In these confusing, seemingly-endless days of lockdown, it’s important to have milestones to look forward to. We have a few of these coming up at Malvern Panalytical: two within the next couple of weeks! As you may have already read in this blog by Ben Cliff, we are extremely excited to be working with Concept Life Sciences to launch a brand new range of services, Amplify Analytics, on June 25th – please do join us on the day to find out more! And hot on the heels of that webinar, on July 1st I’ll be presenting a further web seminar which will focus on using targeted physicochemical analysis to optimize pharmaceutical formulations.
One of my many passions in life lies in understanding how we can help make the lives of pharmaceutical scientists easier, and also how we can help get safe and effective therapies to market more quickly and successfully – that is something which is in everyone’s best interest! Regulatory agencies seem to agree with me on this topic, including the FDA, which is releasing product-specific guidance on such topics as using in vitro analysis for the assessment of bioavailability in complex drug products, including inhaled drugs, sustained-release tablets and nasal sprays. It’s easy to see how this can dramatically cut both costs and time! Where we at Malvern Panalytical can help with this is in microstructural characterization, which feeds directly into the requirements for assessing Q3 bioequivalence in generic drug products.
If we start to consider this in more detail, though, we begin to see the relevance that these guidance documents might hold for those who formulate innovator drug products, rather than only those who develop generics. Information on formulation microstructure is just as important for those trying to optimize their pharmaceutical formulations as it is for those who are trying to prove equivalence with an RLD. This webinar is the first step in a journey on which I hope you will join me, as I begin to unravel and explain the role that physicochemical characterization can play in easing and improving formulation development.
Looking forward to seeing you there!