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A kind of inhalation aerosol, its raw material composition and preparation method

A raw material composition and aerosol technology, which is applied in aerosol delivery, drug combination, drug delivery, etc., can solve the problems of preparation method loss and uneven particle distribution, and achieve the effect of reducing pollution and low loss

Active Publication Date: 2021-11-12
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome defects such as inhomogeneous distribution of particles in the inhalation aerosol in the inhalation aerosol of mometasone furoate fumarate and formoterol in the prior art, serious loss in the preparation method, and provide A kind of inhalation aerosol, its raw material composition and preparation method

Method used

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  • A kind of inhalation aerosol, its raw material composition and preparation method
  • A kind of inhalation aerosol, its raw material composition and preparation method
  • A kind of inhalation aerosol, its raw material composition and preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0057] Produced on a scale of 10,000 bottles

[0058] (1) Preparation of mometasone furoate pharmaceutical granules

[0059] Add 240 grams of mometasone furoate into a solvent (such as ethanol and / or dichloromethane) to dissolve, the amount of solvent is not specifically limited, as long as a uniform solution can be obtained; then add it to the extraction kettle; or directly add the bran Add mometasone furoate into the extraction kettle; fill a certain amount of carbon dioxide in the extraction kettle, control the temperature of the extraction kettle to be 150°C, and control the pressure of the extraction kettle to be 500bar; mometasone furoate reaches a saturated state in the supercritical fluid, and Stable for 15 minutes, mometasone furoate is ejected through a nozzle to form spherical particles, and the particle diameter (d90) of the particles is less than 5 microns (for example, less than 2 microns) (the loss of the drug particles is generally less than 5% by this method, ...

Embodiment 2

[0066] All the other are with embodiment 1, and wherein, the operation of step (2) is as follows:

[0067] Dissolve 6 grams of formoterol fumarate in a solvent (such as methanol), use spray drying equipment, spray speed 2ml / min; spray dry at a temperature of 90°C, collect formoterol fumarate drug particles, particles The particle size d50 = 4 microns.

Embodiment 3

[0069] All the other are with embodiment 1, and wherein, the operation of step (2) is as follows:

[0070] Dissolve 6 grams of formoterol fumarate in a solvent (such as methanol), use spray drying equipment, and spray speed 4ml / min; spray dry at a temperature of 120 ° C, and collect formoterol fumarate drug particles, particles The particle size d50 = 4 microns.

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Abstract

The invention discloses an inhalation aerosol, its raw material composition and a preparation method. The raw material composition of the inhalation aerosol disclosed by the present invention comprises a pharmaceutical active ingredient and a propellant, the pharmaceutical active ingredient comprises a long-acting beta receptor agonist and a glucocorticoid; the propellant comprises tetrafluoroethylene ethane. The inhalation aerosol disclosed by the invention comprises the raw material composition, a pressure-resistant container and a valve system. The inhalation aerosol of the present invention uses tetrafluoroethane as the propellant, and supercritical method and spray drying method are used to prepare drug particles during preparation, so that the inhalation aerosol with uniform particle distribution can be obtained, and the loss in the preparation method is low; In addition, the inhalation aerosol of the present invention adjusts the single-dose injection volume of the medicine, effectively reducing the amount of greenhouse gas consumption of the product.

Description

technical field [0001] The invention relates to an inhalation aerosol, its raw material composition and a preparation method. Background technique [0002] Mometasone furoate formoterol fumarate inhalation aerosol is a compound drug of glucocorticoid and long-acting β receptor agonist, and its product DULERA containing HFC227 was developed by Merck. The drug is indicated for the treatment of asthma in patients ≥ 12 years of age not adequately controlled by moderate to high doses of inhaled corticosteroids, and is not intended for the treatment of patients with acute asthma. The drug is equipped with an electronic counting device, which is counted by the push sensor of the valve. ) Two dosage specifications. [0003] The results of the clinical study confirmed that compared with mometasone furoate and placebo alone, the lung function of patients treated with mometasone furoate formoterol fumarate inhalation aerosol (measured at 0-12h corresponding to Mean area under the co...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K45/06A61K31/58A61K31/167A61K9/72A61P11/06
CPCA61K9/008A61K9/124A61K31/167A61K31/58A61K45/06A61K2300/00
Inventor 邵奇荆志欣周雅茹洪晨文彬孙宁云
Owner SHANGHAI SINE PHARMA LAB
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