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 guidances 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

5 Jan 2023

Case Study – Unidose Nasal Spray Pump for Epilepsy

Case Studies, Pharmaceutical, Device Innovations, Market Insights, Product Solutions

Read More
14 Dec 2022

Building Digital Solutions To Meet The Unique Therapeutic Needs of Patients

Publications, Pharmaceutical, Product Solutions, Innovation & Insights, Device Innovations

Read More
30 Nov 2022

Drug Repositioning – Benefits and Challenges for Lifecycle Management

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

Read More
24 Nov 2022

Step to Success in Nose-to-Brain Drug Delivery

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

Read More
1 2 3 18
Back To Top