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Method for preparing bromocriptine mesylate tablets by virtue of novel production process and application of method

A technology of bromocriptine mesylate tablets and bromocriptine mesylate, which can be used in metabolic diseases, antineoplastic drugs, endocrine system diseases, etc., can solve the problems of degradation and increase in impurities, high production costs, and relatively different tablet contents. Large and other problems, to achieve the effect of small content difference, improved stability, and reduced impurities

Inactive Publication Date: 2016-06-08
RICHTER GEDEON VEGYESZETI GYAR RT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] Although various solubilization technologies have been widely used in insoluble drugs, most of them involve high production costs, advanced equipment, complex processes, restrictions on intellectual property rights, cumbersome design ideas, and insoluble raw materials. Unfavorable factors such as degradation and impurity increase in the process of drug micronization, large content differences between tablets of the same batch of small-sized drugs, etc.

Method used

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  • Method for preparing bromocriptine mesylate tablets by virtue of novel production process and application of method
  • Method for preparing bromocriptine mesylate tablets by virtue of novel production process and application of method
  • Method for preparing bromocriptine mesylate tablets by virtue of novel production process and application of method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] prescription:

[0050]

[0051] Preparation method: Dissolve bromocriptine mesylate in 96% ethanol at room temperature to make a solution. The active ingredient solution is sprayed onto the homogenized and preheated powder mixture (mixture made by mixing lactose, corn starch and croscarmellose sodium), and the organic solvent ethanol is removed by drying. The powder mixture containing the active ingredient bromocriptine mesylate is granulated using a binder solution (made with cornstarch and purified water). Add glidants colloidal silicon dioxide and talc to the granules, then sieve the mixed granules, add magnesium stearate, lubricate the sieved granules, and compress into tablets. A tablet with a product specification of 2.5 mg was obtained.

Embodiment 2

[0053] prescription:

[0054]

[0055] Preparation method: Dissolve bromocriptine mesylate in 96% ethanol at room temperature to make a solution. The active ingredient solution is sprayed onto the homogenized and preheated powder mixture (mixture made by mixing lactose, corn starch and croscarmellose sodium), and the organic solvent ethanol is removed by drying. The powder mixture containing the active ingredient bromocriptine mesylate is granulated using a binder solution (made with cornstarch and purified water). Add glidants colloidal silicon dioxide and talc to the granules, then sieve the mixed granules, add magnesium stearate, lubricate the sieved granules, and compress into tablets. A tablet with a product specification of 0.8 mg was obtained.

Embodiment 3

[0057] prescription:

[0058]

[0059] Preparation method: Dissolve bromocriptine mesylate in 96% ethanol at room temperature to make a solution. The active ingredient solution is sprayed onto the homogenized and preheated powder mixture (mixture made by mixing lactose, corn starch and croscarmellose sodium), and the organic solvent ethanol is removed by drying. The powder mixture containing the active ingredient bromocriptine mesylate is granulated using a binder solution (made with cornstarch and purified water). Add glidants colloidal silicon dioxide and talc to the granules, then sieve the mixed granules, add magnesium stearate, lubricate the sieved granules, and compress into tablets. A tablet with a product specification of 2.5 mg was obtained.

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Abstract

The invention discloses a method for preparing an insoluble drug, namely bromocriptine mesylate tablet, by virtue of a liquid-solid compression technique by taking 96% of ethanol as a solvent as well as application of the method. The bromocriptine mesylate tablet, which is prepared in accordance with the technical scheme of the invention, can significantly enhance the solubility of the insoluble drug and improve the bioavailability thereof; the degradation of bromocriptine mesylate, which serves as an active ingredient, is relieved, the content of impurities is reduced and stability is greatly improved; the bromocriptine mesylate tablet is significant better than commercial bromocriptine mesylate tablets in in-vitro dissolution rate; and content difference among tablets of a same batch is reduced. Therefore, the method disclosed by the invention can overcome shortcomings of the prior part; and the method, as a novel industrial production method for preparing the bromocriptine mesylate tablets, can have a better application prospect in clinical field.

Description

technical field [0001] The invention relates to a method for preparing oral insoluble pharmaceutical preparations by utilizing liquid-solid compression technology. More specifically, the present invention relates to a new liquid-solid compression technology, using a conventional tablet machine to directly compress tablets or using a conventional capsule filling machine to fill capsules, which can significantly increase the solubility of insoluble drugs and improve their biological properties. Utilization, while addressing the content uniformity of low-dose drugs. Especially suitable for preparing bromocriptine mesylate tablets. Background technique [0002] For Class II drugs of the Biopharmaceutics Classification System (BCS), due to the high permeability and poor solubility of the drug, the drug dissolves slowly in the body, and the blood drug concentration is difficult to reach the effective concentration for treatment. Dissolution becomes the rate-limiting step of absor...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/48A61P5/00A61P15/08A61P35/00A61P15/14A61P25/00A61P3/10A61P15/00
Inventor G·维克托尔P·F·A·范鲁克I·巴罗格K·科曼迪L·内梅斯Z·萨伯
Owner RICHTER GEDEON VEGYESZETI GYAR RT
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