GASTRO-RETENTIVE FORMULATIONS

摘要

The present invention relates to pharmaceutical compositions of the poorly soluble drugs, and pharmaceutically acceptable salts thereof, in a controlled-release gastric retained oral dosage form. Such compositions are formulated so as to deliver the majority of the incorporated drug into the stomach and upper gastrointestinal tract, with restricted drug delivery in the lower gastrointestinal tract. The dosage forms have multiple layers including an active layer with a first swellable polymer with raltegravir incorporated therein and a non-active layer with a second swellable polymer having a similar molecular weight or a higher molecular weight as the swellable polymer in the active layer.

主权项

1. An oral drug dosage form comprising
(a) an active layer comprising a poorly soluble drug having a narrow absorption window, or a pharmaceutically active salt thereof, and a first swellable polymer with an average molecular weight in range from greater than 2 million to 5 million; and (b) a non-active layer comprising a second swellable polymer with an average molecular weight greater than 4 million wherein the average molecular weight of the first swellable polymer is equal to or less than the average molecular weight of the second polymer.