New inhalation formulations

Abstract

The invention relates to a novel inhalation preparation, in particular to a preparation suitable for inhalation drug administration of children ranging from 0 to 12 years. After medicine difficult to be dissolved in water and auxiliary materials are mixed, a wet grinding method is adopted for smashing, mixed suspension liquid containing particles with the particle size appropriate is obtained, the particle size is 0.1-7 microns, and preferentially, the particle size is 0.1-5 microns; and further, the preferential particle size is 0.1-3 microns. Solid powder is obtained through a freeze-drying method. Sealing is performed for obtaining the novel inhalation; and before use, the novel inhalation preparation is mixed with liquid suitable for atomization, re-dispersion is performed, and the mixed suspension liquid capable of being used for atomizing inhalation of children is obtained. The preparation is stored and transported in the form of the solid powder, the problem that when a mixed suspension liquid form is adopted, the physical stability and the chemical stability are poor is avoided, the medicine particle size hardly changes, impurity increase is little, and the content hardly changes. Compared with inhalation powder aerosol, the novel inhalation preparation is especially suitable for atomizing medicine administration of children, medicine smaller in particle size can be adopted, and even though under the situations that breathing of an infant is slight and the effective portion deposition rate is low, an ideal medicine effect can also be achieved.

Description

technical field [0001] The invention relates to a novel inhalation preparation, especially a preparation suitable for inhalation administration to children aged 0-12, and belongs to the field of pharmaceutical preparations. Background technique [0002] Asthma is one of the most common chronic respiratory diseases in childhood. According to the survey in 2000, the prevalence rate of asthma in urban children aged 0-14 in my country was 0.5-3.4%. The most common method for the clinical treatment of children's asthma is through inhalation and local administration. On the one hand, it directly acts on the target organs, and on the other hand, it avoids systemic side effects. If inhalation is required for poorly soluble drugs, such as potent corticosteroids, they are usually inhaled in the form of inhalation powders, which have the advantages of easy portability, rapid administration, and rapid onset of effect. However, for children, on the one hand, due to their young age, thei...

AI Technical Summary

Problems solved by technology

However, for children, on the one hand, due to their young age, their lung capacity is insufficient, and on the other hand, their own illness also leads to weak breathing ability, so it is difficult to effectively inhale powder aerosols actively. Suspension, after nebulizing the suspension through an atomizing pump, inhale the nebulized medicinal solution into the respiratory tract through breathing, such as AstraZeneca’s Pulmicort Rescue (budesonide suspension for inhalation)

However, this suspension is a heterogeneous system, and the particle size of the drug is very small and the surface area is large, resulting in poor stability. It is easy to aggregate and precipitate, resulting in larger drug particle size and poor physical stability. On the other hand, the large surface area is prone to degradation reactions such as hydrolysis and oxidation, resulting in poor chemical stability.

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