Generic Nasal Spray Design

Scoping the Design Space for Generic Nasal Sprays

In this article, Deborah Huck-Jones, PhD, Product Manager, Analytical Imaging; and Paul Kippax, PhD, Micrometrics Product Group Manager & Pharmaceutical Portfolio Manager, both of Malvern Instruments, discuss analytical methods that can be helpful for demonstrating bioequivalence in the development of generic nasal sprays, highlighting the importance of understanding how spray formulations and devices interact to impact drug delivery performance.

As a result of the regulatory focus on using a Quality by Design (QbD) approach for ANDAs, generics manufacturers are placing increasing emphasis on the analytical tools that support its application. Most especially, there is a requirement for analytical technologies that help to scope the product design space efficiently. This is the multiparametric space in which the properties that define clinical performance must lie to ensure consistent, controlled efficacy.

When developing nasal sprays, identifying the design space is complicated by the fact that critical features of the delivered dose, such as droplet size, are influenced by interactions between the formulation and the delivery device used. A detailed understanding of the impact of both of these elements is essential to achieving the QbD, knowledge-led approach now associated with successful development and commercialisation of a generic.