Finasteride sustained release tablets and preparation method thereof

A technology for finasteride and sustained-release tablets, applied in the field of finasteride sustained-release tablets and its preparation, can solve the problems of low drug bioavailability, slow disintegration speed, no sustained-release effect, etc., and achieve prolongation The effect of drug action time, promoting disintegration speed, and improving drug bioavailability

Active Publication Date: 2018-08-10
武汉百纳礼康生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The disintegration speed of the current conventional finasteride tablet is relatively slow, does not have a sustained release effect, and the bioavailability of the drug is low

Method used

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  • Finasteride sustained release tablets and preparation method thereof
  • Finasteride sustained release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] In this embodiment, a finasteride sustained-release tablet is prepared from the following raw materials: phosphatidylcholine 120g, glyceryl dioleate 60g, ethanol 55g, finasteride 4g, micropowder silica gel 30g, chitosan 40g , 40 g of polyvinylpyrrolidone, 6 g of low-substituted hydroxypropyl cellulose, 2 g of magnesium stearate, and 0.5 g of mannitol. According to the method above, 1000 sustained-release tablets of this example were prepared, each containing about 4 mg of finasteride.

[0033] All the tablets prepared in this embodiment are easy to demould, have a uniform and smooth surface, and have no cracking or loosening. Take six tablets and test their average disintegration speed in water is 25s.

Embodiment 2

[0035] A finasteride sustained-release tablet in this embodiment is prepared from the following raw materials: phosphatidylethanolamine 120g, glyceryl trioleate 60g, ethanol 55g, finasteride 4g, micropowder silica gel 30g, chitosan 40g, Carboxymethylcellulose sodium 40g, low-substituted hydroxypropylcellulose 6g, zinc stearate 2g, sorbitol 0.5g. According to the method above, 1000 sustained-release tablets of this example were prepared, each containing about 4 mg of finasteride.

[0036] The tablets prepared in this embodiment are easy to demould, and 99.99% of the tablets have a uniform and smooth surface without cracking or loosening. Take six tablets and test their average disintegration speed in water is 26s.

Embodiment 3

[0038] A finasteride sustained-release tablet in this embodiment is prepared from the following raw materials: phosphatidylserine 100g, glyceryl stearate 70g, ethanol 60g, finasteride 4g, micropowder silica gel 50g, chitosan 20g, Ethyl cellulose 60g, low-substituted hydroxypropyl cellulose 10g, magnesium stearate 5g, mannitol 2g. According to the method above, 1000 sustained-release tablets of this example were prepared, each containing about 4 mg of finasteride.

[0039]The tablets prepared in this embodiment are easy to demould, and 99.99% of the tablets have a uniform and smooth surface without cracking or loosening. Take six tablets and test their average disintegration speed in water is 28s.

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Abstract

The invention discloses finasteride sustained release tablets. The finasteride sustained release tablets are prepared from the following raw materials: 100 to 150 mg of phospholipid, 40 to 70 mg of glyceride, 50 to 60 mg of ethanol, 2 to 5 mg of finasteride, 10 to 50 mg of micropowder silica gel, 20 to 60 mg of chitosan, 20 to 60 mg of an adhesive, 2 to 10 mg of low-substituted hydroxypropyl cellulose, 0.5 to 5 mg of a lubricant and 0.2 to 2 mg of a sweetening agent. The preparation method comprises the following steps: mixing the phospholipid, the glyceride and the finasteride; adding the ethanol and mixing uniformly; adding the micropowder silica gel, the chitosan and the adhesive and mixing uniformly; performing wet granulation; drying; adding the low-substituted hydroxypropyl cellulose, the lubricant and the sweetening agent and mixing uniformly; and tabletting. The finasteride sustained release tablets provided by the invention have a remarkable sustained-release effect, are uniform in release speed and can reduce the use times; the tablets have high uniform strength and good taste; and the tablets can be used for treating male pattern alopecia and benign prostatic hyperplasia.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a finasteride sustained-release tablet and a preparation method thereof. Background technique [0002] Finasteride is a 4-azasteroid that is a specific inhibitor of type II 5α-reductase, an intracellular enzyme involved in the metabolism of testosterone to the stronger dihydrotestosterone. Benign prostatic hyperplasia depends on the conversion of testosterone to dihydrotestosterone in the prostate. Finasteride is very effective in reducing DHT in the blood and in the prostate. Contain type II 5α-reductase in the hair follicle, and the hair follicle becomes less in the bald area scalp of male baldness patient, and dihydrotestosterone increases. Administration of finasteride can reduce the concentration of dihydrotestosterone in the scalp and serum of these patients. Men who are congenitally deficient in type II 5α-reductase do not suffer from male pattern ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/58A61K47/24A61K47/14A61K47/10A61K47/36A61K47/38A61K47/04A61P17/14A61P13/08
CPCA61K9/2009A61K9/2013A61K9/205A61K9/2054A61K31/58A61P13/08A61P17/14
Inventor 罗亮黄丽萍孟凡玲
Owner 武汉百纳礼康生物制药有限公司
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