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Novel inhalant containing glucocorticoid and bronchodilator

A technology of glucocorticoids and agonists, which is applied in the direction of respiratory diseases, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problems of reducing lung deposition rate, complex mixing process, and uniformity impact, etc., to achieve Improve the lung deposition rate, simplify the mixing process, and easy to mix evenly

Active Publication Date: 2011-11-23
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As we all know, the more types of drug powders in the dry powder inhaler formula, the more powder properties need to be considered, the more complicated and difficult to handle, and the more complicated the mixing process
Therefore, since the compound dry powder inhaler is composed of two kinds of medicines and excipients which are micronized and mixed separately, its powder and particle properties are relatively complicated, especially after mixing due to the size, shape and fluidity of various particles. , electrical properties, dispersibility, and hygroscopicity are different, and the uniformity of the two drugs in the compound preparation product will be greatly affected during the packaging process. At the same time, there will be adhesion between particles during the storage process, so that The particle size of the dry powder particles increases, which affects the stability of the dry powder inhaler and directly reduces the lung deposition rate, especially when the dry powder of the compound drug is inhaled and reaches the inflammatory site in the lungs, different drug particles are separated, neither can be simultaneously Reaching the inflammatory site, it cannot guarantee that different drugs are more evenly dispersed in the inflammatory site

Method used

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  • Novel inhalant containing glucocorticoid and bronchodilator
  • Novel inhalant containing glucocorticoid and bronchodilator
  • Novel inhalant containing glucocorticoid and bronchodilator

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] The preparation of comparative example 1 fluticasone propionate, xinasalmeterol granules

[0066] Prepare 100 ml of methanol solution of fluticasone propionate at 5 mg / ml and spray-dry to obtain dry powder particles with an average particle size of 3.16 μm for future use. The operating parameters of spray drying are: feed rate 10ml / min, inlet temperature 85°C, additional air 0.55MPa.

[0067] Prepare 100 ml of methanol solution of xinasalmeterol at 1 mg / ml and spray-dry to obtain dry powder particles with an average particle size of 2.79 μm, which is ready for use. The operating parameters of spray drying are: feed rate 10ml / min, inlet temperature 85°C, additional air 0.55MPa.

Embodiment 2

[0068] The preparation of comparative example 2 budesonide, formoterol fumarate granules

[0069] Accurately weigh 1 g of budesonide raw material, evenly disperse in 100 ml of deionized water, and stir at high speed for 20 min to make it into a uniform suspension. The above suspension is subjected to high-pressure homogenization through multiple cycles under a certain pressure, and the pipeline is cooled with ethanol at -20°C. The budesonide slurry after high-pressure homogenization was spray-dried to obtain dry powder particles with an average particle size of 3.59 μm, which was set aside. The operating parameters of spray drying are: feed rate 20ml / min, inlet temperature 115°C, additional air 0.55MPa.

[0070] Accurately weigh 0.06g of formoterol fumarate raw material, evenly disperse in 100mL of deionized water, stir at high speed for 10min, and spray dry to obtain dry powder particles with an average particle size of 1.92μm, and set aside. The operating parameters of spr...

Embodiment 3

[0071] The preparation of comparative example 3 mometasone furoate granules

[0072] Accurately weigh 1g of mometasone furoate API, evenly disperse in 100mL of deionized water, stir at high speed for 20min to make it into a uniform suspension. The above suspension is subjected to high-pressure homogenization through multiple cycles under a certain pressure, and the pipeline is cooled with ethanol at -20°C. After high-pressure homogenization, the mometasone furoate slurry was spray-dried to obtain dry powder particles with an average particle size of 2.99 μm, which was set aside. The operating parameters of spray drying are: feed rate 20mL / min, inlet temperature 115°C, additional air 0.55MPa.

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Abstract

The invention discloses a novel inhalant containing glucocorticoid and bronchodilator, that is, inhalable particles containing glucocorticoid and other medicine, wherein, the other medicine is selected from one of the following medicines: beta 2 receptor stimulant, anticholinergic agent, theophylline agent, leukotriene receptor antagonist, mast cell stabilizer and antihistamine.

Description

Technical field: [0001] The invention relates to a novel inhalation preparation for treating respiratory inflammation with glucocorticoid and other medicines as active ingredients. Background technique: [0002] The present invention relates to a novel inhalation dry powder pharmaceutical composition for treating respiratory inflammation, which has improved stability and uses glucocorticoid and other drugs as active ingredients. [0003] Dry powder inhaler (DPI) is one or more drugs made into a certain range of tiny particles. After being alone or mixed with excipients, the drug enters the respiratory tract and lungs in the form of powder mist through a special drug delivery device, and exerts local or systemic effects. It has the characteristics of targeted, efficient, quick-acting, and less toxic and side effects. Depending on the administration site, it can be divided into nasal powder and oral (pulmonary inhalation) powder. DPIs are effective for inhalation or inhalati...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K45/00A61K31/522A61K9/72A61K9/16A61P11/00A61K31/573
Inventor 孙亮
Owner TIANJIN JINYAO GRP
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