Imatinib mesylate chewable tablet and preparation method thereof

A technology of imatinib mesylate and chewable tablets is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc., to achieve the effects of simple production process, high bioavailability and sweet taste

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

[0048] Embodiment 1 Imatinib mesylate chewable tablet preparation

[0049] 1.1 Formulation

[0050] Imatinib Mesylate 50g

[0051] Lactose 300g

[0052] Cyclamate 50g

[0053] Aspartame 20g

[0054] Magnesium Stearate 20g

[0055] Fresh milk essence 100g

[0056] Ethanol 20g

[0057] Grape coloring 10g

[0058] A total of 1000 pieces were made

[0059] 1.2 To prepare the imatinib mesylate chewable tablet of the above prescription, follow the steps below:

[0060] 1.2.1 The raw and auxiliary materials are passed through a 100-mesh sieve;

[0061] 1.2.2 Mix imatinib mesylate, lactose, cyclamate, aspartame and grape pigment evenly, add ethanol to make a soft material, pass through a 20-mesh sieve to granulate, dry under vacuum at 50°C, and then Pass through a 20-mesh sieve for sizing.

[0062] 1.2.3 Add magnesium stearate and fresh creamer, mix well.

[0063] 1.2.4 Tablets.

Embodiment 2

[0064] Embodiment 2 Imatinib mesylate chewable tablet preparation

[0065] 2.1 Formulation

[0066] Imatinib Mesylate 100g

[0067] Dextrin 400g

[0068] Cyclamate 20g

[0069] Glycyrrhizin 30g

[0070] Micronized silica gel 18g

[0071] Green Apple Flavor 60g

[0072] 5% ethyl cellulose ethanol solution 20g

[0073] Jasmine coloring 5g

[0074] A total of 1000 pieces were made

[0075] 2.2 To prepare the imatinib mesylate chewable tablet of the above prescription, follow the steps below:

[0076] 2.2.1 The raw and auxiliary materials are passed through a 100-mesh sieve;

[0077] 2.2.2 Mix imatinib mesylate, dextrin, cyclamate, glycyrrhizin, and mascara pigment evenly, add 5% ethyl cellulose ethanol solution to make a soft material, pass through a 20-mesh sieve to granulate, Dry under vacuum at 40°C, then pass through a 20-mesh sieve for sizing.

[0078] 2.2.3 Add micronized silica gel and green apple essence, and mix well.

[0079] 2.2.4 Tabletting.

Embodiment 3

[0080] Embodiment 3 Imatinib mesylate chewable tablet preparation

[0081] 3.1 Formulation

[0082] Imatinib Mesylate 200g

[0083] Mannitol 600g

[0084] Erythritol 100g

[0085] Cyclamate 100g

[0086] Stearic acid 10g

[0087] Sweet Orange Flavor 100g

[0088] 5% polyvinylpyrrolidone ethanol solution 100g

[0089] Mastiff Yellow Pigment 60g

[0090] A total of 1000 pieces were made

[0091] 3.2 To prepare the imatinib mesylate chewable tablet of the above prescription, follow the steps below:

[0092] 3.2.1 The raw and auxiliary materials are passed through a 100-mesh sieve:

[0093] 3.2.2 Mix imatinib mesylate, mannitol, erythritol, and cyclamate evenly, add 5% polyvinylpyrrolidone ethanol solution to make a soft material, pass through a 20-mesh sieve to granulate, and granulate under vacuum at 55°C Dry, then pass through a 20-mesh sieve for sizing.

[0094] 3.2.3 Add stearic acid and sweet orange essence, and mix well.

[0095] 3.2.4 Compress the tablet and co...

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PUM

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Abstract

The invention relates to the technical field of pharmaceutical preparation, in particular to a chewable tablet containing imatinib mesylate and a method for preparing the same. The chewable tablet containing the imatinib mesylate consists of the principal imatinib mesylate, a filling agent, a flavour modifying agent, a glidant, an odor modifying agent, and an adhesive. The chewable tablet containing the imatinib mesylate can be applied to patients having difficulty in orally taking the common tablets, has good drug compliance, can be dissolved in saliva after chewing and being absorbed by oral or esophageal mucosa, and has high bioavailability. The chewable tablet not only has sweet taste and good mouthfeel, but also modifies penetrating odors and has flavor; the chewable tablet is convenient to take and carry around; and the chewable tablet is prepared by a direct tabletting method, and has good drug stability, simple production process, and low cost.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing imatinib mesylate, more specifically, the invention relates to a chewable tablet of imatinib mesylate. The present invention also relates to a preparation method of the imatinib mesylate chewable 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 the treatment of gastroin...

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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