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Preparation method of dapoxetine hydrochloride pellet tablet

A technology of dapoxetine hydrochloride and cetine pellets, which can be applied in the directions of medical preparations without active ingredients, medical preparations containing active ingredients, and pill delivery, etc., and can solve problems such as inapplicability

Pending Publication Date: 2021-07-30
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

[0005] Originally developed by Eli Lilly and Company for the treatment of major depressive disorder (MDD), but its pharmacokinetic properties (such as short half-life after oral administration, less accumulation in 24 hours) are not suitable for this indication, so its development stopped

Method used

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  • Preparation method of dapoxetine hydrochloride pellet tablet
  • Preparation method of dapoxetine hydrochloride pellet tablet
  • Preparation method of dapoxetine hydrochloride pellet tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] The prescribing information is as follows:

[0062] Specifications: 30mg, batch size is 1000 tablets.

[0063]

[0064] The preparation process is as follows:

[0065] 1. Premix: Dapoxetine hydrochloride 33.6g, croscarmellose sodium 6g, silicified microcrystalline cellulose 36g, hypromellose 50g, lactose 64.4g, sodium stearyl fumarate 1g, wet In the French granulator, the stirring speed is 300rpm, the shearing speed is 1800rpm, and the premixing is 9min;

[0066] 2. Granulation: pure water spray is added, and the spraying is required to be completed within 2 minutes, and then granulated for 1 minute;

[0067] 3. Wet granulation: Wet granulation with a 16-mesh sieve in the wet granulator swing granulator, and the materials are put into the spheronizing equipment in batches to make pellets;

[0068] 4. Drying: the air inlet temperature of the fluidized bed is 50-70°C, the material temperature is 35-45°C, and dried to a moisture content of 0.9%-2.8%;

[0069] 5. Dry...

Embodiment 2

[0074] The prescribing information is as follows:

[0075] Batches are 2000 pieces.

[0076]

[0077]

[0078] The preparation process is as follows:

[0079] 1. Premix: Dapoxetine hydrochloride 67.2g, croscarmellose sodium 24g, silicified microcrystalline cellulose 104g, hypromellose 120g, lactose 76.8g, sodium stearyl fumarate 6g, wet In the French granulator, the stirring speed is 300rpm, the shearing speed is 1800rpm, and the premixing is 9min;

[0080] 2. Granulation: pure water spray is added, and the spraying is required to be completed within 2 minutes, and then granulated for 1 minute;

[0081] 3. Wet granulation: Wet granulation with a 16-mesh sieve in the wet granulator swing granulator, and the materials are put into the spheronizing equipment in batches to make pellets;

[0082] 4. Drying: the air inlet temperature of the fluidized bed is 50-70°C, the material temperature is 35-45°C, and dried to a moisture content of 0.9%-2.8%;

[0083] 5. Dry granulati...

Embodiment 3

[0088] The prescribing information is as follows:

[0089] Batches are 4000 pieces.

[0090]

[0091] The preparation process is as follows:

[0092] 1. Premix: Dapoxetine hydrochloride 134.4g, croscarmellose sodium 24g, silicified microcrystalline cellulose 120g, hypromellose 280g, lactose 185.6g, sodium stearyl fumarate 4g, wet In the French granulator, the stirring speed is 300rpm, the shearing speed is 1800rpm, and the premixing is 9min;

[0093] 2. Granulation: pure water spray is added, and the spraying is required to be completed within 2 minutes, and then granulated for 1 minute;

[0094] 3. Wet granulation: Wet granulation with a 16-mesh sieve in the wet granulator swing granulator, and the materials are put into the spheronizing equipment in batches to make pellets;

[0095] 4. Drying: the air inlet temperature of the fluidized bed is 50-70°C, the material temperature is 35-45°C, and dried to a moisture content of 0.9%-2.8%;

[0096] 5. Dry granulation: dry gr...

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Abstract

The invention discloses a preparation method of a dapoxetine hydrochloride pellet, and belongs to the field of pharmaceutical preparations. The dapoxetine hydrochloride pellet tablet is prepared from, by weight, 16-17% of dapoxetine hydrochloride, 2-8% of a disintegrating agent, 15-35% of a hydrophilic gel skeleton type sustained-release material, 1-3% of a lubricant, 10-25% of silicified microcrystalline cellulose, and the balance of lactose. The dapoxetine hydrochloride pellet tablet prepared by the preparation method has the advantages that the process is stable, the slow release effect can be well achieved, the release within 24 hours is stable, the phenomena of burst release and difficult dissolution are avoided, the tablet is amplified to 10,000 tablets, the result is good, and the requirement is met.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of dapoxetine hydrochloride pellets. Background technique [0002] Premature ejaculation (PE) is the most common sexual dysfunction in men. According to a survey conducted by the American Health and Longevity Organization, about 71% of adult males have sexual disorders, of which about 39% have erectile dysfunction, and 61% of them have insufficient time for their sexual behavior long and unsatisfactory. [0003] 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: [0004] [0005] Originally developed by Eli Lilly and Company for the treatment of major depressive disorder (MDD), but its pharmacokinetic properties (such as short half-life after oral administration, less acc...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/36A61K47/38A61K31/138A61P15/08
CPCA61K9/2054A61K9/2095A61K9/2866A61K31/138A61P15/08
Inventor 李佳宝张欣宜刘月
Owner 苏州康恒研新药物技术有限公司
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