Twin-Screw Granulation as a Viable Pharmaceutical Process in the Shifting Manufacturing Paradigm

During this webinar, experts will present the principles and mechanisms of patented twin-screw granulation technique for oral solid dosage forms. Experts will also show how the Quality by Design (QbD) approach can be applied to a continuous drug granulation process.

Register Free: https://www.pharmtech.com/pt_w/twin-screw

Event Overview:

Particle size enlargement, through the addition of a liquid to a powder with agitation to produce agglomeration, is the conventional granulation method used in the pharmaceutical industry. However, this method introduces several processing steps that can increase the time, labor, and energy used. The twin-screw granulation process has emerged as an alternative robust and reproducible technique for continuous manufacturing of wet, melt and dry granulation. However, defining the process variables for twin-screw granulation can be tricky with significant effect on granules’ quality.

During this webinar, experts will present the principles, mechanisms and several downstream applications of patented twin-screw granulation technique for oral solid dosage forms. Join this webinar to know how the Quality by Design (QbD) approach can be applied to a continuous drug granulation process.

Key Learning Objectives

• Learn the principles and benefits of patented twin-screw granulation technique
• Discuss key considerations for twin-screw granulation, equipment set up, QbD approaches and process analytical technology
• Understand the potential of twin-screw granulation for development and manufacturing of pharmaceutical products

Who Should Attend

Primary Audience: Pharmaceutical Companies and Consultants
Secondary Audience: Venture Capital Firms

Job function: R&D, Formulation Scientist, Product Development, CMC, Manufacturing & Procurement

Speakers:

Michael A. Repka, Ph.D.
Director of the Pii Center for Pharmaceutical Technology, Distinguished Professor of Pharmaceutics and Drug Delivery
University of Mississippi

Dr. Michael A. Repka received his B.S. in Pharmacy and Ph.D. in Pharmaceutical Science with an emphasis in Pharmaceutics from the University of Texas at Austin. He serves as the Distinguished Professor of the Department of Pharmaceutics & Drug Delivery and Director of the Pii Center for Pharmaceutical Technology at The University of Mississippi. Dr. Repka’s research primarily focuses on enhancing solubility and bioavailability of poorly soluble drugs via hot‐melt extrusion (HME) technology, with novel dosage forms as a common denominator. He has over 30 years’ experience with HME for pharmaceutical dosage form and device advanced manufacturing. In addition, Dr. Repka has utilized HME for patient centric delivery to pediatric, geriatric, and special needs patients. This focus led him to employ 3D printing (Fused Deposition Modeling) to further advance development and delivery of patient focused complex dosages. Furthermore, polymeric drug delivery design and stabilization, formulation, and process development for natural products, antifungal/antibacterial/immunostimulant agents are also important components of his research. Dr. Repka has published over 230 peer-reviewed articles in prestigious pharmaceutical journals. He also serves on the Editorial Advisory Boards of six prominent journals. In addition, he is an Editor for AAPS PharmSciTech and was Associate Editor for Journal of Drug Delivery Science and Technology for over 10 years. He has received various honors including an AAPS Fellow Award, Distinguished Professor designation, and the Distinguished Research and Creative Achievement Award (The University of Mississippi’s highest research award). Dr. Repka regularly presents at national and international HME/3D Printing and formulation symposia/workshops as an invited speaker >80 times over the last 10 years.

Hemlata Patil, Ph.D.
Manager, Hot Melt Extrusion Technology
Catalent

Dr. Hemlata Patil is a strategic manager in Formulation R&D at Catalent, Somerset, NJ, USA. Her research interests are abuse deterrent opioid and modified release/controlled release oral drug delivery systems as well as development of specialized and differentiated products using enabling technologies. Many of these systems are directed toward the delivery of poorly soluble drugs via hot-melt extrusion technique. She has more than 9 years of industrial experience in pre-formulation, formulation/process development of oral drug products, scale-up/technology transfer, commercialization, and US regulatory filings. She has developed a wide range of preclinical and early phase clinical formulations. In her current role at Catalent, Hemlata is responsible for formulation and process development activities and manufacturing for the projects from Catalent’s portfolio of dosage form platforms which mainly includes twin screw extrusion technology. Patents holder with more than 25 publications.

Valérie Vanhoorne, Ph.D.
Professor of Pharmaceutical Technology
Ghent University, Belgium

Dr. Valérie Vanhoorne is a pharmacist by education and obtained her Ph.D. in Pharmaceutical Sciences at Ghent University studying continuous agglomeration technologies in 2016. As a postdoc she closely collaborated with Janssen Pharmaceutica (Belgium) on the development of predictive empirical models for continuous direct compression and platform formulations for continuous twin screw granulation. In 2020 she was appointed assistant Professor in the Laboratory of Pharmaceutical Technology at Ghent University. Her current research focuses on formulation and process development of continuous manufacturing processes as well as personalization of dosage forms (via 3D-printing and multi-particulate dosage forms) to meet the needs of specific patient populations. She is a member of the Editorial Board of Pharmaceutics section "Pharmaceutical Technology, Manufacturing and Devices" and was granted the Rottendorf Pharma Europe Prize in 2021. She has published more than 90 scientific publications and is a patent holder.

Register Free: https://www.pharmtech.com/pt_w/cmc-and-cdmo