Dasatinib pharmaceutical composition and preparation method thereof

Abstract

The invention relates to a dasatinib pharmaceutical composition which comprises dasatinib and pharmaceutical auxiliary materials, wherein the auxiliary materials comprise pregelatinized starch and bonding agent. The dasatinib pharmaceutical composition comprises the following concrete components in percentage by weight: 1-20% of dasatinib, 20-35% of pregelatinized starch and 60-79% of bonding agent, wherein the bonding agent is selected from one or mixture of microcrystalline cellulose, hydroxypropyl cellulose sodium, hydroxymethyl cellulose sodium and hydroxypropyl cellulose. The preparation method of the dasatinib pharmaceutical composition comprises the following steps: weighing the dasatinib, pregelatinized starch and bonding agent according to component proportions; sieving the dasatinib by a sieve with 100 meshes, sieving the pregelatinized starch and bonding agent by a sieve with 80 meshes, and uniformly mixing the dasatinib and the sieved auxiliary materials to obtain powder; and directly pressing the powder to obtain the dasatinib pharmaceutical composition. Because the pregelatinized starch is adopted, the product quality and product stability are greatly improved. The dasatinib pharmaceutical composition is a new preparation which has the advantages of better liquidity, higher stability and low hygroscopicity and is suitable for clinical pharmaceutical applications.

Description

technical field [0001] The invention relates to a pharmaceutical composition of dasatinib, in particular to a pharmaceutical composition of dasatinib using pregelatinized starch as a filler and a preparation method thereof. Background technique [0002] Dasatinib was developed by Bristol-Myers Squibb in the United States and was first launched in the United States in 2006. It is suitable for chronic myeloid leukemia (CML) in various stages and is the first-line drug for chronic myeloid leukemia. The drug is currently approved in most countries around the world. The curative effect is longer lasting and the safety is higher. [0003] Dasatinib currently on the market, the main excipient is lactose monohydrate, lactose is one of the most commonly used fillers in solid formulations, and the produced tablets have high mechanical strength. However, recent concerns have limited its use, such as bovine spongiform encephalopathy (mad cow disease), variant Creutzfeldt-Jakob disease...

AI Technical Summary

Problems solved by technology

[0005] As far as the current literature is concerned, there is no report on the pharmaceutical composition and preparation method of dasatinib using pregelatinized starch as a filler with higher stability and more suitable for clinical medicine.

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