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Isoniazid dry powder inhalant for treating pulmonary tuberculosis

A dry powder inhaler and isoniazid technology, which is applied in powder delivery, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of low drug loading, large amount of excipients, and reduced drug loading to achieve high drug delivery rate, simple preparation process, and high formulation stability

Active Publication Date: 2021-02-09
SHENZHEN SCIENCARE MEDICAL INDUSTRIES CO. LTD.
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The application uses a large amount of gelatin excipients in order to make the two drugs play a sustained release role. Gelatin is derived from animals and may have some immunogenicity when it enters the lungs, so the safety cannot be guaranteed. will reduce
[0006] It can be seen that the clinical demand for isoniazid inhalation dosage forms has not been met, and the currently known isoniazid inhalation dosage forms all suffer from low delivery efficiency, poor preparation stability, unguaranteed safety, and low drug loading, etc. question

Method used

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  • Isoniazid dry powder inhalant for treating pulmonary tuberculosis
  • Isoniazid dry powder inhalant for treating pulmonary tuberculosis
  • Isoniazid dry powder inhalant for treating pulmonary tuberculosis

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Example 1: 10.0 g of isoniazid is passed through a fluidized bed supersonic jet pulverization method to make the particle size reach d 10 =0.5-2.0μm, d 50 =2.0-5.0μm, d 90 =5.0-9.5 μm, take the above-mentioned isoniazid micropowder, mix Inhalac 140 type lactose with isoniazid micropowder, the mixing weight ratio is 1:1; 5%.

Embodiment 2

[0033] Example 2: 10.0 g of isoniazid is passed through a fluidized bed supersonic jet pulverization method to make the particle size reach d 10 =0.5-2.0μm, d 50 =2.0-5.0μm, d 90 = 5.0-9.5 μm, take the above-mentioned isoniazid micropowder, mix Inhalac 230 type lactose with isoniazid micropowder, the mixing weight ratio is 1:1; 5%.

Embodiment 3

[0034]Example 3: 10.0 g of isoniazid is passed through a fluidized bed supersonic jet pulverization method to make the particle size reach d 10 =0.5-2.0μm, d 50 =2.0-5.0μm, d 90 = 5.0-9.5 μm, take the above-mentioned isoniazid micropowder, mix Inhalac 230 type lactose with isoniazid micropowder, the mixing weight ratio is 2:1; 5%.

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Abstract

The invention relates to an isoniazid dry powder inhalant for treating pulmonary tuberculosis. The isoniazid dry powder inhalant comprises isoniazid micro-powder and comprises or does not comprise carrier micro-powder; the particle size of the isoniazid micro-powder is treated to 0.1-10 mu m by a fluidized bed supersonic jet milling method or a spray drying method; preferably, auxiliary materialsincluding leucine, mannitol or phospholipid are added into the dry powder inhalant so as to enhance the pelletizing rate of particles; and furthermore, auxiliary materials including magnesium stearate, mannitol, leucine and / or lactose are added so as to improve the flowability of the medicine and reduce the particle agglomeration phenomenon. The preparation process of the isoniazid dry powder inhalant is simple; and the isoniazid dry powder inhalant with relatively high stability can be prepared. The dry powder inhalant can effectively deliver drugs to pulmonary alveoli so as to effectively kill and inhibit tubercle bacillus in respiratory tracts, and is particularly suitable for treating pulmonary tuberculosis patients with impaired liver functions.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an isoniazid dry powder inhaler for treating pulmonary tuberculosis and a preparation method thereof, as well as its use in preparing medicines for treating various types of pulmonary tuberculosis. Background technique [0002] Tuberculosis is a highly contagious lung disease, which is very destructive to the lungs, and the treatment takes a long time, usually more than half a year. The current clinical treatment of pulmonary tuberculosis often adopts oral quadruple therapy of isoniazid, rifampicin, ethambutol and pyrazinamide. Among them, isoniazid has strong antibacterial activity against Mycobacterium tuberculosis, and is a very effective and rapid Mycobacterium tuberculosis fungicide. The effective concentration is 0.3-10 μg / mL, which can achieve very good antibacterial and bactericidal effects. However, conventional oral preparations have strong hepato...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K31/4409A61K47/26A61K47/12A61P31/06
CPCA61K9/145A61K9/0075A61K31/4409A61P31/06
Inventor 张桐桐王实强曲伟张涛张国立颜携国李勇梁民彩
Owner SHENZHEN SCIENCARE MEDICAL INDUSTRIES CO. LTD.
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