Composition and method for treatment of hepatic encephalopathy

• US 7,256,202 B2
• Filed: 12/31/2003
• Issued: 08/14/2007
• Est. Priority Date: 12/31/2003
• Status: Expired due to Fees

• Current Assignee: George M. Halow
• Original Assignee: George M. Halow
• Inventors: Halow, George M.
• Primary Examiner(s): KWON, YONG SOK
• Application Number:
  US10/748,185
• Publication Number:
  US 20050142099A1
• Time in Patent Office: 1,322 Days
• Field of Search: 424/78.38, 424/601, 424/692, 424/697, 424/738, 514/53, 514/57, 514/312
• US Class Current: 514/312
• CPC Class Codes: A61K 31/7012 Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid gluconic acid A61K31/191; ascorbic acid A61K31/375
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics

Abstract

The inventions provide an improved treatment for hepatic encephalopathy characterized by hyperammonemia and/or constipation, comprising the oral administration of polyethylene glycol (PEG) in amounts sufficient to reduce plasma levels of ammonia and/or to alleviate constipation. Preferably, the PEG is administered in combination with lactulose, which provides a palatable composition for the treatment of HE with excellent therapeutic benefits and reduced side effects as compared to lactulose alone.

Claims

1. A method for the treatment of a patient with hyperammonemia, comprising orally administering to the patient a pharmaceutical composition free of serum electrolytes and comprising from about 0.15 to 3.5 parts by weight polyethylene glycol (PEG) to about 1 part by weight lactulose, in an amount and frequency sufficient to reduce patient plasma ammonia to a clinically-acceptable level or to maintain this level, or both.

2. The method of claim 1, wherein the composition is a dry composition formulated as a liquid drink by admixture with a pharmaceutically-acceptable aqueous carrier.

3. The method of claim 1, wherein the composition comprises from about 0.5 to 3 parts by weight PEG to 1 part by weight lactulose.

4. The method of claim 2, wherein the composition is administered in single dosages each comprising about 5 to 35 gm of dry PEG dissolved in the aqueous carrier.

5. The method of claim 4, wherein each single dosage further comprises about 10 to 30 gm of dry lactulose dissolved in the aqueous carrier.

6. The method of claim 5, wherein each single dosage comprises about 10 to 20 gm PEG and about 10 to 20 gm lactulose dissolved in the aqueous carrier.

7. The method of claim 1, wherein the PEG is solid at room temperature.

8. The method of claim 4, wherein the composition is administered on a continuing basis in at least one single dosage per day.

9. The method of claim 5, wherein the composition is administered on a continuing basis in at least one single dosage per day.

10. The method of claim 6, wherein the composition is administered on a continuing basis in at least one single dosage per day.

11. The method of claim 8, wherein the composition is administered on a continuing basis of once or twice a day.

12. The method of claim 9, wherein the composition is administered on a continuing basis of once or twice a day.

13. The method of claim 10, wherein the composition is administered on a continuing basis of once or twice a day.

14. The method of claim 3, wherein the composition is a dry composition formulated as a liquid drink by admixture with a pharmaceutically-acceptable aqueous carrier.

15. The method of claim 14, wherein the composition is administered in single dosages each comprising about 5 to 35 gm of dry PEG dissolved in the aqueous carrier.

16. The method of claim 15, wherein each single dosage further comprises about 10 to 30 gm of dry lactulose dissolved in the aqueous carrier.

17. The method of claim 16, wherein each single dosage comprises about 10 to 20 gm PEG and about 10 to 20 gm lactulose.

18. The method of claim 15, wherein the composition is administered on a continuing basis in at least one single dosage per day.

19. The method of claim 16, wherein the composition is administered on a continuing basis in at least one single dosage per day.

20. The method of claim 17, wherein the composition is administered on a continuing basis in at least one single dosage per day.

21. The method of claim 18, wherein the composition is administered on a continuing basis of once or twice a day.

22. The method of claim 19, wherein the composition is administered on a continuing basis of once or twice a day.

23. The method of claim 20, wherein the composition is administered on a continuing basis of once or twice a day.

24. The method of claim 3, wherein PEG is a solid at room temperature.