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1. (WO2018043613) AQUEOUS SUSPENSION PREPARATION
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Pub. No.: WO/2018/043613 International Application No.: PCT/JP2017/031275
Publication Date: 08.03.2018 International Filing Date: 30.08.2017
IPC:
A61K 31/496 (2006.01) ,A61K 9/10 (2006.01) ,A61K 47/02 (2006.01) ,A61K 47/10 (2006.01) ,A61K 47/14 (2006.01) ,A61K 47/26 (2006.01) ,A61K 47/32 (2006.01) ,A61K 47/36 (2006.01) ,A61K 47/38 (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
495
having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
496
Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
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
10
Dispersions; Emulsions
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
06
Organic compounds
08
containing oxygen
10
Alcohols; Phenols; Salts 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
14
Esters of carboxylic acids
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
26
Carbohydrates
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
32
Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds
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
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
Applicants:
大日本住友製薬株式会社 SUMITOMO DAINIPPON PHARMA CO., LTD. [JP/JP]; 大阪府大阪市中央区道修町2丁目6番8号 6-8, Dosho-machi 2-chome, Chuo-ku, Osaka-shi, Osaka 5418524, JP
Inventors:
都竹 拓磨 TSUZUKU, Takuma; JP
大仁田 麻衣子 ONITA, Maiko; JP
Agent:
鮫島 睦 SAMEJIMA, Mutsumi; JP
水原 正弘 MIZUHARA, Masahiro; JP
Priority Data:
2016-16959631.08.2016JP
Title (EN) AQUEOUS SUSPENSION PREPARATION
(FR) PRÉPARATION DE SUSPENSION AQUEUSE
(JA) 水性懸濁型製剤
Abstract:
(EN) The present invention provides an aqueous suspension preparation which contains (3aR, 4S, 7R, 7aS)-2-{(1R, 2R)-2-[4-(1, 2- benzoisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4, 7-methano-2H-isoindole-1, 3-dione (compound 1), a pharmaceutically acceptable acid addition product thereof or a mixture of the compound and the acid addition product as an active ingredient, and which has the feature (I) or (II) described below. (I) In cases where a thickening agent is contained in the preparation, the circularity of suspension particles is about 0.960 or less. (II) In cases where a thickening agent is not contained in the preparation, the circularity of suspension particles is about 0.945 or less.
(FR) La présente invention porte sur une préparation en suspension aqueuse qui contient du (3aR, 4S, 7R, 7aS)-2-{(1R, 2R)-2-[4-(1, 2-benzoisothiazol-3-yl)) pipérazin-1-ylméthyl] cyclohexylméthyl} hexahydro-4, 7-méthano-2 H-isoindole-1, 3-dione (composé 1), un produit d'addition d'acide de qualité pharmaceutique ou un mélange du composé et du produit d'addition d'acide comme ingrédient actif, qui a la caractéristique (I) ou (II) décrite ci-dessous. Dans les cas où la préparation contienne un agent épaississant, la circularité des particules de suspension est d'environ 0,960 ou moins. (II) Dans les cas où la préparation de contienne pas d'agent épaississant, la circularité des particules de suspension est d'environ 0,945 ou moins.
(JA) 本発明は、(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-ベンゾイソチアゾール-3-イル)ピペラジン-1-イルメチル]シクロヘキシルメチル}ヘキサヒドロ-4,7-メタノ-2H-イソインドール-1,3-ジオン(化合物1)、その製薬学的に許容される酸付加塩またはこれらの混合物を有効成分として含有する水性懸濁型製剤であって、下記(I)または(II)の特徴を有する水性懸濁型製剤: (I)製剤中に増粘剤を含む場合は、懸濁粒子の円形度が約0.960以下、 (II)製剤中に増粘剤を含まない場合は、懸濁粒子の円形度が約0.945以下 を提供する。
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 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: Japanese (JA)
Filing Language: Japanese (JA)