Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Atomoxetine hydrochloride oral solution and preparation method thereof

A technology of atomoxetine hydrochloride and oral solution, which is applied in the field of atomoxetine hydrochloride oral solution and its preparation, can solve the problems that patients with comorbid tic disorders are not recommended to use, affect growth and development, and cannot be determined, so as to cover up the drug Effects of bad taste, improved stability, and improved compliance

Inactive Publication Date: 2021-03-09
BEIJING DO-PHARMA TECH CO LTD
View PDF2 Cites 4 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Currently, the main drugs recommended for the treatment of attention deficit hyperactivity disorder include central stimulants: long-acting methylphenidate preparations, short-acting methylphenidate preparations, and dexmethylphenidate; central stimulants are limited to patients over 6 years old, because of Stimulant effect, should not be used at night, drug side effects include loss of appetite, insomnia, headache, irritability and irritability, etc. It is not sure whether it will affect growth and development, and it may induce or aggravate the patient's tic symptoms. Patients with comorbid tic disorder are not recommended to use it

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Atomoxetine hydrochloride oral solution and preparation method thereof
  • Atomoxetine hydrochloride oral solution and preparation method thereof
  • Atomoxetine hydrochloride oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] The formula of the atomoxetine hydrochloride oral liquid provided by the present embodiment, every 200L solution is made of the bulk drug and adjuvant of the following weight, as shown in Table 1

[0017] Formulation table of atomoxetine hydrochloride oral liquid in table 1 embodiment 1

[0018]

[0019] Add purified water (11.04kg) to the preparation tank 1, start stirring (stirring speed 500rpm), then add hydroxypropyl-β-cyclodextrin (3.59kg) to it, and stir until the hydroxypropyl-β-cyclodextrin fine dissolved, as solution 1.

[0020] Add 50% ethanol aqueous solution (11.13kg) to the preparation tank 2, start stirring (stirring speed 500rpm), then add atomoxetine hydrochloride (0.92kg) therein, stir until atomoxetine hydrochloride dissolves, as solution 2 .

[0021] Mix solution 2 with solution 1, start stirring (stirring speed 500rpm), mix well and transfer to the grinding tank, start grinding (speed 700rpm), add hydroxypropyl-β-cyclodextrin (3.59kg), and grind...

Embodiment 2

[0024] The formula of the atomoxetine hydrochloride oral liquid provided by the present embodiment, every 200L solution is made up of the crude drug and adjuvant of following weight, as shown in table 2

[0025] The formula table of atomoxetine hydrochloride oral liquid in table 2 embodiment 2

[0026]

[0027] Add purified water (11.04kg) to the preparation tank 1, start stirring (stirring speed 500rpm), then add hydroxypropyl-β-cyclodextrin (3.59kg) to it, and stir until the hydroxypropyl-β-cyclodextrin fine dissolved, as solution 1.

[0028] Add 50% ethanol aqueous solution (11.13kg) to the preparation tank 2, start stirring (stirring speed 500rpm), then add atomoxetine hydrochloride (0.92kg) therein, stir until atomoxetine hydrochloride dissolves, as solution 2 .

[0029] Mix solution 2 with solution 1, start stirring (stirring speed 500rpm), after mixing evenly, put it in a 60°C oven for drying, the dried product is used as intermediate 1, and the calculated yield is...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Wavelengthaaaaaaaaaa
Wavelengthaaaaaaaaaa
Login to View More

Abstract

The invention discloses an atomoxetine hydrochloride oral solution for treating the attention deficit hyperactivity disorder, and a preparation method of the atomoxetine hydrochloride oral solution. The preparation comprises atomoxetine hydrochloride, hydroxypropyl-[beta]-cyclodextrin, pH regulating agent, preservative, essence, 50% ethyl alcohol and water. The preparation method comprises the following steps of: putting the water into a jar 1, carrying out stirring, adding the cyclodextrin, and carrying out dissolving to obtain a solution 1; putting 50% ethyl alcohol into a jar 2, carrying out stirring, adding the atomoxetine hydrochloride, and carrying out dissolving to obtain a solution 2; evenly mixing the solution 1 and the solution 2, transferring an obtained mixture into a grindingjar, carrying out grinding, adding the cyclodextrin, and after one hour, carrying out drying in an oven to obtain an intermediate 1; and putting the water in a preparation jar, adding the converted intermediate 1, sodium dihydrogen phosphate, phosphoric acid and sodium benzoate, carrying out stirring and dissolving, adding the essence, after the obtained mixture is even, measuring the pH value, controlling the pH value to 3.7-4.3, and obtaining 4.6mg / ml of atomoxetine hydrochloride oral solution. The oral aqueous solution improves the stability of the atomoxetine hydrochloride to a high degree, and a higher social value is brought.

Description

technical field [0001] The invention belongs to the technical field of medicines and preparation methods thereof, and relates to a atomoxetine hydrochloride oral liquid and a preparation method thereof, the product of which significantly reduces the strong bitter taste of atomoxetine hydrochloride and improves medication compliance of children and adolescents sex. Background technique [0002] Attention deficit hyperactivity disorder (ADHD), covering attention deficit disorder (English: Attention Deficit Disorder, abbreviated as ADD), is a common type of psychological disorder in childhood, which is not commensurate with age and developmental level inattention and short attention span, hyperactivity, and impulsivity, often with learning difficulties, conduct disturbance, and maladjustment, symptoms usually appear around age twelve and persist beyond six months in at least two contexts ( eg: school, family, leisure activities, etc.). [0003] Currently, the main drugs recom...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K9/08A61K31/138A61K47/69A61P25/14
CPCA61K9/0095A61K31/138A61K47/6951A61P25/14
Inventor 吴龙昊李鹏飞张严源李娟
Owner BEIJING DO-PHARMA TECH CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com