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Desloratadine citrate disodium oral rapidly disintegrating film and preparation method thereof

A technology of oral instant film and loratadine, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., which can solve the problems of children who are difficult to take, difficult to take, slow onset, etc. problems, achieve considerable economic and social benefits, rapid onset of effect, and small amount of auxiliary materials

Inactive Publication Date: 2016-06-01
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since tablets and capsules are solid preparations, it is difficult for the elderly and children to take them; the onset of action is slow, and it is difficult to take them without water

Method used

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  • Desloratadine citrate disodium oral rapidly disintegrating film and preparation method thereof
  • Desloratadine citrate disodium oral rapidly disintegrating film and preparation method thereof
  • Desloratadine citrate disodium oral rapidly disintegrating film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Each tablet contains 8.8 mg of desloratadine citrate, and the composition of 1000 tablets of desloratadine citrate oral instant film is:

[0032]

[0033] The preparation method is as follows:

[0034] (1) Dissolve the prescribed amount of sulfobutyl ether-β-cyclodextrin in purified water of 80% of the total amount of prescribed water, heat to 45°C under stirring, slowly add the prescribed amount of desloratadine citrate , continue stirring for 24 hours;

[0035] (2) Weigh the prescribed amount of sucralose and citric acid, add them to the solution in step (1), and stir until dissolved.

[0036] (3) Weigh the hypromellose E5 and glycerin of prescription quantity, join in the solution of step (2), wait to dissolve completely, let stand overnight, obtain the gel for scraping; Scrape the gel for scraping Apply to a glass plate, dry, then peel off the film from the glass plate and cut.

[0037] (4) Packing the cut film to obtain desloratadine citrate oral instant film...

Embodiment 2

[0040] Each tablet contains 8.8 mg of desloratadine citrate, and the composition of 1000 tablets of desloratadine citrate oral instant film is:

[0041]

[0042] The preparation method is as follows:

[0043] (1) The hydroxypropyl-beta-cyclodextrin of recipe quantity is dissolved in the purified water of 80% of prescription water total amount, is heated to 45 ℃ under stirring state, slowly adds the desloratadine citrate of recipe quantity, Continue stirring for 24 hours;

[0044](2) Weigh the prescribed amount of sucralose and citric acid, add them to the solution in step (1), and stir until dissolved.

[0045] (3) Weigh the hypromellose E5 and glycerin of prescription quantity, join in the solution of step (2), wait to dissolve completely, let stand overnight, obtain the gel for scraping; Scrape the gel for scraping Apply to a glass plate, dry, then peel off the film from the glass plate and cut.

[0046] (4) Packing the cut film to obtain desloratadine citrate oral ins...

Embodiment 3

[0049] Each tablet contains 8.8 mg of desloratadine citrate, and the composition of 1000 tablets of desloratadine citrate oral instant film is:

[0050]

[0051]

[0052] The preparation method is as follows:

[0053] (1) Dissolve the prescribed amount of sulfobutyl ether-β-cyclodextrin in purified water of 80% of the total amount of prescribed water, heat to 45°C under stirring, slowly add the prescribed amount of desloratadine citrate , continue stirring for 24 hours;

[0054] (2) Weigh the prescribed amount of sucralose and citric acid, add them to the solution in step (1), and stir until dissolved.

[0055] (3) Weigh the hypromellose E5 and glycerin of prescription quantity, join in the solution of step (2), wait to dissolve completely, let stand overnight, obtain the gel for scraping; Scrape the gel for scraping Apply to a glass plate, dry, then peel off the film from the glass plate and cut.

[0056] (4) Packing the cut film to obtain desloratadine citrate oral ...

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Abstract

The invention discloses a desloratadine citrate disodium oral rapidly disintegrating film and a preparation method thereof, belonging to the preparation field of desloratadine citrate disodium oral rapidly disintegrating films. The invention firstly discloses a desloratadine citrate disodium oral rapidly disintegrating film which comprises the following components in parts by weight: 2-10 parts of desloratadine citrate disodium, 30-60 parts of film forming material, 10-30 parts of cyclodextrin, 2-8 parts of a plasticizer, 0.2-1.0 part of a flavoring agent, 0.5-1.0 part of a pH regulator and 0.001-0.01 part of a coloring agent. Preferably, the desloratadine citrate disodium oral rapidly disintegrating film disclosed by the technical scheme of the invention further comprises a filling agent. The desloratadine citrate disodium oral rapidly disintegrating film is good in appearance, moderate in flexibility, good in taste, short in disintegrating time, high in effect taking speed, convenient to carry, good in taking compliance, simple in preparation technology and low in cost.

Description

technical field [0001] The invention relates to an orally disintegrating tablet, and also relates to a preparation method of the desloratadine citrate oral instant film, which belongs to the field of preparation of the desloratadine citrate oral instant film. technical background [0002] Urticaria is "a group of heterogeneous diseases with unique and identical skin manifestations". It is a common allergic skin disease with clinical features such as protracted disease course, recurrent attacks, and difficult to cure. Its clinical manifestations are as follows: Itchy skin that appears as pale, bright red, or skin-colored wheals. In some cases, edematous erythema will appear, and the shape and size of the wheal of each patient are different, and the time of attack is not fixed. The cause of the disease is often not found. About 1 / 3 of patients with chronic urticaria have abnormal autoimmune function. Patients have red, swollen and itchy rashes on their body, face or limbs fro...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4545A61K47/48A61K47/38A61K47/10A61P17/00A61P37/08
CPCA61K9/006A61K9/7007A61K31/4545A61K47/10A61K47/38
Inventor 杨贤龙何勇吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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