Beta2 receptor agonist inhalation aerosol and product containing the inhalation aerosol

A β2 receptor, aerosol technology, applied in the field of inhaled pharmaceutical preparations, can solve the problems of product dose uniformity and product stability, and do not meet the large-scale production of products, etc., to improve stability and effective lung deposition, Good market prospects, the effect of avoiding adsorption

Active Publication Date: 2020-02-28
GUANGZHOU JOINCARE RESPIRATORY DRUG ENG TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The formoterol aerosol prescription of patent application 109464429A also contains povidone K25, and adopts uncoated ordinary metal can and quantitative metal valve combination as the container system, but the product dosage uniformity and product stability of its preparation are relatively low. Low, does not meet the requirements of mass production of products

Method used

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  • Beta2 receptor agonist inhalation aerosol and product containing the inhalation aerosol
  • Beta2 receptor agonist inhalation aerosol and product containing the inhalation aerosol
  • Beta2 receptor agonist inhalation aerosol and product containing the inhalation aerosol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～5

[0043] The addition amount of active ingredient micropowder is 0.0114%~0.0853% (w / w), the addition amount of anhydrous lactose micropowder is 0.0857% (w / w), the addition amount of PEG1000 is 0.0201% (w / w), the addition amount of absolute ethanol is 0.9988% (w / w), the amount of PVPK25 added is 0.000092% (w / w), the amount of propellant added is 98.8099% ~ 98.8839% (w / w), and the combination of fluorocarbon coated metal tank and quantitative metal valve is used as the container System, each component is shown in Table 1 below:

[0044] Table 1. Prescription (w / w) of inhaled aerosols of Examples 1-5

[0045] Example number 1 2 3 4 5 Active Ingredient Micronized 0.0114％ 0.0171％ 0.0567％ 0.0716％ 0.0853％ Anhydrous Lactose Powder 0.0857％ 0.0857％ 0.0857％ 0.0857％ 0.0857％ PEG1000 0.0201％ 0.0201％ 0.0201％ 0.0201％ 0.0201％ Absolute ethanol 0.9988％ 0.9988％ 0.9988％ 0.9988％ 0.9988％ PVP K25 0.000092％ 0.000092％ 0.000092％ 0.000092％ 0.0...

Embodiment 6～10

[0053] The addition amount of active ingredient micropowder is 0.0338% (w / w), the addition amount of anhydrous lactose micropowder is 0.0850%~0.3596% (w / w), the addition amount of PEG1000 is 0.0144% (w / w), and the addition amount of absolute ethanol is 0.5094% (w / w), the amount of PVPK25 added is 0.000131% (w / w), the amount of propellant added is 99.0827% ~ 99.3893% (w / w), and the combination of fluorocarbon coated metal tank and quantitative metal valve is used as the container System, each component is shown in Table 4 below:

[0054] Table 4. Prescription (w / w) of inhaled aerosols of Examples 6-10

[0055] Example number 6 7 8 9 10 Active Ingredient Micronized 0.0338％ 0.0338％ 0.0338％ 0.0338％ 0.0338％ Anhydrous Lactose Powder 0.0850％ 0.0857％ 0.1271％ 0.2573％ 0.3596％ PEG1000 0.0144％ 0.0144％ 0.0144％ 0.0144％ 0.0144％ Absolute ethanol 0.5094％ 0.5094％ 0.5094％ 0.5094％ 0.5094％ PVP K25 0.000131％ 0.000131％ 0.000131％ 0.000131...

Embodiment 11～15

[0062] The addition amount of active ingredient micropowder is 0.0405% (w / w), the addition amount of anhydrous lactose micropowder is 0.1524% (w / w), the addition amount of PEG1000 is 0.0023%~0.0516% (w / w), and the addition amount of absolute ethanol is 1.2851% (w / w), the addition of PVP K25 is 0.000670% (w / w), the addition of propellant is 98.4697% to 98.5190% (w / w), and the combination of fluorocarbon coated metal tank and quantitative metal valve is used as For the container system, see the following table 7 for details of each component:

[0063] Table 7. Prescriptions (w / w) of inhalation aerosols of Examples 11-15

[0064] Example number 11 12 13 14 15 Active Ingredient Micronized 0.0405％ 0.0405％ 0.0405％ 0.0405％ 0.0405％ Anhydrous Lactose Powder 0.1524％ 0.1524％ 0.1524％ 0.1524％ 0.1524％ PEG1000 0.0023％ 0.0051％ 0.0208％ 0.0409％ 0.0516％ Absolute ethanol 1.2851％ 1.2851％ 1.2851％ 1.2851％ 1.2851％ PVP K25 0.000670％ 0.000670...

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Abstract

The invention provides a beta2 receptor agonist inhalation aerosol and a product containing the inhalation aerosol. The beta2 receptor agonist inhalation aerosol consists of an active ingredient formoterol or a pharmaceutically-acceptable salt, a medicinal carrier, a medicinal solvent, polyethylene glycol, povidone and a hydrofluoroalkane propellant, and is prepared by adding a suitable auxiliarymaterial povidone into the product prescription, strictly limiting the content of each component in the prescription, and simultaneously combining a fluorocarbon-coated metal tank and a quantitative metal valve as a container system. The product stability and effective lung deposition are improved, and the product has obvious advantages and a good market prospect.

Description

technical field [0001] The invention belongs to the technical field of inhalation pharmaceutical preparations, and in particular relates to a β2 receptor agonist inhalation aerosol and products containing the inhalation aerosol. Background technique [0002] Studies have found that bronchiectasis can significantly relieve dyspnea caused by bronchial asthma, chronic bronchitis, wheezing bronchitis, emphysema and other airway obstructive diseases. At present, the drugs for the treatment of asthma and other lung diseases mainly include the following: (1) β2 receptor agonists; (2) glucocorticoids; (3) antiallergic drugs; (4) xanthine drugs; (5) anticholinergics . Formoterol, as a long-acting selective adrenergic β2 receptor agonist, has a certain bronchodilator effect, can significantly relieve the dyspnea caused by the above diseases, and then achieve the therapeutic effect. [0003] Aerosol is a common inhaled respiratory preparation for the treatment of airway obstructive d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/12A61K31/167A61K47/10A61K47/32A61P11/08
CPCA61K31/167A61K47/10A61K47/32A61K9/0073A61P11/08
Inventor 金方闻聪李立新
Owner GUANGZHOU JOINCARE RESPIRATORY DRUG ENG TECH CO LTD
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