New research highlights efficient in vitro strategies for demonstrating bioequivalence in generic nasal sprays
The presentation, entitled ‘Characterizing Nasal Suspension for Regulatory and Scientific Purposes’, describes work in two key areas. The first concerns measurement of the particle size of the active ingredient in the formulation, in the presence of other excipients. Results for a reference-listed drug product (Nasonex) and a series of generic suspension formulations highlight the ability of Malvern’s Morphologi G3-ID to provide robust particle size distribution data specifically for the active, to confirm, or otherwise, the parity of different formulations. Combining automated imaging technology with Raman spectroscopy, the Morphologi G3-ID delivers particle size, shape and chemical identification via the technique of Morphologically-Directed Raman Spectroscopy (MDRS).
The second focus of the research is the application of rotational rheometry to assess how a formulation is likely to respond when atomized by a given device. Nasal spray formulations are typically designed to be thixotropic, having a high-viscosity in the container to maintain a uniform suspension during storage, but a lower viscosity when atomized to ensure successful delivery to the nasal passages. Rotational rheometry studies with a Malvern Kinexus, in combination with measurements of the force required to actuate the nasal spray and droplet size analysis, demonstrate the direct link between formulation structure and patient-driven performance. This correlation suggests that measuring the rheological properties of nasal spray formulations can be helpful in confirming that the Critical Quality Attributes of a generic are closely similar to those of a reference drug product.
The conclusion from the work is that both MDRS and rheometry can be powerful in vitro techniques for demonstrating bioequivalence in a nasal spray and minimizing the cost of clinical trials.
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.
Most read news
More news from our other portals
See the theme worlds for related content
Topic World Spectroscopy
Investigation with spectroscopy gives us unique insights into the composition and structure of materials. From UV-Vis spectroscopy to infrared and Raman spectroscopy to fluorescence and atomic absorption spectroscopy, spectroscopy offers us a wide range of analytical techniques to precisely characterize substances. Immerse yourself in the fascinating world of spectroscopy!
Topic World Spectroscopy
Investigation with spectroscopy gives us unique insights into the composition and structure of materials. From UV-Vis spectroscopy to infrared and Raman spectroscopy to fluorescence and atomic absorption spectroscopy, spectroscopy offers us a wide range of analytical techniques to precisely characterize substances. Immerse yourself in the fascinating world of spectroscopy!
Topic World Particle Analysis
Particle analysis methods allow us to study tiny particles in various materials and reveal their properties. Whether in environmental monitoring, nanotechnology or the pharmaceutical industry, particle analysis gives us a glimpse into a hidden world where we can decipher the composition, size and shape of particles. Experience the fascinating world of particle analysis!
Topic World Particle Analysis
Particle analysis methods allow us to study tiny particles in various materials and reveal their properties. Whether in environmental monitoring, nanotechnology or the pharmaceutical industry, particle analysis gives us a glimpse into a hidden world where we can decipher the composition, size and shape of particles. Experience the fascinating world of particle analysis!