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Taste-masking orally disintegrating tablets containing sertraline hydrochloride and preparation method thereof

A technology of sertraline hydrochloride and orally disintegrating tablets, which is applied to medical preparations containing active ingredients, medical preparations without active ingredients, and pharmaceutical formulas, and can solve the problem of high compressibility requirements, high cost, and unfavorable issues of industrial production

Inactive Publication Date: 2016-11-16
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Powder direct pressing or freeze drying both require high equipment requirements and the compressibility of excipients, and the cost is high, which is not conducive to industrial production

Method used

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  • Taste-masking orally disintegrating tablets containing sertraline hydrochloride and preparation method thereof
  • Taste-masking orally disintegrating tablets containing sertraline hydrochloride and preparation method thereof
  • Taste-masking orally disintegrating tablets containing sertraline hydrochloride and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018]

[0019] Preparation Process:

[0020] Mix sertraline hydrochloride with Eudragit E100 and microcrystalline cellulose, use hydroxypropyl cellulose as a binder, wet granulate and dry the granules; take 45% of the water in the formula, heat it to 70-80 ℃, and Add glyceryl monostearate (5% of dry polymer) and Tween 80 (40% of glyceryl monostearate) to hot water, homogenize with a high-speed shear homogenizer for 10 minutes, add 0.1% disinfectant Foaming agent simethicone oil, add the remaining water to the emulsion of glyceryl monostearate, stir continuously and cool to room temperature, slowly pour this suspension into the Eudragit water dispersion whose dry weight is 10% of the total weight of the particles At the same time, stir at a medium speed with an ordinary mixer, and filter through a 40-mesh sieve to make a coating solution; set the atomization pressure to 0.1Kg / cm3, and the flow rate of the spray solution to 50mL / min, spray into the coating solution, and turn...

Embodiment 2

[0022]

[0023] Preparation Process:

[0024] Mix sertraline hydrochloride with Eudragit E100 and microcrystalline cellulose, use hydroxypropyl cellulose as a binder, wet granulate and dry the granules; take 45% of the water in the formula, heat it to 70-80 ℃, and Add glyceryl monostearate (5% of dry polymer) and Tween 80 (40% of glyceryl monostearate) to hot water, homogenize with a high-speed shear homogenizer for 10 minutes, add 0.5% disinfectant Foaming agent simethicone oil, add the remaining water to the emulsion of glyceryl monostearate, stir continuously and cool to room temperature, slowly pour this suspension into the Eudragit water dispersion whose dry weight is 30% of the total weight of the particles At the same time, stir at a medium speed with an ordinary mixer, filter through a 40-mesh sieve, and make a coating solution; set the atomization pressure to 0.5Kg / cm 3 , the flow rate of the spray liquid is 50mL / min, spray into the coating liquid, turn on the hea...

Embodiment 3

[0026]

[0027] Preparation Process:

[0028] Mix sertraline hydrochloride with Eudragit E100 and microcrystalline cellulose, use hydroxypropyl cellulose as a binder, wet granulate and dry the granules; take 45% of the water in the formula, heat it to 70-80 ℃, and Add glyceryl monostearate (5% of dry polymer) and Tween 80 (40% of glyceryl monostearate) to hot water, homogenize with a high-speed shear homogenizer for 10 minutes, add 1% disinfectant Foaming agent simethicone oil, add the remaining water to the emulsion of glyceryl monostearate, stir continuously and cool to room temperature, slowly pour this suspension into the Eudragit water dispersion whose dry weight is 10% of the total weight of the particles At the same time, stir at a medium speed with an ordinary mixer, filter through a 40-mesh sieve, and make a coating solution; set the atomization pressure to 0.3Kg / cm 3 , the flow rate of the spray liquid is 150mL / min, spray into the coating liquid, turn on the heat...

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Abstract

The invention discloses a method for preparing taste-masking orally disintegrating tablets containing sertraline hydrochloride. The orally disintegrating tablets contain sertraline hydrochloride and other pharmaceutically acceptable excipients. The taste can be masked by adopting a granule coating technology, the prepared orally disintegrating tablets can be disintegrated in oral cavity without using water, bitterness and spicy and pungent flavor of sertraline hydrochloride, the main active ingredient of the orally disintegrating tablets, can be effectively masked, and the preparation method is simple and convenient in process and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a technical method for masking bad taste of medicines and a preparation method of an orally disintegrating pharmaceutical composition. Background technique [0002] Zoloft (English trade name is Zoloft ® , Sertraline Hydrochloride Tablets) is an antidepressant developed by Pfizer. It was first launched in the UK in 1990, approved by the FDA in December 1991, and launched in the United States in 1992. It has been listed in 96 countries and regions around the world. It is a choice Sexual serotonin reuptake inhibitors (SSRIs), for the treatment of symptoms associated with depression, including depression associated with anxiety, with or without a history of mania. After the curative effect is satisfactory, continuing to take it can effectively prevent the recurrence and recurrence of depression. Zoloft can effectively prevent the recurrence of the i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26A61K31/137A61K47/38A61P25/24A61K9/50
CPCA61K9/0056A61K9/2027A61K9/2054A61K9/2059A61K9/5042A61K31/137
Inventor 王寅洁马莉
Owner BEIJING VENTUREPHARM BIOTECH
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