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.
演講者
Paul Kippax Ph.D. - Sector Lead - Application Specialist
更多資訊
- Who should attend?
- Formulation developers engaged in the development of nasal sprays, inhalers and other OINDPs
- Scientists engaged in selecting appropriate techniques for assessing bioequivalence
- Researchers investigating the physicochemical properties which may be important in understanding and controlling bioavailability of OINDPs
- Laboratory managers interested in selecting material characterisation techniques relevant to understanding OINDP performance
- What will you learn?
- Learn about the regulatory guidance available to aid the development of complex generic drug products such as OINDPs.
Understand the analytical techniques which support in vitro bioequivalence assessment and can therefore speed formulation development and regulatory submission.
Understand more about the challenges of developing and manufacturing orally inhaled and nasal drug products.