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

Abstract

Disclosed is a pharmaceutical formulation for oral administration through a soft gelatin capsule drug delivery device, wherein the pharmaceutical formulation includes Ephedrine HCl and an expectorant as active ingredients. Preferred formulations include Ephedrine embedded into an oily matrix, an expectorant; a surfactant; a suspending agent; and a suspension medium, wherein the expectorant is guaifenesin, the surfactant is lecithin, the suspending agent is yellow beeswax, and the suspension medium is soybean oil. A preferred formulation consists essentially of either about 25 mg or about 12.5 mg by weight of Ephedrine 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.