Aerosol preparation and quantitative inhalation aerosol

An aerosol and preparation technology, which is used in aerosol delivery, inhalers, respiratory diseases, etc., can solve problems such as the inability of drugs to enter the lungs, the decrease in the dose of fine particles, and the adverse effects of active ingredients in aerosols. Conducive to environmental protection, guaranteed curative effect, small damage effect

Active Publication Date: 2017-04-26
SICHUAN PURITY PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] For the above-mentioned prior art, there are few studies on the amount of lubricant and suspending agent added, which has led to the fact that the aerosol products in the prior art tend to be affected by the active ingredients of the aerosol due to lubricants and

Method used

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  • Aerosol preparation and quantitative inhalation aerosol
  • Aerosol preparation and quantitative inhalation aerosol
  • Aerosol preparation and quantitative inhalation aerosol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] An aerosol preparation and a metered dose inhalation aerosol, comprising an active ingredient and a liquefied propellant as a solvent for the active ingredient, the active ingredient comprising budesonide and formolo fumarate, the liquefied propellant being hydrogen The fluorocarbon also includes PVPk25 and PEG1000 added to the liquefied propellant, the content of the PVPk25 in the aerosol preparation is 0.00005-0003wt%, and the content of the PEG1000 in the aerosol preparation is 0.001-0.01wt%.

[0028]In this embodiment, the above combination of budesonide and formoterol fumarate can be used as the treatment of respiratory diseases, that is, it is the active ingredient in this aerosol preparation, the above PVPk25 is the suspending agent in the aerosol preparation, and the above PEG1000 is a lubricant in aerosol formulations. Among the above components, by limiting the content of PVPk25 and PEG1000 in the aerosol preparation, the dosage of fine particles when the aero...

Embodiment 2

[0039] This example is further limited on the basis of Example 1, the content of the PVPk25 in the aerosol preparation is 0.0002wt%, and the content of the PEG1000 in the aerosol preparation is 0.0025wt%. In this scheme, the method for measuring the fine particle dose and delivery dose uniformity of each prescription is determined with reference to the method of "Chinese Pharmacopoeia" 2015 edition general rules (inhalation aerosol) 0111, and the devices used are as follows: delivery dose uniformity determination device, fine particle dose determination The device is used to measure, and the results obtained are: the dose of fine particles of the budesonide component can be about 60%, the dose of fine particles of the formoterol fumarate component can be about 67%, and the delivery dose uniformity of the budesonide component is relatively The standard deviation value is about 4.8%, and the relative standard deviation value of the delivery dose uniformity of the formoterol fumar...

Embodiment 3

[0041] This example is further limited on the basis of Example 1, the content of the PVPk25 in the aerosol preparation is 0.0002-0.001wt%. In this scheme, the method for measuring the fine particle dose and delivery dose uniformity of each prescription is determined with reference to the method of "Chinese Pharmacopoeia" 2015 edition general rules (inhalation aerosol) 0111, and the devices used are as follows: delivery dose uniformity determination device, fine particle dose determination The device is used for measurement, and the results obtained are: the dose of fine particles of the budesonide component is about 60%, the dose of fine particles of the formoterol fumarate component is about 68%, and the delivery dose uniformity of the budesonide component is relatively The standard deviation value is about 4%, and the relative standard deviation value of the delivery dose uniformity of the formoterol fumarate component is about 3.5%.

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Abstract

The invention discloses an aerosol preparation and quantitative inhalation aerosol. The preparation comprises active components and a liquefaction propellant used as an active component solvent, wherein the active components comprise budesonide and formoterol fumarate; the liquefaction propellant is hydrofluorocarbon; the preparation further comprises PVPk25 (Polyvinyl Pyrrolidone k25) and PEG1000 (Polyethylene Glycol 1000), which are added into the liquefaction propellant; the content of PVPk25 in the aerosol preparation is 0.00005wt%-0.003wt%; the content of PEG1000 in the aerosol preparation is 0.001wt%-0.01wt%; and the aerosol comprises the preparation. According to the aerosol preparation and the aerosol, provided by the invention, when the aerosol is sprayed out, the gathering of drug particles can be effectively avoided or alleviated and the dosage of fine particles is improved.

Description

technical field [0001] The invention relates to the field of medical aerosol products, in particular to an aerosol preparation and a quantitative inhalation aerosol. Background technique [0002] Currently, pressurized metered-dose inhalers (MDIs) are the most effective and accepted means for precise delivery of small doses to the human respiratory tract. Therapeutic agents typically delivered by this means include bronchodilators of beta2 adrenergic agonists, particularly beta2 agonists and corticosteroids, and combinations thereof. Typical MDIs include a pressure-resistant tank filled with therapeutic agents, most of which are drugs dissolved in liquefied propellants or micronized particles suspended in liquefied propellants. MDIs are also equipped with metering valves, which can be measured by touching valve to release a quantity of therapeutic agent. [0003] According to the anatomical and physiological structure of the bronchial bronchioles and the lungs, in order to...

Claims

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Application Information

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IPC IPC(8): A61K31/58A61K31/167A61K9/12A61K47/32A61K47/10A61K47/06A61M11/00A61P11/00
CPCA61K9/008A61K9/124A61K31/167A61K31/58A61K47/06A61K47/10A61K47/32A61M15/0065A61K2300/00
Inventor 舒宏侯曙光李丛菊杨丽张静吴君
Owner SICHUAN PURITY PHARM CO LTD
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