Preparation method of dapoxetine hydrochloride sustained release tablet

A technology of dapoxetine hydrochloride and sustained-release tablets, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, can solve the problem of patients not receiving clinical knowledge of premature ejaculation, etc. The effect of lasting blood drug concentration, improving use safety and process stability

Pending Publication Date: 2021-07-23
苏州康恒研新药物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, 76% of patients in this group have not ...

Method used

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  • Preparation method of dapoxetine hydrochloride sustained release tablet
  • Preparation method of dapoxetine hydrochloride sustained release tablet
  • Preparation method of dapoxetine hydrochloride sustained release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Specification: 30mg, batch size is 1000 tablets. The prescribing information is as follows:

[0052]

[0053] The preparation process is as follows:

[0054] 1. Premixing: dapoxetine hydrochloride raw material 33.6g, croscarmellose sodium 4g, ethyl cellulose 10g, lactose 44.4g, in a wet granulator, stirring speed 300rpm, shearing speed 1800rpm, pre-mixing Mix for 7 minutes;

[0055] 2. Granulation: Dissolve 5g of ethyl cellulose in 18g of purified water to make a solution, and spray it into the premix. It is required to complete the spraying within 1 minute, and then granulate for 4 minutes;

[0056] 3. Wet granulation: Wet granulation with 20-mesh sieve in wet granulation swinging granulator;

[0057] 4. Drying: the air inlet temperature of the fluidized bed is 60°C, the material temperature is 35-45°C, and dried to a moisture content of 2.0%-3.0%;

[0058] 5. Dry granulation: dry granules pass through a 20-mesh sieve for dry granulation;

[0059] 6. Total mixi...

Embodiment 2

[0063] The prescribing information is as follows:

[0064] The batch size is 20,000 pieces.

[0065]

[0066] The preparation process is as follows:

[0067] 1. Premixing: dapoxetine hydrochloride raw material 672g, croscarmellose sodium 20g, ethyl cellulose 200g, lactose 1008g, wet granulator, stirring speed 400rpm, shearing speed 2100rpm, premixing 7min ;

[0068] 2. Granulation: Dissolve 20g of ethyl cellulose in 360g of purified water to make a solution, add it by spraying, spraying is required to be completed within 3 minutes, and then granulate for 3 minutes;

[0069] 3. Wet granulation: Wet granulation with 20-mesh sieve in wet granulation swinging granulator;

[0070] 4. Drying: the air inlet temperature of the fluidized bed is 60°C, the material temperature is 35-45°C, and dried to a moisture content of 2.0%-3.0%;

[0071] 5. Dry granulation: dry granules pass through a 20-mesh sieve for dry granulation;

[0072] 6. Total mixing: Calculate the amount of added ...

Embodiment 3

[0076] The prescribing information is as follows:

[0077] Batches are 40,000 pieces.

[0078]

[0079] The preparation process is as follows:

[0080] 1. Premixing: dapoxetine hydrochloride raw material 1344g, croscarmellose sodium 160g, ethyl cellulose 200g, lactose 2056g, wet granulator, stirring speed 400rpm, shearing speed 2100rpm, premixing 7min ;

[0081] 2. Granulation: Dissolve 120g of ethyl cellulose in 720g of purified water to make a solution, add it by spraying, spraying is required to be completed within 3 minutes, and then granulate for 3 minutes;

[0082] 3. Wet granulation: Wet granulation with 20-mesh sieve in wet granulation swinging granulator;

[0083] 4. Drying: the air inlet temperature of the fluidized bed is 60°C, the material temperature is 35-45°C, and dried to a moisture content of 2.0%-3.0%;

[0084] 5. Dry granulation: dry granules pass through a 20-mesh sieve for dry granulation;

[0085] 6. Total mixing: Calculate the amount of added sil...

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Abstract

The invention discloses a preparation method of a dapoxetine hydrochloride sustained release tablet, and belongs to the field of pharmaceutical preparations. The dapoxetine hydrochloride sustained release tablet is prepared from the following raw materials, by weight, 30-34% of dapoxetine hydrochloride, 2-5% of a disintegrating agent, 5-15% of a skeleton type sustained release material, 1-3% of a flow aid and 43.4-58.4% of a filling agent. According to the method, the insoluble skeleton type material is used as a framework carrier to prepare dapoxetine sustained-release granules, the sustained-release granules are pressed into round tablets under proper pressure, finally, coating is performed, and the weight gain of the coating is 2%-5%. The dapoxetine hydrochloride sustained release tablet is stable in process, can play a good sustained-release role, is stable in release within 24 hours, has no burst release and difficulty in dissolution, is amplified to 2-4 thousands of tablets, has good results, and meets the requirements.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of dapoxetine hydrochloride sustained-release tablets. Background technique [0002] Dapoxetine hydrochloride belongs to the selective serotonin reuptake inhibitor (SSRI), the chemical name is (S)-(+)-N,N-dimethyl-3-(1-naphthyloxy)amphetamine hydrochloride Salt, the structural formula is as follows: [0003] [0004] This type of drug was widely used to treat depression and related emotional disorders in the early days, and in recent years it is mainly used to treat male sexual dysfunction. That is, by blocking the reuptake of 5-HT, the bioavailable 5-HT in the synaptic gap will be increased, thereby prolonging the ejaculation latency period and achieving the purpose of delaying ejaculation time and treating premature ejaculation. [0005] The preparation process of dapoxetine was first developed by Eli Lilly and Company of the United...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K47/38A61K31/138A61P25/24A61P15/00
CPCA61K9/2806A61K9/2054A61K31/138A61P25/24A61P15/00
Inventor 黄治民冯超张尚
Owner 苏州康恒研新药物技术有限公司
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