Formulation of l-ornithine phenylacetate

A technology of phenylacetate and ornithine, applied in the field of L-ornithine phenylacetate preparations, can solve problems such as sudden deterioration of symptoms, acute-on-chronic liver failure, etc.

Inactive Publication Date: 2018-08-03
OCERA THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such patients are at risk of a sudden exacerbation of their condition, which can lead to acute-on-chronic liver failure

Method used

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  • Formulation of l-ornithine phenylacetate
  • Formulation of l-ornithine phenylacetate
  • Formulation of l-ornithine phenylacetate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Example 1 - Phase I Pharmacokinetic Study in Healthy Humans

[0088] An open-label, five-agent, five-cycle single-dose crossover Phase I human clinical study to evaluate Pharmacokinetics of (phenylbutyrin)-phenylacetic acid prodrugs compared to phenylacetic acid and phenylacetylglutamine following a single dose of three extended-release oral dosage forms of L-ornithine phenylacetate dynamics. The study also compared the pharmacokinetics of three extended-release oral dosage forms of a single dose of L-ornithine phenylacetate compared to a single dose of L-ornithine phenylacetate in an immediate-release oral solution and security.

[0089] The five therapeutic agents are listed below: Therapeutic Agents A, B, and C each refer to a single oral dose of 10 g of Formulations A, B, and C (each equivalent to about 5 g of PAA), the components of these formulations are summarized in Table 1 below; Treatment D refers to a single oral dose of 6 mL (equivalent to about 5 g ...

Embodiment 2

[0109] Example 2 - Phase I Pharmacokinetic Study in Child-Pugh Class A Subjects

[0110] In this example, a single-dose, partially randomized clinical study was conducted to evaluate 5 subjects with liver cirrhosis (Child-Pugh class A) in the fed state, in the fasted state, or after cessation of lactulose 5g L-ornithine phenylacetate oral solution given under fasting state. The objective was to determine whether subjects with liver cirrhosis (Child-Pugh class A) performed better in the fed, fasted state compared to a single intravenous dose of 5 g of L-ornithine phenylacetate in the fasted state. Pharmacokinetics of PAA and PAGN after administration of a single dose of 5 g of L-ornithine phenylacetate oral solution under state, or under fasting state after cessation of lactulose.

[0111] The therapeutic agents are summarized as follows: Therapeutic agent A is a 5 g single oral dose of L-ornithine phenylacetate oral solution administered in the fasted state; Therapeutic age...

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Abstract

Some embodiments of the present application are directed to oral formulations of L-ornithine phenylacetate and methods of using the same. These oral formulations offer alternative administration routethan the standard intravenous administration of L-ornithine phenylacetate for treating hyperammonemia in patients having various acute and chronic liver diseases and disorders, for example, acute liver failure, liver cirrhosis, liver decompensation, portal hypertension, hepatic encephalopathy, or patients with urea cycle disorders.

Description

[0001] Incorporation by reference of the priority application [0002] This application claims U.S. Provisional Patent Application No. 62 / 255,300, filed November 13, 2015, U.S. Provisional Patent Application No. 62 / 276,754, filed January 8, 2016, and U.S. Application No. 15 / 133,087; the entire contents of all of these applications are hereby expressly incorporated by reference into this specification. Background technique [0003] field [0004] The present application relates to pharmaceutical compositions comprising oral formulations of L-ornithine phenylacetate, as well as methods of administration and use in the treatment of patients with various acute and chronic liver diseases and conditions (such as acute liver failure, cirrhosis, hepatic failure Compensation, portal hypertension, hepatic encephalopathy) or hyperammonemia in patients with urea cycle disorders. [0005] describe [0006] Chronic liver disease is characterized by the gradual destruction of liver ti...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K31/192A61K31/195C07C57/32A61K9/00A61P3/00A61P1/16
CPCA61K9/0053A61K31/198A61P1/16A61P7/00A61P9/12A61P13/00A61P25/00A61K9/5031A61K9/5042A61K9/5078A61P13/02A61P3/00A61P9/00A61K31/195A61K31/192A61K9/0095
Inventor L·王L·S·格莱斯S·布科夫策尔
Owner OCERA THERAPEUTICS INC
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