Dissolution profiling system for biorelevant media volumes
When developing pharmaceutical formulations, especially oral dosage forms, understanding the dissolution behavior in biorelevant media volumes is critical. Accurately measuring high-potency active pharmaceutical ingredients (API) at low concentrations presents unique challenges requiring precise and reliable testing systems.
Measure dissolution rates in small biorelevant volumes
The miniDISS Profiler by Pion is a dissolution profiling system specifically designed for small biorelevant media volumes ranging from 100 to 250 milliliters. This system eliminates the need for time-consuming swaps and revalidation when switching between large and small volume tests. It features an eight-position stirring system with interchangeable vessels of 100 ml, 150 ml, 200 ml, and 250 ml, complying with Chinese Pharmacopoeia standards. The Profiler utilizes Pion’s industry-standard Rainbow technology for UV monitoring, capable of collecting full spectra data (from 200 to 720 nm) as quickly as every two seconds. The system also includes dip-style fiber optic probes with interchangeable path length tips, providing flexibility and precision in small volume dissolution testing. Common applications include formulation development, pediatric drug product testing, and high-potency drug testing under sink and non-sink conditions.
Benefits
- Flexibility to switch between various vessel sizes without revalidation
- Rapid data collection with UV spectra monitoring every two seconds
- Designed to handle high-potency APIs at low concentrations
- Eight-position stirring system for multiple simultaneous tests
- Compatible with biorelevant media volumes from 100 to 250 ml