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Pharmaceutical composition containing tomoxetine and preparation method thereof

A composition and drug technology, applied in the directions of drug combination, nervous system diseases, etc., can solve the problems of high production environment requirements, complicated preparation process of hard capsules, etc., and achieve the effects of good taste, good dissolution and content uniformity, and convenient medication

Inactive Publication Date: 2011-07-06
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the dissolution problem of the drug is better solved, the preparation process of the hard capsule is cumbersome and requires relatively high requirements for the production environment

Method used

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  • Pharmaceutical composition containing tomoxetine and preparation method thereof
  • Pharmaceutical composition containing tomoxetine and preparation method thereof
  • Pharmaceutical composition containing tomoxetine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] The present invention exists in the form of orally disintegrating tablets

[0017]

[0018] The dosage form can be produced using conventional tablet pharmaceutical equipment and prepared using a compression process, and the specific preparation method is as follows:

[0019] 1. The main ingredient is crushed through a 120-mesh sieve, the magnesium stearate is passed through a 60-mesh sieve, and the rest of the excipients are passed through a 80-mesh sieve for later use.

[0020] 2. Weigh the prescribed amount of the main drug and dissolve it in a certain amount of ethanol, and then dissolve the prescribed amount of BHA in it for later use.

[0021] 3. Add the solution containing the main drug and BHA to mannitol for wetting, and then mix it with starch and some low-substituted hydroxypropyl cellulose.

[0022] 4. Add 10% starch slurry as a binder to make soft materials, and make wet granules through a 16-mesh sieve.

[0023] 5. Ventilate and dry at 50°C until the ...

Embodiment 2

[0027] The present invention exists in the form of granules

[0028]

[0029] Concrete preparation method is as follows:

[0030] 1. The main ingredient is crushed through a 120-mesh sieve, the magnesium stearate is passed through a 60-mesh sieve, and the rest of the excipients are passed through a 80-mesh sieve for later use.

[0031] 2. Dissolve the main ingredient in a certain amount of water and set aside.

[0032] 3. Add the solution containing the main drug into lactose to moisten, and then add and mix with microcrystalline cellulose and tartaric acid in equal amounts.

[0033] 4. Add purified water to make soft material, and make wet granules with 16 mesh sieve.

[0034] 5. Ventilate and dry at 50°C until the moisture content is less than 2%.

[0035] 6. Sieve with a 24-mesh sieve for granulation, add the prescribed amount of sodium bicarbonate and magnesium stearate according to the yield, and mix well.

Embodiment 3

[0037] The present invention exists in the form of oral liquid (100 bottles)

[0038]

[0039] Concrete preparation method is as follows:

[0040] 1. Weigh the prescribed amount of atomoxetine, benzoic acid, and citric acid, add them to a 1000ml beaker, and add an appropriate amount of purified water to dissolve.

[0041] 2. Filter with a 0.22um microporous water membrane to obtain the filtrate.

[0042] 3. Add sodium citrate to the filtrate to adjust the pH to 4-5.

[0043] 4. Add the prescribed amount of acesulfame potassium, transfer to a 1000ml measuring bottle and add purified water to make up the volume.

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Abstract

The invention relates to a pharmaceutical composition containing tomoxetine and a preparation method thereof. The pharmaceutical composition contains tomoxetine and carrier auxiliary materials which are pharmaceutically acceptable, and the pharmaceutical composition can exist in solid or liquid form, wherein the essential ingredient is added by being dispersed in a solution.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating attention deficit hyperactivity disorder, which can exist in the form of granules, oral disintegrating agents and oral solutions. Background technique [0002] Over the decades, it has been noted that a significant number of children with persistent hyperactivity disorder and very short attention spans have been noticed, and the medical profession has tried to help them. These children have been treated with methylphenidate for some time with good results. However, the disadvantage of this drug is that it needs to be administered multiple times a day, which can cause rebound effects. Imipramine, nortriptyline, and clomipramine are also used in some cases of attention-deficit / hyperactivity disorder (ADHD), but these tricyclic drugs have many physiological mechanisms and are prone to side effects. [0003] In the last ten years, psychiatrists have realized that attention-deficit / hyperac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61P25/14A61P25/00
Inventor 郭夏段作辉
Owner BEIJING D VENTUREPHARM TECH DEV
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