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Details for Patent: 6,844,459

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Details for Patent: 6,844,459

Title: Pharmaceutical Composition
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)
Filing Date:May 20, 2003
Application Number:10/441,406
Claims:1. A trans-esterification product of corn oil and glycerol comprising a) a free glycerol content of less than 10%, b) less than 1% of palmitic acid and stearic acid mono-, di- and tri-glycerides; and c) 85% or more of linoleic acid and oleic acid mono-, di- and tri-glycerides all parts by weight of the whole composition.

2. A product of claim 1 having 30% to 40% by weight of mono-glycerides.

3. A product of claim 1 having 45% to 55% by weight of di-glycerides.

4. A product of claim 2 having 45% to 55% by weight of di-glycerides.

5. A product of claim 1 having from about 7.5 to about 15% by weight of tri-glycerides.

6. A product of claim 2 having from about 7.5 to about 15% by weight of tri-glycerides.

7. A product of claim 1 having a free glycerol content of less than 5% by weight.

8. A product of claim 2 having a free glycerol content of less than 5% by weight.

9. A product of claim 1 having a free glycerol content of less then 2% by weight.

10. A product of claim 2 having a free glycerol content of less than 2% by weight.

11. A product of claim 1 comprising from about 25% to about 50% by weight of mono-glycerides, from about 30% to about 60% by weight of di-glycerides, and at least 5% by weight of tri-glycerides.

12. A product of claim 11 having 30% to 40% by weight of mono-glycerides.

13. A product of claim 11 having 45% to 55% by weight of di-glycerides.

14. A product of claim 12 having 45% to 55% by weight of di-glycerides.

15. A product of claim 11 having from about 7.5 to about 15% by weight of tri-glycerides.

16. A product of claim 12 having from about 7.5 to about 15% by weight of tri-glycerides.

17. A product of claim 11 having a free glycerol content of less than 5% by weight.

18. A product of claim 11 having a free glycerol content of less than 2% by weight.

19. A pharmaceutical composition comprising an effective amount of a pharmaceutically active compound and a trans-esterification corn oil product of claim 1.

20. A method which comprises solubilizing a pharmaceutically active ingredient in a trans-esterification corn oil product of claim 1.
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