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

6 Nov 2023

Nasal Inhalation Testing: IPAC-RS Droplet Size Analysis

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

Read More
13 Oct 2023

Nasal Drug Delivery: In Vitro Anatomical Models

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

Read More
4 Aug 2023

Aptar Pharma Discusses Intranasal Drug Delivery with PharmTech

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

Read More
3 Jul 2023

Nasal Spray Orientation & Sumatriptan Exposure using PK Modelling

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

Read More
1 2 3 22
Back To Top