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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
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  • 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

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  • 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...

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PUM

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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

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Application Information

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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
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