Test method and device for improving in-vivo and in-vitro correlation of inhaled preparation

Abstract

In order to solve a plurality of defects of the aerodynamic characteristic determination of the micro-particles of the preparation by adopting a cascade impactor, the invention provides a test devicefor improving the in-vivo and in-vitro correlation of an inhaled preparation. The device comprises a drug delivery device 1, a human respiratory tract model 2 and a breathing simulator 3, wherein thehuman respiratory tract model 2 comprises an adapter 21 and a real human respiratory tract 3D solid model 22, the breathing simulator 3 comprises a connection control assembly 31, a piston type movement device 32, a control system 33 and a breathing data acquisition device 34, and the device is characterized in that the real human respiratory tract 3D solid model 22 is provided with a plurality offirst quick-connection interfaces 221, the plurality of first quick-connection interfaces 221 are finally converged into a total air path through a plurality of air paths and then connected to the inlet end of the connection control assembly 31, the outlet end of the connection control assembly 32 is connected to the piston type movement device 32; and the connection control assembly 31 comprisesa first solenoid valve 311, a second solenoid valve 312, a third solenoid valve 313, an electronic flow meter 315, and a main body air path.

Description

technical field [0001] The invention belongs to the technical field of medical devices. More specifically, the invention relates to a test method and equipment for improving the in vitro and in vivo correlation of inhalation preparations. The test method and equipment are used to evaluate the deposition of inhalation preparations in the human respiratory tract in vitro Improve the correlation between in vitro test results and in vivo test results, improve the accuracy of in vitro evaluation of inhalation preparations, and reduce the development time and in vivo test costs of inhalation preparations. Background technique [0002] The respiratory system is an important part of the human body and an important way for the human body to exchange substances with the outside world. Of course, it is also the way for external particles to enter the respiratory tract. There are many diseases caused by the respiratory process, such as: asthma, chronic obstructive pulmonary disease (COP...

AI Technical Summary

Problems solved by technology

[0008] First, the existing cascade impactor only uses an L-shaped connection management of one size to replace the human mouth structure, which is significantly different from the actual human mouth structure, and due to differences in age, gender, race, medical history, etc. There are large differences in the structure of the respiratory tract and cannot represent different groups of people

[0009] Second, the existing cascade impactor directly adopts L-shaped connection management to replace the structure of the human mouth, and does not take into account the changes in the structure of the respiratory tract under different breathing states.

The human body has different mouth volume, tongue position, and glottis size in different breathing states, so the existing L-shaped connecting tube cannot cover all different breathing states

[0010] Third, the existing cascade impactor uses a vacuum pump as a device to provide negative pressure, which can only test the deposition of preparation particles at a constant flow rate, but the real situation is the difference in respiratory flow when the human body uses the drug delivery device to inhale the preparation Huge, the deposition of preparations in the respiratory tract is closely related to the respiratory flow, which directly leads to the inability of the existing cascade impactors to simulate the results of changes in the real respiratory flow of the human body

[0011] Fourth, the use of a vacuum pump as a device to provide negative pressure can only test the deposition of the preparation in the inhalation state, and cannot test the effect of the exhalation state on the deposition

[0012] Fifth, the result of the measurement of the aerodynamic properties of the fine particles of the preparation using the cascade impactor is the cumulative mass of the fine particles specified in the cascade impactor. At the same time, this technology regards the deposition amount of the aerodynamic diameter less than 5um as the inhaled preparation As an important indicator of evaluation, the industry generally believes that particles with an aerodynamic diameter smaller than 5um can enter the deep lung and be absorbed by the human body; but the fact is that particles with an aerodynamic diameter larger than 5um may also enter the deep lung and be absorbed by the human body, while the Particles with a dynamic diameter of less than 5um may only be deposited in the throat area but cannot enter the deep lung. Therefore, the results of the measurement of the aerodynamic properties of the fine particles of the preparation using a cascade impactor cannot fully correspond to the in vivo test.

[0013] Sixth, the inhalation preparations for the treatment of different diseases require drug particles to be deposited in different positions of the respiratory tract, such as the upper respiratory tract, bronchi, etc., and it is impossible to test the preparations in different parts of the respiratory tract by using a cascade impactor to measure the aerodynamic properties of the fine particles of the preparation. of deposition

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