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Medical quantitative inhalation aerosol

An aerosol and preparation technology, applied in the field of metered dose inhalation aerosols, can solve the problem of not being able to solve the problem of degradation well, and achieve the maintenance and enhancement of physical stability, significant physical stability, and enhanced chemical and physical stability. Effect

Active Publication Date: 2021-03-05
SICHUAN PURITY PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ipratropium bromide aerosol from Boehringer Ingelheim Pharmaceuticals The formula just contains water and ethanol, and the prescription of different third detropammonium bromide solution aerosol is: different third detropammonium bromide (monohydrate) 0.0374%, citric acid 0.0040%, dehydrated alcohol 15.0000%, water 0.5000%, The rest is HFA134a (Reference 3: CN1054282C, Stable Drug Aerosol Solution Preparation, 2000-07-12, Table 3 on page 11, "Normal Concentration"), mainly by adding citric acid to inhibit these two degradation reactions , but it does not solve the degradation problem very well

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] In this experiment, the influence of different combinations of pressure-resistant containers and different sealing gasket metering valves on the accelerated chemical stability of ipratropium bromide medical quantitative inhalation aerosol was investigated.

[0037] Combination type of container tank-metering valve: non-coated aluminum tank-EPDM sealing gasket metering valve, fluorocarbon polymer coated aluminum tank-EPDM sealing gasket metering valve, stainless steel tank-EPDM sealing gasket metering valve Rubber Gasket Metering Valve; Uncoated Aluminum Can-Chlorobutyl Rubber Gasket Metering Valve, Fluorocarbon Polymer Coated Aluminum Can-Chlorobutyl Rubber Gasket Metering Valve, Stainless Steel Tank-Chlorobutyl Rubber Seal Gasket metering valve.

[0038] Aerosol preparations: In order to accurately investigate the impact of the container-metering valve combination on the stability, a single variable is controlled in this embodiment 1. All the above-mentioned container-...

Embodiment 2

[0050] This experiment compares the ipratropium bromide solution-type aerosol combined with the metering valve combination of non-coated aluminum can and chlorobutyl rubber sealing gasket with the commercially available ipratropium bromide solution-type aerosol of Boehringer Ingelheim Pharmaceutical Company The chemical and physical stability of the agent in the accelerated test.

[0051] According to reference 4 (Boehringer Ingelheim, "Ipratropium bromide aerosol manual"), With stainless steel tank - metering valve combination with gasket of unknown material.

[0052] Comparison group: commercially available ipratropium bromide solution aerosol from Boehringer Ingelheim Pharmaceutical Company It adopts the metering valve combination of stainless steel tank and unknown gasket, and sets upright comparison group and inverted comparison group respectively.

[0053] Experimental group: ipratropium bromide solution-type aerosol of the present invention, it adopts non-coated...

Embodiment 3

[0068] The influence of different tank-metering valve combinations on the physical stability of ipratropium bromide solution aerosol is also reflected in the measurement of aerodynamic particle size distribution (Aerodynamic Particle Size Distribution, APSD).

[0069]According to the guidelines of reference 6 ("Guiding Principles for Quality Control Opinions on Metered-Dose Inhaler and Dry Powder Inhaler Products" issued by the US FDA in April 2018), the aerodynamic particle size distribution is determined using "Quality by Design (QbD) )" concept to develop a "critical quality attribute" (Critical Quality Attribution, CQA) in metered dose inhalation aerosol products. The Anderson Cascade Impactor (ACI, figure 2 Its structure is shown, including 8 grades - 0-7 grades and the last layer of filter paper "F layer") to determine the aerodynamic particle size distribution (Reference 7: Chinese Pharmacopoeia 2015 edition, "Inhalation preparations fine particle air Kinetic Properti...

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Abstract

The invention provides medical quantitative inhalation aerosol. The medical quantitative inhalation aerosol has enhanced chemical and physical stability, the aerosol comprises an aerosol formulation comprising an active ingredient for treatment of chronic obstructive pulmonary diseases and a pressurised metered inhaler for loading the aerosol formulation, The pressurized metered inhaler comprisesa container tank, a metering valve and a driver, wherein the container tank is an aluminum tank, and the metering valve and a tank opening of the container tank are sealed through a chlorinated butylrubber sealing washer. According to the invention, the problems that the ipratropium bromide active ingredients in medicines react with water or ethanol in the storage process to be degraded and the degradation is accelerated under the influence of improper packing materials are solved, and the medicine safety and the medicine effectiveness are improved.

Description

technical field [0001] The invention belongs to the technical field of quantitative inhalation aerosol, in particular to a quantitative inhalation aerosol for preventing or treating COPD (chronic obstructive pulmonary disease). Background technique [0002] Pressurized metered-dose inhalers (MDIs) are effective drug-loading devices for small-dose precise drug delivery to the respiratory tract. MDIs generally include a pressure-resistant tank containing an aerosol preparation and a metering valve to control the dose. The preparation mainly contains a liquefied propellant and a small amount of other auxiliary agents in addition to the active ingredient of the drug. If the active ingredient of the drug is dissolved in an aerosol formulation, it is solution MDIs. If the active ingredient of the drug is not dissolved in the aerosol formulation, these are suspension MDIs. Generally speaking, the chemical stability of solution-type aerosol is far inferior to that of suspension-ty...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/46A61K31/40A61K31/439A61P11/00A61M15/00B65D83/52
CPCA61K9/12A61K9/008A61K31/46A61K31/40A61K31/439A61P11/00A61M15/009B65D83/52
Inventor 贺钢民陈志坚舒宏李丛菊侯曙光朱柯武郭城
Owner SICHUAN PURITY PHARM CO LTD
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