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Integrated device and method for improving pulmonary inhalation medication through lactose micropowder pre-deposition

A lactose micropowder and pre-deposition technology, applied in inhalers, pharmaceutical formulations, drug delivery, etc., can solve the problems of unknown safety and few cases

Active Publication Date: 2019-05-21
湖南致雅生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Using a variety of compound excipients is an effective way to increase the lung deposition rate of drug powder. However, due to the unknown safety of the combination of various excipients, the dry powder inhaler approved by the US Food and Drug Administration (FDA) basically only recognizes lactose as The only safe carrier excipient; although mannitol excipients have also been used in dry powder inhalers in recent years, there are very few cases

Method used

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  • Integrated device and method for improving pulmonary inhalation medication through lactose micropowder pre-deposition
  • Integrated device and method for improving pulmonary inhalation medication through lactose micropowder pre-deposition
  • Integrated device and method for improving pulmonary inhalation medication through lactose micropowder pre-deposition

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Experimental program
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Effect test

Embodiment 1

[0029] like figure 1 (Schematic diagram of the device integration for improving pulmonary inhalation by pre-deposition of lactose micropowder) As shown, the device integration for improving pulmonary inhalation by pre-deposition of lactose micropowder mainly includes inhaler (1), head and throat (2) , Breathing pipeline (3) and lung model equipment (4), the air outlet of the inhaler (1) is connected with the air inlet of the head and throat (2), and the air outlet of the head and throat (2) is connected with the air inlet of the breathing pipeline (3) The air outlet of the respiratory pipeline (3) is connected with the air inlet of the lung model equipment (4); the inhaler (1) mainly includes a filter tip (1-1), an air inlet of the inhaler (1-2) , powder compartment (1-3), lactose micropowder compartment (1-4), V-shaped compartment switching baffle (1-5), compartment switching knob (1-6) and inhaler air outlet (1- 7), the head and throat (2) mainly includes the head and throa...

Embodiment 2

[0042] According to the device integration and method for improving lung inhalation medication through pre-deposition of lactose micropowder, this embodiment provides a specific clinical drug delivery procedure, including:

[0043] S1: For the target administration site is the respiratory tract and lungs, load 20 mg of flower-shaped lactose with a particle size of 10-50 microns (the material has a nitrogen adsorption surface area of ​​20-30m 2 / g);

[0044] S2: Inhalation of gas, administration of anhydrous lactose micropowder to make it pre-deposited in the respiratory tract;

[0045] S3: Exhale completely, adjust the inhaler within one minute, and prepare for reinhalation;

[0046] S4: Administer tiotropium bromide powder normally by inhaling it, and keep it for 5-10 seconds so that the powder reaches the lungs completely.

[0047] use figure 1 The equipment shown is simulated, first inhaling anhydrous lactose micropowder, making it settle in the wet pipeline, then inhali...

Embodiment 3

[0049] According to the device integration and method for improving lung inhalation medication through pre-deposition of lactose micropowder, this embodiment provides a specific clinical drug delivery procedure, including:

[0050] S1: For the target drug administration site is the lungs, load 100 mg of flower-shaped lactose with a particle size of 5-10 microns (the nitrogen adsorption surface area of ​​this material is 30-40m 2 / g);

[0051] S2: Inhalation of gas, administration of anhydrous lactose micropowder to make it pre-deposited in the respiratory tract;

[0052] S3: Exhale completely, adjust the inhaler within one minute, and prepare for reinhalation;

[0053] S4: Administer budesonide powder by normal inhalation, and keep for 5-10 seconds so that the powder reaches the lungs completely.

[0054] use figure 1 The equipment shown is simulated, first inhaling anhydrous lactose micropowder, making it settle in the wet pipeline, then inhaling the drug powder, and measu...

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Abstract

The invention relates to an integrated device and method for improving pulmonary inhalation medication through lactose micropowder pre-deposition, wherein the integrated device mainly comprises an inhaler, a head and throat part, a respiratory pipeline model device and a lung model device; the inhaler comprises two modes of pre-deposition lactose administration and normal administration; and the respiratory pipeline model device can simulate the real environment of a human body by wetting the pipe wall during measurement. According to the novel administration method, a lactose micro-powder pre-deposition step is arranged one minute before prior inhalation administration, and 20-200 milligrams of anhydrous lactose micro-powder such as flower-shaped lactose, amorphous coated lactose and thelike are pre-deposited in the moist and viscous head and throat part, the respiratory pipeline and part of a lung trachea, so that a smooth inhalation environment is provided for the inhalation of subsequent medicinal powder, and the deposition rate of the medicinal powder in a target area of the lung trachea is improved by 30-200%.

Description

technical field [0001] The invention relates to the technical field of dry powder inhalers, in particular to an equipment integration and method for improving pulmonary inhalation medication by pre-depositing lactose micropowder. Background technique [0002] Dry powder inhaler is a pharmaceutical dosage form of inhalation, such as tiotropium bromide powder, budesonide powder, beclomethasone dipropionate and cromolyn sodium compound powder, salmeterol and fluticasone propionate compound powder, antibiotics, insulin, etc. Dry powder inhaler. This type of medicine uses the method of drug dry powder inhalation, allowing the drug powder with a particle size of 1 to 5 microns to reach the lungs from the inhaler, head and throat, and respiratory tract, so as to exert its drug effect. Particles with a particle size larger than 5 microns are difficult to reach the lungs and will be deposited in the mouth and respiratory tract; particles with a particle size smaller than 1 micron ar...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K47/26A61M15/00
Inventor 谭淞文刘敏谭旭陈训财谭松林谭越谭燕辉
Owner 湖南致雅生物科技有限公司
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