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Capecitabine tablet composition and preparation method thereof

A technology of capecitabine and its composition, which is applied in the field of capecitabine tablet composition and its preparation, can solve the problems that it is not suitable for making dispersible tablets, and achieve the effects of qualified quality, reduced production process, and good feasibility

Active Publication Date: 2015-10-28
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although dispersible tablets have the characteristics of convenient administration, rapid disintegration, and fast absorption, it is well known that drugs usually made into dispersible tablets should be poorly soluble drugs, and capecitabine is not suitable for making dispersible tablets because of its good solubility.

Method used

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  • Capecitabine tablet composition and preparation method thereof
  • Capecitabine tablet composition and preparation method thereof
  • Capecitabine tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Preparation Process:

[0033] (1) Ingredients: Weigh the prescribed amount of capecitabine, lactose, microcrystalline cellulose, and croscarmellose sodium, pass the capecitabine raw materials through an 80 mesh screen, and weigh the prescribed amount of hydroxypropyl Methyl cellulose, prepared into a 2.5% (w / w) aqueous solution for use;

[0034] (2) Pre-mixing: mix the capecitabine, lactose, microcrystalline cellulose weighed in step (1) and 3 / 4 prescription amount of croscarmellose sodium;

[0035] (3) Granulation: Put the mixed material in a wet granulator, stir for 3~5min, add 2.5% (w / w) hypromellose aqueous solution to the material to make wet granules after the stirring is complete, and the slurry is completed After that, turn on the shearing knife, stir and cut, and use a granulator to wet granulate;

[0036] (4) Drying: Put the wet particles into the drying equipment, the inlet air temperature is not higher than 80℃, and the moisture content is controlled to be less tha...

Embodiment 2

[0042] Preparation process: same as the preparation process of Example 1, the hardness of the tablet is controlled within 50-70N, and the disintegration time limit is less than 7 minutes.

Embodiment 3

[0044] Preparation process: same as the preparation process of Example 1, the hardness of the tablet is controlled within 60-80N, and the disintegration time limit is less than 13 minutes.

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Abstract

The invention provides a new capecitabine tablet composition and a preparation method of a capecitabine table which realizes controllable quality and guarantees product stability. By adopting a wet granulation tabletting technology, the particle has good compression formability, the particle size is uniform, the fluidity is good, and the wear resistance is stronger; the preparation technology has better feasibility, does not need to perform superfine grinding treatment on raw materials, improves the yield of the raw materials and reduces the production processes; and moreover, a small quantity of accessories are used in a prescription, thus the production cost is effectively reduced.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a capecitabine tablet composition and a preparation method thereof. Background technique [0002] Capecitabine, chemical name: 5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine, molecular formula: C 15 H 22 O 6 N 3 F, molecular weight is 359.35, chemical structure formula is: [0003] [0004] Capecitabine is a new type of 5-fluoropyrimidine prodrug developed by Roche, Switzerland. It is the first oral fluoropyrimidine carbamate anti-tumor drug that has been marketed for the treatment of breast cancer and colorectal cancer. Of new targeted drugs. It can be selectively activated in tumor tissues to produce high concentrations of active cytotoxic substances, thereby improving the tolerance of tumor patients and maximizing anti-cancer activity. [0005] Chinese patent application number 200780036204.9 discloses a capecitabine pediatric tablet, and Chinese patent applic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K31/7068A61P35/00
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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