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Claims for Patent: 5,985,321

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Claims for Patent: 5,985,321

Title: Soft gelatin capsule manufacture
Abstract:Soft gelatin capsules having a capsule shell comprising gelatin, plasticizers and, if desired or required, further auxiliary agents, and a capsule filling containing a solvent including a migrateable solvent such as 1,2-propyleneglycol as a solvent in the capsule filling and in the capsule shell. The manufacture of said capsules is improved, if in the process for making the soft gelatin capsules the gelatin bands are cooled with a liquid, and preferably with water.
Inventor(s): Brox; Werner (Beerfelden, DE), Meinzer; Armin (Freiburg, DE), Zande; Horst (Schonbrun, DE)
Assignee: Novartis AG (Summit, NJ) R.P. Scherer GmbH (Eberbach/Baden, DE)
Application Number:08/841,734
Patent Claims: 1. A soft gelatin capsule which comprises a shell and a liquid filling, wherein at the time of encapsulation said shell comprises gelatin and 1,2-propylene glycol and said filling comprises cyclosporin A and 1,2-propylene glycol in a carrier medium therefor, wherein the shell, after drying, comprises 2-40% by weight 1,2-propylene glycol.

2. A capsule of claim 1 wherein the shell, after drying, comprises 5-40% 1,2-propylene glycol.

3. A capsule of claim 1 wherein the shell is produced from a gelatin composition comprising 1-35% by weight 1,2-propylene glycol.

4. A capsule of claim 1 wherein the weight ratio of 1,2-propylene glycol to gelatin is 1:1 to 1:47.

5. A capsule of claim 4 where the ratio is from 1:1 to 1:4.

6. A capsule of claim 1, where the shell further comprises plasticizers and, optionally further auxiliary agents.

7. A capsule of claim 1, wherein the liquid filling comprises a lipophilic component.

8. A capsule of claim 1, wherein the liquid filling comprises a surfactant.

9. A capsule of claim 1, wherein the liquid filling is capable of forming an emulsion on mixing with water.

10. A capsule of claim 1, wherein the liquid filling is a microemulsion preconcentrate.

11. A capsule of claim 1, wherein the liquid filling further comprises ethanol as a cosolvent.

12. A capsule of claim 1, wherein the shell, after drying, comprises 5-32% by weight 1,2-propylene glycol.

13. A capsule of claim 12, where the shell, after drying, comprises 10-32% by weight 1,2-propylene glycol.

14. A soft gelatin capsule which comprises a shell and a liquid filling, wherein at the time of encapsulation said shell comprises gelatin and 1,2-propylene glycol and said filling comprises cyclosporin A and 1,2-propylene glycol in a carrier medium therefor, wherein said shell is produced from a gelatin composition comprising 1-35% by weight 1,2-propylene glycol.

15. A capsule of claim 14, further comprising glycerol in the shell at the time of encapsulation.

16. A capsule of claim 14, wherein the liquid filling is a microemulsion preconcentrate.

17. A capsule of claim 14, wherein the shell is produced from a gelatin composition comprising 4-30% by weight 1,2-propylene glycol.
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