Nasal inhalation powder preparation and device thereof

A powder and preparation technology, applied in the field of pharmaceutical preparations, can solve the problems of poor tissue penetration and low oral bioavailability

Inactive Publication Date: 2019-07-02
SHENZHEN HUALIKANG BIOLOGICAL MEDICINE +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Zanamivir molecule has strong polarity and good water solubili

Method used

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  • Nasal inhalation powder preparation and device thereof
  • Nasal inhalation powder preparation and device thereof
  • Nasal inhalation powder preparation and device thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Precisely weigh an appropriate amount of zanamivir and lactose, place them in a mortar and grind them respectively, pass the ground powder through a 100-mesh and 1250-mesh drying net, and accurately weigh one part of sieved zanamivir and four parts of The sieved lactose is mixed, and after mixing evenly, a single dose of 25 mg is filled in a single-dose nasal inhalation device.

Embodiment 2

[0020] Accurately weigh an appropriate amount of zanamivir, place it in a mortar and grind it, and pass the ground powder through a 100-mesh and 1250-mesh drying net respectively, and accurately weigh one part of sieved zanamivir and four parts of 230 type of lactose, after mixing evenly, fill it in a capsule with a single dose of 25 mg, and place the capsule in a nasal cavity inhalation device during use.

Embodiment 3

[0022] The Zanamivir nasal inhalation powder formulation constructed in Example 2 is tested, including:

[0023] (1) Particle size of the powder: tested by Malvern laser particle size analyzer Mastersizer 3000, the method is dry test, the parameters are: air pressure 2bar, refractive index 1.52.

[0024] Changes in particle size during the stability process of self-developed samples

[0025]

[0026] The results show that the particle size of the sample does not change significantly under the conditions of the influencing factors, indicating that the dispersion of the sample is relatively stable.

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Abstract

The present invention relates to a nasal inhalation powder preparation and a device thereof. The nasal inhalation powder preparation comprises the following materials in mass ratio: 1 part of zanamivir and 3-5 parts of a pharmaceutically acceptable adjuvant. The nasal inhalation powder preparation has a particle diameter of D10 > 5 [mu]m, D50 < 150 [mu]m and D90 < 300 [mu]m. The nasal inhalation powder preparation can be used for prevention of influenza viruses.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a nasal inhalation powder preparation containing zanamivir and a device thereof, which can be used for preventing influenza virus. Background technique [0002] Influenza (flu for short) causes certain economic and health burdens worldwide every year. According to WHO statistics, influenza infects about 1 billion people around the world every year, including 3-5 million severe cases, and eventually leads to 300,000-500,000 deaths. The 2008 influenza survey found that between 28,000 and 111,500 children with influenza among children younger than 5 years old died of lower respiratory tract infections associated with influenza. [0003] Neuraminic acid NA inhibitor is currently recognized as the drug of choice for the treatment of influenza. Zanamivir inhalation powder (trade name Leganqing or Relenza) developed by GSK was approved by the US Food and Drug Administration i...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K31/351A61M11/00A61M31/00A61P31/16
CPCA61K9/0043A61K9/143A61K9/145A61K9/146A61K31/351A61M11/00A61M31/00A61M2210/0618A61M2210/005
Inventor 王泽人徐俊陈顺彭继千井绪文
Owner SHENZHEN HUALIKANG BIOLOGICAL MEDICINE
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