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Method for preparing fluticasone propionate suspension for inhalation

A technology of fluticasone propionate and suspension, applied in the field of medicine, can solve the problems of increased production cost, hidden danger of product safety, inappropriate sterilization method and the like, and achieves the effect of saving cost

Inactive Publication Date: 2014-01-15
SHANGHAI CHENPON PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] For liquid preparations in the form of suspensions, the sterilization method of microporous membrane filtration is not applicable, because the active ingredients may also be filtered out and killed by other sterilization methods (such as steam sterilization, dry heat sterilization) Microorganisms will remain in the product, causing hidden dangers to product safety
To address this challenge, the microbial load of all raw materials used in the formulation must be controlled within acceptable limits, which in turn leads to an intolerable increase in production costs

Method used

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  • Method for preparing fluticasone propionate suspension for inhalation
  • Method for preparing fluticasone propionate suspension for inhalation
  • Method for preparing fluticasone propionate suspension for inhalation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020]

[0021] Add the Tween-20 of the above prescription amount to half the amount of water for injection, stir to dissolve completely, add the prescription amount of sodium dihydrogen phosphate dihydrate and disodium hydrogen phosphate anhydrous, dissolve and pass through a microporous filter with a pore size of 0.22 μm Membrane filtration, then add aseptically treated micronized fluticasone propionate while stirring, add water for injection to the full amount, stir to disperse evenly, and divide into packages to obtain.

Embodiment 2

[0023]

[0024] Add the Tween-80 of the above prescription amount to half the amount of water for injection, stir to dissolve completely, add the prescription amount of sodium dihydrogen phosphate dihydrate and disodium hydrogen phosphate anhydrous, dissolve and pass through a microporous membrane with a pore size of 0.22 μm Filter, then add aseptically treated micronized fluticasone propionate while stirring, add water for injection to the full amount, stir to disperse evenly, and divide into packages to obtain.

Embodiment 3

[0026]

[0027] Add the Tween-20 of the above prescription amount to half the amount of water for injection, stir to dissolve completely, add the prescription amount of anhydrous citric acid and sodium citrate, dissolve and filter through a microporous membrane with a pore size of 0.22 μm, and then stir While adding aseptically treated micronized fluticasone propionate, add water for injection to the full amount, stir to disperse evenly, and divide into packages to obtain.

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PUM

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Abstract

The invention discloses a method for preparing fluticasone propionate suspension for inhalation. Sterile fluticasone propionate suspension is prepared in a way of treating fluticasone propionate and accessories respectively. A solution is prepared from the accessories, and is filtered and sterilized through a microporous filter membrane, and microbial load control over each accessory is not required, so that the cost is lowered.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to medicines for treating respiratory diseases, and more specifically to a preparation method of fluticasone propionate suspension for inhalation. Background technique [0002] Delivery of drugs to the lungs through oral inhalation is an important drug delivery method for the treatment of respiratory diseases (such as asthma, chronic obstructive pulmonary disease, etc.). Compared with systemic drug delivery (such as oral administration, injection, etc.), inhalation Drugs can be delivered directly to the site of action, avoiding the side effects of systemic administration. [0003] Existing inhalation drug products include aerosol, powder aerosol and nebulized inhalation solution. Among them, aerosol and powder aerosol use specific drug delivery devices, and the drug delivery process requires the patient to inhale the drug and operate the device. Coordination between these drugs can effectiv...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/56A61P11/00
Inventor 马广磊沈莹徐磊杜狄峥
Owner SHANGHAI CHENPON PHARMA TECH
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