Claims for Patent: 6,262,022

Summary for Patent: 6,262,022

Title:	Pharmaceutical compositions containing cyclosporin as the active agent
Abstract:	Pharmaceutical compositions comprising a cyclosporin in a novel galenic formulations for oral administration. The compositions typically comprise a cyclosporin, 1,2-propylene glycol, a mixed mono-, di- and tri-glyceride and a hydrophilic surfactant. Further a refined glycerol-transesterified corn oil is provided representing a mixed mono-, di- and tri-glyceride suitable for the novel formulation. Dosage forms include in particular oral dosage forms.
Inventor(s):	Hauer; Birgit (Lahr, DE), Meinzer; Armin (Freiburg-Munzingen, DE), Posanski; Ulrich (Freiburg, DE), Vonderscher; Jacky (Riedisheim, DE)
Assignee:	Novartis AG (Basel, CH)
Application Number:	09/488,215
Patent Claims:	1. A pharmaceutical composition comprising cyclosporin as an active agent in a carrier medium, wherein the carrier medium comprises: (a) 1,2-propylene glycol; (b) a mixture of C.sub.12-20 fatty acid mono-, di-, and tri-glycerides wherein the mixture predominantly comprises linolenic acid, linoleic acid and oleic acid mono-, di-, and triglycerides; and (c) a surfactant. 2. The composition of claim 1, wherein component (b) predominantly comprises linoleic acid and oleic acid mono-, di- and tri-glycerides. 3. The composition of claim 1, wherein component (b) is a transesterification product predominantly comprising linoleic acid and oleic acid mono-, di- and tri-glycerides. 4. The composition of claim 1, wherein component (b) is a transesterification product of corn oil and glycerol predominantly comprising linoleic acid and oleic acid mono-, di- and tri-glycerides. 5. The composition of claim 1, wherein component (b) comprises linoleic acid and oleic acid mono-, di- and tri-glycerides in an amount that is 85% or more of the whole composition. 6. The composition of claim 1, wherein component (b) comprises a transesterification product of corn oil and glycerol treated so that the linoleic acid and oleic acid mono-, di- and tri-glycerides are present in an amount that is 85% or more of the whole composition. 7. The composition of claim 1, having a free glycerol content of less than 1 percent by weight based on the total weight of free glycerol plus mono-, di- and tri-glycerides. 8. The composition of claim 1, wherein the surfactant has an HLB value of at least 10. 9. The composition of claim 1, wherein the surfactant comprises a reaction product of a natural or hydrogenated castor oil and ethylene oxide. 10. The composition of claim 1, wherein the carrier medium additionally comprises a hydrophilic phase co-component. 11. The composition of claim 1, further comprising ethanol. 12. The composition of claim 1, encapsulated in a gelatin capsule.