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1. (WO2018030862) PHARMACEUTICAL PREPARATION FOR ORAL ADMINISTRATION WITH CONTROLLED DISSOLUTION RATE, THE PREPARATION COMPRISING TAMSULOSIN HYDROCHLORIDE-CONTAINING SUSTAINED-RELEASE PELLETS
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Pub. No.: WO/2018/030862 International Application No.: PCT/KR2017/008800
Publication Date: 15.02.2018 International Filing Date: 11.08.2017
IPC:
A61K 9/16 (2006.01) ,A61K 47/38 (2006.01) ,A61K 9/50 (2006.01) ,A61K 9/48 (2006.01) ,A61K 31/18 (2006.01) ,A61K 31/58 (2006.01) ,A61K 31/4985 (2006.01)
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
16
Agglomerates; Granulates; Microbeadlets
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
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
48
Preparations in capsules, e.g. of gelatin, of chocolate
50
Microcapsules
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
48
Preparations in capsules, e.g. of gelatin, of chocolate
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
16
Amides, e.g. hydroxamic acids
18
Sulfonamides
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
56
Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
58
containing heterocyclic rings, e.g. aldosterone, danazol, stanozolol, pancuronium, digitogenin
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
495
having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
4985
Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
Applicants:
한미약품 주식회사 HANMI PHARM. CO., LTD. [KR/KR]; 경기도 화성시 팔탄면 무하로 214 214, Muha-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do 18536, KR
Inventors:
김재호 KIM, Jae Ho; KR
이벤자민준 LEE, Benjamin Joon; KR
김진철 KIM, Jin Cheul; KR
김용일 KIM, Yong Il; KR
박재현 PARK, Jae Hyun; KR
우종수 WOO, Jong Soo; KR
Agent:
리앤목 특허법인 Y.P.LEE, MOCK & PARTNERS; 서울시 강남구 언주로 30길 13 대림아크로텔 12층 12F Daelim Acrotel, 13 Eonju-ro 30-gil Gangnam-gu, Seoul 06292, KR
Priority Data:
10-2016-010326912.08.2016KR
Title (EN) PHARMACEUTICAL PREPARATION FOR ORAL ADMINISTRATION WITH CONTROLLED DISSOLUTION RATE, THE PREPARATION COMPRISING TAMSULOSIN HYDROCHLORIDE-CONTAINING SUSTAINED-RELEASE PELLETS
(FR) PRÉPARATION PHARMACEUTIQUE POUR ADMINISTRATION ORALE À VITESSE DE DISSOLUTION CONTRÔLÉE, LA PRÉPARATION COMPRENANT DES PASTILLES À LIBÉRATION PROLONGÉE CONTENANT DU CHLORHYDRATE DE TAMSULOSINE
(KO) 탐수로신 염산염 함유 서방성 펠렛을 포함하는 용출률이 제어된 경구투여용 약제학적 제제
Abstract:
(EN) The present invention provides: a pharmaceutical preparation for oral administration with a controlled dissolution rate, the preparation comprising Tamsulosin hydrochloride-containing sustained-release pellets, wherein the sustained-release pellets comprise (i) a Tamsulosin hydrochloride, (ii) hydroxypropyl methylcellulose (HPMC), (iii) an acid-resistant acryl polymer, and (iv) two or more kinds of insoluble diluents; and a preparation method therefor. According to the present invention, the Tamsulosin hydrochloride-containing sustained-release pellets with a predetermined size can be reproducibly produced, thereby controlling the release rate and reducing the size of pellets, thus improving drug compliance.
(FR) La présente invention concerne : une préparation pharmaceutique destinée à être administrée par voie orale avec un taux de dissolution contrôlé, la préparation comprenant des pastilles à libération prolongée contenant du chlorhydrate de tamsulosine, les pastilles à libération prolongée comprenant (i) un chlorhydrate de tamsulosine, (ii) de l'hydroxypropylméthylcellulose (HPMC), (iii) un polymère acrylique résistant aux acides, et (iv) deux types ou plus de diluants insolubles ; et son procédé de préparation. Selon la présente invention, les pastilles à libération prolongée contenant du chlorhydrate de tamsulosine ayant une taille prédéterminée peuvent être produites de manière reproductible, ce qui permet de réguler le taux de libération et de réduire la taille des pastilles, améliorant ainsi l’observance du médicament.
(KO) 본 발명은 탐수로신 염산염 함유 서방성 펠렛을 포함하는 용출률이 제어된 경구투여용 약제학적 제제에 관한 것으로서, 상기 서방성 펠렛은 (i) 탐수로신 염산염, (ii) 하이드록시프로필 메틸셀룰로스(HPMC), (iii) 내산성 아크릴 중합체, 및 (iv) 2종류 이상의 불용성 희석제를 포함하는, 경구투여용 약제학적 제제 및 이의 제조방법을 제공한다. 본 발명에 따르면 특정 크기를 갖는 탐수로신 염산염 함유 서방성 펠렛을 재현성 있게 생산가능하여 방출 속도를 제어할 수 있을 뿐만 아니라 그 크기를 감소시켜 복약 순응도를 높일 수 있다.
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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)