WO2005065429B1 - Composition and method for treatment of hepatic encephalopathy - Google Patents
Composition and method for treatment of hepatic encephalopathyInfo
- Publication number
- WO2005065429B1 WO2005065429B1 PCT/US2005/000001 US2005000001W WO2005065429B1 WO 2005065429 B1 WO2005065429 B1 WO 2005065429B1 US 2005000001 W US2005000001 W US 2005000001W WO 2005065429 B1 WO2005065429 B1 WO 2005065429B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- composition
- peg
- lactulose
- administered
- patient
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims abstract 34
- 208000007386 Hepatic Encephalopathy Diseases 0.000 title claims abstract 7
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract 24
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract 24
- JCQLYHFGKNRPGE-FCVZTGTOSA-N Lactulose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 JCQLYHFGKNRPGE-FCVZTGTOSA-N 0.000 claims abstract 16
- 229960000511 lactulose Drugs 0.000 claims abstract 16
- 206010010774 Constipation Diseases 0.000 claims abstract 6
- QGZKDVFQNNGYKY-UHFFFAOYSA-N ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims abstract 4
- 206010020575 Hyperammonaemia Diseases 0.000 claims abstract 2
- 230000036823 Plasma Levels Effects 0.000 claims abstract 2
- 239000007788 liquid Substances 0.000 claims 5
- 239000003792 electrolyte Substances 0.000 claims 4
- 239000007787 solid Substances 0.000 claims 4
- 239000000843 powder Substances 0.000 claims 3
- 210000002381 Plasma Anatomy 0.000 claims 2
- 231100000486 side effect Toxicity 0.000 abstract 1
- 230000001225 therapeutic Effects 0.000 abstract 1
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 palatale composition 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 hepatic encephalopathy (HE) characterized by hyperammonemia, comprising orally administering to the patient a liquid drink composition comprising polyethylene glycol (PEG) in an amount sufficient to reduce ammonia plasma levels in the patient.
2. The method of claim 1, wherein the composition consists essentially of PEG.
3. The method of claim 1, wherein the composition is administered in single dosages each comprising from about 5 to 35 gm of dry PEG dissolved in aqueous liquid.
4. The method of claim 1, wherein the composition further comprises lactulose.
5. The method of claim 4, wherein the composition comprises from about 0.15 to 3.5 parts by weight PEG to 1 part lactulose.
6. The method of claim 5, wherein the composition comprises from about 0.5 to 3 parts by weight PEG to 1 part by weight lactulose.
7. The method of claim 1, wherein the composition is administered in single dosages each comprising from about 5 to 35 gm of dry PEG dissolved in aqueous liquid.
8. The method of claim 7, wherein each dosage further comprises from about 10 to 30 gm of dry lactulose dissolved in aqueous liquid. 15
9. The method of claim 8, wherein each dosage comprises from 10 to 20 gm PEG and 10 to 20 gm lactulose.
10. A composition for the treatment of HE comprising PEG and lactulose.
11. The composition of claim 10 comprising from about 0.15 to 3.5 parts by weight PEG to 1 part by weight lactulose.
12. A single dosage composition for the treatment of HE comprising from about 5 to 35 gm of PEG.
13. The single dosage composition of claim 12, further comprising from about 10 to 30 gm of lactulose.
14. The single dosage composition of claim 13, comprising from about 10 to 20 gm PEG and 10 to 20 gm lactulose.
15. A method according to claim 1, wherein the PEG is solid at room temperature.
16. A method according to claim 4, wherein the PEG is solid at room temperature.
17. A composition according to claim 10, wherein the PEG is solid at room temperature.
18. A composition according to claim 12, wherein the PEG is solid at room temperature.
19. A composition according to claim 10, wherein the lactulose and PEG are .each a dry powder. 16
20. A composition according to claim 13, wherein the lactulose and PEG are each a dry powder.
21. A composition according to claim 14, wherein the lactulose and PEG are each a dry powder.
22. A method according to claim 1, wherein the composition is free of added electrolytes.
23. A method according to claim 4, wherein the composition is free of added electrolytes.
24. A composition according to claim 10, wherein the composition is free of added electrolytes.
25. A composition according to claim 12, wherein the composition is free of added electrolytes.
26. The method of claim 7, wherein the composition is administered on a continuing basis in at least one single dosage per day.
27. The method of claim 8, wherein the composition is administered on a continuing basis in at least one single dosage per day.
28. The method of claim 26, wherein the composition is administered in an amount and frequency sufficient to reduce plasma ammonia to clinically-acceptable levels and to maintain these levels.
29. The method of claims 27, wherein the composition is administered in an amount and frequency sufficient to reduce plasma ammonia to clinically-acceptable levels and to maintain these levels. 17
30. The method of claim 1, wherein the amount of the composition administered is sufficient to alleviate constipation in the patient.
31. The method of claim 4, wherein the amount of the composition administered is sufficient to alleviate constipation in the patient.
