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In Vitro-In Vivo Correlation Test System

Application

TEL86-10-56370031

Description

Features

Specification

Standards

Video

The actual drug delivery dose, fine particle distribution and lung deposition of inhalers depend on three correlating factors: patients, prescriptions and delivery devices. Due to the characteristics of inhalers' forms, the current in vitro test methods regulated by Pharmacopoeia as well as the individual differences, the correlation between in vitro and in vivo is weak and IVIVC studies become necessary. One of the IVIVC studies is conducting in vitro tests by simulated human breathing.

There are individual differences between different patients, and the actual breathing pattern and inspiratory flow of the patient during inhalation are not consistent with the set flow in the in vitro test, which affects the drug distribution in the lungs and leads to inconsistent results in the in vitro test. 

 This instrument can simulate human breathing in the in vitro test, which makes the results more consistent with the actual situation and can be analyzed. IVIVC studies enhance the consistency evaluation of inhalers and bioequivalence.

 

Compressed air flow rate

0~100L/min

Simulate peak inspiratory and expiratory flow

0~100L/min

Increased flow rate

0-15L/s2

Customized breath curve

 Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products(2013)

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