Atomoxetine hydrochloride rapidly disintegrating oral film agent and preparation method thereof

A technology of atomoxetine hydrochloride and oral instant film, which is applied in the direction of medical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. Affect the medication compliance of patients and children, and achieve the effect of good taste, safe and reliable route of administration, and improvement of medication compliance

Inactive Publication Date: 2018-02-27
北京达因高科儿童药物研究院有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technique uses cyclodexymeterhesis (CD) containing choline salt called sugar alcohol octanoate(CAS No.: 9891-92-8), which can be used alone or mixed together with other substance like glycerol monolaureate (GML). CD helps improve smoking cessations caused from opioid overdose due to its ability to block certain receptive neurons that help control breathing movements during respiration. It also enhances how easily it works when taken through food products such as chewing gum tablets. Overall this technical effect makes an effective medicine available at home while minimizing harmful chemical compounds released into our environment.

Problems solved by technology

The technical problem addressed in this patented text relates to providing new ways to overcome these difficulties associated with smoking cigarettes due to their unpleasant tastings during use.

Method used

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  • Atomoxetine hydrochloride rapidly disintegrating oral film agent and preparation method thereof
  • Atomoxetine hydrochloride rapidly disintegrating oral film agent and preparation method thereof
  • Atomoxetine hydrochloride rapidly disintegrating oral film agent and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] prescription:

[0035]

[0036] Note: *Used in formulation but removed during processing

[0037] Preparation:

[0038] 1) Add cyclodextrin to purified water at 20-50°C, stir to dissolve, add atomoxetine hydrochloride to the cyclodextrin solution, and stir for 0.5-4 hours to obtain the cyclodextrin-coated atomoxetine hydrochloride Xitine;

[0039]2) Dissolving the film-forming material in water at 50-70°C, adding the atomoxetine hydrochloride cyclodextrin inclusion compound prepared in 1), and continuously stirring;

[0040] 3) Add flavoring agent, plasticizer and disintegrant sequentially to the dispersion formed in 2), and stir for 0.5 hours;

[0041] 4) the drug-containing glue formed in 3) is left to stand for defoaming;

[0042] 5) Coating the drug-containing glue obtained in 4), drying at 50-60° C., and cutting to obtain the atomoxetine hydrochloride film.

Embodiment 2

[0044] prescription:

[0045]

[0046] Note: *Used in formulation but removed during processing

[0047] Preparation:

[0048] 1) Add cyclodextrin to purified water at 20-50°C, stir to dissolve, add atomoxetine hydrochloride to the cyclodextrin solution, and stir for 0.5-4 hours to obtain the cyclodextrin-coated atomoxetine hydrochloride Xitine;

[0049] 2) Dissolving the film-forming material in water at 50-70°C, adding the atomoxetine hydrochloride cyclodextrin inclusion compound prepared in 1), and continuously stirring;

[0050] 3) Add flavoring agent, plasticizer and disintegrant sequentially to the dispersion formed in 2), and stir for 0.5 hours;

[0051] 4) the drug-containing glue formed in 3) is left to stand for defoaming;

[0052] 5) Coating the drug-containing glue obtained in 4), drying at 50-60° C., and cutting to obtain the atomoxetine hydrochloride film.

Embodiment 3

[0054] prescription:

[0055]

[0056] Note: *Used in formulation but removed during processing

[0057] Preparation:

[0058] 1) Add cyclodextrin to purified water at 20-50°C, stir to dissolve, add atomoxetine hydrochloride to the cyclodextrin solution, and stir for 0.5-4 hours to obtain the cyclodextrin-coated atomoxetine hydrochloride Xitine;

[0059] 2) Dissolving the film-forming material in water at 50-70°C, adding the atomoxetine hydrochloride cyclodextrin inclusion compound prepared in 1), and continuously stirring;

[0060] 3) Add flavoring agent, plasticizer and disintegrant sequentially to the dispersion formed in 2), and stir for 0.5 hours;

[0061] 4) the drug-containing glue formed in 3) is left to stand for defoaming;

[0062] 5) Coating the drug-containing glue obtained in 4), drying at 50-60° C., and cutting to obtain the atomoxetine hydrochloride film.

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Abstract

The invention relates to a pharmaceutical composition containing atomoxetine hydrochloride and a preparation method thereof, in particular to an atomoxetine hydrochloride rapidly disintegrating oral film agent and a preparation method thereof. According to the invention, the atomoxetine hydrochloride rapidly disintegrating oral film agent can rapidly dissolve in the oral cavity, takes effect rapidly without water, is convenient to take, good in taste and easy to be accepted by patients of the pediatric department, solves the disadvantage of poor compliance of children medication of existing atomoxetine hydrochloride preparations, improves the medication compliance of patients of the pediatric department, and meets the clinical medication requirement of children.

Description

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Claims

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Application Information

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Owner 北京达因高科儿童药物研究院有限公司
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