Orally administrable pharmaceutical formulation

Details Orally administrable pharmaceutical formulation Orally administrable pharmaceutical formulation

2005-08-09

2005-08-09

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Capsules

C424S460000, C424S461000, C514S653000

Reexamination Certificate

active

06926906

ABSTRACT:
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.

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