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Aerosol inhalant and preparation method thereof

A technology of nebulized inhalant and atomizing device, which is applied in the field of medicine to achieve the effect of simple production process, small particle size and good repeatability

Inactive Publication Date: 2020-10-30
SHANGHAI ANOVENT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the storage and use of the dry powder inhaler, the drug powder may be affected by moisture. For multi-dose DPI, there may be a release dose content uniformity (DDCU problem)

Method used

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  • Aerosol inhalant and preparation method thereof
  • Aerosol inhalant and preparation method thereof
  • Aerosol inhalant and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Preparation of sample 1 and sample 2 inhalation solution: Weigh 50% benzalkonium chloride and Tween-80 of the prescription in Table 1 with a weighing bottle, dissolve in 95% ethanol of the prescription in Table 1 in three times and transfer to the prepared solution. In the weighed 100ml volumetric flask, add umeclidinium bromide and vilanterol triphenylacetate in the recipe quantities in Table 1, and dissolve by ultrasonic. Then add the prescription amount of edetate disodium dihydrate dissolved in an appropriate amount of pure water, and then ultrasonically dissolve, and make up the volume to 100ml with pure water. Both samples 1 and 2 are clear solutions, and the measured content results are shown in Table 2, indicating that both umeclidinium bromide and vilanterol triphenylacetate have been completely dissolved in the dilute ethanol solution containing Tween-80 .

[0053] Table 1 Recipe for sample 1 and sample 2 inhalation solutions

[0054] Element Sam...

Embodiment 2

[0058] Weigh the 50% benzalkonium chloride and Tween-80 of the recipe amount in Table 3 with a weighing bottle, dissolve and transfer to the weighed 100ml volumetric flask with the 95% ethanol of the recipe amount in Table 3 in three times, and then add The umeclidinium bromide and vilanterol triphenylacetate of recipe quantity in table 3, ultrasonic dissolving. Add the disodium edetate dihydrate of the recipe quantity that dissolves with an appropriate amount of pure water again, and ultrasonically dissolve again, and make up to 100ml with pure water. Sample 3, sample 4 and sample 5 are all clear solutions, and the measured content results are shown in Table 4, indicating that umeclidinium bromide and vilanterol triphenylacetate have been completely dissolved in dilute solution containing Tween-80. in ethanol solution.

[0059] Table 3 Recipe for sample 3, sample 4 and sample 5 inhalation solutions

[0060]

[0061] Table 4 Assay results of sample 3, sample 4 and sample ...

Embodiment 3

[0064] Weigh the 50% benzalkonium chloride and Tween-80 of the recipe in Table 5 with a weighing bottle, dissolve and transfer to the weighed 100ml volumetric flask with the 95% ethanol of the recipe in Table 5 in three times, and then add in Table 5. The prescribed amounts of umeclidinium bromide and vilanterol triphenylacetate were dissolved by ultrasonic. Then add the prescribed amount of edetate disodium dihydrate dissolved in an appropriate amount of pure water, then dissolve by ultrasonic, and make up to 100ml with pure water. Sample 3, sample 4 and sample 5 are all clear solutions, and the measured content results are shown in Table 6.

[0065] Table 5 Recipe for sample 6, sample 7 and sample 8 inhalation solutions

[0066] Element Sample 6 Sample 7 Sample 8 umeclidinium bromide 21mg 21mg 21mg vilanterol triphenylacetate 11mg 11mg 11mg Disodium Edetate Dihydrate 11mg 11mg 11mg 50% benzalkonium chloride 20mg 20mg...

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Abstract

The invention discloses an aerosol inhalant and a preparation method thereof. The aerosol inhalant comprises the following components: active components including umeclidinium bromide and vilanterol triphenyl acetate, a solubilizer, a bacteriostatic agent and a solution carrier. In addition, the invention also discloses a pharmaceutical composition. The active components, namely the umeclidinium bromide and the vilanterol triphenyl acetate, of the aerosol inhalant are good in stability, propellants are not contained, and the prepared aerosol inhalant is small in particle size and beneficial for pulmonary absorption of medicines. The preparation method for the aerosol inhalant is simple in production process, good in repeatability and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an atomized inhaler and a preparation method thereof. Background technique [0002] Uclidinium bromide is a white powder with a molecular weight of 508.5 and a molecular formula of C 29 H 34 NO 2 Br, slightly soluble in water, its structural formula is as follows: [0003] [0004] Vilanterol triphenylacetate is a white powder with a molecular weight of 774.8 and a molecular formula of C24H33Cl2NO5.C20H16O2. It is almost insoluble in water. Its structural formula is as follows: [0005] [0006] In December 2013, the US FDA approved GlaxoSmithKline's umeclidinium bromide vilanterol inhalation powder for once-daily oral inhalation for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. During storage and use of dry powder inhalers, drug powders may be affected by moisture, and for multi-dose DPIs, a drug-d...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/12A61K47/18A61K47/10A61K31/439A61K31/137A61P11/00A61P11/02A61P31/06A61P31/10
CPCA61K9/0078A61K9/12A61K31/137A61K31/439A61K47/10A61K47/183A61P11/00A61P11/02A61P31/06A61P31/10A61K2300/00A61K9/08A61K47/18
Inventor 黄才古许英爱袁辉
Owner SHANGHAI ANOVENT PHARMA CO LTD
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