Selfemulsifiable formulation having enhanced bioabsorption...

Details Selfemulsifiable formulation having enhanced bioabsorption... Selfemulsifiable formulation having enhanced bioabsorption...

2006-06-06

2006-06-06

Page, Thurman (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Capsules

C424S451000

Reexamination Certificate

active

07056530

ABSTRACT:
A selfemulsifiable formulation comprising a lipophilic system consisting of a medium chain triglyceride of caprylic acid and capric acid, and of labrasol, wherein labrasol also serves as a surfactant, which is combined with other selected surfactants, like cremophore RH 40 and/or polysorbate 80 and wherein the formulation also comprises immunosuppression agent, essentially cyclosporine, hydrophilic agent preferably ethanol, antioxidant preferably alpha-tocopherol and preservative preferably benzyl alcohol. The formulation is prepared by dissolving immunosuppression agent in hydrophilic agent followed by entrapping with lipophilic agent and subsequent treatment with surfactants, preservative and anioxidant. The formulation is filled in a soft-gelatin shell capable of rupturing in less than 10 minutes to deliver the formulation in an upper part of the gastrointestinal tract, wherein it forms thermodynamically stable oil in water microemulsions in situ to have enhanced bioavailability and bioabsorption of immunosuppression agent, which can show its enhanced immunosuppression activites thereby.

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