Methods of treating Celiac disease

• US 10,350,278 B2
• Filed: 03/15/2013
• Issued: 07/16/2019
• Est. Priority Date: 05/30/2012
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M., Heil, Matthew, Szigethy, James, Fallon, James J.
• Primary Examiner(s): Paguio Frising, Michelle F.
• Application Number:
  US13/836,135
• Publication Number:
  US 20130323223A1
• Time in Patent Office: 2,314 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: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders

Abstract

Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of celiac disease or a related disorder. Also described herein is a method for treating a subject with celiac disease or a related disorder using digestive enzymes and their derivatives to alleviate the symptoms of celiac disease or a related disorder. 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 celiac disease or a related disorder.

Claims

1. A method for treating Celiac Disease in a subject in need thereof, wherein the subject is not on a gluten-free diet, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising digestive enzymes and one or more excipients to the subject, wherein the digestive enzymes comprise an amylase, a lipase, and a protease, and wherein the pharmaceutical composition comprises from 155,000 to 310,000 United States Pharmacopeia (U.S.P.) units per dose of protease activity, whereby Celiac Disease is treated.

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

1 to 20;

1.

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

1 to 10;

1.

4. The method of claim 1, wherein the pharmaceutical composition is administered to the subject orally.

5. 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.

6. The method of claim 1, wherein treatment comprises treatment of one or more symptoms selected from the group consisting of abdominal pain, bloating, gas, indigestion, constipation, decreased appetite, diarrhea, lactose intolerance, nausea, vomiting, unexplained weight loss, bruising easily, depression, anxiety, chronic headaches, migraines, fatigue, growth delay in children, hair loss, itchy skin, missed menstrual periods, mouth ulcers, muscle cramps, joint pain, nosebleeds, seizures, tingling or numbness in the hands or feet, unexplained short height, defects in the tooth enamel and changes in tooth color, delayed puberty, irritable and fussy behavior, poor weight gain, slowed growth, shorter than normal height, and a combination thereof.

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

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

9. The method of claim 1, wherein the pharmaceutical composition comprising digestive enzymes 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 treatment comprises treatment of one or more symptoms selected from the group consisting of an abnormal stool, osteoporosis, a vitamin deficiency, a mineral deficiency, malaise, an iron deficiency anemia, and a combination thereof.