PHARMACEUTICAL PREPARATION FOR THE TREATMENT OF THE SYMPTOMS OF ADDICTION AND METHOD OF DIAGNOSING SAME

• US 20120070504A1
• Filed: 10/12/2011
• Published: 03/22/2012
• Est. Priority Date: 04/18/2008
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: FALLON, Joan M.
• Granted Patent: US 8,318,158 B2
• Time in Patent Office: Days
• US Class Current: 424/498
• 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

1-16. -16. (canceled)

17. 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 or 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;

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

(c) 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.

18. The method of claim 17, wherein the proteases comprise chymotrypsin, trypsin, papain or a combination thereof.

19. The method of claim 17, wherein the digestive enzymes are prepared using a technology comprising enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation or a combination thereof.

20. The method of claim 17, 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.

21. The method of claim 17, wherein the amount of amylases ranges from 10,000 to 60,000 USP units/dose.

22. The method of claim 17, wherein the amount of proteases ranges from 10,000 to 70,000 USP units/dose.

23. The method of claim 17, wherein the amount of lipases ranges from 4,000 to 30,000 USP units/dose.

24. The method of claim 17, wherein the amount of pancreatin ranges from 2,000 to 6,000 USP units/dose.

25. The method of claim 18, wherein the amount of papain ranges from 3,000 to 10,000 USP units/dose.

26. The method of claim 18, wherein the amount of trypsin ranges from 60 to 100 mg.

27. The method of claim 17, wherein one of the one or more symptoms of the drug or alcohol addiction is ameliorated.

28. The method of claim 17, wherein the total amount of the digestive enzymes ranges from about 4,000 to about 176,000 USP units/dose.

29. The method of claim 17, wherein the normal level is 8.4 U/gram.

30. The method of claim 17, wherein the level of chymotrypsin present in the fecal sample is measured using enzymatic photospectrometry analysis.

32. The method of claim 30, wherein the individual is diagnosed as having a symptom of drug or alcohol addiction if the measured chymotrypsin level is below 8.4 U/gram.

33. The method of claim 30, wherein the level of chymotrypsin present in the fecal sample is measured using enzymatic photospectrometry analysis.

34. The method of claim 30, wherein the individual has symptoms that comprise a lack of protein digestion, a lack or nutrient absorption or a combination thereof.

31. A method of diagnosing an individual as being at risk of becoming an alcoholic or substance abuse addicted individual comprising:

(a) obtaining a fecal sample from the individual;

(b) measuring a level of chymotrypsin present in the fecal sample; and

(c) diagnosing the individual as being at risk of becoming an alcoholic or substance abuse addicted individual if the measured chymotrypsin level is sub-normal.

35. A method of identifying an individual as being at risk of relapsing into alcohol or substance abuse;

comprising;

(d) obtaining a fecal sample from the individual;

(e) measuring a level of chymotrypsin present in the fecal sample; and

(f) identifying the individual as being at risk of relapsing into alcohol or substance abuse if the measured chymotrypsin level is sub-normal.

36. The method of claim 35, wherein the individual previously was addicted to drugs or alcohol.

37. The method of claim 35, wherein the individual is identified as being at risk of relapsing into alcohol or substance abuse if the measured chymotrypsin level is below 8.4 U/gram.

38. The method of claim 35, wherein the level of chymotrypsin present in the fecal sample is measured using enzymatic photospectrometry analysis.

39. The method of claim 35, wherein the individual has symptoms that comprise a lack of protein digestion, a lack or nutrient absorption or a combination thereof.

40. A pharmaceutical preparation comprising a therapeutically effective amount of a composition comprising one or more digestive enzymes;

wherein the pharmaceutical preparation comprises lipid-encapsulation of the composition; and

wherein the amount of digestive enzymes ranges from about 4,000 to about 176,000 USP units/dose.