Pharmaceutical composition comprising at least one active agent and a binder, which swells in an acidic media

摘要

The invention relates to a pharmaceutical composition, which comprises at least one active agent and which further comprises a binder and/or a retarding agent, wherein the binder swells in an acidic medium, and the retarding agent retards the release of the active agent in an acidic or alkaline medium.

主权项

1. A pharmaceutical composition comprising at least one active agent,
wherein the active agent is an active agent which is rapidly absorbed from the upper small intestine such that the time to reach maximum plasma concentration (Tmax) is shorter than 2.5 hours, and which shows undesired side effect at high plasma concentrations; or wherein the active agent is an active agent which damages the stomach and/or the small intestine due to high local stomach and/or intestinal concentrations, wherein the composition further comprises: (a) from 2% to 8% of carboxymethylcellulose sodium as a binder; (b) from 2% to 8% of croscarmellose sodium as a disintegrant; and (c) optionally, from 4% to 8% of hydroxypropyl methylcellulose as a retarding agent and wherein the composition provides the following release profile: in 15 minutes between 10% and 30% of said active ingredient is released, in 30 minutes between 15% and 35% of said active ingredient is released, in 60 minutes between 35% and 55% of said active ingredient is released, and in 120 minutes between 45% and 70% of said active ingredient is released.