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Tomoxetine hydrochloride oral solution and preparation method thereof

A technology of atomoxetine hydrochloride and oral solution is applied in the field of atomoxetine hydrochloride oral solution and preparation thereof, and can solve the problems of too bitter taste and poor compliance of atomoxetine hydrochloride, and achieve good therapeutic effect and production efficiency. High, good flavor effect

Inactive Publication Date: 2020-11-20
JIANMIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the technical problems existing in the prior art, the present invention provides atomoxetine hydrochloride oral solution and its preparation method, which solves the problems of poor compliance of atomoxetine hydrochloride due to its bitter taste

Method used

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  • Tomoxetine hydrochloride oral solution and preparation method thereof
  • Tomoxetine hydrochloride oral solution and preparation method thereof

Examples

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preparation example Construction

[0029] The preparation method of described atomoxetine hydrochloride oral solution comprises the following steps:

[0030] 1) First add 20-30°C purified water with 30% of the total amount of liquid into the liquid mixing tank, heat and control the temperature to 45-65°C, then add the prescribed amount of atomoxetine hydrochloride, sodium benzoate, phosphoric acid Add sodium dihydrogen, phosphoric acid, sorbitol, xylitol and sucralose into the liquid preparation tank, and stir evenly to obtain a mixed solution;

[0031] 2) After cooling the mixed solution to room temperature (20-30°C), add the prescribed amount of strawberry essence into the liquid mixing tank, and stir evenly to obtain the main solution;

[0032] 3) measure the pH value of the main solution, when the pH value deviates, adjust the pH value of the main solution to 4.5-6.5 with 1mol / L sodium hydroxide solution;

[0033] 4) After adjusting the pH value, dilute to volume with purified water, and stir evenly to obt...

Embodiment 1

[0041] The preparation method of oral solution described in the present embodiment comprises the following steps:

[0042] 1) First add 25°C purified water with 30% of the total amount of liquid to the liquid preparation tank, heat and control the temperature to 55°C, then add the prescribed amount of atomoxetine hydrochloride, sodium benzoate, sodium dihydrogen phosphate, Phosphoric acid, sorbitol, xylitol and sucralose are added to the liquid preparation tank and stirred evenly to obtain a mixed solution;

[0043] 2) After cooling the mixed solution to 25°C, add the prescribed amount of strawberry essence into the liquid mixing tank, and stir evenly to obtain the main solution;

[0044] 3) measure the pH value of the main solution, when the pH value deviates, adjust the pH value of the main solution to 5.5 with 1mol / L sodium hydroxide solution;

[0045] 4) After adjusting the pH value, dilute to 100 mL with purified water, and stir evenly to obtain atomoxetine hydrochloride...

Embodiment 2

[0048] The preparation method of oral solution described in the present embodiment comprises the following steps:

[0049]1) First add 20°C purified water with 30% of the total amount of liquid to the liquid preparation tank, heat and control the temperature to 45°C, then add the prescribed amount of atomoxetine hydrochloride, sodium benzoate, sodium dihydrogen phosphate, Phosphoric acid, sorbitol, xylitol and sucralose are added to the liquid preparation tank and stirred evenly to obtain a mixed solution;

[0050] 2) After cooling the mixed solution to 20°C, add the prescribed amount of strawberry essence into the liquid mixing tank, and stir evenly to obtain the main solution;

[0051] 3) measure the pH value of the main solution, when the pH value deviates, adjust the pH value of the main solution to 6.5 with 1mol / L sodium hydroxide solution;

[0052] 4) After adjusting the pH value, dilute to 100 mL with purified water, and stir evenly to obtain atomoxetine hydrochloride ...

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Abstract

The invention relates to a tomoxetine hydrochloride oral solution. The tomoxetine hydrochloride oral solution comprises the following components in percentage by mass: tomoxetine hydrochloride 4.6 mg / mL, sodium benzoate 0.2-2 mg / mL, sodium dihydrogen phosphate 5-30 mg / mL, phosphoric acid 0.2-2 mg / mL, sorbitol 10-50 mg / mL, xylitol 100-500 mg / mL, sucralose 2-20 mg / mL, strawberry essence 2-20 mg / mL,and the balance being purified water; and the oral solution has pH of 4.5-6.5. The invention also provides a preparation method of the tomoxetine hydrochloride oral solution. The oral solution has advantages of good taste correction effect, good mouthfeel, high comprehensive acceptance and convenience in taking, has an obvious effect on improving medication compliance of children and rationality of clinical medication, has a better treatment effect on attention deficit hyperactivity disorder patients, and effectively solves a problem of poor compliance of tomoxetine hydrochloride due to bittertaste.

Description

technical field [0001] The invention belongs to the technical field of medicines and preparation methods thereof, and in particular relates to atomoxetine hydrochloride oral solution and a preparation method thereof. Background technique [0002] Attention deficit hyperactivity disorder, also known as ADHD, is a common type of mental disorder in childhood. Manifested by inattention and short attention span, hyperactivity, and impulsivity that are disproportionate to age and developmental level, often accompanied by learning difficulties, conduct disorders, and maladjustment. The disease starts before school and is a chronic process. The disease not only affects children's school, family and out-of-school life, but also easily leads to persistent learning difficulties, behavioral problems and low self-esteem in children. Such children have difficulty getting along with others at home and school. If not treated in time, some children will still have symptoms in adulthood, wh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/138A61K47/02A61K47/04A61K47/12A61K47/26A61P25/14
CPCA61K31/138A61K9/0095A61K47/12A61K47/02A61K47/26A61P25/14
Inventor 吴雪英任霞王绮赵刚郭平余丽花杨颃张梦婷黄珮闻
Owner JIANMIN PHARMA GRP CO LTD
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