The present invention relates to a pharmaceutical formulation for oral administration
through a soft gelatin capsule drug delivery device, wherein the pharmaceutical
formulation has Pseudoephedrine HCl as the active pharmaceutical ingredient. The
active pharmaceutical ingredient is embedded into an oily matrix, also the formulation
comprises viscosity imparting agents, a surfactant; a suspending agent; and a suspension
medium. The viscosity-imparting agents are partially hydrogenated vegetable oil
and colloidal silicon dioxide, the surfactant is lecithin, the suspending agent
is yellow beeswax, and the suspension medium is soybean oil. In one preferred embodiment,
the formulation consists essentially of about 60 mg by weight of Pseudoephedrine
HCl, about 15-25 mg by weight of partially hydrogenated vegetable oil, about 10-20
mg by weight of yellow beeswax, about 2-8 mg by weight of lecithin, about 2-8 mg
by weight of silicon dioxide; and about 150-250 mg by weight of soybean oil. Also
disclosed is a process for preparing the formulation.
