Amorphous Solid Dispersions: Increasing Solubility From API to Tablet

Up to 90% of the drugs in the pharmaceutical pipeline are classified as poorly soluble, according to the Biopharmaceutical Classification System. Amorphous solid dispersions have emerged as one of the preferred methods to increase aqueous solubility of drugs.

Selection of polymer and optimal active pharmaceutical ingredient (API) load in an amorphous solid dispersion is critical for the performance and stability of the dispersion. Formulation screening can be a time and material consuming exercise with a heavy analytical workload. The use of computational methods and miniaturization tools provides a reduction of material requirements and development time while enabling a formulation platform to increase API exposure and its development success.

The formulation of an amorphous solid dispersion into a tablet is the subsequent step that will define the ultimate presentation of the amorphous solid dispersion. The tablet formulation must ensure that the performance of the solid dispersion is not affected by the densification, and in some cases, the final formulation step may be driven to further improve performance.

This webinar will focus on several aspects of the formulation screening of amorphous solid dispersions, for both the drug product intermediate and the final drug product. Different in-silico and miniaturization techniques will be presented to reduce experimental work while maximizing the generation of information. This approach decreases the overall development time and initial API requirements while optimizing the amorphous solid dispersion physical stability and drug product performance and target a right-first-time development program.

Speakers

João Henriques, MSc, Team Leader, Hovione

João Henriques joined Hovione in 2008 as a PAT specialist supporting Particle Engineering and formulation projects. He has been working as a Formulation and Process Development Scientist since 2013. Since then, he has supported development and validation of spray drying, jet-milling, roller compaction and tableting projects. João is currently the Team Leader for Particle Design and Formulation at the Drug Product Development Group.

João Henriques is a Biological Engineer by training. He specialized in process monitoring and control as a PAT specialist for pharma and biopharma processes.

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Paulo Lino, PhD, Scientist, Hovione

Paulo Lino joined Hovione’s Drug Product Development group in 2007 as a Scientist and has been involved in projects that range from multivariate formulation screening and development up to the tech-transfer and scale-up of several solubility enhancement and particle engineering projects.

Paulo has a Master’s degree in Pharmaceutical Sciences from Universidade Lusófona and has done a PhD and Post-Doc in Pharmaceutical Technology at the Faculty of Pharmacy, Universidade de Lisboa, spanning areas from biopharmaceutical formulation/engineering and freeze-drying to particulate polymeric drug delivery systems.

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