Orally disintegrating tablet containing sertraline and preparation method thereof

A technology of orally disintegrating tablets and sertraline, which is applied in the field of orally disintegrating tablets containing sertraline and its preparation, can solve the problems of poor water solubility, inability to guarantee the taste, and bioinequivalent surfactants

Inactive Publication Date: 2015-10-28
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most acrylic resins are pH-dependent. For example, the dispersion of ethyl acrylate and methyl methacrylate copolymer needs to be dissolved when pH>5, and the amine alkyl methacrylate copolymer E needs to be dissolved when pH<5. Moreover, acrylic resin is ...

Method used

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  • Orally disintegrating tablet containing sertraline and preparation method thereof
  • Orally disintegrating tablet containing sertraline and preparation method thereof
  • Orally disintegrating tablet containing sertraline and preparation method thereof

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Embodiment Construction

[0026] The following examples are used to further illustrate the present invention, to further understand a kind of orally disintegrating tablet containing sertraline and its preparation method, but the present invention is not limited thereto.

[0027] The tablets compressed in the following examples and comparative examples, unless otherwise specified, were all compressed with the same type of tablet press, and the hardness was controlled within the range of 25-40N.

[0028] 1. Test

[0029] Table 1

[0030]

[0031] Preparation Process:

[0032] (1) Crush the sertraline until the particle size is less than 30 μm;

[0033] (2) In Example 1, the bulk drug and povidone potassium were fully dispersed with water to prepare a dispersion, and dried until the water content was <3.00%; in Example 2 and Comparative Example 1, the bulk drug was mixed with crospovidone and β- Cyclodextrin is fully mixed; Comparative Example 2 dissolves E100 in 50% aqueous ethanol as a binder; ...

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Abstract

The invention discloses an orally disintegrating tablet containing sertraline and a preparation method thereof. The tablet contains a water-soluble filler, a binder, a disintegrating agent, a lubricant and an odor masking agent, and the taste of the tablet is improved through combined usage of solid dispersion technology. The orally disintegrating tablet has the characteristics of good taste, good oral compliance, rapid action, etc., and is applicable to treatment of patients with depression. The invention also provides the preparation method. The preparation method is simple, has low cost and belongs to the technical fields of medical science and pharmacy.

Description

technical field [0001] The invention relates to an antidepressant sertraline orally disintegrating tablet and a preparation method thereof, and particularly provides a method for correcting the taste of a bitter and numb drug, the active ingredient of which is sertraline, and the preparation process of the preparation is simple and controllable. It still has the same and stable dissolution characteristics of the active ingredient under different contents (25, 50, 100mg specifications), has fast onset and good compliance when taken orally, and belongs to the field of medical technology. Background technique [0002] Sertraline, the chemical name is (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine, It is a selective serotonin reuptake inhibitor (SSRI), often in the form of hydrochloride for clinical treatment, suitable for major depression, obsessive-compulsive disorder (50mg / day), panic disorder, post-traumatic stress disorder And social anxiety di...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/135A61P25/24A61P25/22A61P25/00
Inventor 李自丹马莉
Owner AVENTIS PHARMA HAINAN
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