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Finasteride-containing orally disintegrating tablets and preparation method thereof

A technology of oral disintegrating tablets and finasteride, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as delaying the effective treatment time of patients, and achieve good taste , good promotion prospects, avoid the effect of repeated investment

Inactive Publication Date: 2011-05-18
BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the dissolution problem of the drug is better solved, finasteride is not easily soluble in water, and cannot be well dispersed in oily liquid or semi-solid, and the bitter taste of finasteride is difficult to be accepted by people. These factors All delay the effective treatment time of patients

Method used

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  • Finasteride-containing orally disintegrating tablets and preparation method thereof
  • Finasteride-containing orally disintegrating tablets and preparation method thereof
  • Finasteride-containing orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] The formulation of the present invention consists of the following components in parts by weight

[0014]

[0015] The dosage form can be produced using conventional tablet pharmaceutical equipment and prepared using a compression process, and the specific preparation method is as follows:

[0016] 1. Weigh the prescribed amount of finasteride and mannitol, and pulverize them together through a pulverizer until the powder D90 is less than or equal to 75 microns;

[0017] 2. Add low-substituted hydroxypropyl cellulose, increase in equal amounts, and mix well;

[0018] 3. Granulate with starch slurry as binder;

[0019] 4. Add the prescribed amount of menthol and magnesium stearate after blast drying, and mix well;

[0020] 5. Carry out intermediate content detection and tablet compression to obtain orally disintegrating tablets.

Embodiment 2

[0022] The formulation of the present invention consists of the following components in parts by weight

[0023]

[0024] The dosage form can be produced using conventional tablet pharmaceutical equipment and prepared using a compression process, and the specific preparation method is as follows:

[0025] 1. Weigh the prescribed amount of finasteride and lactose, and pulverize them together through a pulverizer until the powder D90 is less than or equal to 50 microns;

[0026] 2. Then add sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose, add in equal amounts, and mix well;

[0027] 3. Granulate with water as binder;

[0028] 4. Add stevioside, lauryl magnesium sulfate, and magnesium stearate in the prescribed amount after blast drying, and mix well;

[0029] 5. Carry out intermediate content detection and tablet compression to obtain orally disintegrating tablets.

Embodiment 3

[0031] The formulation of the present invention consists of the following components in parts by weight

[0032]

[0033]

[0034] The dosage form can be produced using conventional tablet pharmaceutical equipment and prepared using a compression process, and the specific preparation method is as follows:

[0035] 1. Weigh the prescribed amount of finasteride and mannitol, and use a pulverizer to pulverize them until the powder D90 is less than or equal to 20 microns;

[0036] 2. Add low-substituted hydroxypropyl cellulose and microcrystalline cellulose, increase in equal amounts, and mix well;

[0037] 3. Granulate with water;

[0038] 4. Add the prescribed amount of stevioside and magnesium stearate after blast drying, and mix well;

[0039] 5. Carry out intermediate content detection and tablet compression to obtain orally disintegrating tablets.

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Abstract

The invention relates to finasteride-containing orally disintegrating tablets and a preparation method thereof. The orally disintegrating tablets are prepared by jointly grinding a main medicine and a filler; by the preparation process, the particle size of finasteride can be controlled in a certain range, and the finasteride and the filler are fully mixed, so that the bitter taste of the medicine can be effectively masked, and the dissolution rate of the medicine can be effectively improved; and the orally disintegrating tablets have sufficient hardness, can meet the requirements of production, packaging, storage and transportation, and can be used for treating benign prostatic hyperplasia.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating benign prostatic hyperplasia, in particular to an orally disintegrating tablet composition containing finasteride and a preparation method thereof. Background technique [0002] Finasteride is a competitive inhibitor of type II 5α-reductase. It can form a stable enzyme complex with 5α-reductase. The transformation of this complex is very slow, but it has no affinity for androgen. 5α-reductase is an intracellular enzyme that converts the male hormone testosterone (T) into 5α-dihydrotestosterone (DHT), and male sexual development is mediated by both testosterone (T) and 5α-dihydrotestosterone (DHT) , DHT controls prostate growth and male pattern baldness, and the development and enlargement of the prostate depends on the activity of DHT. [0003] Benign prostatic hyperplasia (BPH) is a common disease in elderly men, and research results show that most men over 50 years old have different...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/58A61K47/38A61K47/36A61K47/32A61P13/08
Inventor 张晓蔡巍
Owner BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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