Compositions and use thereof for treating symptoms of preeclampsia

• US 8,658,163 B2
• Filed: 03/13/2008
• Issued: 02/25/2014
• 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:
  US12/047,818
• Publication Number:
  US 20090232789A1
• Time in Patent Office: 2,175 Days
• Field of Search: None
• US Class Current: 424/94.63
• 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 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 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 having preeclampsia characterized by hypertension, proteinuria, or a combination thereof, comprising administering a preparation of digestive enzymes comprising an amylase, a lipase, and a protease to the individual, wherein the individual having preeclampsia is treated.

2. The method of claim 1, wherein the protease comprises chymotrypsin, trypsin, papain, or a combination thereof.

3. The method of claim 1, wherein the digestive enzymes are obtained from a source comprising animal enzymes, plant enzymes, synthetic enzymes, or a combination thereof.

4. The method of claim 1, wherein the preparation of digestive enzymes is manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof.

5. The method of claim 1, wherein the preparation of digestive enzymes is administered orally via a dosage formulation selected from the group consisting of:

pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof.

6. The method of claim 1, wherein the preperation of digestive enzymes comprises amylase in an amount from 10,000 to 60,000 USP units/dose.

7. The method of claim 1, wherein the preparation of digestive enzymes comprises protease in an amount from 10,000 to 70,000 USP units/dose.

8. The method of claim 1, wherein the preparation of digestive enzymes comprises lipase in an amount from 4,000 to 30,000 USP units/dose.

9. The method of claim 2, wherein the chymotrypsin is present in an amount from 2 to 5 mg.

10. The method of claim 2, wherein the papain is present in an amount from 3,000 to 10,000 USP units/dose.

11. The method of claim 2, wherein the trypsin is present in an amount from 60 to 100 mg.

12. The method of claim 1, wherein the total amount of digestive enzymes present is in an amount from about 4,000 to about 176,000 USP/dose.