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Capecitabine dispersible tablet and preparation method thereof

A technology of capecitabine and dispersible tablets, which is applied in the direction of non-active ingredient medical preparations, active ingredient-containing medical preparations, and pharmaceutical formulas, and can solve the problems that the stability and dissolution rate are difficult to meet the requirements of the Pharmacopoeia. Achieve good application prospects, enhance bioavailability, and simple production process

Active Publication Date: 2013-03-27
哈药集团股份有限公司 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0012] But in the process of preparing dispersible tablets, the inventors found that the results obtained using different formulations and different process conditions vary widely, especially in terms of stability and dissolution rate, it is difficult to reach the requirements of the Pharmacopoeia. The formula and process were screened, and finally a highly efficient and stable dispersible tablet formula and preparation method were obtained

Method used

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  • Capecitabine dispersible tablet and preparation method thereof
  • Capecitabine dispersible tablet and preparation method thereof
  • Capecitabine dispersible tablet and preparation method thereof

Examples

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Embodiment 1

[0066] Add 75% capecitabine to a 120-mesh sieve, microcrystalline cellulose 10% (w / w), and croscarmellose sodium 15% (w / w) into a three-dimensional motion mixer and mix thoroughly Uniformly; put the uniformly mixed material into a high-efficiency wet granulator, and set aside; add 5% polyvinylpyrrolidone K30 soft material, pass through a 20-mesh sieve, dry at 50°C, dry for 6 hours, granulate, and mix Uniform, ready to be pressed into tablets.

Embodiment 2

[0068] Add 80% capecitabine to a 120-mesh sieve, microcrystalline cellulose 7.5% (w / w), and croscarmellose sodium 7.5% (w / w) into a three-dimensional motion mixer and mix thoroughly Uniformly; put the uniformly mixed material into a high-efficiency wet granulator, and set aside; add 5% polyvinylpyrrolidone K30 soft material, pass through a 20-mesh sieve, dry at 50°C, dry for 6 hours, granulate, and mix Uniform, ready to be pressed into tablets.

Embodiment 3

[0070] Add capecitabine 75%, microcrystalline cellulose 15% (w / w), and croscarmellose sodium 7.5% (w / w) into a three-dimensional motion mixer, and mix well; Put the material into a high-efficiency wet granulator, and set it aside; add 2.5% polyvinylpyrrolidone K30 soft material, pass through a 20-mesh sieve, dry, granulate, mix evenly, and tablet.

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Abstract

The invention discloses a capacitabine dispersible tablet and a preparation method thereof. The formula of the dispersible tablet is as follows: the proportion of a main drug of capacitabine ranges from 70%-80%; the proportion of an adhesive of polyvinylpyrrolidone K30 ranges from 3%-7%; the proportion of a disintegrating agent of cross-linked sodium carboxymethyl cellulose ranges from 3%-7%; and the proportion of a filling agent of microcrystalline cellulose ranges from 10%-20%.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a safe and stable capecitabine dispersible tablet and a preparation method thereof. Background technique [0002] Capecitabine (English name Capecitabine) is the first oral fluoropyrimidine carbamate antineoplastic drug, and its chemical name is 5′-deoxy-5-fluoro-N[(pentyloxy)carbonyl]-cell ( pyrimidine nucleosides. Chemical Structure: [0003] [0004] Capecitabine is suitable for single-drug adjuvant therapy for colon cancer patients with Dukes' C stage, after radical resection of the primary tumor, who are suitable for fluoropyrimidine therapy alone. The disease-free survival (DFS) of its treatment is not inferior to that of 5-fluorouracil and leucovorin (5-FU / LV). Neither capecitabine alone nor in combination with other drugs can prolong overall survival (OS), but experimental data have shown that capecitabine in combination chemotherapy can improve disease-fr...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7068A61K47/38A61P35/00
Inventor 袁淑杰王丽娜苏宏健王忠李郑武崔琳马赛高晶宋紫玉
Owner 哈药集团股份有限公司
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