Pharmaceutical preparation for the treatment of the symptoms of addiction and method of diagnosing same

• US 8,486,390 B2
• Filed: 07/31/2012
• Issued: 07/16/2013
• Est. Priority Date: 04/18/2008
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Primary Examiner(s): HANLEY, SUSAN MARIE
• Application Number:
  US13/562,999
• Publication Number:
  US 20130059001A1
• Time in Patent Office: 350 Days
• Field of Search: 424/94.6, 424/94.61, 424/94.63, 435/195, 435/198, 435/201, 435/202, 435/212, 435/213, 435/219
• US Class Current: 424/94.61
• 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 38/4826 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: A61K 38/54 Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 25/30 for treating abuse or dependence
• CPC Class Codes: A61P 25/32 Alcohol-abuse

Abstract

A therapeutic agent for the treatment of the symptoms of addiction and the method for preparing the therapeutic agent is disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using of a biomarker, the presence of chymotrypsin in the gastrointestinal tract to determine the presence of symptoms of addiction, and the likelihood of relapsing into addiction is disclosed.

Claims

1. A method for treating an alcohol or drug addicted individual exhibiting one or more symptoms of alcohol or drug addiction, wherein the one or more symptoms comprise lack of protein digestion, a lack of nutrient absorption or a combination thereof, and wherein the individual has a subnormal level of chymotrypsin, the method comprising:

administering a therapeutically effective amount of composition comprising digestive enzymes comprising pancreatin, amylases, lipases, proteases or a combination thereof, to the individual.

2. The method of claim 1, wherein the proteases comprise chymotrypsin, trypsin, papain, or a combination thereof.

3. The method of claim 2, wherein the amount of chymotrypsin ranges from 2 to 5 mg.

4. The method of claim 2, wherein the amount of papain ranges from 3,000 to 10,000 USP units/mg.

5. The method of claim 2, wherein the amount of trypsin ranges from 60 to 100 mg.

6. The method of claim 1, wherein the enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof.

7. The method of claim 1 wherein the composition is manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof.

8. The method of claim 1, wherein the composition 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.

9. The method of claim 1, wherein the amount of amylase ranges from 10,000 to 60,000 USP units/mg.

10. The method of claim 1, wherein the amount of protease ranges from 10,000 to 70,000 USP units/mg.

11. The method of claim 1, wherein the amount of lipase ranges from 4,000 to 30,000 USP units/mg.

12. The method of claim 1, wherein the amount of pancreatin ranges from 2,000 to 6,000 USP units/mg.