP]; JP (UsOnly)
吉原 慶一 YOSHIHARA Keiichi [JP/JP]; JP (UsOnly)
伊藤 直樹 ITOU Naoki [JP/JP]; JP (UsOnly)
アステラス製薬株式会社 Astellas Pharma Inc. [JP/JP]; 東京都中央区日本橋本町二丁目3番11号 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 1038411, JP (AllExceptUS)
Inventors:
若生 佑子 WAKO Yuko; JP
吉原 慶一 YOSHIHARA Keiichi; JP
伊藤 直樹 ITOU Naoki; JP
Agent:
森田 憲一 MORITA Kenichi; 東京都板橋区板橋二丁目67番8号 板橋中央ビル5階 5th Fl., Itabashi-chuo Bldg., 67-8, Itabashi 2-chome, Itabashi-ku, Tokyo 1730004, JP
Priority Data:
61/202,71230.03.2009US
Title (EN) SOLID PHARMACEUTICAL COMPOSITION CONTAINING AMORPHOUS BODY OF SOLIFENACIN
(FR) COMPOSITION PHARMACEUTIQUE SOLIDE CONTENANT UN CORPS AMORPHE DE SOLIFÉNACINE
(JA) ソリフェナシン非晶質体を含有した固形医薬組成物
Abstract:
(EN) Disclosed is a solid pharmaceutical composition which contains a stable amorphous body of solifenacin or a pharmaceutically acceptable salt thereof, said amorphous body can be suppressed in decomposition over time. The solid pharmaceutical composition is used for the purpose of providing a preparation of solifenacin or a pharmaceutically acceptable salt thereof to a clinical site. Specifically disclosed is a solid pharmaceutical composition which contains: an amorphous body of solifenacin or a pharmaceutically acceptable salt thereof; citric acid or a pharmaceutically acceptable salt thereof (excluding a calcium salt); and one or more stabilizers for the amorphous body of solifenacin, said stabilizers being selected from the group consisting of sodium pyrosulfite and pharmaceutically acceptable salts of ethylenediaminetetraacetic acid.
(FR) L'invention porte sur une composition pharmaceutique solide qui contient un corps amorphe stable de solifénacine ou un sel pharmaceutiquement acceptable de celui-ci, ledit corps amorphe pouvant être supprimé par décomposition au cours du temps. La composition pharmaceutique solide est utilisée afin de fournir une préparation de solifénacine ou un sel pharmaceutiquement acceptable de celle-ci vers un site clinique. L'invention porte spécifiquement sur une composition pharmaceutique solide qui contient : un corps amorphe de solifénacine ou un sel pharmaceutiquement acceptable de celle-ci ; de l'acide citrique ou un sel pharmaceutiquement acceptable de celui-ci (à l'exclusion d'un sel de calcium) ; et un ou plusieurs stabilisants pour le corps amorphe de solifénacine, lesdits stabilisants étant choisis dans le groupe constitué par le pyrosulfite de sodium et des sels pharmaceutiquement acceptables de l'acide éthylènediaminetétraacétique.
(JA)  本発明は、ソリフェナシンまたはその製薬学的に許容される塩の製剤を臨床現場に提供するに当たり、経時的な分解を抑制できる安定なソリフェナシンまたはその製薬学的に許容される塩の非晶質体を含有する固形医薬組成物の提供に関する。より詳細には、本発明は、ソリフェナシンまたはその製薬学的に許容される塩の非晶質体、クエン酸またはその製薬学的に許容される塩(但しカルシウム塩を除く)、ピロ亜硫酸ナトリウム、及びエチレンジアミン四酢酸の製薬学的に許容される塩からなる群より選択される1種または2種以上のソリフェナシン非晶質体の安定化剤を含有してなる、固形医薬組成物に関するものである。
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (EPO) (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
Publication Language: Japanese (JA)
Filing Language: Japanese (JA)