Tuesday, 4 June 2024

This workshop delves into the complexities surrounding the formulation of poorly soluble drugs, a prevalent concern affecting a significant percentage of active pharmaceutical ingredients. Explore the scientific nuances of amorphous forms and their role in amorphous solid dispersions (ASDs), offering insights into enhanced solubility and dissolution. The workshop is broken down into three sections:

Harnessing The Amorphous and Ionic Liquid Forms of APIs

API-Ionic Liquids (API-ILs) are liquid drug forms that present a new paradigm in addressing problems presented by poorly bioavailable drugs. As liquid drug forms, they mitigate the problems linked to the crystalline API form, such as low water solubility. However, the viscous liquid nature of room temperature API-ILs poses significant challenges in terms of handling and processing, which has hindered their clinical and commercial exploitation thus far. ASDs and solidified forms of API-ILs both offer opportunities to overcome the biopharmaceutical challenges posed by poorly soluble drugs. Rational approaches to the formulation and production of physically stable ASDs will be discussed in this presentation, while the generation of solid forms of API-ILs, either as ASDs or polymer-encapsulated liquids, will also be explored.

Predictive Modeling and Simulation Tools

Navigate through the intricacies of predictive modeling and simulation tools, employing AI/ML platforms to guide the progression of poorly soluble molecules from discovery to clinical trials. Utilize molecular structures to inform technology selection, solubility enhancement, and formulation design. Gain a comprehensive understanding of material science and powder behavior through Compaction Simulation and Discrete Element Methods (DEM), offering an efficient and material-sparing to formulation development, process scale-up, and tech-transfer.

Process Development and Scale-Up of Spray Drying

Expand on your foundations and principles of spray drying for ASDs, from lab-scale development tools to the scale-up of processes. Utilize mechanistic and statistical modeling to delve into the impact of spray drying conditions and material attributes on downstream processing. Join us for an academic exploration where knowledge converges with scientific rigor, providing a thorough understanding of the formulation intricacies of poorly soluble drugs.

Instructors:

Professor Anne Marie Healy, PhD, (Professor Trinity College Dublin) is a distinguished academic serving as Professor of Pharmaceutics and Pharmaceutical Technology at Trinity College Dublin. With co-directorship of the Centre for Doctoral Training in Transformative Pharmaceutical Technologies and co-principal investigator at SSPC, she earned the SSPC Researcher of the Year in 2019 for her outstanding contributions, particularly in pharmaceutical material science, formulation, and drug delivery. www.linkedin.com/in/anne-marie-healy-33228714

Dr. Sanjay Konagurthu PhD, (Sr. Director, Science and Innovation, Thermo Fisher Scientific) currently holds the position of Senior Director, Science and Innovation at Thermo Fisher Scientific. With over 25 years of experience, he specializes in managing drug compound development, predictive modeling, oral drug delivery technologies, and lifecycle management. Dr. Konagurthu has numerous patents, publications, and an academic background from the Indian Institute of Technology, Madras and the University of Colorado, Boulder. www.linkedin.com/in/sanjay-konagurthu-a61b9b10

Joao Henriques, MS (Director Oral Product Development, Hovione)is a results-driven pharmaceutical development manager with 14 years of expertise. Currently serving as the Director of Oral Product Development at Hovione, Joao has showcased leadership in a variety of pharmaceutical programs, spanning pre-clinical to commercial stages. His proficiency in strategic coordination, process validation, and implementation of cutting-edge R&D platforms has contributed significantly to the success of numerous projects across different organizations. www.linkedin.com/in/joaolgh

Moderator:

Dr. Kevin J. Bittorf, PhD,(Principal Consultant, SCxCMC Solutions) is the founder and principal consultant at SCxCMC, a consultancy firm specializing in comprehensive solutions for clinical and commercial products. With over two decades of experience in the pharmaceutical industry, he excels in CMC, formulation development, project management, quality assurance, and supply chain management. Kevin’s influence extends beyond consultancy, as he has contributed to three non-profit conferences(Compaction Simulation Forum, Advancing Drug Development Forum and Continuous Manufacturing Form). www.linkedin.com/in/bittorf/