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Dabrafenib mesylate sustained-release tablet and preparation method thereof

A technology of dabrafenib mesylate sustained-release tablets and methanesulfonic acid, which is applied in the fields of pharmaceutical formulation, coating, pill delivery, etc., can solve the problems of endangering the health of patients, forgetting to take the medicine frequently, and cumbersome taking, etc. Achieve good stability, reduce peak and valley phenomena, and reduce the number of times of taking

Inactive Publication Date: 2017-03-29
JIAMUSI UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing preparations with dabrafenib mesylate as the main component are mainly capsules. Although dabrafenib mesylate capsules can be administered orally by themselves, they need to be taken at least twice a day, which is cumbersome to take and may There are situations such as forgetting to take and missing doses due to taking too many medicines, which seriously endanger the health of patients

Method used

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  • Dabrafenib mesylate sustained-release tablet and preparation method thereof
  • Dabrafenib mesylate sustained-release tablet and preparation method thereof
  • Dabrafenib mesylate sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A kind of dabrafenib mesylate sustained-release tablet, prepared according to the following steps:

[0028] Chip composition:

[0029]

[0030]

[0031] Coating composition:

[0032]

[0033] Preparation process:

[0034] (1) Take dabrafenib mesylate, hypromellose, lactose, sodium alginate, pregelatinized starch, and microcrystalline cellulose in the prescribed amount and mix them into fine powder (all pass through a No. 5 sieve and The amount of the No. 6 sieve that can pass must not be less than 95% of the total amount), sieved;

[0035] (2) Add the prescribed amount of ethanol solution to the above mixed powder, mix and granulate (extrude and granulate through a 24-mesh sieve), put the prepared wet granules in a hot air oven, set the temperature at 40-60°C, and dry When the moisture content of the granules is ≤3%, the whole granules (through a 18-mesh sieve) are set aside;

[0036] (3) the magnesium stearate of recipe quantity is pulverized and crossed 1...

Embodiment 2

[0075] A kind of dabrafenib mesylate sustained-release tablet, prepared according to the following steps:

[0076] Chip composition:

[0077]

[0078] Coating composition:

[0079]

[0080] Preparation process: prepared according to the preparation process of Example 1.

[0081] (1) Determination of release rate

[0082] Measure according to embodiment 1 release degree measuring method, the measurement result of its release degree is shown in Table 2, figure 2 (done six samples to measure).

[0083] Table 2 Sustained-release tablet sample release rate (%) of the present invention

[0084]

[0085]

[0086] test results:

[0087] Appearance: Film-coated tablet with smooth surface.

[0088] Release: Dabrafenib Mesylate Sustained-release Tablets The main drug, Dabrafenib Mesylate, is released slowly, which can meet the requirements of sustained-release tablets.

[0089] (2) A kind of dabrafenib mesylate sustained-release tablet stability experiment of the pres...

Embodiment 3

[0110] A kind of dabrafenib mesylate sustained-release tablet, prepared according to the following steps:

[0111] Chip composition

[0112]

[0113]

[0114] Coating composition:

[0115]

[0116] Preparation process: prepared according to the preparation process of Example 1.

[0117] (1) Determination of release rate

[0118] Measure according to embodiment 1 release degree measuring method, the measurement result of its release degree is shown in Table 3, image 3 (done six samples to measure).

[0119] Table 3 Sustained-release tablet sample release rate (%) of the present invention

[0120]

[0121] test results:

[0122] Appearance: Film-coated tablet with smooth surface.

[0123] Release: Dabrafenib Mesylate Sustained-release Tablets The main drug, Dabrafenib Mesylate, is released slowly, which can meet the requirements of sustained-release tablets.

[0124] (2) A kind of dabrafenib mesylate sustained-release tablet stability experiment of the presen...

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Abstract

The invention relates to a dabrafenib mesylate sustained-release tablet, which is prepared from the following raw materials and auxiliary materials: 1 part of dabrafenib mesylate, 0.3 to 0.9 part of sustained-release framework materials, 0.05 to 0.11 parts of glidants, 1.1 to 3.1 parts of filling agents and 1 to 6 parts of binding agents. The dabrafenib mesylate sustained release tablet prepared according to the invention has the advantages that the main medicine of dabrafenib mesylate is slowly released; the release period reaches up to 12h, so that the taking times of a product of the dabrafenib mesylate sustained-release tablet can be fewer than the taking times of a conventional capsule; the main medicine of the product of the dabrafenib mesylate is slowly released, so that the stable and durable effective blood concentration is provided; the blood concentration peak valley phenomenon is avoided or reduced; the use safety of the medicine is favorably improved; meanwhile, the stability of a product is high; the shelf life is as long as 24 months; and the preparation method is simple and feasible, and is worthy of being popularized and applied in markets.

Description

technical field [0001] The invention mainly relates to the field of pharmaceutical technology, in particular to a sustained-release tablet whose main component is dabrafenib mesylate and a preparation method thereof. Background technique [0002] Cutaneous melanoma is the most aggressive form of all skin cancers. Although it accounts for only 4% of all cancers, its incidence continues to rise worldwide, outpacing all other cancers. Worldwide, approximately 132,000 people are expected to be diagnosed with melanoma each year, and approximately 37,000 people are expected to die from the disease each year. [0003] Tini drugs are a class of molecular targeted drugs developed in recent years and successfully applied clinically. These drugs are mainly used for non-small cell lung cancer, breast cancer, pancreatic cancer, kidney cancer, melanoma, chronic myeloid leukemia and other cancers. The treatment mainly inhibits tumor growth by specifically targeting and inhibiting the act...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/22A61K47/38A61K47/36A61K47/26A61K31/506A61P35/00
CPCA61K9/2866A61K9/0002A61K9/2018A61K9/2054A61K9/2059A61K31/506
Inventor 孙维彤吕佳书
Owner JIAMUSI UNIVERSITY
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