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Stable Montelukast oral film preparation

An oral film and stabilizer technology, applied in the field of medicine, can solve the problems of high safety risk, inducing cancer, loss of activity, etc., and achieve the effect of avoiding Tibetan medicine, good taste and bright color

Active Publication Date: 2015-07-22
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, BHT and BHA have phenolic reaction characteristics, and trace amounts of metals or light can cause discoloration and loss of activity
Both are almost insoluble in water, and organic solvents need to be used to dissolve them in the process. Recent studies have found that long-term use of BHA has the risk of inducing cancer. As a pediatric drug, the safety risk is relatively high

Method used

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  • Stable Montelukast oral film preparation
  • Stable Montelukast oral film preparation
  • Stable Montelukast oral film preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The influence of embodiment 1 disodium edetate on product stability

[0036]

[0037] *Used in prescription but removed during processing.

[0038] Preparation process: Dissolve or disperse all components except montelukast sodium and film-forming material in water under stirring under dark conditions, add montelukast sodium and stir to dissolve to obtain a drug-containing solution; add film-forming material , stirred until completely dissolved to obtain the drug-containing glue; stirred and defoamed under vacuum conditions, evenly coated the drug-containing glue on the polyester tape with a scraper, heated and dried, and cut into certain sizes to obtain pink Montelukast sodium orally dissolving film.

Embodiment 2

[0048] Embodiment 2 The impact of different dosages of edetate disodium on product stability

[0049]

[0050]

[0051] *Used in prescription but removed during processing.

[0052] Preparation process: Dissolve or disperse all components except montelukast sodium and film-forming material in water under stirring under dark conditions, add montelukast sodium and stir to dissolve to obtain a drug-containing solution; add film-forming material , stirred until completely dissolved to obtain the drug-containing glue; stirred and defoamed under vacuum conditions, evenly coated the drug-containing glue on the polyester tape with a scraper, heated and dried, and cut into certain sizes to obtain pink Montelukast sodium orally dissolving film.

Embodiment 3

[0065] Embodiment 3 The impact of different types of stabilizers on product stability

[0066]

[0067] *Used in prescription but removed during processing.

[0068] Preparation process: Dissolve or disperse all components except montelukast sodium and film-forming material in water under stirring under dark conditions, add montelukast sodium and stir to dissolve to obtain a drug-containing solution; add film-forming material , stirred until completely dissolved to obtain the drug-containing glue; stirred and defoamed under vacuum conditions, evenly coated the drug-containing glue on the polyester tape with a scraper, heated and dried, and cut into certain sizes to obtain pink Montelukast sodium orally dissolving film.

[0069] The sample of Example 3 was placed under the conditions of 40° C. and 75% relative humidity for 30 days, and samples were taken at 0, 15, and 30 days for determination according to the method of Test Example 1. The result is as follows:

[0070] T...

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Abstract

The invention relates to a stable Montelukast oral film preparation. The oral film preparation contains an effective amount of Montelukast or pharmaceutically acceptable salts of the Montelukast, a drug stabilizer at least comprising edetic acid and / or editate as well as pharmaceutically acceptable auxiliary materials. The Montelukast oral film preparation obtained according to the formula is accurate in dose, stable in quality and capable of effectively preventing oxidization and degradation of effective components, has the advantages of bright color, good taste, capability of being quickly dissolved in an oral cavity without water, improves the administration compliance of a patient and is particularly suitable for infants and patients suffering from dysphagia.

Description

technical field [0001] The invention relates to a stable montelukast oral thin film preparation, which belongs to the technical field of medicine. Background technique [0002] The chemical name of montelukast sodium is [R-(E)]-1-[[[1-[3-[2-[7-chloro-2-quinoline]vinyl]phenyl-3-[2- (1-Hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropane sodium acetate, the structural formula is as follows: [0003] [0004] Montelukast sodium is a potent and selective leukotriene D4 receptor antagonist, which can selectively inhibit various stimuli (sulfur dioxide, exercise and cold air, etc.) and various allergens (pollen, dander, etc.) etc.) caused by the increase of inflammatory factor leukotriene polypeptide, thereby inhibiting the immediate phase and delayed phase inflammatory response, reducing or preventing a series of airway reactions (bronchoconstriction, mucus secretion, increased vascular permeability and eosinophilic Cell aggregation), widely used in the prevention an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/47A61K47/18A61P29/00A61P11/06A61P11/02A61P37/08
Inventor 张明会张勇王栋海杨清敏程廷廷
Owner QILU PHARMA CO LTD
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