Foster Analytical Services Speed Time to Market for Drug Delivery Formulations

Foster Delivery Science, a business unit for Foster Corporation, recently announced it has added comprehensive in-house laboratory services to expedite the screening of early stage formulations, process development, and post-extrusion studies of solid dose drug delivery forms using hot-melt extrusion. As a contract research and manufacturing company that specializes in hot-melt extrusion, Foster Delivery Science analytical services includes thermal analysis, spectroscopy, and chromatography equipment specifically designed for solid oral doses produced from this processing method.

Foster’s new thermogravimetric analysis (TGA), differential scanning calorimeter (DSC), and Fourier Transform infrared spectroscopy (FTIR) equipment allow for screening of drug-polymer combinations with suitable mixing characteristics. These tests are also used to characterize crystalline and amorphous solids and in the melt-extruded drug-polymer matrix. High-performance liquid chromatography equipment (HPLC) provides quantitation of the drug and its related substances in the melt-extruded formulations and in dissolution studies, a critical characteristic when attempting to enhance the solubility of a poorly soluble drug molecule.

Foster Delivery Science is a unique pharmaceutical contract organization with a sole focus on hot-melt extrusion for drug delivery. With the addition of analytical services, the company is able to provide rapid screening of drug-polymer candidates suitable for hot-melt extrusion, and leverage this information to establish extrusion conditions for initial trials. Samples can be evaluated immediately after initial trials to confirm an amorphous solid solution or dispersion formation and monitor recrystallization of the drug in the matrix. This closed-loop approach greatly enhances evaluation and development time of dosage forms using hot-melt extrusion.

“We have over 2 decades of hot-melt extrusion experience in healthcare applications, and in the pharmaceutical industry, there are really no other contract service providers that focus only on this process for solid dose drug delivery. The addition of in-house characterization services allows us to accelerate time to market for our customers with rapid data-based decision-making throughout the development cycle,” said Tony Listro, Managing Director at Foster Delivery Science. “This is part of a bigger initiative to continue to provide leadership as a pharmaceutical contract organization specializing in hot melt extrusion.”