Title:
HIGH-STABILITY ALFACALCIDOL LIQUID ORAL FORMULATION AND PREPARATION METHOD THEREFOR
Document Type and Number:
WIPO Patent Application WO/2024/066734
Kind Code:
A1
Abstract:
The present invention relates to a high-stability alfacalcidol liquid oral formulation and a preparation method therefor. Each 100 mL of the liquid oral formulation comprises the following raw materials by weight: less than or equal to 0.002 g of alfacalcidol, 8-15 g of ethanol, 1-3.5 g of polyoxyethylene hydrogenated castor oil, 0.001-0.0025 g of DL-α-tocopherol, 0.1-0.2 g of a bacteriostatic agent, 35-45 g of sorbitol, 0.01-0.05 g of citric acid or a sodium salt thereof, and the balance of purified water. The pH value of the liquid oral formulation is 6.0-7.5. The pH value of the alfacalcidol liquid oral formulation of the present invention is neutral. The purity of the medicament is still higher than 97 wt% after 18 months of stable storage. The alfacalcidol liquid oral formulation has good stability and can be stably stored for 18 months.
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Inventors:
LI YONGJIN (CN)
CHEN YANDE (CN)
CHEN YANDE (CN)
Application Number:
PCT/CN2023/110923
Publication Date:
April 04, 2024
Filing Date:
August 03, 2023
Export Citation:
Assignee:
HUBEI XINZEFEI PHARMACEUTICAL CO LTD (CN)
International Classes:
A61K9/08; A61K31/593; A61K47/12; A61K47/22; A61K47/26; A61K47/44; A61P19/10
Domestic Patent References:
| WO2007036802A2 | 2007-04-05 |
Foreign References:
| CN102770143A | 2012-11-07 | |||
| CN104800156A | 2015-07-29 | |||
| CN115350151A | 2022-11-18 | |||
| CN1382036A | 2002-11-27 | |||
| CN1846671A | 2006-10-18 | |||
| US20050026877A1 | 2005-02-03 |
Attorney, Agent or Firm:
WUHAN KEHAO INTELLECTUAL PROPERTY ATTORNEYS (SPECIAL GENERAL PARTNERSHIP) (CN)
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