Application of PERMETRO in Bioequivalence and IVIVC
The Logan PERMETRO™ system consists of a proprietary dynamic dissolution-permeation apparatus and novel artificial intestinal membrane. PERMETRO was developed to overcome the limitations and bottlenecks of traditional IVIVC permeation testing by improving prediction of particle engineering, reformulation effects, and bioavailability enhancement.
PERMETRO System Applications:
- OSD R&D and QC to assist formulation screening
- Provide data support before in vivo BE experiments
- Generic vs. original comparison studies
- IVIVC and IVIVC model development
- Gastrointestinal absorption of fasted/meal medication
- GIT absorption differences of CR formulations in different modes of administration, e.g., water, alcohol
- OSD R&D and QC to assist formulation screening
- Provide data support before in vivo BE experiments
- Generic vs. original comparison studies
- IVIVC and IVIVC model development
- Gastrointestinal absorption of fasted/meal medication
- GIT absorption differences of CR formulations in different modes of administration, e.g., water, alcohol
Current dissolution tests do not monitor drug permeation. Typical pre-BE tests require a lot of resources, and there are ethical issues. To overcome these problems, PERMETRO studies the dissolution curves and permeability comparison of generic vs. original drugs. It can predict and increase the success rate of BE experiments and reduce the requirement for in vivo studies.
The integrated PERMETRO system includes:
- Logan dynamic permeation cells
- PermeaPad™ - Logan’s novel artificial intestinal membrane
- A unique dual-pump design that integrates the dissolution sampling pump and permeation pump
- Automatic collection of permeation test samples at all time points
- Dry heating for convenient cleaning and support for online HPLC analysis
- Online HPLC analysis
1. Dissolution-Permeation Studies
PERMETRO makes simultaneous in vitro dissolution and permeability testing possible and more representative of the in vivo state. The knowledge gained saves valuable research time and expense in vivo testing. Drug permeation can be tested completely in vitro.
The in vitro bioequivalence prediction system can use artificial intestinal membranes to simulate the release and absorption process of drugs from the stomach to the intestine. The device is compatible with USP methods 1-7, and the backend can be used with UV or HPLC analysis systems.
2. Branded vs. Generic BE Studies
Although the dissolution profiles of generic and reference APIs may be the same, the dissolution rates of excipients that affect permeability can be different. Excipients such as SLS can change the permeability of the gastrointestinal tract, so the absorption rates of the drugs are different, which may easily lead to BE failure.
For more information about PERMETRO, contact infoDT@loganinstruments.com
