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Title:
GLYCEROL PHENYLBUTYRATE GRANULES AND PREPARATION METHOD THEREFOR AND APPLICATION THEREOF
Document Type and Number:
WIPO Patent Application WO/2023/000350
Kind Code:
A1
Abstract:
Glycerol phenylbutyrate granules, comprising the following components in percentage by mass: 5%-15% of glycerol phenylbutyrate, 5%-45% of a solid carrier, 40%-80% of a filler, 1%-5% of an adhesive, 0.5%-3% of a disintegrating agent, 0.1%-1% of a lubricant, and 0.01%-0.5% of a flavoring agent. The present invention further provides a preparation method for the glycerol phenylbutyrate granules and an application of the glycerol phenylbutyrate granules in the preparation of a drug for treating an urea cycle disorder. By screening the type and proportion of the solid carrier and a combination mode of the solid carrier and the glycerol phenylbutyrate, the glycerol phenylbutyrate can be uniformly adsorbed onto the solid carrier, and then granulated together with conventional adjuvants to obtain the granules. The granules have the characteristics of being convenient in carrying, good in stability, high in compliance, capable of mitigating stomach discomfort, etc.

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Inventors:
DAI XIANGRONG (CN)
LI LINGZHI (CN)
LI XIAOYI (CN)
YIN LEI (CN)
Application Number:
PCT/CN2021/108380
Publication Date:
January 26, 2023
Filing Date:
July 26, 2021
Export Citation:
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Assignee:
ZHAOKE PHARMACEUTICAL GUANGZHOU CO LTD (CN)
International Classes:
A61K9/16; A61K31/216; A61K47/10; A61K47/26; A61K47/69; A61P3/00; A61P43/00
Foreign References:
CN105764497A2016-07-13
CN1758901A2006-04-12
US20170348269A12017-12-07
US20190076386A12019-03-14
CN102448460A2012-05-09
Other References:
YANG ZHEN-ZHENG: "Glycerylphenylbutyrate, a drug used in the treatment of urea cycle disorders", PROGRESS IN PHARMACEUTICAL SCIENCES, vol. 37, no. 2, 25 February 2013 (2013-02-25), pages 96 - 97, XP093027132
Attorney, Agent or Firm:
BEIJING EASTKING PATENT AGENT FIRM (CN)
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