Ashworth, Judy,Arkenau-Maric, Elisabeth,Bartholomäus, Johannes,Kugelmann, Heinrich
申请号：
ES12001792
公开号：
ES2651016T3
申请日:
2006.02.06
申请国别(地区):
ES
年份:
2018
代理人:
摘要：
Dosage form comprising - a physiologically active substance (A)； - optionally one or more physiologically compatible auxiliary agents (B)； - a synthetic polymer (C)； and - optionally a natural, semi-synthetic or synthetic wax (D), where the substance (A) is present in a retarding matrix, where the retarding matrix comprises polymer (C) and / or optional wax (D) as matrix material delayed release； wherein the polymer (C) is a polyalkylene oxide selected from the group consisting of polymethylene oxide, polyethylene oxide, polypropylene oxide, copolymers, block copolymers and mixtures thereof, where the polymer (C) has an average molecular weight in viscosity of at least 0.5106 g / mol； and where the dosage form - has a breaking strength of at least 400 N, and - under physiological conditions, release the physiologically active substance (A) at most 99% after 5 hours, with the proviso that the Dosage form (1) is not a tablet with a breaking strength of at least 500 N, the tablet with a total weight of 300.0 mg, a diameter of 10 mm and a radius of curvature of 8 mm； It is obtained by compressing a mixture heated to 80 ° C and consisting of 100 g of tramadol hydrochloride and 200 g of polyethylene oxide, with a molecular weight of 7 000 000 per tablet using a tablet forming tool with upper punch, lower punch and blade maintaining an applied pressure for at least 15 seconds； releases 15%, 52%, 80% and 99% of the substance (A) after 30 min, 240 min, 480 min and 720 min, respectively, in a determination of in vitro release according to Ph. Eur. with a vane stirrer apparatus containing the release means at a rotation speed of 75 rpm； and where at the beginning of the test, the tablet is added to 600 ml of artificial gastric juice of 1.2, pH which is increased by the addition of an alkaline solution at 2.3 after 30 min, at 6.5 after 90 min more 7.2 after another 60 min； (2) it is not a tablet with a breaking strength of at least 500 N, with a total weight of 300.0 mg, a diam
