Publications, Pharmaceutical

Using Raman for the characterization of nasal drug suspension products

Demonstrating bioequivalence (BE) in locally acting nasal suspension drug products is a significant challenge, though essential for the commercialization of generics.

This paper presents studies of the utility of morphologically directed Raman spectroscopy (MDRS) within this context, based on measurement of the particle size distribution of mometasone furoate monohydrate (MFM) in different suspension formulations. FDA product specific guidance for nasal drug suspension products highlight the potential to use MDRS in place of comparative clinical endpoint studies, a strategy with potential to accelerate generics to market. Drug substance particle size distribution data were measured using MDRS for a reference listed drug (Nasonex) and four test formulations. Other characteristics such as dissolution profile were also assessed. The data highlight the potential of dissolution testing as an orthogonal, critical analytical tool in BE studies.

Download Publication
28 Apr 2021

Learn more about Aptar Pharma Expertise
in Nasal Drug Delivery

Find Out More

This Might Also Be of Interest

24 Apr 2024

Advancing OINDP Clinical Trials with Speed and Efficiency: Strategies for Success

Publications, Pharmaceutical, Innovation & Insights, Market Insights, Product Solutions

Read More
24 Apr 2024

Exploring Nasal Casts in Nasal Drug Development

Publications, Pharmaceutical, Innovation & Insights, Market Insights, Product Solutions

Read More
3 Apr 2024

Delivering Nasally Administered Biologics

Webinars, Pharmaceutical, Product Solutions, Innovation & Insights, Device Innovations, Market Insights

Read More
3 Apr 2024

Nasal Casts, Tools to Enable Nasal Drug Delivery Development

Webinars, Pharmaceutical, Device Innovations, Market Insights, Product Solutions

Read More
1 2 3 25
Back To Top