Pharmaceutical combination tablet containing dapoxetine hydrochloride and preparation method thereof

A dapoxetine hydrochloride and combination tablet technology, which is applied in the direction of drug combination, medical preparations containing active ingredients, medical preparations without active ingredients, etc., can solve problems such as organic substance residues, and achieve small batch-to-batch differences , Simple production process, good fluidity effect

Pending Publication Date: 2022-04-29
海南卓力制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the following steps are adopted in China: Dapoxetine hydrochloride and organic solvents (ethanol, ethyl acetate, acetone, etc.) Dissolution is good, but due to the use of organic solvents, it is easy to produce certain organic substance residues

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0025] The preparation method of above-mentioned tablet is as follows:

[0026] S1 Mix dapoxetine hydrochloride with silicon dioxide half of the formula amount, pass through an 80-mesh sieve and add to the mixer, then add the remaining dapoxetine and stir and mix;

[0027] S2 adds the cross-linked sodium carboxymethyl cellulose, lactose, and microcrystalline cellulose of formula quantity into the mixer and mixes for 30 minutes;

[0028] S3 adds the magnesium stearate of formula quantity in the blender and mixes back tabletting;

[0029] S4 prepares the coating solution that concentration is 10% with Opadry and purified water, and the preparation amount of coating solution is 130% of theoretical consumption, uses coating solution to carry out pre-coating to the tablet in S3, and coating weight gain is about Stop spraying after 4-6%;

[0030] S5 is obtained by drying after pre-coating.

Embodiment 1

[0032] Recipe amount (by weight)

[0033] Main drug: 27.5 parts of dapoxetine hydrochloride;

[0034] Filler: 35 parts of lactose, 1.5 parts of croscarmellose sodium;

[0035] Lubricants: 19 parts of microcrystalline cellulose, 1.5 parts of silicon dioxide, 1.5 parts of magnesium stearate;

[0036] Coating powder: Opadry 33 parts.

[0037] The preparation method of above-mentioned tablet is as follows:

[0038] S1 Mix dapoxetine hydrochloride with silicon dioxide half of the formula amount, pass through an 80-mesh sieve and add to the mixer, then add the remaining dapoxetine and stir and mix;

[0039] S2 adds the cross-linked sodium carboxymethyl cellulose, lactose, and microcrystalline cellulose of formula quantity into the mixer and mixes for 30 minutes;

[0040] S3 adds the magnesium stearate of formula quantity in the blender and mixes back tabletting;

[0041] S4 uses Opadry and purified water to prepare a coating solution with a concentration of 10%, and uses the co...

Embodiment 2

[0047] Recipe amount (by weight)

[0048] Main ingredient: 25 parts of dapoxetine hydrochloride;

[0049] Filler: 33 parts of lactose, 1.5 parts of croscarmellose sodium;

[0050] Lubricants: 19 parts of microcrystalline cellulose, 1.5 parts of silicon dioxide, 1.5 parts of magnesium stearate;

[0051] Coating powder: Opadry 30 parts.

[0052] The preparation method of the above-mentioned tablet is the same as that in Example 1, but the weight gain of the coating in S4 is about 4%.

[0053] The water content, content, total impurities, dissolution rate and dissolution ratio of the tablets obtained in this embodiment were tested, and the results are shown in Table 2.

[0054] Table 2

[0055] month of study moisture content total impurities Dissolution Dissolution ratio 0 month 3.8 98.5％ 0.02％ 94.7％ 94.33％ Accelerate January 3.7 99.6％ 0.03％ 96.2％ 93.47％ Accelerate February 4.1 98.5％ 0.04％ 95.3％ 95.21％ Accelerate March 4...

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PUM

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Abstract

The invention relates to a pharmaceutical composition tablet containing dapoxetine hydrochloride and a preparation method thereof. The tablet comprises 20-35 parts of dapoxetine hydrochloride (main drug), 30-40 parts of lactose (filler), 1-2 parts of croscarmellose sodium (filler), 18-20 parts of microcrystalline cellulose (lubricant), 1-2 parts of silicon dioxide (lubricant) and 1-2 parts of magnesium stearate (lubricant). The preparation method comprises the following steps: S1, mixing dapoxetine hydrochloride which is half of the formula amount with silicon dioxide, sieving, adding into a mixer, adding the rest dapoxetine, and stirring and mixing; s2, adding a filling agent and microcrystalline cellulose into a mixing machine for mixing; s3, adding magnesium stearate into the mixer, mixing, and tabletting; s4, preparing a coating solution by using coating powder and purified water, and pre-coating the tablets in S3 by using the coating solution; and S5, drying after the pre-coating is finished.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a drug combination tablet containing dapoxetine hydrochloride and a preparation method thereof. Background technique [0002] Dapoxetine hydrochloride (dapoxetine hydrochloride) is a light tryptamine reuptake inhibitor (SSRI), developed by Eli Lilly (Eli Lilly), listed in Europe in 2009, the trade name is Priligy, for the treatment of male Premature ejaculation (PE). The drug has a short half-life, few adverse reactions, and significant effects. It is the first oral prescription drug approved for the treatment of PE in the world. In early 2009, Johnson & Johnson announced that dapoxetine hydrochloride (dapoxetine hydrochloride) was used as a new drug for the treatment of PE, and it was approved by the European countries Finland and Sweden, and men aged 18-64 were used as the applicable population. [0003] At present, the following steps are adopted in China: Dapoxetine hydroc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/04A61K31/138A61P15/00
CPCA61K9/2806A61K9/2009A61K9/2054A61K9/2059A61K31/138A61P15/00
Inventor 魏西雨梁勇
Owner 海南卓力制药有限公司
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