Escitalopram oxalate oral dissolution film agent and preparation method thereof

A film-dissolving and oxalic acid technology, applied in pharmaceutical formulations, sheet delivery, nervous system diseases, etc., can solve problems such as unpublished product stability data, unfavorable large-scale production, etc., achieving good environmental and economic benefits, and good taste , the effect of good stability

Inactive Publication Date: 2016-12-07
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In view of the high volatility of ethanol, a large amount of ethanol vapor will inevitably be generated during the drying process, which poses a great challenge to the safety of production personnel in the workshop and the explosion protection of the workshop, which is not conducive to industrialized mass production
[0009] In addition, considering the extreme instability of raw materials under conditions such as oxidation and high temperature, the above-mentioned published technology has not published any product stability data

Method used

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  • Escitalopram oxalate oral dissolution film agent and preparation method thereof
  • Escitalopram oxalate oral dissolution film agent and preparation method thereof
  • Escitalopram oxalate oral dissolution film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1: Antioxidant influences on product stability

[0037]

[0038] *Used in prescription but removed in final product.

[0039] Preparation:

[0040] [1] Add plasticizers, flavoring agents, colorants, antioxidants and raw materials into water and stir evenly at room temperature to obtain a dispersion system;

[0041] [2] Add a polymer film-forming material to the dispersion system in step 1, stir fully at room temperature to obtain a drug-containing glue, and perform degassing treatment if necessary;

[0042] [3] Coating the drug-containing glue in step 2, drying at 30°C, and cutting after drying to obtain the mouth-melting film.

[0043] The prepared film is white in color, has good smoothness and plasticity, and meets the requirements of cutting, packaging, transportation and clinical use.

[0044] Product 1, product 2 and product 3 were placed under the conditions of 40°C and 75% relative humidity for 30 days respectively, and samples were taken to det...

Embodiment 2

[0049] Embodiment 2: drying temperature influences on product stability

[0050]

[0051] *Used in prescription but removed in final product.

[0052] Preparation:

[0053] [1] Add plasticizers, flavoring agents, colorants, antioxidants and raw materials into water and stir evenly at room temperature to obtain a dispersion system;

[0054] [2] Add a polymer film-forming material to the dispersion system in step 1, stir fully at room temperature to obtain a drug-containing glue, and perform degassing treatment if necessary;

[0055] [3] Apply the drug-containing glue in step 2, dry under predetermined temperature conditions (35°C for both products 4 and 5; 40°C for product 6), and cut after drying to obtain the mouth-melting film.

[0056] The prepared film is white in color, has good smoothness and plasticity, and meets the requirements of cutting, packaging, transportation and clinical use.

[0057] Product 4, product 5 and product 6 were placed under the conditions of ...

Embodiment 3

[0069] Example 3: BHA as an antioxidant

[0070]

[0071]

[0072] *Used in prescription but removed in final product.

[0073] Preparation:

[0074] [1] Add plasticizers, flavoring agents, colorants, antioxidants and raw materials into water and stir evenly at room temperature to obtain a dispersion system;

[0075] [2] Add a polymer film-forming material to the dispersion system in step 1, stir fully at room temperature to obtain a drug-containing glue, and perform degassing treatment if necessary;

[0076] [3] Coating the drug-containing glue in step 2, drying at a predetermined temperature, and cutting after drying to obtain the mouth-melting film.

[0077] The prepared film is dark yellow in color, has good smoothness and plasticity, and meets the requirements of cutting, packaging, transportation and clinical use.

[0078] Product 7 was placed at 40°C and 75% relative humidity for 30 days, and samples were taken to detect related substances on days 0 and 30. The...

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PUM

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Abstract

The invention belongs to the technical field of medicinal preparation and particularly relates to an escitalopram oxalate oral dissolution film agent and a preparation method thereof. The escitalopram oxalate oral dissolution film agent comprises an antioxygen, a high polymer film-forming material and the like. The film agent provided by the invention is novel in appearance and excellent in taste, can be dissolved in an oral cavity quickly, can be taken without water, and can be accepted and adopted by patients easily; in addition, compared with common drugs, the film agent provided by the invention is different in appearance and taste, not only can relieve mental stress of patients, but also can protect patients' privacy. The product adopts the process of low temperature drying, is used together with the antioxygen, and ensures excellent product stability. The preparation process is environmentally friendly, low in cost, and has excellent environmental benefits and economic benefits.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an escitalopram oxalate oral film-dissolving agent and a preparation method thereof, which are used for treating depression and panic disorder with or without agoraphobia. Background technique [0002] Depression is a common mental disorder, which is called "blue worry" in the West. In today's society, with the obvious acceleration of the pace of life and work, people's mental stress is increasing day by day, and mental illnesses, especially those suffering from depression or those who are prone to depression, are increasing exponentially. According to the World Health Organization (WHO) survey, the incidence of depression in the world is about 3.1%, and in my country it is about 4%, and it is increasing year by year. It is estimated that by 2020, the number of patients with functional disabilities caused by depression will increase. To the second ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/10A61K47/14A61K31/343A61P25/24
CPCA61K9/0056A61K9/7007A61K31/343A61K47/10A61K47/14
Inventor 杨清敏周志超王栋海张明会
Owner QILU PHARMA CO LTD
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