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