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A COATED TABLET COMPOSTION
专利权人:
发明人:
STANKO SKRTIC,JORGEN JOHNSSON,HANS LENNERNAS,THOMAS HEDNER,GUDMUNDUR JOHANNSSON
申请号:
IN6945/DELNP/2006
公开号:
IN284186B
申请日:
2006.11.21
申请国别(地区):
IN
年份:
2017
代理人:
摘要:
A coated tablet composition for administration once daily comprising a coating and a tablet core, wherein the coating comprises an immediate release part comprising one or more glucocorticoids and one or more pharmaceutically acceptable immediate release excipients or carriers adapted so that the one or more glucocorticoids are substantially immediately released and wherein the tablet core comprises an extended release part comprising one or more glucocorticoids in an amount of 60-80% of the total hydrocortisone equivalents in the composition and one or more pharmaceutically acceptable extended release excipients or carriers adapted so that the one or more glucocorticoids are released over an extended period of time of at least about 8 hours, wherein the amount of the one or more glucocorticoids in total corresponds to a daily dose of from about 1 to 80 mg hydrocortisone equivalents and wherein the amount of the one or more glucocorticoids of the immediate release part in the coating, expressed as hydrocortisone equivalents, being in a range of from about 20-40% of the total hydrocortisone equivalents in the composition and determined as the amount released 1 hour after start of testing of the composition in an in vitro dissolution test according to USP employing USP Dissolution Apparatus No. 2 (paddle), 50 rpm and simulated intestinal fluid without enzymes as dissolution medium, and wherein the one or more pharmaceutically acceptable immediate release excipients or carriers in the coating are selected from the group consisting of methylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, acrylic polymers, ethylcellulose, cellulose acetate phthalate, polyvinyl acetate phthalate, hydroxypropyl methylcellulose phthalate, polyvinylaclcohol, sodium carobxymethylcellulose, cellulose acetate, cellulose acetate phthalate, gelatin, methacrylic acid copolymer, polyethylene glycol, shellac, sucrose, titanium dioxide, camauba wax, microcrystalline wax, glyceryl mon
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