Formulation of deoxycholic acid and its salts

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专利权人:

キテラ;バイオファーマシューティカルズ，インコーポレイテッド

发明人:

ホッジ，ロバート エミル,ウェブスター，ジェフリー ダグラス,モリアーティ，ロバート エム．

申请号：

JP2018112471

公开号：

JP6594486B2

申请日:

2018.06.13

申请国别(地区):

JP

年份:

2019

代理人:

摘要：

PROBLEM TO BE SOLVED: To provide a method of inhibiting precipitation of a salt of deoxycholic acid in an aqueous pharmaceutical composition.SOLUTION: There is provided a method of maintaining the pH in the range from 8.1 to 8.5 in an aqueous pharmaceutical composition comprising an aqueous solution that comprises 0.4% w/v to less than 2% w/v of a salt of deoxycholic acid and at least one pharmaceutically acceptable excipient. Preferably, the method includes an aqueous solution that comprises 0.5% w/v of a salt of deoxycholic acid, 0.9% w/v of benzyl alcohol, and 1% w/v of sodium chloride. Preferably, the salt of deoxycholic acid is a sodium salt.SELECTED DRAWING: None

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