Investigating orthogonal in vitro analytical approaches to demonstrate bioequivalence of nasal suspension formulations
Gonçalo Farias1, Robert Price1 Debbie Huck-Jones2, & Jagdeep Shur2
1Department of Pharmacy and Pharmacology, University of Bath, UK.
2Malvern Instruments Limited, Grovewood Road, Malvern, UK
The objective of this study was to investigate a range of orthogonal analytical tools to investigate API particle size in nasal suspensions formulations to demonstrate comparability between test and reference nasal suspensions. The application of these approaches are designed to be utilized to support in vitro bioequivalence of nasal suspension drug products. The aim of this proposal is to present a pathway whereby it may be possible to demonstrate Q3-equivalence between test and reference nasal suspension formulations. For such an approach to be successful, the application of advanced analytical tools to characterize formulation and raw material properties within the nasal suspension formulation are required.
Our proposed approach utilizes a combination of orthogonal techniques to support characterization nasal suspension formulations. These techniques include morphology directed Raman spectroscopy (MDRS) and UniDose-enabled dissolution testing. We will assess the API particle size in the formulation using MDRS to enable quantification of the size, shape and distribution of the formulation microstructure, which will be further investigated using UniDose-enabled dissolution testing. Together, these data will provide a systematic approach to quantify and compare the microstructure of nasal suspension formulation systems. Moreover, the structure-function of the formulation will be investigated rheological analysis.