Process for preparation of liquid dosage form containing sodium 4-phenylbutyrate

A technology of sodium phenylbutyrate and phenylbutyric acid, which is used in medical preparations containing active ingredients, pharmaceutical formulas, blood diseases, etc., can solve problems such as inability to mask bitterness

Inactive Publication Date: 2008-09-24
NAVINTA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The article describes the bitter taste of sodium phenylbutyrate in powdered form and that many attempts have been made to mask this bitterness

Method used

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  • Process for preparation of liquid dosage form containing sodium 4-phenylbutyrate

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Experimental program
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Embodiment 1

[0044] About 12.5 g of sodium 4-phenylbutyrate was transferred to a 25 mL volumetric flask, about 10 mL of water was added to the flask, and the resulting mixture was stirred to dissolve the butyrate and form a solution. To the resulting solution were added about 0.05 g of sodium saccharin, 0.05 g of sodium benzoate, and the solution was mixed well. This solution was mixed with water to obtain a 25 mL liquid oral dosage form.

Embodiment 2

[0046] Transfer approximately 12.5 g of sodium 4-phenylbutyrate to a 25 mL volumetric flask. About 10 mL of water was added to the flask, and the resulting mixture was stirred to dissolve the butyrate. To this solution was added about 0.05 g of raspberry flavor (eg, raspberry XBF-700194, available from IFF International Flavors & Fragrances, New York, NY), 0.05 g of sodium benzoate, and mixed well. The mixture was made up to 25 mL with water. Any flavoring agent that is dispersible in water can generally be used in the present invention.

Embodiment 3

[0048] Transfer about 12.5 g of sodium 4-phenylbutyrate into a 25 mL volumetric flask, add about 10 mL of water into the flask, and stir to dissolve. To this solution was added about 0.05 g of sodium benzoate and mixed well. The resulting mixture was made up to 25 mL with water.

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Abstract

A process for preparing a stable aqueous dosage form of sodium 4-phenylbutyrate, including such dosage forms in a highly concentrated solution, as well as methods for making 4-phenylbutyrate and 4-phenylbutyric acid, and for using 4-phenylbutyrate. The stable aqueous dosage forms do not freeze at 0 DEG C.

Description

technical field [0001] The invention relates to a method for preparing highly concentrated sodium 4-phenylbutyrate solution in an aqueous medium, which is used to replace the current high-dose treatment means for treating urea cycle disorder, sickle cell anemia and cancer. Background technique [0002] Sodium 4-phenylbutyrate is currently used to treat urea cycle disorders in children. The drug is marketed in the United States under the trademark BUPHENYL (Ucyclyd Pharma, Inc., Glen Burnie, MD) and in Europe under the trademark AMMONAPS (Orphan Europe). The urea cycle is the metabolic process by which nitrogen is excreted from the body. There are 6 enzymes involved in this process. A defect in either enzyme disrupts this metabolic process, resulting in excess nitrogen (in the form of ammonia) being retained in the body. The 6 kinds of urea cycle disorders are: carbamoyl phosphate synthase deficiency disease; N-acetylglutamate synthase deficiency disease; ornithine carbamo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192
CPCA61K31/192A61K9/0095A61P35/00A61P7/00A61P7/06
Inventor C·N·乔布德维拉坎R·J·J·穆蒂亚
Owner NAVINTA
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