Methods and compositions for the treatment of symptoms of neurological and mental health disorders

Patent metadata

Field	Value
Publication number	US-11016104-B2
Application number	US-200913002136-A
Country	US
Kind code	B2
Filing date	Jul 1, 2009
Priority date	Jul 1, 2008
Publication date	May 25, 2021
Grant date	May 25, 2021

Abstract

A therapeutic composition for the treatment of the symptoms of neurological and mental health disorders, such as Alzheimer's, bipolar disorder, obsessive compulsive disorder, and oppositional defiant disorder, and the method for preparing the therapeutic agents 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 fecal chymotrypsin level as an indicator of the presence of neurological and mental health disorders, such as Alzheimer's, bipolar disorder, obsessive compulsive disorder, and oppositional defiant disorder, or the likelihood of an individual to develop these disorders is disclosed.

First claim

What is claimed is:

1. A method for treating Bipolar Disorder in a subject diagnosed with Bipolar Disorder, wherein the subject to be treated does not have Autism, comprising administering to the subject a pharmaceutical composition that comprises digestive enzymes; wherein the digestive enzymes comprise a protease, an amylase, and a lipase, and wherein a total protease and a total lipase in the pharmaceutical composition in United Stages Pharmacopeia (U.S.P.) units are present in a ratio of protease to lipase of from about 1:1 to about 20:1, whereby Bipolar Disease is treated in the subject.

2. The method of claim 1 , wherein the digestive enzymes further comprise one or more enzymes selected from the group consisting of a cellulase, a sucrase, and a maltase.

3. The method of claim 1 , wherein the digestive enzymes comprise one or more pancreatic enzymes.

4. The method of claim 1 , wherein the digestive enzymes comprise animal enzymes, microbial enzymes, plant enzymes, or are synthetic.

5. The method of claim 4 , wherein the digestive enzymes comprise animal enzymes from a pig.

6. The method of claim 1 , wherein the pharmaceutical composition comprises the amylase, a mixture of proteases, and the lipase, and wherein the mixture of proteases comprises chymotrypsin and trypsin.

7. The method of claim 6 , wherein the mixture of proteases comprises the chymotrypsin, and wherein the chymotrypsin is present in the pharmaceutical composition in an amount of from about 2 to about 5 mg/dose.

8. The method of claim 6 , wherein the mixture of proteases comprises the trypsin, and wherein the trypsin is present in the pharmaceutical composition in an amount of from about 60 to about 100 mg/dose.

9. The method of claim 1 , wherein the digestive enzymes comprise the amylase, and wherein the amylase is present in the pharmaceutical composition in an amount of from about 10,000 to about 60,000 U.S.P. units/dose.

10. The method of claim 1 , wherein the total protease and the total lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of protease to lipase of from about 4:1 to about 10:1.

11. The method of claim 1 , wherein the pharmaceutical composition comprises 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, and a combination thereof.

12. The method of claim 1 , wherein the digestive enzymes comprise the protease, and wherein the protease is present in the pharmaceutical composition in an amount of from about 10,000 to about 70,000 U.S.P. units/dose.

13. The method of claim 1 , wherein the digestive enzymes comprise the lipase, and wherein the lipase is present in the pharmaceutical composition in an amount of from about 4,000 to about 30,000 U.S.P. units/dose.

Assignees

• Fallon Joan M
• Curemark Llc

Inventors

• Fallon Joan M

Classifications

• A61K38/4826

  Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1) · CPC title

• G01N2800/304

  Mood disorders, e.g. bipolar, depression · CPC title

• A61K38/488

  Aspartic endopeptidases (3.4.23), e.g. pepsin, chymosin, renin, cathepsin E · CPC title

• A61K38/4873

  Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H · CPC title

• G01N2333/976

  Trypsin; Chymotrypsin · CPC title