날짜 기록: May 21 2020
Drug product developers face many challenges as they seek to develop new drug products based on novel dosage forms or delivery technologies. This particularly true of Orally Inhaled and Nasal Drug Products (OINDPs), where developers must not only develop an effective formulation but also understand how this can be reproducibly delivered to a patient using a complex device. As a result, development of new and generic OINDPs is considered high risk, with many projects failing to meet project timescales or even reach market at all. This can limit access to critical therapies, as has become more apparent during the current situation with COVID-19 where demand for inhaled drug treatments has increased dramatically.
In this webinar, we will discuss the novel analytical methods available from Malvern Panalytical which can be applied to the characterisation of OINDPs in order to speed candidate formulation development. In response to the challenges associated with OINDP development, regulators such as the US FDA have released a number of product-specific bioequivalence guidance documents describing the application of physicochemical analysis techniques to enable in vitro assessment of bioequivalence. Although this guidance is targeted at enabling the rapid development and launch of generic products, it also highlights the critical material attributes which can be considered in order to advance R+D for new OINDP products. We will present case studies showing the application of the in vitro methods highlighted within regulatory guidance and how the data generated, along with other supporting evidence, can aid formulation optimization and therefore help speed successful product development and regulatory submission.