Method of treating proteinuria in pregnancy

• US 9,925,250 B2
• Filed: 06/17/2016
• Issued: 03/27/2018
• Est. Priority Date: 03/13/2008
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Primary Examiner(s): ROBINSON, HOPE A
• Application Number:
  US15/185,511
• Publication Number:
  US 20160287683A1
• Time in Patent Office: 648 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• 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 38/4826 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 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/06 Antiabortive agents; Labour repressants
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: C12Y 301/00 Hydrolases acting on ester bonds (3.1)
• 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)
• CPC Class Codes: C12Y 304/21001 Chymotrypsin (3.4.21.1)
• CPC Class Codes: C12Y 304/21004 Trypsin (3.4.21.4)
• CPC Class Codes: C12Y 304/22002 Papain (3.4.22.2)

Abstract

A therapeutic agent for the treatment of toxemia, preeclampsia and eclampsia and a method for preparing the therapeutic agent are 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 by other methods. Further, a method of using the presence of chymotrypsin in the maternal GI tract as a biomarker, to determine the likelihood of developing preeclampsia, a pregnancy induced hypertension, and eclampsia/toxemia is disclosed.

Claims

1. A method for treating an individual exhibiting pregnancy-related elevated proteinuria, the method comprising administering to the individual a therapeutically effective amount of a pharmaceutical preparation comprising digestive enzymes, wherein the digestive enzymes comprise an amylase, a lipase, a protease, or a combination thereof, whereby pregnancy-related elevated proteinuria is treated.

2. The method of claim 1, wherein the digestive enzymes comprise the protease, wherein the protease comprises chymotrypsin or trypsin.

3. The method of claim 1, wherein the digestive enzymes comprise an amylase, a lipase, and a protease.

4. The method of claim 3, wherein the digestive enzymes are provided as pancreatin.

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

6. The method of claim 1, wherein the pharmaceutical preparation is administered orally.

7. The method of claim 1, wherein the pharmaceutical preparation 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.

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

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

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

11. The method of claim 4, wherein an amount of the pancreatin in the pharmaceutical preparation ranges from about 2,000 to about 6,000 U.S.P. units/dose.

12. The method of claim 2, wherein the protease comprises chymotrypsin, and wherein an amount of the chymotrypsin in the pharmaceutical preparation ranges from about 2 to about 5 mg/dose.

13. The method of claim 2, wherein the protease comprises trypsin, and wherein an amount of the trypsin in the pharmaceutical preparation ranges from about 60 to about 100 mg/dose.

14. The method of claim 1, wherein the digestive enzymes comprise the protease, the amylase and the lipase.