For complex generic pharmaceutical products such as locally-acting nasal sprays, the US Food and Drug Administration’s (FDA) guidance outlines methods for determining the equivalence of physicochemical properties between the reference listed drug product (RLD) and the test product as a key step on the route to determining bioequivalence in-vitro.
These include the measurement of critical quality attributes such as drug particle size and shape, formulation rheological profile and spray droplet or aerosolised particle size distributions. Characterising the RLD according to these requirements during the early deformulation stage of a development workflow will ensure full understanding of the properties of the drug and will help accelerate product development by ensuring the appropriate tools are available for test products to be routinely compared to the reference, so any potential problems can be identified and addressed early on. Critically, this minimises the risk of failure when comes to performing in-vitro bioequivalence studies.
This webinar will provide an overview of Malvern Panalytical’s set of analytical techniques designed to accelerate the deformulation of orally inhaled and nasal drug products (OINDP), along with example case studies for nasal sprays and a discussion of how this workflow could be successfully implemented for dry powder inhaler products.
This webinar will take place on 16 October from 10:30 (GMT-5:00) to 11:30.
Debbie Huck-Jones will be presenting the webinar for anyone involved in the development and manufacture of generic OINDPs, and anyone interested in complex drug deformulation and development or the possibilities of and requirements for establishing bioequivalence in-vitro.
Attendees will learn how physicochemical measurement techniques can be applied to speed the deformulation of complex drug products such as orally inhaled and nasal drug products. They will also learn how these technologies are used to help establish Q3 bioequivalence for nasal sprays, and how they may be applied to other OINDPs such as dry powder inhalers (DPI) in the future.