Methods and compositions for the treatment of symptoms of Williams Syndrome

Patent metadata

Field	Value
Publication number	US-9320780-B2
Application number	US-49312209-A
Country	US
Kind code	B2
Filing date	Jun 26, 2009
Priority date	Jun 26, 2008
Publication date	Apr 26, 2016
Grant date	Apr 26, 2016

Abstract

A therapeutic composition for the treatment of the symptoms of Williams Syndrome and the method for preparing the therapeutic agents is disclosed. The therapeutic composition is a stable pharmaceutical composition comprising one or more digestive and/or pancreatic enzymes. The therapeutic composition may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic composition may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using fecal chymotrypsin level as a biomarker for the presence of Williams Syndrome, or the likelihood of an individual to develop Williams Syndrome is disclosed.

First claim

What is claimed is:

1. A method for treating Williams Syndrome in a patient diagnosed with Williams Syndrome comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising digestive enzymes, wherein said digestive enzymes comprise a protease, a lipase and an amylase, and wherein the patient exhibits abdominal pain.

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

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

4. The method of claim 1 , wherein the protease comprises chymotrypsin and trypsin.

5. The method of claim 1 , wherein the digestive enzymes are independently obtained from an animal source, a microbial source, or a plant source, or are synthetically prepared.

6. The method of claim 5 , wherein the animal source is a pig.

7. The method of claim 1 , wherein the protease comprises a mixture of proteases, wherein the pharmaceutical composition comprises at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, and at least one lipase.

8. The method of claim 1 , wherein the pharmaceutical composition comprises per dose: amylases from about 10,000 to about 60,000 U.S.P.; proteases from about 10,000 to about 70,000 U.S.P.; lipases from about 4,000 to about 30,000 U.S.P.; chymotrypsin from about 2 to about 5 mg; trypsin from about 60 to about 100 mg; papain from about 3,000 to about 10,000 U.S.P. units; and papaya from about 30 to about 60 mg.

9. The method of claim 1 , wherein the protease and lipase in the pharmaceutical composition (in U.S.P. units) are present in a ratio of protease to lipase of from about 1:1 to about 20:1.

10. The method of claim 9 , wherein the protease and 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 is 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.

12. The method of claim 1 , wherein the pharmaceutical composition comprises an amylase in an amount of from about 10,000 to about 60,000 U.S.P. per dose.

13. The method of claim 1 , wherein the pharmaceutical composition comprises a protease in an amount of from about 10,000 to about 70,000 U.S.P. per dose.

14. The method of claim 1 , wherein the pharmaceutical composition comprises a lipase from about 4,000 to about 30,000 U.S.P. per dose.

15. The method of claim 1 , wherein the pharmaceutical composition comprises chymotrypsin in an amount of from about 2 to about 5 mg per dose.

16. The method of claim 1 , wherein the pharmaceutical composition comprises trypsin in an amount of from about 60 to about 100 mg per dose.

17. The method of claim 1 , wherein the composition is administered orally.

18. The method of claim 1 , wherein the patient further exhibits a difficulty in concentrating.

Assignees

• Fallon Joan M
• Curemark Llc

Inventors

• Fallon Joan M

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• C12Y302/01002

  Beta-amylase (3.2.1.2) · CPC title

• C12Y304/21004

  Trypsin (3.4.21.4) · CPC title

• G01N33/6896

  Neurological disorders, e.g. Alzheimer's disease · CPC title

• G01N2800/2814

  Dementia; Cognitive disorders · CPC title