Advancing Lipid-Based Formulations and Softgels in Drug Development

This webinar will provide an in-depth exploration of formulation and manufacturing strategies, enriched by case studies on lipid-based drug delivery systems and softgels. Experts will also explore the complexities involved in developing dissolution methods for softgels, including addressing capsule variability, sensitivity to capsule composition, and the importance of accurately mimicking the in vivo environment.

Register Free: https://www.pharmtech.com/pt_w/softgels

Event Overview:

Softgel capsules offer a versatile and cost-effective solution to the challenges faced throughout the drug product lifecycle. By carefully selecting fill formulations during the early stages of development, softgel can successfully meet the specific requirements for bioavailability and stability for clinical trial and supply. Softgels also provide patients with benefits such as convenient dosing and controlled release mechanisms, resulting in improved patient compliance. In addition, the softgel manufacturing process has been optimized for low batch sizes using commercial encapsulation equipment, allowing for seamless scalability and eliminating scaling issues or commercial capacity constraints. From the analytical development perspective, the dissolution test is a crucial quality control method for softgels. The selection of the dissolution method is critical in ensuring the accuracy and reliability of the results.

In this presentation, experts will provide an in-depth exploration of formulation and manufacturing strategies, enriched by case studies on lipid-based drug delivery systems and softgels. Experts will also explore the complexities involved in developing dissolution methods for softgels, including addressing capsule variability, sensitivity to capsule composition, and the importance of accurately mimicking the in vivo environment.

Key Learning Objectives

• Learn the intricacies of formulations that use lipids as a base, and gain a deeper understanding of their properties, applications, and potential benefits
• Learn how softgel technology offers formulators versatility in designing patient centric drug products
• Gain insight into the advances in softgel technology and new design variants that can help deliver medication through various routes of administration

Who Should Attend

• C-level, Senior Directors, VP – Formulation, Research & Development, Product Development, CMC, Consultants

Speaker:

Ben Boyd, Ph.D.
Professor, Drug Delivery Sciences
University of Copenhagen and Monash University

Professor Ben Boyd is a colloid and physical chemist with PhD from the University of Melbourne. After industry experience in the explosives and pharmaceutical industries, he commenced an academic position at Monash Institute of Pharmaceutical Sciences (MIPS) at Monash University in Australia. He has previously held an Australian Research Council Future Fellowship, and was recently awarded a Novo Nordisk Laureate Research Fellowship, based primarily at the University of Copenhagen. His research focuses on colloidal and structural aspects of lipids, lipid self-assembly and pharmaceutical systems, and his group is active in developing new synchrotron-based characterization approaches for lipid and solid-state systems. He is an elected Fellow of the Controlled Release Society, and AAPS. He has held leadership positions across a range of scientific societies, most recently as President of the Controlled Release Society and President of the Australasian Colloid and Interface Society. He is also co-editor of the Journal of Colloid and Interface Science and was Editor for Asia for Drug Delivery and Translational Research.

Speaker’s LinkedIn: Ben Boyd

Karunakar Sukuru R.Ph., Ph.D.
Global Vice President, Rx Product Development
Catalent

Karunakar Sukuru R.Ph., Ph.D., Global Vice President, Rx Product Development at Catalent Pharma Solutions is an accomplished and recognized pharmaceutical leader with over 29 years of experience in Drug Product and Technology Development, Manufacturing, involving a wide variety of Drug Delivery Systems and Technologies. Karu is a proven and reliable leader and strategic thinker with direct responsibility for P&L, successful product development, execution and troubleshooting of projects globally. Karu had technical oversight of more than a dozen CDMOs around the globe while at Endo Pharma and while at Catalent currently is working with more than 300 pharmaceutical customers including top BioPharma companies globally. He has developed innovative CR platform technologies in softgel form (two granted patents) and has more than a dozen pending patent applications in the area of modified shell and fill suitable for capsules for enteric and colonic delivery. After obtaining his Ph.D., in Pharmaceutics from IIT-BHU, India in 1995, Karu started his career at Natco Pharma in India for 2 years developing variety of oral dosage forms. In 1997 he joined Banner Pharmacaps (India and NC-USA), where he worked on softgel and gel enrobed tablets. Karu joined Endo Pharma in 2006 and Catalent in 2016 as a VP-Product Development.

Speaker’s LinkedIn: Karunakar Sukuru

Register Free: https://www.pharmtech.com/pt_w/softgels