Ковшель Анна Юрьевна (RU),Парфёнова Валентина Сергеевна (RU),Флисюк Елена Владимировна (RU)
申请号:
RU2013159324/15
公开号:
RU2013159324A
申请日:
2013.12.31
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. An oral solid dosage form with controlled release of betahistine or a pharmaceutically acceptable salt thereof, wherein the controlled release is achieved by using a matrix based on a copolymer of polyvinyl acetate and povidone, known under the trade name Kollidon SR.2. The oral solid dosage form with controlled release of betahistine or a pharmaceutically acceptable salt thereof according to Claim. 1, characterized in that it contains 4,8-20% by weight, of betahistine or a pharmaceutically acceptable salt thereof and 35-63% by weight of Kollidon SR.3. The oral solid dosage form with controlled release of betahistine or a pharmaceutically acceptable salt thereof characterized in that the addition of betahistine or a pharmaceutically acceptable salt thereof and Kollidon SR may comprise additional excipients commonly used in oral dosage formah.4. The oral solid dosage form with controlled release of betahistine or a pharmaceutically acceptable salt thereof according to claim 1, characterized in that exhibits such characteristics of the release profile of the active substance:. 1 hour - less than 45%, 4 hours - less than 70%, 8 watches - 70% .5. The oral solid dosage form with controlled release of betahistine or a pharmaceutically acceptable salt thereof according to Claim. 1, characterized in that it is made in the form kapsul.6. The oral solid dosage form with controlled release of betahistine or a pharmaceutically acceptable salt thereof according to Claim. 1, characterized in that it is made in the form tabletok.7. The oral solid dosage form with controlling1. Пероральная твердая лекарственная форма с контролируемым высвобождением бетагистина или его фармацевтически приемлемых солей, отличающаяся тем, что контролируемое высвобождение достигается путем использования матрицы на основе сополимера поливинилацетата и повидона, известной под торговым названием Коллидон SR.2. Пероральная твердая лекарственная форма с контролируемым высвобождением бетагистина или его ф