Speeches

Speech: The Multifaceted Impact of Pharmaceutical Excipients: Fakes, Nanotechnology and Innovation Considerations

Firstly, will start with an overview of challenges in drug development as it relates to pharmaceutical excipients including as it relates to taste/palatability, age-related medicines (with a focus on paediatrics to complement Sandra Klein’s talk), manufacture, and tolerance.
The talk will delve deeper and provide an overview of the multifaceted impact of pharmaceutical excipients in drug development. Focusing on the global impact of falsified, substandard and unregulated/unlicensed excipients (with a focus on anti-malarials to complement Jennifer Cain Birkmose’s talk), application of nanotechnology strategies in drug delivery more specifically solid dispersion and the important role of excipients in this.
The talk will end with a discussion on the importance of pharma excipient innovation with a call to action encouraging participants to see the increased need for further work in this area.

Panel: “Malaria and paediatric formulation needs”

Speech: The Importance of Excipient Composition and its Impact on Drug Performance

Excipients are typically not pure substances but rather, they are mixtures of the nominal component with various other concomitant components, additives and other materials.  It is the overall excipient composition profile, which can vary significantly for excipients from multiple suppliers meeting the same pharmacopeial monograph, which gives the excipient it’s unique functionality.  This presentation will discuss various excipient realities related to their composition and why it is important to have a good understanding of excipient composition to develop robust drug formulations and processes in a quality by design world.  This understanding is also critical when changing excipient suppliers.

Panel: What is needed to drive excipient innovation for first class drug products for the future?

This panel discussion focusses on the need for novel excipients going forward to help us innovate in drug development and solve patient issues. Novel excipients are going to be very important going forward to resolve many of the issues we all have with drug solubility, patient-centric dosage form development for improved compliance, the implementation of advanced technologies in manufacturing such as continuous manufacturing and 3D Printing and many other drug development challenges.

In touching these questions this panel tries to summarize the various topics and ideas raised during the two ExciPerience days and gives an outlook on the future of excipients.

Functional Related Chemical Profiling (FRCP) of excipients during formulation development

Functional Chemical testing is nowhere to be found on an ordinary CoA or in Pharmacopeal test procedures, yet it makes or breaks a product development when changing from a supplier, when changing from R&D samples to cGMP, or from batch to batch of an excipient from the same supplier. If during QBD it is identified that changing an excipient is a risk, FRCP is there to understand what is the cause of this risk and then can be used to control it. For example if during a stability it appears that compound X is not compatible with excipient Y, we can shift to excipient Z and start again without having any real understanding of the cause of the incompatibility, or we can investigate first with FRCP, which parameter of excipient Y causes the incompatibility and then include a control/limit for that parameter in the product sourcing specifications. Another example would be a formula with highly variable dissolution profiles from one lot to the next and the identification of the root cause being differences in the substitution degree of the rate controlling polymer from batch to batch. Completely different functional grades of an excipient can all comply to the same EP monograph, yet act completely different in a formula in terms of stability and/or dissolution.

Speech: What space will excipients occupy in our consciousness in the next decade?

In our progress towards the science of pharmaceutical quality, the immaturity of the science of materials we call excipients or inactive ingredients determines our regulatory and quality management systems’ maturity. Effective corrective and preventive action to stop repeating mistakes is but a step to credibility. Sustainability of the sector demands continual improvement in control of excipients and innovating new excipients that assure reliability at wrap speed in real-time.  The maturity of a system is not just the maturity of some of its parts. Increasing the order of excipient consciousness is essential to compliance in the age of lockdowns & disruptions.

Panel: What is needed to drive excipient innovation for first class drug products for the future?

This panel discussion focusses on the need for novel excipients going forward to help us innovate in drug development and solve patient issues. Novel excipients are going to be very important going forward to resolve many of the issues we all have with drug solubility, patient-centric dosage form development for improved compliance, the implementation of advanced technologies in manufacturing such as continuous manufacturing and 3D Printing and many other drug development challenges.

In touching these questions this panel tries to summarize the various topics and ideas raised during the two ExciPerience days and gives an outlook on the future of excipients.

Taste Masking (for paediatrics) using Hot Melt Coating

Participants will gain insights into the hot melt coating technique. Raphael shows how this technique is applied and which raw materials are used. Formulation examples for taste masking and dissolution profiles give the audience an impression of how efficient this coating technique is. Last but not least, a video demonstrates how pellets are coated.

Excipients and Quality by Design in Formulation Design and Development

This presentation will provide an overview of excipients: why they are used, their variability, and how their variability can be incorporated into Quality by Design (QbD) development projects. In particular, the limitations of manufacturers’ samples for incorporation into QbD Design of Experiments (DoE) will be discussed, together with some ways to overcome such problems.

Lipid nanoparticle technology: Paving the way for RNA therapeutics

Recently approved RNA therapeutics, including the first-ever siRNA drug and COVID-19 mRNA vaccines, demonstrate that lipid nanoparticle (LNP) technology is poised to revolutionize drug development. This talk will focus on the current status and future prospects of gene therapies utilizing LNP systems to silence, express or edit genes.

Insights and Trends of Film Coatings

In this presentation, we will provide an overview of the importance of film coating for product safety, efficacy, identification, and compliance. Recent trends in the film coating space will also be discussed.

Immediate release coating for improved patient acceptance at optimized process time and cost: A new ready-to-use solution

Fully formulated systems for aqueous film coating are the quickest method to enhance tablet appearance, swallowability, taste and feel of oral drug products with an immediate release profile. In this talk, Evonik will introduce a new one step ready-to-use dry powder for immediate release coatings that produces films with high glossiness at reduced processing time and cost which do not affect dissolution or disintegration profiles.

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection.

Aprecia 3DP Technology – Combining Precision with Flexibility and Freedom

How to effectively stabilise release profiles, protect and solubilise pharmaceutical excipients

Lipid nanoparticles: The role of excipients in nucleic acid therapies

Keynote: Are public private development partnerships the future of R&D?
How the partnership model for development in neglected diseases could be the answer

Panel: “Malaria and paediatric formulation needs”

Reset your chronobiological clock – novel micro pellets formulation to relieve of wake-up difficulties