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1. (WO2018062941) PHARMACEUTICAL COMPOSITION FOR PREVENTING OR TREATING DEMENTIA AND COGNITIVE DYSFUNCTION, CONTAINING DONEPEZIL OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND MEMANTINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PREPARATION METHOD THEREFOR
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Pub. No.: WO/2018/062941 International Application No.: PCT/KR2017/010953
Publication Date: 05.04.2018 International Filing Date: 29.09.2017
IPC:
A61K 31/445 (2006.01) ,A61K 31/13 (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
44
Non-condensed pyridines; Hydrogenated derivatives thereof
445
Non-condensed piperidines, e.g. piperocaine
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
13
Amines, e.g. amantadine
Applicants: BIO PHARMARTIS CO., LTD.[KR/KR]; 811, 108, Gasan digital 2-ro Geumcheon-gu Seoul 08506, KR
Inventors: KOO, Hyoung Mo; KR
KO, Chan Young; KR
LEE, Mase; KR
Agent: LEE, Cheo Young; 11F. 123, Teheran-ro Gangnam-gu Seoul 06133, KR
CHANG, Je Hwan; 11F. 123, Teheran-ro Gangnam-gu Seoul 06133, KR
Priority Data:
10-2016-012623030.09.2016KR
10-2017-012522027.09.2017KR
Title (EN) PHARMACEUTICAL COMPOSITION FOR PREVENTING OR TREATING DEMENTIA AND COGNITIVE DYSFUNCTION, CONTAINING DONEPEZIL OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND MEMANTINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PREPARATION METHOD THEREFOR
(FR) COMPOSITION PHARMACEUTIQUE POUR LA PRÉVENTION OU LE TRAITEMENT D'UNE DÉMENCE ET D'UN DYSFONCTIONNEMENT COGNITIF, CONTENANT DU DONÉPÉZIL OU UN SEL DE QUALITÉ PHARMACEUTIQUE DE CELUI-CI ET DE LA MÉMANTINE OU UN SEL DE QUALITÉ PHARMACEUTIQUE DE CELLE-CI, ET SON PROCÉDÉ DE PRÉPARATION
(KO) 도네페질 또는 그의 약학적으로 허용 가능한 염 및 메만틴 또는 그의 약학적으로 허용 가능한 염을 함유하는 치매 및 인지기능 장애 예방 또는 치료용 약학 조성물 및 이의 제조방법
Abstract:
(EN) The present invention relates to a pharmaceutical composition for preventing or treating dementia and cognitive dysfunction, containing donepezil or a pharmaceutically acceptable salt thereof and memantine or a pharmaceutically acceptable salt thereof, and a preparation method therefor, the method comprising the steps of: granulating donepezil or a pharmaceutically acceptable salt thereof through a wet process; and directly compressing a mixture in which memantine or a pharmaceutically acceptable salt thereof is added to the granulated donepezil or the pharmaceutically acceptable salt thereof and homogenizing the same, so as to resolve the problem, in which the efficacy of the active ingredient, donepezil, can be reduced because of a dissolution-lowering phenomenon when Aricept (donepezil hydrochloride) and Ebixa (memantine hydrochloride), which are conventionally on the market, are co-administered, and ensure amount uniformity by selecting an excipient having a particle size similar to that of particles of the active ingredient. In addition, the present pharmaceutical composition of the present invention is very stable with low impurity.
(FR) La présente invention concerne une composition pharmaceutique pour la prévention ou le traitement d'une démence et d'un dysfonctionnement cognitif, contenant du donépézil ou un sel de qualité pharmaceutique de celui-ci et de la mémantine ou un sel de qualité pharmaceutique de celle-ci, et son procédé de préparation, le procédé comprenant les étapes suivantes : granulation du donépézil ou d'un sel de qualité pharmaceutique de celui-ci par un procédé par voie humide; et compression directe d'un mélange dans lequel de la mémantine ou un sel de qualité pharmaceutique de celle-ci est ajouté au donépézil ou au sel de qualité pharmaceutique de celui-ci granulé, cela étant suivi d'une homogénéisation du mélange, de manière à résoudre le problème qui fait que l'efficacité du principe actif, le donépézil, peut être réduite en raison d'un phénomène de dégradation de la dissolution lorsque de l'Aricept (chlorhydrate de donépézil) et de l'Ebixa (chlorhydrate de mémantine), qui sont classiquement disponibles sur le marché, sont co-administrés, et à assurer une uniformisation des quantités en choisissant un excipient ayant une taille de particule similaire à celle des particules de principe actif. De plus, la présente composition pharmaceutique de la présente invention est très stable et présente une faible teneur en impuretés.
(KO) 도네페질 또는 그의 약학적으로 허용되는 염 및 메만틴 또는 그의 약학적으로 허용되는 염을 포함하는 치매 및 인지기능 장애 예방 또는 치료용 약학 조성물 및 이의 제조방법에 관한 것으로 도네페질 또는 그의 약학적으로 허용되는 염을 습식 공정으로 과립화하는 단계; 및 상기 과립화된 도네페질 또는 그의 약학적으로 허용되는 염에 메만틴 또는 그의 약학적으로 허용되는 염을 첨가한 혼합물을 직접 압착하여 균질화하는 단계;를 포함함으로써, 종래 시판되고 있는 아리셉트(도네페질 염산염)과 에빅사(메만틴 염산염)의 병용 투여 시 도네페질 활성성분의 용출 저하 현상으로 인해 약효가 감소될 수 있는 문제를 해결하였으며, 유효성분의 입자와 유사한 입자크기를 갖는 부형제를 선택하여 함량 균일성을 확보하였다. 또한, 본 발명의 본 약학 조성물은 유연물질이 거의 없이 매우 안정하다.
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Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 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, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, 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, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: Korean (KO)
Filing Language: Korean (KO)