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Capecitabine tablet

A capecitabine and tablet technology, which is applied in the field of medicine, can solve the problems of extended tablet disintegration time, difficulty in direct tablet compression, and poor fluidity of capecitabine, and achieve the effect of fast dissolution and simple process

Active Publication Date: 2015-05-27
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem that plagues the inventors is: direct compression, although it will shorten the disintegration time of the tablet, is difficult to achieve due to the poor fluidity of capecitabine, and the raw materials need to be processed to solve their fluidity and compressibility Problem: Wet granulation requires adding a large amount of disintegrant to ensure rapid disintegration of the drug, and placing it in a humid environment will prolong the disintegration time of the tablet

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]

[0035] Preparation Process

[0036] (1) Pass capecitabine through a 120-mesh sieve, mix evenly with the prescribed amount of carboxymethyl starch sodium, then add an appropriate amount of ethanol, granulate, granulate through a 16-mesh sieve, dry at 40°C, and set aside;

[0037] (2) The dried granules are added to the fluidized bed, coated with 80% ethanol (V / V) solution of cellulose acetate containing povidone and instant sorbitol, the coating temperature is 38°C, and the air inlet temperature is 42°C, spray speed 20ml / min;

[0038] (3) Mix the coated granules evenly with lactose, crospovidone and magnesium stearate, and compress into tablets.

Embodiment 2

[0040]

[0041]

[0042] Preparation Process

[0043] (1) Pass the capecitabine through a 120-mesh sieve, mix evenly with the prescribed amount of crospovidone, then add an appropriate amount of ethanol, granulate, granulate through a 18-mesh sieve, dry at 45°C, and set aside;

[0044] (2) The dried granules are added to the fluidized bed, coated with 85% ethanol (V / V) solution of cellulose acetate containing povidone and instant sorbitol, the coating temperature is 40°C, and the air inlet temperature is 45°C, spray speed 25ml / min;

[0045] (3) Mix the coated granules with microcrystalline cellulose, crospovidone and magnesium stearate evenly, and compress into tablets.

Embodiment 3

[0047]

[0048] Preparation Process

[0049] (1) Pass the capecitabine through a 120-mesh sieve, mix evenly with the prescribed amount of crospovidone, then add an appropriate amount of ethanol, granulate, granulate through a 16-mesh sieve, dry at 40°C, and set aside;

[0050] (2) The dried granules are added to the fluidized bed, coated with 80% ethanol (V / V) solution of cellulose acetate containing povidone and instant sorbitol, the coating temperature is 38°C, and the air inlet temperature is 42°C, spray speed 20ml / min;

[0051] (3) Mix the coated granules evenly with lactose, crospovidone and magnesium stearate, and compress into tablets.

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Abstract

The invention discloses a capecitabine tablet. The capecitabine tablet is prepared by the following steps: after mixing and pelletizing the capecitabine and a disintegrating agent, coating and pressing with the disintegrating agent, the filler and the lubricant, wherein material for coating comprises povidone, instant sorbitol and cellulose acetate, and the medicine can be dissolved out due to the bad osmotic pressure of the tablet, so that the excellent technical effect can be obtained. Compared with the prior art, the tablet is rapid in dissolving speed and free of humidity influence, and simple in process and suitable for mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a capecitabine tablet. Background technique [0002] Capecitabine is the first oral fluoropyrimidine carbamate antineoplastic drug on the market, and it is a new targeted drug for the treatment of breast cancer and colorectal cancer. The drug was developed by Roche with the product name "Xeloda". It was approved for marketing in the United States in April 1998, and was subsequently launched in Switzerland and other countries. In November 1999, it began to conduct clinical trials for registration in China. The clinical trials were conducted by five national anti-tumor drug clinical trial research centers in Beijing, Shanghai, Guangzhou and other places, and it was listed under the trade name "Xeloda". [0003] The physical and chemical properties of capecitabine are white or off-white powder. Melting point: 110-121°C. Capecitabine is easily soluble in methanol, soluble in etha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/7068A61K47/38A61K47/32A61K47/10A61P35/00
Inventor 张贵民郭增光朱姚亮
Owner SHANDONG NEWTIME PHARMA
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