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COMPOSITIONS OF TABLETS WITH IMMEDIATE RELEASE
专利权人:
АСТРАЗЕНЕКА ЮКЕЙ ЛИМИТЕД (GB);БРИСТОЛ-МАЙЕРС СКВИББ КАМПАНИ (US)
发明人:
ХАЛЛГРЕН Агнета (SE),СВЕНСОН Ральф Магнус Вернер (SE)
申请号:
RU2012124238/15
公开号:
RU2012124238A
申请日:
2010.11.12
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A pharmaceutical composition comprising (1) an SGLT2 inhibitor or a pharmaceutically acceptable salt or solvate thereof; (2) metformin or a pharmaceutically acceptable salt or solvate thereof; and (3) optionally a coating, wherein the pharmaceutical composition is an immediate release composition, and wherein the composition is in the form of a tablet, parent granulate or capsule. The pharmaceutical composition according to claim 1, wherein the SGLT2 inhibitor is dapagliflozin, dapagliflosin propylene glycol hydrate (S) or dapagliflozin propylene glycol hydrate (R). The pharmaceutical composition of claim 2, further comprising one or more binders, one or more excipients, one or more disintegrants, and one or more glidants. The pharmaceutical composition according to claim 3, wherein the SGLT2 inhibitor is dapagliflozin or dapagliflozin propylene glycol hydrate (S); metformin is metformin hydrochloride; the binder is hydroxypropyl cellulose; the filler is microcrystalline cellulose; the disintegrant is sodium starch glycolate or low substitution hydroxypropyl cellulose; and the glidant is magnesium stearate. 5. The pharmaceutical composition according to claim 4, characterized in that it contains about 0.1-2% dapagliflozin or dapagliflozin propylene glycol hydrate (S); about 55-85% metformin hydrochloride; about 1-15% hydroxypropyl cellulose; about 2-25% microcrystalline cellulose; about 1-12% sodium starch glycolate or about 3-10% hydroxypropyl cellulose with a low degree of substitution; and about 0.25-5% of magnesium stearate. 6. The pharmaceutical composition according to claim 4, characterized in that1. Фармацевтический состав, содержащий (1) ингибитор SGLT2 или его фармацевтически приемлемую соль или сольват; (2) метформин или его фармацевтически приемлимую соль или сольват; и (3) необязательно покрытие, причем фармацевтический состав представляет собой состав с немедленным высвобождением, и причем состав находится в форме таблетки, исходного гранулята или к
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