- Unique approach to studying biorelevant drug dissolution
- One API – One method
- Proven to achieve Level A IVIVC
FloVitro™ is a dissolution assay designed to bridge the gap between in vitro dissolution data and in vivo outcome in drug development. Using a single set of pharmacokinetic data, the “starting point algorithm” in FloVitro™ will select optimum assay conditions required to achieve Level A IVIVC for a given API or drug product. FloVitro™ instrumentation was originally developed by The Dow Chemical Company and is now offered as an analytical service by Sirius.
The instrumentation comprises three cells: gastric, intestinal and systemic. Dissolution media is pumped through the system, while each cell is held at a specific pressure, temperature and pH. The chosen dosage form is introduced into the gastric cell where disintegration and initial dissolution take place. Small particles are transferred to the intestinal cell for further dissolution. Dissolved drug is then passed through a membrane and into the systemic cell and subsequently cleared. UV data are collected from the intestinal and systemic cells in real time. Concentration versus time data are used to plot a dissolution curve.
Typical analytical projects have three stages:
1. Obtaining in vivo data
2. Designing and optimising a method and running FloVitro™
experiments using the “originator drug” to simulate the in vivo profile
3. Using the same method to evaluate new formulations, generic drugs or other versions of the drug