Ethanol fill formulation for sofgels etc.

• US 4,888,239 A
• Filed: 08/25/1987
• Issued: 12/19/1989
• Est. Priority Date: 08/29/1986
• Status: Expired due to Term

• Current Assignee: Catalent Pharma Solutions Incorporated (Catalent, Inc.), Catalent Pharma Solutions Limited (Catalent, Inc.), Catalent USA Packaging LLC (Catalent, Inc.), Catalent USA Paintball, Inc. (Catalent, Inc.), Catalent USA Woodstock, Inc. (Catalent, Inc.)
• Original Assignee: R.P. Scherer Corporation (Cardinal Health, Inc.)
• Inventors: Brox, Werner
• Primary Examiner(s): Nelson, Peter A.
• Application Number:
  US07/089,065
• Time in Patent Office: 847 Days
• Field of Search: 428/320.2, 428/402.2
• US Class Current: 428/402.2
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: Y10T 428/2984 Microcapsule with fluid core [includes liposome]

Abstract

Gelatin capsules of the type having an outer shell comprising gelatin and, optionally, a plasticizer, and a capsule filling, the filling containing at least one active substance and/or a dietetic agent or foodstuff as well as a solvent mixture, the solvent mixture containing about 5-50% by weight, preferably 10-30% by weight of ethanol and about 20-95% by weight, preferably 40-90% by weight of one or more of partial glycerides of fatty acids havig from 6 to 18 carbon atoms. The capsules are prepared by dissolving the active ingredients in the solvent mixture and filling the resulting mixture into the gelatin capsules.

Claims

1. A capsule having a gelatin shell and the filling therein, said filling comprising an active material and a solvent, said solvent consisting essentially of at least 5% by weight of ethanol and at least 20% by weigh of partial glycerides of fatty acids having from 6-18 carbon atoms.

2. The capsule of claim 1 wherein said active substance is a dietary substance.

3. The capsule of claim 1 wherein said active substance is a food supplement.

4. The capsule of claim 1 wherein said active substance is a pharmaceutical substance.

5. The capsule of claim 1 wherein said ethanol is present in an amount of about 5-50% by weight and said partial glycerides of fatty acids are present in an amount of about 20-95% by weight.

6. The capsule of claim 1 wherein said ethanol is present in an amount of about 10-30% by weight and said partial glycerides of fatty acids are present in an amount of about 40-95% by weight.

7. The capsule of claim 1 wherein said partial glycerides of fatty acids have from 6-12 carbon atoms.

8. The capsule of claim 1 wherein said partial glycerides of fatty acids is ricinoleate acid.

17. The capsule of claim 1 wherein said solvent additionally includes a fatty acid triglyceride.

18. The capsule of claim 1 wherein said solvent additionally includes a polyethylene glycol.

9. A process for preparing a gelatin capsule of the type having a gelatin shell and a fill material enclosed within said gelatin shell, said process comprising the steps of dissolving an active substance in a solvent, said solvent consisting essentially of at least 5% by weight of ethanol and at least 20% by weight of partial glycerides of fatty acids having from 6-18 carbon atoms, and filling the solution into the gelatin capsule.

10. The process of claim 9 wherein said active substance is a dietary substance.

11. The process of claim 9 wherein said active substance is a food supplement.

12. The process of claim 9 wherein said active substance is a pharmaceutical substance.

13. The process of claim 9 wherein said ethanol is present in an amount of about 5-50% by weight and said partial glycerides of fatty acids are present in an amount of about 20-95% by weight.

14. The process of claim 9 wherein said ethanol is present in an amount of about 10-30% by weight and said partial glycerides of fatty acids are present in an amount of about 40-90% by weight.

15. The process of claim 9 wherein said partial glycerides of fatty acids have from 6-12 carbon atoms.

16. The process of claim 9 wherein said partial glycerides of fatty acids is ricinoleate acid.

19. The process of claim 9 wherein said solvent additionally includes a fatty acid triglyceride.

20. The process of claim 9 wherein said solvent additionally includes a polyethylene glycol.