Hot Melt Extrusion for Poorly Soluble Drugs: Formulation Strategies and Scale-Up Insights

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As the pharmaceutical industry faces an increasing number of poorly water-soluble drug candidates, innovative formulation technologies are essential for achieving optimal bioavailability. Hot melt extrusion (HME) has become a key solution for formulating these challenging drug substances, enabling the creation of amorphous solid dispersions (ASDs) that significantly enhance solubility and dissolution rates.

This webinar will provide a systematic framework for developing bioavailable oral dosage forms using HME. It will guide attendees through key stages, including preformulation considerations (excipient selection and drug-polymer compatibility), formulation strategies for stable ASDs, and process development for scale-up to production. Real-world case studies and best practices will be shared, demonstrating how HME can overcome bioavailability challenges while maintaining product stability and quality.

Key Learning Outcomes:
• Understand the bioavailability challenges of poorly soluble drugs and how HME enhances dissolution and absorption.
• Learn a systematic approach to HME development, from preformulation to final formulation.
• Explore formulation strategies, including polymer selection, drug-excipient compatibility, and stabilization techniques to prevent recrystallization.
• Master process development and scale-up, optimizing HME parameters for successful technology transfer and maintaining product quality during scale-up.

Target Audience: Pharmaceutical scientists, formulation specialists, R&D professionals, heads of CMC, C-suite executives at emerging biotechs, and regulatory affairs experts. Anyone focused on enhancing drug solubility and bioavailability will find valuable insights in this webinar.

Presenters

Hibreniguss Terefe, PhD
Director, Product Development at Ardena Somerset, NJ
With over 27 years of experience in pharmaceutical research, development, and manufacturing, he leads the development of preclinical and clinical solid oral dosage forms. Previously, he served as Director of R&D at Catalent Pharma Solutions and Vice President of R&D at ExxPharma Therapeutics. He specializes in drug product development, commercial manufacturing, and CMC, with deep expertise in solubility enhancement, modified-release formulations, and twin-screw extrusion processes. Holding a Ph.D. in Pharmaceutical Chemistry and a Pharmacy degree from Westfälische Wilhelms-Universität Münster, Germany, he was also a Fulbright Visiting Scholar at UC Berkeley.

Shabab Kashani Rahimi, PhD
Lead Principal Scientist, Product Development at Ardena Somerset, NJ
An expert in pharmaceutical formulation and process development with 7 years of experience, specializing in solubility and bioavailability enhancement technologies such as hot melt extrusion and spray drying. His work includes the development of immediate and modified release dosage forms, as well as complex drug delivery systems. Holding a PhD in Polymer Science and Engineering, he has previously worked as a Formulation Principal Scientist at Catalent Pharma Solutions and BioDuro, and as a Postdoctoral Research Fellow at the University of Texas at Austin’s Molecular Pharmaceutics and Drug Delivery Department.​​​​​​​

Duration
45-55 minutes