Inhalation aerosol containing anticholinergic drug, preparation process and application method of inhalation aerosol

An aerosol and antistatic agent technology, which is applied in the field of inhalation aerosols containing anticholinergic drugs, can solve the problems of low drug deposition rate in the lungs, less than expected curative effect, and poor reproducibility of drug treatment. Achieve the effects of reducing systemic adverse reactions, improving drug stability, and improving drug compliance

Active Publication Date: 2020-06-19
SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
View PDF5 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At the same time, when patients use the existing device to inhale ipratropium bromide aerosol, the lung deposition rate of the drug is low; Factors that make the reproducibility of drug treatment poor, and the curative effect cannot meet expectations

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Inhalation aerosol containing anticholinergic drug, preparation process and application method of inhalation aerosol
  • Inhalation aerosol containing anticholinergic drug, preparation process and application method of inhalation aerosol
  • Inhalation aerosol containing anticholinergic drug, preparation process and application method of inhalation aerosol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～6

[0043] Inhalation Aerosols Containing Anticholinergic Drugs:

[0044]The addition amount of active ingredients is 0.0281% (w / w), the addition amount of anhydrous ethanol is 12.5323% (w / w), the addition amount of anhydrous citric acid is 0.0000% to 0.0050% (w / w), and the addition amount of purified water is 0.4440% (w / w), and the amount of propellant added is 86.9906% to 86.9956% (w / w), as shown in Table 1 below:

[0045] Table 1. Formulations (w / w) of Examples 1 to 6

[0046]

[0047]

[0048] The preparation method is:

[0049] One-step pressure filling is adopted, and the specific steps are as follows:

[0050] (a) Use suitable solvents such as ethanol and blank propellant to clean and disinfect the preparation pot and pipeline;

[0051] (b) take by weighing the ipratropium bromide of recipe quantity, add the dehydrated alcohol that is about recipe quantity 15% (w / w), stir and dissolve;

[0052] (c) take by weighing anhydrous citric acid, add the purified water of ...

Embodiment 7～10

[0065] Inhalation Aerosols Containing Anticholinergic Drugs:

[0066] The dosage of active ingredients is 0.0279% (w / w), the dosage of absolute ethanol is 12.9024% (w / w), the dosage of oleic acid is 0.0000%~0.1500% (w / w), and the dosage of purified water is 0.2587% (w / w), the amount of propellant added is 86.6610% to 86.8110% (w / w), see Table 4 for details:

[0067] Table 4. Formulations (w / w) of Examples 7-10

[0068] Example number 7 8 9 10 ipratropium bromide monohydrate 0.0279％ 0.0279％ 0.0279％ 0.0279％ anhydrous ethanol 12.9024％ 12.9024％ 12.9024％ 12.9024％ Oleic acid 0.0000％ 0.0126％ 0.1009％ 0.1500％ purified water 0.2587％ 0.2587％ 0.2587％ 0.2587％ Tetrafluoroethane (HFA 134a) 86.8110％ 86.7984％ 86.7101％ 86.6610％

[0069] The preparation method is:

[0070] One-step pressure filling is adopted, and the specific steps are as follows:

[0071] (a) Use suitable solvents such as ethanol and blank propellant to clean an...

Embodiment 11～15

[0085] Inhalation Aerosols Containing Anticholinergic Drugs:

[0086] The addition amount of active ingredients is 0.0275% (w / w), the addition amount of absolute ethanol is 10.0% to 15.0% (w / w), the addition amount of anhydrous citric acid is 0.0030% (w / w), and the addition amount of purified water is 0.3617% (w / w), and the added amount of propellant is 84.6078%-89.6078% (w / w), as shown in Table 7:

[0087] Table 7. Formulations (w / w) of Examples 11-15

[0088]

[0089]

[0090] The preparation method is:

[0091] One-step pressure filling is adopted, and the specific steps are as follows:

[0092] (a) Use suitable solvents such as ethanol and blank propellant to clean and disinfect the preparation pot and pipeline;

[0093] (b) take by weighing the ipratropium bromide of recipe quantity, add the dehydrated alcohol that is about recipe quantity 25% (w / w), stir and dissolve;

[0094] (c) take by weighing anhydrous citric acid, add the purified water of recipe quantity...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention provides an inhalation aerosol containing an anticholinergic drug, a preparation process and an application method of the inhalation aerosol. The inhalation aerosol consists of an activeingredient ipratropium bromide, or a monohydrate or a pharmaceutically acceptable salt thereof, a hydrofluoroalkane propellant, a latent solvent absolute ethyl alcohol and a pH regulator. The inhalation aerosol provided by the invention can achieve an effective lung deposition rate meeting requirements, and meanwhile, the drug stability is remarkably improved; meanwhile, the inhalation aerosol can be used in combined utilization with a mist storage device, the medication compliance of old people and children is improved, the curative effect of medicine used by patients is improved, and side effects are reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an anticholinergic drug-containing inhalation aerosol as well as a preparation process and a use method thereof. Background technique [0002] Studies have found that bronchiectasis can significantly relieve dyspnea caused by bronchial asthma, chronic bronchitis, asthmatic 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 . Ipratropium bromide is the fifth class of drugs. It is a potent anticholinergic drug with high selectivity for bronchial smooth muscle M receptors. [0003] Aerosols are common inhaled respiratory preparations for the treatment of obstructive airways. Aerosol means that the drug-containing emulsion or s...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/12A61K31/46A61P11/08A61M11/00
CPCA61K9/0078A61K31/46A61P11/08A61M11/00A61K9/12
Inventor 金方闻聪李立新占彦丽郑蒙蒙
Owner SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap