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Itraconazole inhalation powder spray and preparation method thereof

A technology for inhaling powder and itraconazole, which is applied in the field of medicine, can solve the problems of significant individual differences, unstable absorption, and large food influence, and achieve the effects of less dosage, good physical stability, and fast dissolution rate

Active Publication Date: 2017-11-24
GUANGZHOU NEWORLD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, intravenous injection is prone to adverse reactions such as visual impairment and abnormal renal function, while oral administration is unstable, with significant individual differences, and is greatly affected by food. Due to the high permeability of oral liquid, patients are often accompanied by nausea, vomiting, abdominal pain and diarrhea And adverse reactions such as gastric mucosal bleeding

Method used

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  • Itraconazole inhalation powder spray and preparation method thereof
  • Itraconazole inhalation powder spray and preparation method thereof
  • Itraconazole inhalation powder spray and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] In this example, an itraconazole inhalation powder is prepared from 2.002 g of itraconazole as the active ingredient and 7.998 g of the carrier mannitol.

[0042] The preparation method of above-mentioned itraconazole inhalation powder and spray, comprises the steps:

[0043] (1) Get 2.002g itraconazole crude drug, 7.998g mannitol, mix homogeneously, obtain mixture;

[0044] (2) Set the extrusion temperature of the twin-screw hot-melt extruder to 160°C, start the screw after reaching the preset temperature, the screw speed is 150 rpm, and add the uniformly mixed physical mixture into the extrusion by manual injection In the machine, the mixture is extruded in strips through the screw; the hot-melt extruded strips are placed in a drier to cool at room temperature, and the itraconazole solid dispersion is obtained by preliminarily pulverizing with a micro-powder machine, and the obtained itraconazole The solid dispersion is then passed through a jet mill (nozzle air pres...

Embodiment 2

[0047] This example is an itraconazole inhalation powder, the components of which are basically the same as those in Example 1, the difference is that the raw material of itraconazole is 4.996g, and that of mannitol is 5.004g.

Embodiment 3

[0049] This example is an itraconazole inhalation powder, the components of which are basically the same as those in Example 1, the difference is that the raw material of itraconazole is 7.982g, and that of mannitol is 2.018g.

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Abstract

The invention discloses an itraconazole inhalation powder aerosol and its preparation method. The inhalation powder aerosol is prepared by using itraconazole and 20-80mass% of a carrier, and the carrier is at least one of lactose, mannitol, inulin and amino acids. The method comprises the following steps: mixing itraconazole with the carrier, adding the obtained mixture into a double screw hot melt extruder, setting the extrusion temperature at 150-170DEG C, starting screws after the preset temperature is reached, and carrying out strip extrusion under a screw rotating speed of 150-200r / min, cooling obtained strips in a dryer to room temperature, crushing by using a micro pulverization machine, and micronizing by using an airflow crusher to obtain the above powder. The inhalation powder aerosol has the advantages of good physical stability, good powder fluidity, high deposition amount at effective positions, high dissolution rate, fast dissolution speed, small drug dose, and low incidence rate of toxic side effects; and the method has the advantages of simple technology, no organic solvents, antiseptics or other impurities in the process, good reappearance and easy industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an itraconazole inhalation powder and a preparation method thereof. Background technique [0002] As an important drug delivery route, the pulmonary drug delivery route can be applied to local or systemic delivery of drugs to achieve safe, targeted, quick-acting, and highly effective therapeutic purposes. Local administration of the lung has significant advantages in the treatment of lung diseases, such as asthma, chronic obstructive pulmonary disease, cystic fibrosis, invasive pulmonary fungal infection and other diseases. Reduce the dosage and reduce systemic adverse reactions. Due to the special physiological structure of the lung, the surface area is large (about 100m 2 ), rich blood flow (about 5l / min), thin alveolar epithelial cells (about 0.1-0.5μm), which is conducive to the diffusion of drugs into the blood, and low enzyme activity, drug administration thr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K31/496A61K47/26A61K47/16A61P31/10
Inventor 吴传斌林玲陆明
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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