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Finasteride dispersible tablet and preparation method thereof

A technology of finasteride and dispersible tablets, applied in the preparation of finasteride dispersible tablets, in the field of finasteride dispersible tablets, can solve the problems of difficult product quality control, influence on treatment effect, incomplete dissolution, etc. Convenience, improved compliance, high dissolution effect

Active Publication Date: 2014-06-18
广东罗特制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Finasteride is almost insoluble in water, and its ordinary tablets have problems such as low dissolution rate and incomplete dissolution
Prescriptions from different units, or products from different batches of the same prescription, all have large dissolution differences, making it difficult to control product quality, thus affecting the therapeutic effect

Method used

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  • Finasteride dispersible tablet and preparation method thereof
  • Finasteride dispersible tablet and preparation method thereof
  • Finasteride dispersible tablet and preparation method thereof

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preparation example Construction

[0021] Adding glidants in the preparation method of dispersible tablets can not only improve the fluidity of powders and granules, but also its strong polarity and hydrophilicity are conducive to the penetration of water into tablets, and can significantly increase the dissolution rate of insoluble drugs. Glidants that can be used in the present invention include: micronized silica gel and silicon dioxide, etc. The content of the glidant in the dispersible tablet is preferably 7.5-22.5 parts by weight, more preferably 15.0 parts by weight.

[0022] The kind of disintegrant is very important to the disintegration of dispersible tablet, dissolution effect, and the disintegrating agent that generally requires selecting for use has a swelling degree greater than 5ml / g, and the disintegrating agent that can be used in the present invention includes: dry starch, carboxymethyl starch sodium, Low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, cross-linked sodi...

preparation example 1-3

[0061] Finasteride dispersible tablets having the following composition were prepared:

[0062] Ingredients name 1000 tablets dosage

[0063] Finasteride 5.0g

[0064] Mannitol 119.2g

[0065] Microcrystalline Cellulose 36.0g

[0066] Silica 15.0g

[0067] Croscarmellose Sodium 48.0g

[0068] Tween-80 2.4 g

[0069] Sodium starch glycolate 12.0g

[0070] Magnesium Stearate 2.4g

[0071] The preparation method comprises the following steps:

[0072] (i) Weighing finasteride, silicon dioxide and Tween-80, mixing and micronizing, the particle size of the obtained micronized mixture is below 5 μm;

[0073] (ii) Weigh mannitol, microcrystalline cellulose, croscarmellose sodium and the above-mentioned micronized mixture, mix thoroughly, add 40ml of 70% ethanol to moisten the soft material, granulate with a 20-mesh sieve, and dry ( <60°C), granulate with 18 mesh sieve, add sodium carboxymethyl starch and magnesium stearate, blend, compress into tablets, pack to obtain the pr...

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Abstract

The invention relates to a preparation method of a finasteride dispersible tablet. The method comprises the following steps: (i), mixing finasteride, a flow aid and a surfactant to carry out micronization to form a micronized mixture; (ii), uniformly mixing the micronized mixture with a filler and an internally added disintegrating agent, adding a wetting agent for wetting, then, carrying out pelletizing, drying and straightening, adding an externally added disintegrating agent and a lubricating agent for uniformly mixing again, and finally tabletting to prepare the finasteride dispersible tablet. The preparation method is characterized in that in step (i), the grain size of the micronized mixture is less than 5 mu m. The invention further relates to a finasteride dispersible tablet obtained by the preparation method. The preparation process of the finasteride dispersible tablet disclosed by the invention is simple and stable; the obtained finasteride dispersible tablet is good in stability, high in dissolution rate, high in bioavailability and convenient to take, improves medicine-taking compliance of a patient, and is especially suitable for the old, the crowd with difficulty in taking medicine as well as the crowd who travel and are on a business strip.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a method for preparing finasteride dispersible tablets and finasteride dispersible tablets prepared by the method. Background technique [0002] With the acceleration of population aging, the health of the elderly has increasingly become the focus of attention from all walks of life. BPH is a typical senile disease, most common in men over 50 years old. About 50% of men aged 51 to 60 have pathological changes of benign prostatic hyperplasia, and it reaches 90% when they are 90 years old. Many benign prostatic hyperplasias cause urethral obstruction and gradual loss of bladder function. Most of them are clinically manifested as changes in urination, such as Frequent urination, urgency, weak urination, dribbling, hematuria and urinary retention seriously affect the health and quality of life of the elderly. [0003] Finasteride is a 4-aza steroid compound with the structural formula: ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/58A61K47/38A61P13/08A61P13/02
Inventor 罗楚波
Owner 广东罗特制药有限公司
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