Pharmaceutical Preparation for the Treatment of the Symptoms of Addiction and Method of Diagnosing Same

• US 20180071374A1
• Filed: 05/11/2017
• Published: 03/15/2018
• Est. Priority Date: 04/18/2008
• Status: Active Application

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Granted Patent: US 10,272,141 B2
• Time in Patent Office: Days
• 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 individual addicted to cocaine and having an enzyme deficiency, the method comprising administering to the individual a therapeutically effective amount of a pharmaceutical preparation that comprises digestive enzymes, whereby the cocaine addiction is treated.

2. The method of claim 1, wherein the digestive enzymes comprise an amylase, a lipase, and a protease.

3. The method of claim 1, wherein the digestive enzymes consist of an amylase, a lipase, and a protease.

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

6. The method of claim 1, wherein the pharmaceutical preparation is administered orally via a dosage formulation selected from the group consisting of a pill, a table, a capsule, a microcapsule, a mini-capsule, a time released capsule, a mini-tab, a sprinkle, and a combination thereof.

7. The method of claim 2, wherein the amount of amylase in the pharmaceutical preparation ranges from 10,000 to 60,000 U.S.P. units/dose.

8. The method of claim 2, wherein the amount of protease in the pharmaceutical preparation ranges from 10,000 to 70,000 U.S.P. units/dose.

9. The method of claim 2, wherein the amount of lipase in the pharmaceutical preparation ranges from 4,000 to 30,000 U.S.P. units/dose.

14. The method of claim 1, wherein the pharmaceutical preparation is administered orally via a dosage formulation selected from the group consisting of a pill, a table, a capsule, a microcapsule, a mini-capsule, a time released capsule, a mini-tab, a sprinkle, and a combination thereof

20. The method of claim 1, wherein the individual has a fecal chymotrypsin level of less than 8.4 U/mg.

5. (canceled)

10. A method for treating an individual addicted to a drug or alcohol, the method comprising administering to the individual a therapeutically effective amount of a pharmaceutical preparation that comprises digestive enzymes, whereby the drug or alcohol addiction is treated.

11. The method of claim 10, wherein the digestive enzymes comprise an amylase, a lipase, and a protease.

12. The method of claim 10, wherein the digestive enzymes consist of an amylase, a lipase, and a protease.

13. The method of claim 10, wherein the digestive enzymes are selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof.

15. The method of claim 10, wherein the amount of amylase in the pharmaceutical preparation ranges from 10,000 to 60,000 U.S.P. units/dose.

16. The method of claim 10, wherein the amount of protease in the pharmaceutical preparation ranges from 10,000 to 70,000 U.S.P. units/dose.

17. The method of claim 10, wherein the amount of lipase in the pharmaceutical preparation ranges from 4,000 to 30,000 U.S.P. units/dose.

18. A method of diagnosing a drug or alcohol addiction in an individual, comprising:

(a) obtaining a stool sample from the individual;

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

(c) administering to the individual a pharmaceutical preparation that comprises digestive enzymes when the level of fecal chymotrypsin is less than 8.4 U/mg.

19. The method of claim 18, wherein measuring a level of fecal chymotrypsin comprises enzymatic photospectrometry or a colorimetric method.