COMBINATION ENZYME FOR CYSTIC FIBROSIS

• US 20080166334A1
• Filed: 03/24/2008
• Published: 07/10/2008
• Est. Priority Date: 09/28/2004
• Status: Abandoned Application

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Application Number:
  US12/054,343
• Publication Number:
  US 20080166334A1
• Time in Patent Office: Days
• US Class Current: 424/94.63
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/48 acting on peptide bonds (3.4)
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
• CPC Class Codes: A61K 38/4873 Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes

Abstract

A stable preparation of digestive/pancreatic enzymes which can be readily formed into a dosage formulation is provided as a treatment of pancreatic insufficiency in persons having cystic fibrosis. The dosage formulation can be administered either by an oral preparation including, but not limited to, a microcapsule, mini-capsule, time released capsule, sprinkle or other methodology. A further object of this invention is to provide a stabilized preparation of a combination medicant which resists degradation by light, heat, humidity or association with commonly used excipients.

Claims

1. A pharmaceutical preparation to treat pancreatic disorders comprising a therapeutically effective amount of digestive/pancreatic enzymes selected from the group consisting of:

amylase, lipase, protease, chymotrypsin, trypsin, papaya, papain, and a combination thereof.

2. The pharmaceutical preparation of claim 1, wherein the preparation comprises protease, amylase and lipase.

3. The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase and chymotrypsin.

4. The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase, chymotrypsin, and papain.

5. The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase, trypsin, chymotrypsin, and papain.

6. The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase, trypsin, chymotrypsin, pancreatin and papain

7. The pharmaceutical preparation of claim 1 wherein the enzymes are derived from animal sources.

8. The pharmaceutical preparation of claim 1 wherein the enzymes are synthetic.

9. The pharmaceutical preparation of claim 1 wherein the preparation is used to treat pancreatic enzyme insufficiency associated with cystic fibrosis.

11. The pharmaceutical preparation of claim 1 wherein the preparation is manufactured using Prosolv technology.

12. The pharmaceutical preparation of claim 1 wherein the preparation is manufactured utilizing a direct compression technology.

13. The pharmaceutical preparation of claim 1 wherein the enzymes are derived from plant sources.

14. The pharmaceutical preparation of claim 1 wherein the enzymes are derived from a combination of animal and plant sources.

15. The pharmaceutical preparation of claim 1, wherein the preparation is administered orally via a dosage formulation selected from the group consisting of:

pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof.

16. The pharmaceutical preparation of claim 1, wherein the preparation is resistant to degradation by light.

17. The pharmaceutical preparation of claim 1, wherein the preparation is resistant to degradation by heat.

18. The pharmaceutical preparation of claim 1, wherein the preparation is resistant to degradation by humidity.

19. The pharmaceutical preparation of claim 1, wherein the preparation is resistant to degradation by association with an excipient.

20. The pharmaceutical preparation of claim 1, wherein the preparation is made by direct compression.

21. The pharmaceutical preparation of claim 1, wherein the preparation is made by dry granulation.

22. The pharmaceutical preparation of claim 1, wherein the preparation is made by wet granulation.

10. (canceled)

23-27. -27. (canceled)