This is a growing list of practical application notes designed to demonstrate the benefits of our products which help save time, resources and drive critical decisions made by pharmaceutical companies. These notes may be downloaded by clicking on the link of interest.
Fiber Optic Spectroscopy: Real Time Dissolution and Solubility
These application notes pertain to the µDISS Profiler™ , Spectra™ and the Rainbow Dynamic Dissolution Monitor® System.
AN166-1 Rev. 1: Rational Drug Formulation: Evaluating Potential Drug Availability in vivo
Solubility is critical to the availability of new drug compounds. Dynamic solubility-pH studies of precipitation behavior in artificial stomach-duodenum models better assess in vivo solubility. When these studies are conducted with the UV-based µDISS Profiler™, real-time transient drug concentrations not achievable with liquid sampling based methods are obtained. Studies using the µDISS Profiler™ allow the drug developer to quickly evaluate, better understand API supersaturation and evaluate preformulation performance in biorelevant media.
AN172-1 Rev. 1: Sustained Release Testing with Fiber Optics in USP Apparatus 4
Release of dexamethasone from (DM) polymeric microspheres comprised of polylactic-co-glycolic acid (PLGA) was evaluated using USP Apparatus 4. Concentration monitoring with in situ UV fiber optic spectroscopy was 16% higher than with a “sample-and-separate” method conducted over a 30 day period. Material loss of microspheres during liquid sampling is suspected as the source of the discrepancy between the two methods. Also, the ten-fold greater density of data points produced by fiber optic spectrocopy also provides a better statistical basis upon which to calculate release rate.
High Throughput Permeability
These notes pertain to PAMPA Systems.
AN213-1 Rev. 1: A Low-cost Permeability Screen: BBB PAMPA
A high throughput, 96 well permeability method (PAMPA) has been developed using an artificial membrane constructed from porcine brain lipid (PBL) extract that shows good correlation (r2=0.79) with rat brain perfusion data using thirty test compounds. The in vitro results were more predictive of in situ brain penetration than published cell-based MDCK data. BBB PAMPA costs 1,000 times less than in vivo testing. Complete PAMPA Systems including a UV plate reader, all reagents, plates, control test samples, data collection/processing software ensure excellent system performance right out of the box.
High Throughput Solubility
These notes pertain to µSOL Systems.
AN215-1 Rev. 1 High Throughput: Enhanced Solubility in Biorelevant Media
Since drug solubility in biorelevant media (BRM) is often greater than in simple buffer systems, these measurements may provide a better understanding of in vivo absorption. The Pion 96- well µSOL miniaturized shake flask method was evaluated for solubility measurements of 7 test compounds in FaSSIF and FeSSIF as well as the corresponding buffer blanks which did not contain solubilizing agents (lecithin, sodium taurocholate). It was demonstrated the µSOL miniaturized shake flask is an easy, fast method suitable for these light-scattering media. As expected, the majority of the compounds exhibited enhanced solubility in the media containing solubilizing agents.
