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Medical aerosol preparation and quantitatively-inhaled aerosol

A quantitative inhalation and aerosol technology, which is used in aerosol delivery, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Delivering dose uniformity and other issues to achieve the effect of reducing the dose and increasing the stability of the liquid

Active Publication Date: 2017-05-10
SICHUAN PURITY PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Aiming at the problem in the above-mentioned prior art that because formolofumarate is slightly soluble in ethanol, the particle size of the drug will aggregate after being placed for a long time, resulting in uneven concentration of the drug solution, thereby affecting the uniformity of the drug delivery dose

Method used

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  • Medical aerosol preparation and quantitatively-inhaled aerosol
  • Medical aerosol preparation and quantitatively-inhaled aerosol
  • Medical aerosol preparation and quantitatively-inhaled aerosol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A medical aerosol preparation, comprising an active ingredient and a liquefied propellant as a solvent for the active ingredient, the active ingredient including mometasone furoate and formyl fumarate, the liquefied propellant is hydrofluorocarbon, and It includes ethanol and Span 80 added to the liquefied propellant, and the weight ratio of the Span 80 in the aerosol formulation is 0.01%-0.1% w / w.

[0027] Specifically, in view of the above-mentioned problem that ethanol affects the uniformity of drug delivery dose, in the prior art, oleic acid is added to aerosol preparations. However, as the aerosol preparation is placed for a longer time, the uniformity of drug delivery dose gradually deteriorates.

[0028] In this solution, by adding Span 80 as a surfactant to the aerosol formulation, the Span 80 can maintain a uniform concentration of the drug solution for a long time, thereby achieving the purpose of increasing the stability of the drug solution. The above limitation ...

Embodiment 2

[0050] This embodiment is further limited on the basis of Embodiment 1. As a further technical solution of the medical aerosol preparation described above, the effective components in the aerosol preparation can be effectively divided or deposited in the bronchus, On the bronchioles and lungs, the mometasone furoate and the fumarate fumarate are all fine powders with a median particle size less than 5 microns obtained after airflow pulverization. In this solution, since a certain amount of Span 80 is added to the aerosol formulation, although the effective ingredients with the median particle size above have a large surface energy, they are still not easily adsorbed on the surface of the container.

[0051] As a solution for realizing a liquefied propellant that is beneficial to environmental protection, the HFC is any one of HFA 134a and HFA 227 or a mixture of both.

Embodiment 3

[0053] This embodiment is further limited on the basis of Embodiment 1. As a further technical solution of the above medical metered dose inhalation aerosol, the pressurized metered-dose inhaler includes a container 1, a metering valve 2 and a driver 3. The material of the containing tank 1 is magnesium-aluminum alloy, and part or all of the inner wall of the containing tank 1 is coated with perfluorocarbon high polymer.

[0054] The above containing tank 1 is used as a storage container for aerosol preparations. Because the natural oxide film on the surface of the ordinary magnesium aluminum alloy is thin and soft, the density is poor, the surface is uneven, and it is easy to absorb the particles in the drug, and the surface layer of the tank 1 is also contained The magnesium, aluminum, etc. will penetrate into the liquid medicine. In this solution, the inner wall of the containing tank 1 is partially or completely coated with perfluorocarbon polymer, so that a dense coating can...

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Abstract

The invention discloses a medical aerosol preparation and quantitatively-inhaled aerosol. The preparation comprises active components and a liquid propellant which is used as a solvent of the active components, wherein the active components comprise mometasone furoate and formoterol fumarate; the liquid propellant is hydrofluorocarbon; the medical aerosol preparation also comprises ethyl alcohol and span-80 which are added into the liquid propellant; the weight ratio of the span-80 in the aerosol preparation is 0.01-0.1%w / w; medical liquid in the aerosol is the medical aerosol preparation. According to the scheme, span-80 is added into the aerosol preparation and is used as a surfactant; span-80 is capable of maintaining uniform concentration of the medical liquid for a long time, so that the purpose of improving the stability of the medical liquid is achieved; the addition amount of span-80 is limited, so that the influence on generation of the medical aerosol and reduction of dosage of fine particles caused by excessive span-80 can be avoided when span-80 achieves the effects of assisting suspension and lubricating.

Description

Technical field [0001] The invention relates to the field of medical aerosol products, in particular to a medical aerosol preparation and a quantitative inhalation aerosol. Background technique [0002] At present, pressurized metered-dose inhalers (MDIs) are the most effective and acceptable way to accurately administer small doses to the human respiratory tract. Therapeutic agents generally delivered in this manner include bronchodilators of β2 adrenergic agonists, particularly β2 agonists and cortisol and combinations thereof. Typical MDIs include a pressure-resistant tank containing a therapeutic agent. The therapeutic agent is mostly a drug dissolved in a liquefied propellant or micronized particles suspended in the liquefied propellant. MDIs are also equipped with a metering valve, which can be measured by touch Valve to release a certain amount of therapeutic agent. [0003] According to the anatomy and physiological structure of the bronchial bronchioles and the lungs, in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K31/167A61K9/72A61K9/12A61K47/22A61P11/08A61P11/00A61M15/00
CPCA61K47/22A61M15/0065A61K9/0078A61K9/124A61K31/167A61K31/58A61K2300/00A61M15/009A61K9/008A61K47/26A61K47/10A61K47/06
Inventor 舒宏侯曙光李丛菊贺钢民张静吴君
Owner SICHUAN PURITY PHARM CO LTD