Catalent & BASF Workshop: Lipid Formulation For Drug Development




Click here to register for the workshop.

Workshop Title: REVOLUTIONARY THEN, RELEVANT TODAY: Lipid Formulation for Drug Development

Date: September 25, 2018

Location: Hilton Boston Back Bay 
40 Dalton Street
Boston, MA

In the past few decades, innovative solubilization technologies have been widely used to address bioavailability issues of new drug candidates. Over 80 years ago, lipid based drug delivery system (LBDDS) was introduced to the pharmaceutical industry with the principle objectives of enhancing bioavailability for poorly soluble molecules. Today, LBDDS is a very well-studied and widely utilized solubilization technology that has brought more than 60 unique drug molecules to the market.

The commercial success of LBDDS is in large part due to its ability to be encapsulated in soft gelatin capsules (softgel). Preferred by patients and drug developers, softgels have become the most common dosage form to deliver oral LBDDS formulations. Continued innovations have expanded the application of softgel technology beyond bioavailability enhancement: drug stability, potent drug formulation, orphan/fast track drug development, dose uniformity and many others.

Join Catalent and BASF to learn from academic and industry experts to develop a better understanding of excipients, LBDDS formulation development, and softgel technology to help you overcome your development challenges and advance your drug molecule into a drug product.

Agenda

8:30am – 9:00am REGISTRATION & BREAKFAST
9:00am – 9:15am WELCOME & INTRODUCTION
 Dr. Nigel Langley, BASF Corporation
 Mr. Stephen Tindal, Catalent 
9:15am – 10:00am EARLY PHASE SCREENING APPROACH FOR LIPID FORMULATIONS
 Dr. Giang (Ellie) Au, Catalent
10:00am – 10:45am UTILIZING CRYSTALLIZATION INHIBITION TO MAXIMIZE DRUG BIOAVAILABILITY
 Dr. Shaukat Ali, BASF Corporation
10:45am – 11:30am MECHANISTIC STUDIES AND MODELING TO PREDICT THE IMPACT OF LIPIDS ON ORAL ABSORPTION
 Dr. Rebecca Carrier, Northeastern University
11:30am – 1:00pm NETWORKING LUNCH & MEET THE EXPERTS
1:00pm – 1:45am BIOAVAILABILITY AND BEYOND: INNOVATIONS IN SOFTGEL FORMULATION AND MANUFACTURING TO ADVANCE MORE MOLECULES
 Mr. Stephen Tindal,Catalent
1:45pm – 2:30pm ENABLING FUNCTIONAL AND MODIFIED DRUG RELEASE PROFILES FROM SOFTGEL FORMULATIONS
 Dr. Ashish Joshi, BASF Corporation
2:30pm – 2:45pm BREAK
2:45pm – 3:45pm PANEL DISCUSSION
 ALL SPEAKERS
3:45pm – 4:00pm CONCLUDING REMARKS

Expert Speakers & Presentations

Mechanistic Studies and Modeling to Predict the Impact of Lipids on Oral Absorption
Dr. Rebecca Carrier, Professor and Associate Chair for Research, Chemical Engineering, Northeastern University

Drug delivery technologies, such as lipid-based delivery systems, have shown great promise for enabling oral delivery of compounds. Quantitative mechanistic understanding of transport phenomena in the drug delivery environment could enable rational design of effective lipid-based drug delivery systems. In this talk, I will describe mechanistic studies of key oral drug delivery processes, such as drug dissolution and lipid digestion, paired with systems-based modeling to enable quantitative prediction of the impact of lipids on oral compound bioavailability.

Utilizing Crystallization Inhibition to Maximize Drug Bioavailability 
Dr. Shaukat Ali, BASF Corporation

Currently, a multitude of solubilization techniques exist to enhance the solubility and bioavailability of poorly soluble APIs. As the API travels through the GI tract, there is an overall tendency for rapid recrystallization, which curtails the desired supersaturation. This is also known as the “spring effect”, wherein, the API undergoesa rapid increase and subsequent precipitous decrease in drug concentration due to commencement of re-crystallization. Fortunately, this can be overcome by utilization of advanced crystallization inhibition technology that allows the API to yield a “parachute effect”, wherein, the API is maintained in supersaturation, and undergoes a slow and controlled precipitation as it travels through the GI tract, thus improving the absorption and increasing the bioavailability overall. This talk focuses on the theory and practical application of crystallization inhibition – combined with case studies performed using biorelevant testing.

Enabling Functional and Modified Drug Release Profiles from Softgel Formulations
Dr. Ashish Joshi, BASF Corporation

Softgels are an attractive method of delivering a wide range of APIs to the human body in an elegant, simple and accepted dosage form. However, the dynamic nature of softgels, due to the constant water and oxygen flux, as well as the inherently flexible nature of the shell, render it challenging to utilize traditional coatings and modified release technologies common to tablets and other solid oral doses. In this work, formulation and processing guidance are shared, as well as important formulation characteristics to modify the release of APIs from the softgel form to include instant, enteric and sustained release formulation.

Bioavailability and beyond: Innovations in softgel formulation and manufacturing to advance more molecules
Dr. Giang (Ellie) Au, Scientist, Product Development, Catalent Pharma Solutions

Lipid based formulations delivered in softgel technology are a trusted and proven method to deliver solubility challenged molecules, but often times a therapy requires solutions beyond bioavailability enhancement to succeed. Recent advances in softgel formulation technology now enable an even wider range of molecules and release profiles, making softgel a primary consideration for delivery of more types of molecules.

Early phase screening approach for lipid formulations
Mr. Stephen Tindal or Dr. Jeff Browne, Director, Science & Technology, Catalent Pharma Solutions

Implementing a bioavailability enhancing technology during pre-clinical development has the potential to improve the odds of developing a successful drug product. Thorough characterization and pre-formulation and the Developability Classification System (DCS) provide guidance on which enabling technology can address your molecule’s biopharmaceutical hurdles. This presentation will cover what types of molecules are best fit for LBDDS and an in-depth review of early LBDDS formulation screening tools to improve molecule solubility and possess robust performance.

Click here to register for the workshop.