CONTROLLED RELEASE AND TASTE MASKING ORAL PHARMACEUTICAL COMPOSITION

摘要

Controlled release and taste masking compositions containing one or more active principles inglobated in a three-component matrix structure, i.e. a structure formed by successive amphiphilic, lipophilic or inert matrices and finally inglobated or dispersed in hydrophilic matrices. The use of a plurality of systems for the control of the dissolution of the active ingredient modulates the dissolution rate of the active ingredient in aqueous and/or biological fluids, thereby controlling the release kinetics in the gastrointestinal tract.

主权项

1. An oral dosage form for extended release of budesonide in the gastrointestinal tract of a human, said oral dosage form being in the form of a tablet comprising:
9 mg of budesonide in a core; and a gastro-resistant coating to control the release of said budesonide from said dosage form, wherein following oral administration of a single dose, the dosage form provides a Tmax of budesonide in said human of about 13.3±5.9 hours.