Complex Generics: Physicochemical Characterization Analysis for Deformulation and In Vitro Bioequivalence Studies

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00:00:00 Complex Generics: Physicochemical Characterization Analysis for Deformulation and In Vitro Bioequivalence Studies

Meeting the challenge of bringing new complex generic drugs to market requires access to appropriate physicochemical characterization methods to enable rapid deformulation of the reference listed drug product (RLD) and assess whether Q3 equivalence has been achieved as part of in vitro bioequivalence testing. In this webinar, Malvern Instruments' scientific team will introduce a toolset of physicochemical analysis techniques which are increasingly being applied to complex generic formulation development. Specific case studies describing approaches to deformulation and Q3 in vitro bioequivalence testing for topical drug products and orally inhaled and nasal drug products (OINDPs) will be presented.

One of the most significant challenges facing heath care providers is that of maintaining access to drug products based around complex formulations at a price which is sustainable. The overall market for generic products is growing rapidly, with the industry delivering billions of dollars of cost reductions, and supplying over 80% of patient prescriptions in the US. However, this growth has mainly been driven by the development of traditional immediate-release oral solid dose generics. In contrast, there remains a significant number of off-patent complex product drugs for which there are few or no generic versions. In response to this issue, regulators such as the US FDA are actively encouraging drug companies to take on the challenge of developing and launching complex generics by releasing product-specific guidance describing in vitro bioequivalence approaches which may be used in lieu of clinical studies. This guidance offers significant benefits to developers by illustrating routes to market for complex generic products which have reduced risk, costs and time required.

Traditional routes for establishing bioequivalence can be challenging for complex generic products, especially those designed for local action, such as topicals and nasal sprays. Clinical studies for obtaining in vivo pharmacokinetic (PK) and pharmacodynamic (PD) data are expensive and time-consuming – the latter being the greatest barrier to generics developers. In addition, systemic exposure, as measured as part of a PK study, may not provide a good basis for assessing bioequivalence for locally-acting drug products, as it is the in situ (non-systemic) drug concentration at the site of action which determines bioavailability. To address these challenges, recent US FDA guidance for complex generics has outlined the requirements for assessing Q3 equivalence - that is, the equivalence of physicochemical properties between the reference listed drug product and the test product – as a route to determining bioequivalence in vitro. Regulators and leading companies engaged in the research and development of complex generics are therefore seeking to both apply existing physicochemical measurement technologies and also invest in new techniques in order to aid deformulation and rapidly establish Q3 bioequivalence within complex generic drug product development programs.

Malvern Instruments' toolset of analytical techniques includes methods for measuring many of the physicochemical properties referenced by the US FDA, including critical quality attributes such as drug particle size and shape, formulation rheological profile and spray droplet size distributions. These technologies are widely applied as part of deformulation and in vitro bioequivalence testing, as the studies presented in this webinar will show.


Dr. Paul Kippax, Director of Product Management – Morphology, Malvern Instruments

From creating mud pies as a child through to researching food emulsions during his PhD, Paul Kippax has always been fascinated with particles and their behavior. To Paul, particles are not just for work, they are for life. His passion for particles even gets him into trouble at dinner parties, as he always has a story to tell about the dessert which relates to particle size analysis, much to his family's amazement - or annoyance! This love for particles led him to join Malvern Instruments around 20 years ago, where he started by bouncing sound waves off particles to understand their properties and then progressed to using light scattering and imaging techniques. He now heads up one of the product management groups at Malvern, and is still learning the true scope of particle science and the impact it has on everyday products and materials. Paul has a specific interest in the application of Malvern's technologies within pharmaceutical product development.

Dr. Anne Virden, Technical Support Supervisor – Analytical Imaging and Laser Diffraction, Malvern Instruments

Taking playing with magnets a little too far, Anne Virden entered the world of particle sizing when she gained her PhD in fine particle magnetism. She performed transmission electron microscopy on the particles that get dispersed into ferrofluids, so that she could understand their magnetic properties. This interest in the importance of particle size in magnetism led her to a role with Malvern Instruments as a Technical Specialist for Laser Diffraction, where she measured slightly larger particles and learned that particle size is important for everything! For the last 10 years, Anne has been helping Malvern's laser diffraction customers get the best use out of their instruments, and for the last three years she has gone beyond assuming all particles are spherical using automated image analysis to measure particle size and shape. Anne now works as a Technical Support Supervisor for Malvern's Imaging and Laser Diffraction technologies, and has a particular interest in measuring spray systems and their wide-ranging applications; from those that fit in the lab, such as nasal sprays, to those that definitely don't, like snow cannons and fuel injection systems.

Dr. Katy Langley, Associate Product Manager – Analytical Imaging, Malvern Instruments

Rather than using lasers to generate diffraction patterns to determine particle size, Katy spent her DPhil working with a variety of light sources to rock, bend and stretch molecules into revealing their true identities. This molecular interrogation enabled the detection of trace biomarkers in breath and it was the fun she had in developing prototype instrumentation for a real-life application that led Katy to Malvern 5 years ago, initially as an Applications Development Scientist in the R&D division.

She was then given the opportunity to move to Japan for 18 months, working in Malvern's Application Laboratory in Tokyo to develop her understanding of a wide variety of analytical imaging applications and to investigate the feasibility of new ones (whilst also conducting a very important study into Japanese food). Katy has a particular interest in exploring how Morphologically-Directed Raman Spectroscopy (MDRS) can be used in new application areas. On Katy's return to the UK in September 2016, she took up the position of Associate Product Manager for analytical imaging and diffraction.

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Who should attend?

This webinar will appeal to scientists involved in the development of generic drugs, particularly those considered complex generics because of their formulation or method of delivery.

The presentation will be of most interest to those who work on investigating and establishing bioequivalence between reference listed drugs and their counterpart test products, and would like to know more about technologies which are being developed to ease the regulatory burden and speed complex generic products to market.

The webinar will include some excellent case study data for both OINDPs and topical generic drugs and show how analytical techniques are being applied in real-world scenarios.

Relevant job functions include:

  • Principal Scientist
  • Research Scientist
  • Senior Scientist
  • Formulation Scientist
  • Researcher
  • R&D Manager
  • Lab Manager
  • Head of R&D
  • Head of Analytical Development
  • Project Leader
  • Team Leader
  • Group Leader
  • Department Head
  • Chief Formulation Scientist
  • Chief Scientific Officer
  • Compliance Officer
  • Regulatory Officer