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A suspension of triazole antifungal drugs for nebulizer

A technology of antifungal drugs and triazoles, applied in antifungal agents, pharmaceutical formulations, liquid delivery, etc., can solve problems such as poor stability of suspensions, unsuitable for medicinal use, and aggregation of drug particles

Active Publication Date: 2022-05-24
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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  • A suspension of triazole antifungal drugs for nebulizer
  • A suspension of triazole antifungal drugs for nebulizer
  • A suspension of triazole antifungal drugs for nebulizer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Example 1 Itraconazole suspension for 100kg co-nebulizer

[0049] (1) in the preparation tank, add about 90kg of water for injection, 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 of 6.0, and obtain an auxiliary material solution;

[0052] (4) passing the auxiliary material solution through a 0.2 μm sterilizing filter, and then transferring it to a sterile storage tank;

[0053] (5) put 500g of sterile itraconazole crude drug into the auxiliary material solution after sterilization filtration under the condition of A-level laminar flow protection; stir or homogenize to make itraconazole evenly dispersed;

[0054] (6) Aseptic filling and sealing.

Embodiment 2

[0055] Example 2 Itraconazole suspension for 100kg co-nebulizer

[0056] (1) in the preparation tank, add about 90kg of water for injection, 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 of 6.0, and obtain an auxiliary material solution;

[0059] (4) passing the auxiliary material solution through a 0.2 μm sterilizing filter, and then transferring it to a sterile storage tank;

[0060] (5) Put 500 g of sterile itraconazole crude drug into the auxiliary material solution after sterilization and filtration 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 Itraconazole suspension for 100kg co-nebulizer

[0063] (1) in the preparation tank, add the water for injection of about 90kg, add 25g 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 of 6.0, and obtain an auxiliary material solution;

[0066] (4) passing the auxiliary material solution through a 0.2 μm sterilizing filter, and then transferring it to a sterile storage tank;

[0067] (5) Put 500 g of sterile itraconazole crude drug into the auxiliary material solution after sterilization and filtration 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 triazole antifungal drugs for nebulizers and a preparation method thereof. The pH of the suspension is 3-8, including triazole antifungal drugs, surfactants, osmotic pressure regulators, metal complexing agents, pH regulators and water; wherein, the triazole antifungal The D50 diameter of the fungal drug is 1-10 μm, accounting for 0.025%-1% of the total mass of the suspension, and the mass ratio of the surfactant is: the triazole antifungal drug: surfactant=1: 1~50:1. The invention also provides a preparation method of the suspension. The suspension provided by the invention has good stability and can be placed at room temperature for one year without significant increase in particle size.

Description

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

Claims

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Application Information

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Patent Type & Authority Patents(China)
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