Orally administrable pharmaceutical formulation comprising pseudoephedrine hydrochloride and process for preparing the same

Abstract

Disclosed are pharmaceutical formulations for oral administration through a soft gelatin capsule drug delivery device, wherein the pharmaceutical formulation, in a preferred embodiment, contains Pseudoephedrine HCl and an expectorant as the active ingredients. The active pharmaceutical ingredient is embedded into an oily matrix. The formulation also includes an expectorant; a surfactant; a suspending agent; and a suspension medium, wherein, in a preferred embodiment, the expectorant is guaifenesin, the surfactant is lecithin, the suspending agent is yellow beeswax, and the suspension medium is soybean oil. In a preferred embodiment, the formulation consists essentially of about 30.5 mg by weight of Pseudoephedrine HCl, about 200 mg by weight of guaifenesin, about 0.1-5.0 mg by weight of yellow beeswax, about 10-15 mg by weight of lecithin; and about 200-300 mg by weight of soybean oil. Also disclosed is a process for preparing the formulation.

Dependencies are inferred from the claim text.