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Imatinib mesylate orally disintegrating tablets and preparation method thereof

A technology of imatinib mesylate and orally disintegrating tablets, applied in the preparation of imatinib mesylate orally disintegrating tablets, in the field of imatinib mesylate orally disintegrating tablets, to achieve good taste, Effect of rapid disintegration and shortened dissolution time

Inactive Publication Date: 2009-04-08
BEIJING TRADE STAR MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current clinical dosage forms of imatinib mainly include tablets and capsules, which need to be swallowed by patients with water, which is inconvenient for children, the elderly and patients who cannot swallow solid medicines

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Imatinib mesylate 50g (calculated as imatinib)

[0046] Mannitol 88g

[0047] Low-substituted hydroxypropyl cellulose 18g

[0048] Microcrystalline Cellulose 72g

[0049] Aspartame 3g

[0050] Magnesium Stearate 3g

[0051] Appropriate amount of water

[0052] Concrete preparation method is as follows:

[0053]Weigh imatinib mesylate, mannitol, and aspartame that have passed through a 100-mesh sieve, mix them evenly, add appropriate amount of water to granulate, and add excipients low-substituted hydroxypropyl cellulose and microcrystalline cellulose according to the prescription Mix evenly with dry granules, add magnesium stearate after the semi-finished product passes the inspection, mix evenly, and press into tablets to make 1000 tablets.

Embodiment 2

[0055] Imatinib mesylate 50g (calculated as imatinib)

[0056] Erythrose 125g

[0057] Low-substituted hydroxypropyl cellulose 32g

[0058] Microcrystalline Cellulose 96g

[0059] Aspartame 4g

[0060] Menthol 1g

[0061] Magnesium Stearate 4g

[0062] 50% ethanol solution appropriate amount

[0063] Concrete preparation method is as follows:

[0064] Weigh imatinib mesylate, erythrose, aspartame, and menthol that have passed through a 100-mesh sieve, mix well, add an appropriate amount of 50% ethanol solution to granulate, and weigh the additional excipients low-substituted hydroxypropyl Mix cellulose, microcrystalline cellulose and dry granules evenly, add magnesium stearate after the semi-finished product passes the inspection, mix evenly, and press into tablets to make 1000 tablets.

Embodiment 3

[0066] Imatinib mesylate 100g (calculated as imatinib)

[0067] Erythrose 125g

[0068] Crospovidone 40g

[0069] Microcrystalline Cellulose 80g

[0070] Citric acid 8g

[0071] Sodium bicarbonate 4g

[0072] Magnesium Stearate 4g

[0073] 50% ethanol solution appropriate amount

[0074] Concrete preparation method is as follows:

[0075] Weigh imatinib mesylate and erythrose that have passed through a 100-mesh sieve, mix evenly, add an appropriate amount of 50% ethanol solution to granulate, and weigh the additional auxiliary materials crospovidone, microcrystalline cellulose, and citric acid according to the prescription and sodium bicarbonate and dry granules are mixed evenly, after the semi-finished product is qualified, magnesium stearate is added, after mixing, it is pressed into tablets to make 1000 tablets, to get final product.

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PUM

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Abstract

The invention relates to the technical field of pharmaceutical preparation, in particular to an orally disintegrating tablet containing imatinib mesylate and a method for preparing the same, wherein the orally disintegrating tablet comprises effective amount of the imatinib mesylate and a pharmaceutic adjuvant which is acceptable in pharmacy and can rapidly collapse and release drugs in an oral cavity. The orally disintegrating tablet containing the imatinib mesylate has the advantages of faster action speed compared with the prior tablets and capsulated drugs, has convenient use and good taste in taking, and is more suitable for children, the elderly, and patients who can not swallow solid medicines.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing imatinib mesylate, more specifically, the invention relates to an orally disintegrating imatinib mesylate tablet. The present invention also relates to a preparation method of the imatinib mesylate orally disintegrating tablet. Background technique [0002] Imatinib Mesylate is a derivative of aniline, and is a specific tyrosine kinase inhibitor (tyrosine kinases inhibitors, TKI) developed by Swiss Novartis. On May 10, 2001, imatinib oral capsule preparation entered the US FDA’s express approval channel with a breakthrough anti-tumor mechanism, and it is used for the treatment of α-interferon-failed embryonic crisis, chronic disease and accelerated disease. Drugs for the treatment of myeloid leukemia. [0003] After extensive clinical verification, imatinib has been highly appraised by the global medical community. On February 1, 2002, the FDA approved its second indication—a drug for t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/506A61P35/00
Inventor 潘成玉张耀春司成桃
Owner BEIJING TRADE STAR MEDICAL TECH
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