COMBINATION ENZYME FOR CYSTIC FIBROSIS

• US 20100233218A1
• Filed: 05/25/2010
• Published: 09/16/2010
• Est. Priority Date: 09/28/2004
• Status: Abandoned Application

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Application Number:
  US12/786,739
• Publication Number:
  US 20100233218A1
• Time in Patent Office: Days
• US Class Current: 424/400
• 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 method for treating one or more symptoms of cystic fibrosis in a patient comprising administering a pharmaceutical composition comprising a therapeutically effective amount of a protease, an amylase, and a lipase, and wherein the pharmaceutical preparation comprises microcrystalline cellulose.

2. The method of claim 1, wherein the pharmaceutical composition further comprises one or more of cellulase, bromelain, papain, pancreatin, chymotrypsin, and trypsin.

3. The method of claim 1, wherein the pharmaceutical composition is an oral dosage form.

4. The method of claim 1, wherein the pharmaceutical composition is a tablet, capsule, pellet or sprinkle dosage form.

5. The method of claim 1, wherein the pharmaceutical composition is capable of providing time release delivery of the protease, amylase, and lipase.

6. The method of claim 1, wherein the microcrystalline cellulose is silicified microcrystalline cellulose.

7. The method of claim 6, wherein the silicified microcrystalline cellulose has a mean particle size of about 90 micrometers.

8. The method of claim 6, wherein the silicified microcrystalline cellulose has a mean particle size of about 40-50 micrometers.

9. The method of claim 1, wherein the protease, amylase, and lipase are, independently, derived from animal or plants or are synthetically prepared.

10. The method of claim 1, wherein the pharmaceutical composition further comprises chymotrypsin.

11. The method of claim 1, wherein the pharmaceutical composition further comprises one or more disintegrants, lubricants, or coloring agents.

12. The method of claim 1, wherein the pharmaceutical composition is capable of providing a pulse delivery of the protease, amylase, and lipase.