ДЮМУЛЕН Ив (CA),ГОТЬЕ Карл (CA),МОРО Хью (FR),ПАУЭЛЛ Дэвид (US)
申请号：
RU2012125186/15
公开号：
RU2012125186A
申请日:
2010.12.16
申请国别(地区):
RU
年份:
2014
代理人:
摘要：
1. Mesalamine rectal suppository, comprising mesalamine particles and one or more pharmaceutically acceptable excipients, where the mesalamine particles have an area of from about 0.1 m / g to about 2.8 m / g, the drug load of the suppository is in the range from 35% to 50% and the suppository releases at least approximately 85% of the weight of mesalamine within 1 hour of dissolution, as measured using a USP apparatus No. 2 at 40 ° C, stirrer rotation speed of 125 rpm, and 3 turns of sinker in 0.2 M phosphate buffer at pH 7.5.2. The mesalamine rectal suppository according to claim 1, wherein the mesalamine particles have an area of from about 0.1 m / g to about 1.3 m / g. The mesalamine rectal suppository according to claim 1, wherein the at least one pharmaceutically acceptable excipient has an increasing melting point in the range of 32 to 33.5 ° C. The mesalamine rectal suppository according to claim 1, wherein the at least one pharmaceutically acceptable excipient is an oily or fatty base having an increasing melting point of 33 to 35.5 ° C. The mesalamine suppository according to claim 1, wherein the drug load is in the range of from about 39 to about 45%. The mesalamine suppository according to claim 5, wherein the drug load is in the range of from about 41 to about 43%. The mesalamine suppository according to claim 1, wherein the suppository releases at least 90% by weight of mesalamine within 30 minutes of dissolution, as measured using a USP apparatus No. 2 at 40 ° C, a stirrer speed of 125 rpm, and 3 turns of sinker at 0 , 2 M phosphate buffer at pH 7.5.8. Mesalamine Rect�1. Месаламиновый ректальный суппозиторий, включающий частицы месаламина и один или более фармацевтически приемлемых наполнителей, где частицы месаламина имеют площадь от приблизительно 0,1 м/г до приблизительно 2,8 м/г, нагрузка лекарственным средством суппозитория находится в диапазоне от 35% до 50% и суппозиторий высвобождает по меньшей мере приблизительно 85% от веса месаламина в тече
