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

• US 8,318,158 B2
• Filed: 10/12/2011
• Issued: 11/27/2012
• 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:
  US13/271,783
• Publication Number:
  US 20120070504A1
• Time in Patent Office: 412 Days
• Field of Search: 424/94.61, 424/94.6, 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 a lack of protein digestion, a lack of nutrient absorption or a combination thereof;

the method comprising;

(a) obtaining a fecal sample from the individual;

(b) measuring a level of chymotrypsin present in the fecal sample, wherein measuring comprises enzymatic photospectrometry analysis;

(c) comparing the level of chymotrypsin present in the fecal sample to a normal level of fecal chymotrypsin;

(d) administering a therapeutically effective amount of digestive enzymes to the individual if the measured fecal level of chymotrypsin is less than the normal level of fecal chymotrypsin;

wherein the digestive enzymes comprise pancreatin, amylases, lipases, proteases or a combination thereof.

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

3. The method of claim 1, wherein the digestive enzymes are prepared using a technology comprising enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation or a combination thereof.

4. The method of claim 1, wherein the digestive enzymes are administered orally via a dosage formulation comprising pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, or a combination thereof.

5. The method of claim 1, wherein the amount of amylases ranges from 10,000 to 60,000 USP units/dose.

6. The method of claim 1, wherein the amount of proteases ranges from 10,000 to 70,000 USP units/dose.

7. The method of claim 1, wherein the amount of lipases ranges from 4,000 to 30,000 USP units/dose.

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

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

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

11. The method of claim 1, wherein one of the one or more symptoms of the drug or alcohol addiction is ameliorated.

12. The method of claim 1, wherein the total amount of the digestive enzymes ranges from about 4,000 to about 176,000 USP units/dose.

13. The method of claim 1, wherein the normal level is 8.4 U/gram.