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Imatinib mesylate pill and preparation method thereof

A technology of imatinib mesylate and imatinib mesylate, which is applied in the field of imatinib mesylate pills and its preparation, and can solve problems such as inconvenience for patients to take, large size, and difficulty in tablet disintegration

Inactive Publication Date: 2013-11-27
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] However, the inventors have found in practice that it is more difficult to disintegrate the tablet, and it takes a long time. This is due to the characteristics of imatinib mesylate tablets. Water will cause viscosity, and the specifications of imatinib mesylate tablets are relatively large, 100mg and 400mg respectively. After testing the weight of the original tablet, it is found that the proportion of the drug in the tablet is about 60%, such a high proportion It is difficult for the tablet to disintegrate due to the drug. In addition, because the tablet does not contain flavoring agents, and the drug has a bitter taste, it is inconvenient for patients to take it.

Method used

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  • Imatinib mesylate pill and preparation method thereof
  • Imatinib mesylate pill and preparation method thereof
  • Imatinib mesylate pill and preparation method thereof

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Effect test

Embodiment 1-2

[0037]

[0038] 1. Preparation process:

[0039] 2. Mix imatinib mesylate, lactose, crospovidone or croscarmellose sodium in a wet granulation pot,

[0040] 3. Dissolve and disperse povidone into 95% ethanol solution, add it to the granulation pot to prepare soft material,

[0041] 4. Extrude the soft material obtained in step "2" to obtain strips,

[0042] 5. Round the strips to get pills.

[0043] 6. Dry the balls,

[0044] 7. Sieve the dried balls to obtain balls within the required particle size range.

[0045] 8. The balls prepared in step "6" can be optionally coated with Opadry85G68918 stomach-soluble coating powder. Coating was performed using fluidized bed bottom spray coating.

[0046] 9. Pour the balls into the bag.

Embodiment 3～4

[0048]

[0049] Preparation Process:

[0050] 1. Mix imatinib mesylate, mannitol, lactose, and crospovidone,

[0051] 2. Pour the mixed material into a centrifugal spray granulator, spray 95% ethanol solution, and prepare pellets.

[0052] 3. Dry the balls obtained in step "2",

[0053] 4. Sieve the balls obtained in step "3" to obtain balls within the required particle size range.

[0054] 5. Fill the prepared balls into the bag.

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Abstract

The invention discloses an imatinib mesylate pill and a preparation method thereof. The imatinib is used for treating granulocytic leukemia and gastrointestinal stromal tumor. The medicine in capsules and tablets is only marketed at present, and no pill comes into the market, while for patients who have difficulties in swallowing, the pills have the obvious advantages compared with the capsules and tablets, and can improve medication compliance of patients.

Description

technical field [0001] The invention relates to an imatinib mesylate pill and a preparation method thereof. Background technique [0002] Imatinib mesylate, developed by Novartis, is the world's first approved inhibitor of tumorigenesis-related signal transduction. Its chemical name is: 4-[(4-methyl-1-piperazine)methyl]N-[4-methyl-3-[[4-(3-pyridine)-2-pyrimidine]amino]phenyl ]-aniline methanesulfonate. [0003] Molecular formula: C29H31N7O CH4SO3 [0004] Molecular weight: 589.7 [0005] The simplified structure is: [0006] [0007] WO2009 / 042803 discloses the technology of producing imatinib mesylate tablets by dry granulation process, and the ratio of its raw material drug is 23-29%. [0008] EP1762230B1 protects the process of producing coated tablets, mainly dry granulation process, and the API content is between 25-80%. [0009] CN200910142577.5 discloses a process of wet granulation with water to prepare tablets. [0010] In addition, from FDA, CFDA, EMEA an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K31/506A61J3/06A61P35/00
Inventor 彭俊清曹宇卢俊余慧顾喜燕杨专
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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