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Orally disintegrating tablet 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, which can solve the problem of difficulty in achieving taste-masking effects, high cost, and unfavorable industrial production And other issues

Inactive Publication Date: 2016-06-01
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The raw material of sertraline hydrochloride itself has a strong sense of bitterness, numbness, and spicy stimulation. Adding flavoring agents to taste is the most preferred method for preparations. This method is effective for small doses of drugs with a slightly bitter taste. It is difficult to achieve the taste-masking effect by conventional methods such as preservatives, so it is necessary to adopt targeted taste-masking technology on the basis of flavor correction
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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  • Orally disintegrating tablet containing sertraline hydrochloride and preparation method thereof
  • Orally disintegrating tablet containing sertraline hydrochloride and preparation method thereof
  • Orally disintegrating tablet containing sertraline hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012]

[0013] Preparation Process

[0014] Magnetically stir sertraline hydrochloride and polacrilin potassium in 40 times the weight of purified water for 3 hours, centrifuge at 4000rpm for 10 minutes, collect the precipitate and dry it at 50°C, grind it, add microcrystalline cellulose, mannitol and sodium carboxymethyl starch to pass through 80 mesh Sieve 3 times and mix well, use water as binder, granulate with 24-mesh sieve, blast dry at 50°C, dry to 1-3% moisture, pass the dried granules through 24-mesh sieve for granulation, weigh, and convert yield, Add sodium carboxymethyl starch, microcrystalline cellulose, aspartame and magnesium stearate, Φ10 flat punched tablets, tablet weight 350mg, hardness 20-60N. The preparation prepared by the prescription is sweet in the mouth, bitter, numb and spicy in aftertaste, and the oral disintegration time is greater than 60 s.

Embodiment 2

[0016]

[0017] Preparation Process

[0018] Magnetically stir sertraline hydrochloride and polacrilin potassium in 40 times the weight of purified water for 4 hours, centrifuge at 4000rpm for 10 minutes, collect the precipitate and dry it at 50°C, grind it, add microcrystalline cellulose, mannitol and sodium carboxymethyl starch to pass through 80 mesh Sieve 3 times and mix well, use water as binder, granulate with 24-mesh sieve, blast dry at 50°C, dry to 1-3% moisture, pass the dried granules through 24-mesh sieve for granulation, weigh, and convert yield, Add sodium carboxymethyl starch, microcrystalline cellulose, aspartame and magnesium stearate, Φ10 flat punched tablets, tablet weight 350mg, hardness 20-60N. The preparation prepared by the prescription is sweet in the mouth, without bitterness, numbness and spicy feeling, and the oral disintegration time is less than 60s.

Embodiment 3

[0020]

[0021] Preparation Process

[0022] Magnetically stir sertraline hydrochloride and polacrilin potassium in 20 times the weight of purified water for 4 hours, centrifuge at 4000rpm for 10 minutes, collect the precipitate and dry it at 50°C, grind it, add microcrystalline cellulose, mannitol and sodium carboxymethyl starch to pass through 80 mesh Sieve 3 times and mix well, use water as binder, granulate with 24-mesh sieve, blast dry at 50°C, dry to 1-3% moisture, pass the dried granules through 24-mesh sieve for granulation, weigh, and convert yield, Add sodium carboxymethyl starch, microcrystalline cellulose, aspartame and magnesium stearate, Φ10 flat punched tablets, tablet weight 350mg, hardness 20-60N. The preparation prepared by this prescription is sweet in the mouth, slightly bitter, numb and spicy in aftertaste, and the oral disintegration time is greater than 60s.

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Abstract

The invention discloses a preparation method of an orally disintegrating tablet containing sertraline hydrochloride. The orally disintegrating tablet contains a sertraline hydrochloride-polacrilin potassium compound and other pharmaceutically acceptable auxiliary materials. An ion exchange technology is adopted to mask taste, and the orally disintegrating tablet is prepared by wet granulation and tabletting and can be disintegrated in the oral cavity without needing water, thereby effectively masking the bitter, pungent and spicy taste of the main active ingredient, namely sertraline hydrochloride. 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 an orally disintegrating pharmaceutical composition for taste-masking by a technical method and a preparation method thereof. Background technique [0002] Zoloft (English trade name is Zoloft ? , sertraline hydrochloride tablets) is an antidepressant developed by Pfizer, belonging to the selective serotonin reuptake inhibitor (SSRI), for the treatment of symptoms related to depression, including depression associated with anxiety, with or without a history of mania disease. After the curative effect is satisfactory, continuing to take it can effectively prevent the recurrence and recurrence of depression. After Zoloft is satisfied with the curative effect of treating obsessive-compulsive disorder, continuing to take it can effectively prevent the recurrence of the initial symptoms of obsessive-compulsive disorder. Zoloft ? It was first launche...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/137A61K47/32A61K47/38A61P25/24A61P25/22
CPCA61K9/006A61K9/2027A61K9/2054A61K31/137
Inventor 王寅洁张庭
Owner AVENTIS PHARMA HAINAN
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