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SOLID MEDICINAL FORMS OF VALSATRAN AND AMLODIPINE AND METHOD FOR PRODUCING THEM
专利权人:
НОВАРТИС АГ (CH)
发明人:
ЙОШИ Ятиндра (US),ВАГНЕР Роберт Франк (US),ПУДИПЕДДИ Мадхусудхан (US),СУНКАРА Гангадхар (US),ЛИ Пин (US)
申请号:
RU2012131668/15
公开号:
RU2012131668A
申请日:
2012.07.24
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A solid dosage form of valsartan containing: valsartan, amlodipine, and pharmaceutically acceptable additives suitable for the preparation of solid dosage forms of valsartan in which amlodipine is in the form of amlodipine besylate, and in which the amount of valsartan / free amlodipine, which is present in solid dosage form, selected from 80 / 2.5 mg, 80/5 mg, 160/5 mg, 160/10 mg, 320/5 mg, 320/10 mg. 2. The solid dosage form according to claim 1, wherein the amount of valsartan / free amlodipine that is present in the solid dosage form is selected from 80 / 2.5 mg, 160/5 mg and 320/10 mg. The solid dosage form according to claim 1 or 2, wherein the solid dosage form is in the form of a monolayer tablet and where the amount of valsartan / free amlodipine that is present in the solid dosage form is selected from 80 / 2.5 mg and 160/5 mg. The solid dosage form according to claim 1, wherein the solid dosage form is in the form of a two-layer tablet having valsartan in the first layer and amlodipine in the second layer and the amount of valsartan / free amlodipine that is present in the solid dosage form is selected from 320/5 mg and 320 / 10 mg. 5. A solid dosage form according to any one of claims 1, 2 and 4, wherein the pharmaceutically acceptable additives are selected from the group consisting of diluents, disintegrating agents, glidants, lubricants, colorants, and combinations thereof. The method of producing a solid dosage form of valsartan according to claim 3, comprising the following steps: (a) mixing valsartan, amlodipine and pharmaceutically acceptable additives, thereby obtaining a mixed material, (b) sieving the mixed material, and obtaining a sieved material, (c) mixing sifted material, while getting1. Твердая дозированная форма валсартана, содержащая:валсартан,амлодипин, ифармацевтически приемлемые добавки, пригодные для получения твердых дозированных форм валсартана,в которой амлодипин представлен в виде амлодипина безилата;и в которой количество ва
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