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Suspension of triazole antifungal drug for atomizer

A technology of antifungal drugs and triazoles, which can be used in antifungal agents, liquid delivery, pharmaceutical formulations, etc., and can solve problems such as poor suspension stability, unsuitability for medicinal use, and drug particle agglomeration.

Active Publication Date: 2020-09-15
SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] When the inventor was developing the suspension of triazole antifungal drugs for nebulizers, he found that when the suspension was prepared according to the specifications of this product, the prepared The stability of the suspension is poor, and the drug particles will be obviously agglomerated after being placed at room temperature for 3 months, which is not suitable for medicinal use

Method used

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  • Suspension of triazole antifungal drug for atomizer
  • Suspension of triazole antifungal drug for atomizer
  • Suspension of triazole antifungal drug for atomizer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Example 1 100kg itraconazole suspension for co-atomizer

[0049] (1) Add about 90kg of water for injection in the preparation tank, add 500g of Tween 80, stir to dissolve completely;

[0050] (2) Add 800g sodium chloride, 10g disodium edetate, 180g disodium hydrogen phosphate and 940g sodium dihydrogen phosphate, stir to dissolve completely;

[0051] (3) Add water to 99.5kg, stir to mix evenly, measure the pH value to 6.0, and obtain the auxiliary material solution;

[0052] (4) Pass the excipient solution through a 0.2 μm sterile filter, and then transfer it to a sterile storage tank;

[0053] (5) Put 500 g of sterile itraconazole bulk drug into the sterile-filtered excipient solution under the condition of A-level laminar flow protection; stir or homogenize to make itraconazole disperse evenly;

[0054] (6) Aseptic filling and sealing.

Embodiment 2

[0055] Example 2 100kg itraconazole suspension for co-atomizer

[0056] (1) Add about 90kg of water for injection in the preparation tank, add 100g of Tween 80, stir to dissolve completely;

[0057] (2) Add 800g sodium chloride, 10g disodium edetate, 180g disodium hydrogen phosphate and 940g sodium dihydrogen phosphate, stir to dissolve completely;

[0058] (3) Add water to 99.5kg, stir to mix evenly, measure the pH value to 6.0, and obtain the auxiliary material solution;

[0059] (4) Pass the excipient solution through a 0.2 μm sterile filter, and then transfer it to a sterile storage tank;

[0060] (5) Put 500 g of sterile itraconazole bulk drug into the excipient solution after sterilizing and filtering under the condition of A-level laminar flow protection. Stir or homogenize to disperse itraconazole evenly;

[0061] (6) Aseptic filling and sealing.

Embodiment 3

[0062] Example 3 100kg itraconazole suspension for co-atomizer

[0063] (1) Add about 90kg of water for injection in the preparation tank, add 25g of Tween 80, stir to dissolve completely;

[0064] (2) Add 800g sodium chloride, 10g disodium edetate, 180g disodium hydrogen phosphate and 940g sodium dihydrogen phosphate, stir to dissolve completely;

[0065] (3) Add water to 99.5kg, stir to mix evenly, measure the pH value to 6.0, and obtain the auxiliary material solution;

[0066] (4) Pass the excipient solution through a 0.2 μm sterile filter, and then transfer it to a sterile storage tank;

[0067] (5) Put 500 g of sterile itraconazole bulk drug into the excipient solution after sterilizing and filtering under the condition of A-level laminar flow protection. Stir or homogenize to disperse itraconazole evenly;

[0068] (6) Aseptic filling and sealing.

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Abstract

The invention provides a suspension of a triazole antifungal drug for an atomizer, and a preparation method of the suspension. The pH of the suspension is 3-8. The suspension comprises the triazole antifungal drug, surfactant, osmotic pressure regulation agent, metal complexing agent, a pH regulation agent and water, wherein the D50 diameter of the triazole antifungal drug is 1-10 [mu] m, the triazole antifungal drug occupies the total mass of the suspension by 0.025-1%, and a mass ratio of the triazole antifungal drug to the surfactant is 1:1-50:1. The invention also provides a preparation method for the suspension. The suspension provided by the invention has good stability and can be placed for one year at a constant temperature without obviously increasing a particle size.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a liquid preparation for an atomizer. Background technique [0002] With the increase of immunosuppressed population, the incidence of fungal infection showed a clear upward trend. Because fungal infection is mostly caused by airway inhalation of fungal spores, the lung is a high-incidence site for invasive fungal infection, so maintaining a high drug concentration in the lung tissue and inhibiting the reproduction of spores in the lung is the key to preventive and targeted antifungal treatment . In order to maintain high drug concentration in lung tissue, the dosage of antifungal drugs must be increased through conventional routes (intravenous infusion / oral administration), but at the same time, adverse reactions increase significantly. Compared with conventional medication, aerosol inhalation can achieve higher drug concentration in the lungs, control fungal infecti...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K47/18A61P31/10A61K31/4196A61K31/506A61K31/496
CPCA61K9/10A61K9/0078A61K47/183A61P31/10A61K31/4196A61K31/506A61K31/496A61K9/0073A61K47/26A61K47/02A61K47/12
Inventor 金方连晓培郭翠翠
Owner SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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