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Budesonide and formoterol spray inhalation suspension and preparation method thereof

A technology of atomization inhalation and budesonide, which is applied in the directions of pharmaceutical formulation, liquid delivery, dispersion liquid delivery, etc., can solve the problems of inaccurate delivered dose, low compliance, usage restrictions, etc., and achieve accurate, controllable and compliant delivery dose. The effect of good sex and avoiding potential harm

Inactive Publication Date: 2016-07-13
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] CN101991582A discloses the application of budesonide and formoterol powder inhalation in the prevention of asthma. Through clinical trials on 50 asthmatic patients, the marked rate is 90%, and the effective rate is 100%. The preparation has a preventive effect on asthma attacks, but this powder aerosol needs to be inhaled with a strong respiratory airflow to start the nebulization. For the elderly and children with chronic lung disease, there are certain limitations in its use
[0006] 2011103309507 discloses an aerosol of budesonide and formoterol and its preparation method, but the aerosol contains a propellant, and its use requires good coordination between breathing action and starting atomization action , otherwise it will be difficult to deliver an effective dose of the drug to the respiratory tract, or the delivered dose will be inaccurate and the compliance will be low

Method used

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  • Budesonide and formoterol spray inhalation suspension and preparation method thereof
  • Budesonide and formoterol spray inhalation suspension and preparation method thereof
  • Budesonide and formoterol spray inhalation suspension and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0034]

[0035] Add water to 1000ml, adjust pH to 5.00 with sodium hydroxide

[0036] Step A: dissolving formoterol fumarate in water to form solution a, adding sodium chloride, disodium edetate, citric acid and sodium citrate to solution a, and ultrasonically dispersing and dissolving to form solution b;

[0037] Step B: filter and sterilize solution b with a 0.22 μm membrane filter;

[0038] Step C: Dissolving Tween-80 in water to obtain solution c, adding budesonide to solution c, performing ultrasonic dispersion, then performing high-pressure homogenization treatment at a pressure of 500 bar, and circulating 5 times to obtain a suspension d;

[0039] Step D: Sterilize the suspension d at 120°C for 15 minutes;

[0040] Step E: Mix solution b and suspension d evenly under aseptic conditions, add water for injection to 1000ml, adjust pH to 5.0 with sodium hydroxide, and aseptically dispense them into single-dose packaging containers.

Embodiment 2

[0042]

[0043] Add water to 1000ml, adjust pH to 4.00 with acetic acid

[0044] Preparation:

[0045] Step A: dissolving formoterol tartrate in water to form solution a, adding sodium chloride, sodium acetate and dicalcium diamine tetraacetate to solution a, and ultrasonically dispersing and dissolving to form solution b;

[0046] Step B: filter and sterilize solution b with a 0.22 μm membrane filter;

[0047] Step C: dissolving Tween-60 in water to obtain solution c, adding budesonide to solution c, performing ultrasonic dispersion, then performing high-pressure homogenization treatment at a pressure of 1500 bar, and circulating 3 times to obtain a suspension d;

[0048] Step D: Sterilize the suspension d at 115°C for 30 minutes;

[0049] Step E: Mix solution b and suspension d evenly under aseptic conditions, add water for injection to 1000ml, adjust pH to 4.0 with acetic acid, and aseptically dispense them into single-dose packaging containers.

Embodiment 3

[0051]

[0052] Add water to 1000ml and adjust the pH to 6.00 with sodium hydroxide.

[0053] Preparation:

[0054] Step A: Dissolve formoterol fumarate in water to form solution a, add glycerin, sodium dihydrogen phosphate, disodium hydrogen phosphate and disodium edetate to solution a, and ultrasonically disperse and dissolve to form solution b ;

[0055] Step B: filter and sterilize solution b with a 0.22 μm membrane filter;

[0056] Step C: Dissolve Span-80 in water to obtain solution c, add budesonide to solution c, perform ultrasonic dispersion, then perform high-pressure homogenization treatment at a pressure of 1000 bar, and circulate 4 times to obtain suspension d ;

[0057] Step D: Sterilize the suspension d at 120°C for 20 minutes;

[0058] Step E: Mix solution b and suspension d evenly under aseptic conditions, add water to 1000ml, and adjust the pH to 6.0 with sodium hydroxide.

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Abstract

The invention discloses a budesonide and formoterol spray inhalation suspension and a preparation method thereof.The budesonide and formoterol spray inhalation suspension comprises, per 1000 ml, the following components: 0.5-5 g of budesonide, 10-100 mg of formoterol, 0.1-0.5 g of a dispersant, 1-100 g of isoosmotic adjusting agent, 0.1-1 g of metal ion complexing agent, 0.1-20 g of pH buffer, pH regulator to adjust pH of a system to 4.0-6.0, and the balance of water, adding up to 1000 ml.The potential hazard of a lactose vector in powder aerosols can be avoided, delivery dosage is accurate and controllable, the requirement on ventilation flow is low, and compliance is good; the preparation method is simple to perform, required equipment is simple, and the requirement for asepsis of products can be met.

Description

technical field [0001] The invention relates to the field of preparations of budesonide and formoterol, in particular to a nebulized inhalation suspension of budesonide and formoterol and a preparation method thereof. Background technique [0002] Budesonide is a glucocorticoid that inhibits the synthesis and release of bronchoconstrictor substances and reduces the contractile response of bronchial smooth muscle. Budesonide has less systemic side effects, so it is widely used in the treatment of asthma and COPD. [0003] Formoterol is a selective β2-receptor agonist that dilates the bronchi by stimulating adrenergic receptors and can also inhibit the release of histamine from mast cells, thereby reducing airway hyperresponsiveness. [0004] Studies have shown that the combination of budesonide and formoterol in the treatment of asthma and COPD can exert an obvious synergistic effect. Glucocorticoids can increase the number of β2 receptors in bronchial smooth muscle cells, w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/10A61K31/58A61P11/06A61P11/00A61K31/137
CPCA61K9/0078A61K9/10A61K31/137A61K31/58A61K47/22A61K47/26A61K2300/00
Inventor 康彬马洋侯惠民王健
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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