Method of treatment of schizophreniform disorder

• US 10,279,016 B2
• Filed: 09/14/2016
• Issued: 05/07/2019
• Est. Priority Date: 04/21/2011
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M., Heil, Matthew, Szigethy, James, Fallon, James
• Primary Examiner(s): Gitomer, Ralph J
• Application Number:
  US15/265,415
• Publication Number:
  US 20170189501A1
• Time in Patent Office: 965 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 38/48 acting on peptide bonds (3.4)
• 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: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: C12Y 301/01 Carboxylic ester hydrolases (3.1.1)
• CPC Class Codes: C12Y 302/01 Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
• CPC Class Codes: C12Y 304/00 Hydrolases acting on peptide bonds, i.e. peptidases (3.4)

Abstract

Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of a neuropsychiatric disorder. Also described herein is a method for treating an individual with a neuropsychiatric disorder using digestive enzymes and their derivatives to alleviate the symptoms of neuropsychiatric disorders. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of the neuropsychiatric disorder.

Claims

1. A method for treating a schizophreniform disorder in a subject having a schizophreniform disorder, comprising orally administering to the subject a dose of a therapeutically effective amount of a pharmaceutical composition that comprises digestive enzymes;

wherein the digestive enzymes comprise a protease, an amylase, and a lipase, and wherein the dose of the pharmaceutical composition comprises from about 5,000 to about 1,000,000 U.S.P. units of protease activity, whereby the schizophreniform disorder is treated.

2. 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-release capsule, a mini-tab, a sprinkle, and a combination thereof.

3. The method of claim 1, wherein the pharmaceutical composition comprises amounts of the protease and the lipase in United States Pharmacopeia (U.S.P.) units/dose in a ratio from about 1:

1 to about 20;

1; and

amounts of the protease and the amylase in U.S.P. units/dose in a ratio of from about 1;

0.1 to about 1;

10.

4. The method of claim 1, wherein the pharmaceutical composition comprises amounts of the protease and the lipase in U.S.P. units/dose in a ratio of from about 4:

1 to about 10;

1.

5. The method of claim 1, wherein the pharmaceutical composition comprises amounts of the protease and the lipase in U.S.P units/dose in a ratio of about 6.1.

6. The method of claim 1, wherein the pharmaceutical composition comprises amounts of the protease and the lipase in U.S.P. units/dose in a ratio of about 1:

1.

7. The method of claim 1, wherein the pharmaceutical composition further comprises a coating.

8. The method of claim 7, wherein the coating comprises a lipid coating.

9. The method of claim 1, wherein the pharmaceutical composition is manufactured using a technology selected from the group consisting of direct compression, dry granulation, wet granulation, and a combination thereof.

10. The method of claim 1, wherein the pharmaceutical composition is administered to the subject 1, 2, 3 or 4 times daily.

11. The method of claim 1, wherein the pharmaceutical composition is administered to the subject 1, 2, 3 or 4 times weekly.

12. The method of claim 1, wherein the digestive enzymes are animal enzymes, plant enzymes, synthetic enzymes, or a combination thereof.

13. The method of claim 12, wherein the digestive enzymes are animal enzymes that are derived from a mammal.

14. The method of claim 13, wherein the mammal is a pig.

15. The method of claim 12, wherein the digestive enzymes are animal enzymes that are derived from a pancreas.

16. The method of claim 7, wherein the coating comprises an enteric coating.

17. The method of claim 1, wherein the pharmaceutical composition is administered to the subject in a dosage of about 10 mg/ml or about 20 mg/ml.

18. The method of claim 1, wherein the dose of the pharmaceutical composition comprises from about 50,000 to about 750,000 U.S.P. units of protease activity.

19. The method of claim 1, wherein the dose of the pharmaceutical composition comprises from about 100,000 to about 500,000 U.S.P. units of protease activity.

20. The method of claim 1, wherein the dose of the pharmaceutical composition comprises from about 150,000 to about 350,000 U.S.P. units of protease activity.

21. The method of claim 1, wherein the dose of the pharmaceutical composition comprises about 155,000 U.S.P. units of protease activity.

22. The method of claim 1, wherein the dose of the pharmaceutical composition comprises about 310,000 U.S.P. units of protease activity.