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Formulation and Delivery

Rapid Fires: Enabling Technologies and Materials for Formulation Innovation 1

Enhancing BCS II & IV Drugs Bioavailability with Lipid Formulations

Tuesday, November 11, 2025

3:45 PM - 4:00 PM CT

Location: Stars at Night B1

Rapid Fire Speaker(s)

Karunakar Sukuru, R.Ph., PhD (he/him/his)

Global Vice President-Pharma Product Development & Head- Scientific Advisory
Catalent Pharma Solutions
Saint Petersburg, Florida

Lipid-based formulations (LBFs) offer an effective strategy to overcome the solubility and permeability limitations of BCS Class II and IV drugs as well as potentially for oral peptides. This presentation will cover key principles behind excipient selection, formulation development (e.g., SEDDS, SMEDDS, suspension and solution), and how these influence biopharmaceutical performance. Case studies will illustrate how to translate successful lab-scale prototypes for IND-enabling studies. Attendees will gain insight into designing LBFs with robust in vivo performance, with a focus on oral delivery challenges and strategies to de-risk early development.

Learning Objectives:

Analyze the key formulation and excipient selection principles underlying lipid-based delivery systems (e.g., SEDDS, SMEDDS, suspensions, and solutions) to address solubility and permeability challenges in BCS Class II and IV drugs.
Apply case-based approaches to translate lab-scale lipid formulations into IND-enabling studies, ensuring scalability, manufacturability, and biopharmaceutical performance.
Evaluate strategies for designing robust lipid-based formulations that enhance oral bioavailability and de-risk early development of poorly soluble and poorly permeable compounds.