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|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, FR)|
|Assignee:||Novartis AG (Basel, CH)|
1. A composition comprising 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.
2. The composition of claim 1, predominantly comprising linoleic acid and oleic acid mono-, di- and tri-glycerides.
3. The composition of claim 1, herein the composition is a transesterification product predominantly comprising linoleic acid and oleic acid mono-, di- and tri-glycerides.
4. The composition of claim 1, wherein the composition 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, comprising 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, comprising 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, encapsulated in a gelatin capsule.
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