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1. (WO2018164128) ALGINATE LIQUID FORMULATION
Latest bibliographic data on file with the International BureauSubmit observation

Pub. No.: WO/2018/164128 International Application No.: PCT/JP2018/008592
Publication Date: 13.09.2018 International Filing Date: 06.03.2018
IPC:
A61K 31/734 (2006.01) ,A61K 9/08 (2006.01) ,A61K 47/02 (2006.01) ,A61K 47/04 (2006.01) ,A61P 19/00 (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
70
Carbohydrates; Sugars; Derivatives thereof
715
Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
734
Alginic acid
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
08
Solutions
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
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
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
19
Drugs for skeletal disorders
Applicants:
持田製薬株式会社 MOCHIDA PHARMACEUTICAL CO., LTD. [JP/JP]; 東京都新宿区四谷一丁目7番地 7, Yotsuya 1-chome, Shinjuku-ku, Tokyo 1608515, JP
Inventors:
遠藤 秋一 ENDO Shuichi; JP
中原 基 NAKAHARA Motoi; JP
Agent:
田中 伸一郎 TANAKA Shinichiro; JP
弟子丸 健 DESHIMARU Takeshi; JP
▲吉▼田 和彦 YOSHIDA Kazuhiko; JP
箱田 篤 HAKODA Atsushi; JP
浅井 賢治 ASAI Kenji; JP
山崎 一夫 YAMASAKI Kazuo; JP
市川 さつき ICHIKAWA Satsuki; JP
服部 博信 HATTORI Hironobu; JP
Priority Data:
2017-04309507.03.2017JP
Title (EN) ALGINATE LIQUID FORMULATION
(FR) FORMULATION LIQUIDE À BASE D'ALGINATE
(JA) アルギン酸液剤
Abstract:
(EN) Provided is a sterile alginate aqueous solution preparation which includes: (a) a monovalent metal salt of a low endotoxin alginate having a weight average molecular weight measured by a GPC-MALS method of 50000-400000; (b) a salt selected from among monovalent metal salts and ammonium salts; and (c) water. The concentration of component (a) is 1.5 mass% or higher. The concentration of component (b) is 0.5-2 mass%. The viscosity measured at 20˚C using a rotational viscometer is 2700 mPa∙s or higher. The alginate aqueous solution preparation is loaded in a sealed container or an air-tight container, is (ready-to-use) capable of being used immediately, and exhibits storage stability. Also provided is a production method for the alginate aqueous solution preparation. The alginate aqueous solution preparation is an aqueous solution preparation of a monovalent metal salt of a low endotoxin alginate and is (ready-to-use) capable of being used immediately.
(FR) L'invention concerne une préparation de solution aqueuse d'alginate stérile qui comprend : (a) un sel métallique monovalent d'un alginate à faible teneur en endotoxines ayant un poids moléculaire moyen en poids mesuré par un procédé DE GPC-MALS de 50 000 à 400 000 ; (b) un sel choisi parmi des sels métalliques monovalents et des sels d'ammonium ; et (c) de l'eau. La concentration du constituant (a) est de 1,5 % en masse ou plus. La concentration du constituant (b) est de 0,5 à 2 % en masse. La viscosité mesurée à 20 °C à l'aide d'un viscosimètre rotatif est de 2 700 mPa∙s ou plus. La préparation de solution aqueuse d'alginate est chargée dans un récipient scellé ou un récipient étanche à l'air, peut être utilisée immédiatement (prête à l'emploi), et présente une stabilité au stockage. L'invention concerne également un procédé de production de la préparation de solution aqueuse d'alginate. La préparation de solution aqueuse d'alginate est une préparation en solution aqueuse d'un sel métallique monovalent d'un alginate à faible teneur en endotoxines et peut être utilisée immédiatement (prête à l'emploi).
(JA) (a)GPC-MALS法による重量平均分子量5万~40万の低エンドトキシンアルギン酸の1価金属塩、(b)1価金属塩及びアンモニウム塩から選ばれる塩及び(c)水を含有し、成分(a)の濃度が1.5質量%以上、成分(b)の濃度が0.5~2質量%であり、回転粘度計を用いて、20℃で測定した粘度が2700mPa・s以上である、密封容器または気密容器に充填された、すぐに使用可能(ready-to-use)な、保存安定性を有する、無菌のアルギン酸塩水溶液製剤及びその製造方法を提供する。このアルギン酸塩水溶液製剤は、すぐに使用可能(ready-to-use)な低エンドトキシンアルギン酸の1価金属塩水溶液製剤である。
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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, KR, 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 Organization (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (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: Japanese (JA)
Filing Language: Japanese (JA)