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

• US 10,272,141 B2
• Filed: 05/11/2017
• Issued: 04/30/2019
• 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 M
• Application Number:
  US15/593,121
• Publication Number:
  US 20180071374A1
• Time in Patent Office: 719 Days
• Field of Search: None
• 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 a chymotrypsin 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.

5. 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 tablet, a capsule, a microcapsule, a mini-capsule, a time released capsule, a mini-tab, a sprinkle, and a combination thereof.

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

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

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

9. The method of claim 1, wherein determination that the individual has the chymotrypsin deficiency comprises measuring a level of chymotrypsin in a stool sample obtained from the individual with enzymatic photospectrometry or a colorimetric method, and comparing the level of chymotrypsin present in the stool sample to a normal level of chymotrypsin.