In vitro dissolution testing is used to characterize drug compounds throughout their development. In early drug development it is used to support the choice of a particular formulation. During drug production it is a critical component of the quality control process and is used to assess the changes in manufacturing processes or formulation. In order for dissolution results to be meaningful at each stage, the test and the process need to be reliable, consistent, predictive and accurate.
Filtration as the only sample preparation step plays an important role in the dissolution process, yet this step is often taken for granted. The choice of frits or syringe filters is often based on experience with previous formulations or availability in the lab. Selecting the wrong filter can result in inadequate filtration, low analyte recovery, solvent incompatibility or extractables that reduce accuracy and reproducibility. The wrong pore size or device can result in clogging that can adversely affect throughput and sample processing.
This seminar describes different membrane characteristics and provides guidance in selecting the right filtration devices for sample preparation following in vitro dissolution. Problems that result from using the wrong filter are presented along with steps one can take to solve each problem. Filter characteristics that affect drug recovery and downstream analysis, such as non-specific binding and extractable levels, are presented. Steps one can take to optimize throughput and reduce downtime are addressed including a discussion on membrane properties and guidance on the use of multi-layer and automation compatible filters. Recommendations are presented for choosing the right sample preparation device that will help improve throughput, reduce sample processing time and enhance test accuracy and reproducibility.
Vivek Joshi, Ph.D.
Applications and Market Adoption Manager
Vivek Joshi, Ph.D. is an Applications and Market Adoption Manager developing new products and applications for products that span analytical workflows, molecular and protein science workflows and cell culture workflows. Prior to joining us, Dr. Joshi worked on high throughput LC‐MS applications at ArQule. Dr. Joshi’s doctoral research focused on molecularly imprinted polymers (MIPs), and he completed postdoctoral studies of MIPs and capillary electrochromatography. Recently, Dr. Joshi was the presenter of a sample preparation module as part of the Drug Dissolution Training offered by the United States Pharmacopeia (USP).
Research and disease areas
Session 1:presented May 31, 2021
To continue reading please sign in or create an account.Don't Have An Account?