I have just come back from presenting my talk ‘Application of Morphologically-Directed Raman Spectroscopy in deformulation and in vitro bioequivalence studies’ at the pharma focus session of Powtech 2017.
The talk indicated how there are still many drug products that have come of patent but do not yet have generic equivalents available and how there is a drive from the regulatory bodies to make health care more accessible and so they are producing many guidance documents to help address this.
I gave an overview of a proposed workflow for developing generic drug products and showed where MDRS plays a role at the early stages when characterizing the Reference listed drug, and then again later, when proving Q3 equivalence to allow in vitro bioequivalence studies to be used during regulatory submission to avoid lengthy clinical trials.
The main focus of the talk was to show how MDRS is being used in real applications so we looked at the deformulation of an oral solid dose tablet to identify and characterize the particle size distribution of the APIs. We also looked at how we could determine the relative proportion of 2 APIs present in a dry powder inhalation formation. To demonstrate how MDRS is being used show Q3 equivalence for in vitro bioequivalence studies, I showed the analysis of the particle size distribution of the API within a nasal spray formulation. Here the morphologically-directed nature of the technique is key as it allows for a much more efficient analysis.
If you missed the talk but would like to find out more you can request a copy of the presentation by clicking HERE
I had some great feedback at the end. Once a member of the audience told me it was really refreshing to hear from someone who clearly knew the applications personally and didn’t just present a techie talk!
Mark Wingfield – General Manager GmbH and Stefan Hoffmann – XRF & Fusion specialist also gave talks during the show titled:
- The Application of XRD in Pharmaceutical Technology
- Rohstoffidentitätsprüfung und Katalysatorenrückstandsanalyse mit der Röntgenfluoreszenz (RFA)
- Einfluss Partikelgröße, Zetapotenzial und rheologischen Eigenschaften auf Stabilität von pharmazeutischen Dispersionen
If you missed their talks and you would like to request the presentation, feel free to contact us.
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