发明名称 Method for producing spherical base granules comprising hardly water-soluble drug
摘要 Spherical base granules comprising a hardly water-soluble drug and suited for film coating thereon are produced by layering spherical core particles with a drug-containing layering liquid comprising both micronized microcrystalline cellulose and an emulsifier therein and therefore having improved suspension stability.
申请公布号 US9095512(B2) 申请公布日期 2015.08.04
申请号 US200712310067 申请日期 2007.08.09
申请人 ASAHI KASEI CHEMICALS CORPORATION 发明人 Yaginuma Yoshihito;Matsumoto Rika
分类号 A61K9/28;A61K9/16;A61K31/166;A01N43/56;A61K9/14 主分类号 A61K9/28
代理机构 Staas & Halsey LLP 代理人 Staas & Halsey LLP
主权项 1. A production method of a pharmaceutical product, comprising: providing pharmaceutically inert elliptical core particles having a minor axis/major axis ratio of 0.7 or greater; and spraying a layering liquid on the core particles, thereby coating the core particles with a drug-containing layer, wherein the layering liquid comprises: (1) from 0.01 to 50% by mass of hardly water-soluble drug particles having a maximum major axis of not greater than 30% of an average minor axis of the core particles and a maximum minor axis of not greater than 12% of the average minor axis of the core particles;(2) from 0.1 to 2% by mass of a micronized microcrystalline cellulose; and(3) from 0.01 to 1% by mass of an emulsifier, wherein the hardly water-soluble drug is any one selected from the group consisting of amcinonide, ibuprofen, indomethacin, ethenzamide, cefotiam hexetil hydrochloride, nicardipine hydrochloride, omeprazole, prednisolone valerate acetate, diflucortolone valerate, dexamethasone valerate, betamethasone valerate, clarithromycin, griseofulvin, clonazepam, chloramphenicol, synthetic peptide compounds, cortisone acetate, diflorasone diacetate, dexamethasone acetate, triamcinolone acetate, paramethasone acetate, hydrocortisone acetate, fludrocortisone acetate, methylprednisolone acetate, diazepam, digitoxin, digoxin, difluprednate, beclometasone dipropionate, betamethasone dipropionate, sulpiride, sulfathiazole, cefuroxime axetil, dexamethasone, triamcinolone, triamcinolone acetonide, nicardipine, nifedipine, nilvadipine, noscapine, halcinonide, hydrocortisone, flumetasone pivalate, phenacetin, phenitoin, budesonide, prazepam, fluocinonide, fluocinolone acetonide, fluorometholone, fludroxycortide, prednisolone, alclometasone dipropionate, clobetasol propionate, dexamethasone propionate, deprodone propionate, betamethasone, migrenin, methylprednisolone, ubidecarenone, clobetasone butyrate, hydrocortisone butyrate, hydrocortisone butyrate propionate, riboflavin butyrate, lansoprazole, and riboflavin.
地址 Tokyo JP