32. A method for the treatment of a patient with HE characterized by ammonemia and constipation, comprising orally administering to the patient a liquid drink composition comprising PEG or PEG and lactulose in an amount and frequency sufficient to alleviate constipation.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/748,185 | 2003-12-31 | ||
| US10/748,185 US7256202B2 (en) | 2003-12-31 | 2003-12-31 | Composition and method for treatment of hepatic encephalopathy |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| WO2005065429A2 WO2005065429A2 (en) | 2005-07-21 |
| WO2005065429A3 WO2005065429A3 (en) | 2006-02-23 |
| WO2005065429B1 true WO2005065429B1 (en) | 2006-04-06 |
Family
ID=34700855
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2005/000001 WO2005065429A2 (en) | 2003-12-31 | 2005-01-03 | Composition and method for treatment of hepatic encephalopathy |
Country Status (2)
| Country | Link |
|---|---|
| US (2) | US7256202B2 (en) |
| WO (1) | WO2005065429A2 (en) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102006017672B4 (en) * | 2006-04-12 | 2008-07-03 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh | Composition for use as a laxative |
| HUE065491T2 (en) | 2008-10-02 | 2024-05-28 | Salix Pharmaceuticals Ltd | Treatment of hepatic encephalopathy using rifaximin |
| US20110035232A1 (en) * | 2008-10-02 | 2011-02-10 | Salix Pharmaceuticals, Ltd. | Methods of treating hepatic encephalopathy |
| US7928115B2 (en) * | 2008-10-02 | 2011-04-19 | Salix Pharmaceuticals, Ltd. | Methods of treating travelers diarrhea and hepatic encephalopathy |
| FI9608U1 (en) * | 2010-11-04 | 2012-03-29 | Norgine Bv | Formulations |
| EP2887806B1 (en) | 2012-07-20 | 2019-11-13 | University Of Rochester | Method of treating and preventing brain impairment using na+-k+ -2ci- cotransporter isoform 1 inhibitors |
| AU2014331610B2 (en) * | 2013-10-03 | 2019-11-07 | Trustees Of The University Of Pennsylvania | Compositions comprising a defined microbiome and methods of use thereof |
| US10058576B2 (en) | 2013-10-03 | 2018-08-28 | The Trustees Of The University Of Pennsylvania | Compositions and methods comprising a defined microbiome and methods of use thereof |
| CN106572692A (en) | 2014-04-29 | 2017-04-19 | 科罗纳里康赛普茨有限责任公司 | Foods, systems, methods, and kits for providing electrolyte replacement |
| KR20200040286A (en) | 2015-03-02 | 2020-04-17 | 코로나리콘셉츠 엘엘씨 | Compounds and Methods for PEG Metabolite and PEG Breakdown Product Assays |
| AU2017206073A1 (en) * | 2016-01-08 | 2018-08-09 | Colonaryconcepts Llc | Food based delivery of therapeutic agent for treatment of hepatic encephalopathy |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3505309A (en) * | 1967-09-25 | 1970-04-07 | Research Corp | Process for lactulose |
| JPS4944331B1 (en) * | 1971-05-31 | 1974-11-27 | ||
| US4100161A (en) * | 1974-04-15 | 1978-07-11 | The Johns Hopkins University | Promotion of protein synthesis and suppression of urea formation in the body by keto analogs of essential amino acids |
| GB1499717A (en) * | 1975-07-04 | 1978-02-01 | Morinaga Milk Industry Co Ltd | Process for preparing a lactulose containing powder for feed |
| US4147773A (en) * | 1977-12-12 | 1979-04-03 | Morinaga Milk Industry Co., Ltd. | Powdery composition comprising viable Bifidobacteria cells and lactulose |
| US4966236A (en) * | 1987-08-12 | 1990-10-30 | Texas Iron Works, Inc. | Cementing method and arrangement |
| IL89624A0 (en) * | 1988-03-18 | 1989-09-10 | Duphar Int Res | Preparation of solid lactulose |
| US4996236A (en) | 1988-06-22 | 1991-02-26 | Takeda Chemical Industries, Ltd. | Therapeutic composition for hepatic encephalopathy |
| SG43680A1 (en) * | 1990-10-12 | 1997-11-14 | Duphar Int Res | Solid lactulose |
| US5571783A (en) | 1993-03-09 | 1996-11-05 | Clintec Nutrition Company | Composition and method for treating patients with hepatic disease |
| DE4314705A1 (en) * | 1993-05-04 | 1994-11-10 | Bolder Arzneimittel Gmbh | Lactulose pastilles |
| IT1297538B1 (en) * | 1997-08-01 | 1999-12-17 | Francesco Vicidomini | LACTULOSE / LACTITOL ENTEROCLISM WITH OR WITHOUT ADDITION OF NEOMYCIN FOR THE TREATMENT OF ACUTE PORTOSYSTEM ENCEPHALOPATHY |
| US6444198B1 (en) * | 1999-02-22 | 2002-09-03 | Smithkline Beecham Corporation | Effervescent laxatives |
| KR100484328B1 (en) * | 1999-03-17 | 2005-04-20 | 모리나가 세이카 가부시키가이샤 | Foods containing cocoa component |
| EP1312667B1 (en) * | 2000-08-25 | 2008-12-31 | Wakamoto Pharmaceutical Co., Ltd. | Probiotic products containing L. salivarius strain |
| US6645481B1 (en) * | 2000-09-28 | 2003-11-11 | Braintree Laboratories, Inc. | Method of achieving overnight laxation and control of bowel function |
| DK1663257T3 (en) * | 2003-07-09 | 2009-04-14 | Braintree Lab | Use of laxatives to treat colon irritable |
-
2003
- 2003-12-31 US US10/748,185 patent/US7256202B2/en not_active Expired - Fee Related
-
2005
- 2005-01-03 WO PCT/US2005/000001 patent/WO2005065429A2/en active Application Filing
-
2007
- 2007-07-06 US US11/822,445 patent/US20070269403A1/en not_active Abandoned
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