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Fluoxetine capsule and preparation method thereof

A technology of fluoxetine capsules and fluoxetine, which is applied in the field of medicine, can solve the problems of low patient compliance, the total weight of tablets, and large tablet volume, and achieve the effects of simple preparation process, easy quality control, and easy absorption

Inactive Publication Date: 2011-03-23
SHANGHAI CHENPON PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Fluoxetine sustained-release capsules and enteric-coated preparations are complicated and expensive
Fluoxetine dispersible tablets have a large total tablet size and a large tablet volume, and the patient's compliance is low during clinical application

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Prescribe as follows:

[0039] a) 22.36g of fluoxetine hydrochloride;

[0040] b) 49.00g of precrossified starch;

[0041] c) 72.64 g of microcrystalline cellulose;

[0042] d) 1.00 g of magnesium stearate.

[0043] The above-mentioned capsules are produced according to the following method: under the conditions of relative humidity of 45% and temperature of 25°C, a), b), c) and d) are mixed and pulverized, passed through a 120-mesh sieve, sampled for uniformity inspection and then packed into Pack 1000 hollow hard capsules to make fluoxetine capsules.

[0044] The prepared capsules were subjected to quality control according to the capsule quality standard described in Chinese Pharmacopoeia 2005 edition, and stability investigation was carried out according to the principles of stability experiments. The results showed that the dissolution rate and stability of the capsules were good.

Embodiment 2

[0046] Formulated according to the following components:

[0047] a) 23.11 g of fluoxetine hydrochloride;

[0048] b) 50.20g of precrossified starch;

[0049] c) 75.62 g of microcrystalline cellulose;

[0050] d) 0.98 g of magnesium stearate.

[0051] The above-mentioned capsules are produced according to the following method: under the conditions of relative humidity of 60% of the preparation environment and a temperature of 25°C, after mixing and pulverizing a), b), c) and d), pass through a 120-mesh sieve, take samples for uniformity inspection and then pack them into 1000 hollow hard capsules make fluoxetine capsules.

[0052] The prepared capsules were subjected to quality control according to the capsule quality standard described in Chinese Pharmacopoeia 2005 edition, and stability investigation was carried out according to the principles of stability experiments. The results showed that the dissolution rate and stability of the capsules were good.

Embodiment 3

[0054] Formulated according to the following components:

[0055] a) 21.80g of fluoxetine hydrochloride;

[0056] b) 51.30g of precrossified starch;

[0057] c) 78.91 g of microcrystalline cellulose;

[0058] d) 1.05 g of magnesium stearate.

[0059] The above-mentioned capsules are produced according to the following method: under the conditions of preparation environment relative humidity 75% and temperature 25°C, a), b), c) and d) are mixed and pulverized, passed through a 120-mesh sieve, sampled for uniformity inspection and then packed into 1000 hollow hard capsules make fluoxetine capsules.

[0060] The prepared capsules were subjected to quality control according to the capsule quality standard described in Chinese Pharmacopoeia 2005 edition, and stability investigation was carried out according to the principles of stability experiments. The results showed that the dissolution rate and stability of the capsules were good.

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PUM

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Abstract

The invention relates to a fluoxetine capsule and a preparation method thereof. The capsule is composed of certain proportion of active component, microcrystal fiber and pregelatinized starch. In the environment that relative humidity is not more than 75%, the components are mixed, smashed and sieved, and the mixture is packaged into empty capsules after uniformity degree is detected to be qualified, thus obtaining the fluoxetine capsule. The capsule can be used for treating mental disease. The fluoxetine capsule provided by the invention has the characteristics of simple preparation process, low cost and easy industrialization production.

Description

technical field [0001] The invention belongs to the field of medicine and relates to a pharmaceutical preparation and a preparation method thereof, in particular to a fluoxetine capsule and a preparation method thereof. Background technique [0002] Fluoxetine, N-methyl-3-(p-trifluoromethylphenoxy)-3-phenylpropylamine, is an antidepressant. Compound medicines of fluoxetine and salts thereof are disclosed in US Patent Nos. 4,314,081 and 4,626,549, and the active ingredient of currently marketed products is fluoxetine hydrochloride. Fluoxetine and its salts have antidepressant effects and can inhibit the reuptake of 5-HT by the central nervous system. It is clinically used in the treatment of depression and related anxiety symptoms, and is also used in the treatment of bulimia nervosa and obsessive-compulsive ideas and behaviors disorder. [0003] At present, the dosage forms of fluoxetine in foreign countries include: solution, dispersible tablet, ordinary tablet, capsule, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/138A61K47/38A61K47/36A61K47/12A61P25/24
Inventor 吴晓毅杜狄峥
Owner SHANGHAI CHENPON PHARM TECH CO LTD
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