Lipid-Based Drug Delivery: Dosage Form Design from Preclinical to First-in-Human

A high proportion of new drug candidates never reach market due to poor solubility, which limits their potential for absorption. As such, the solubility and permeability of an active pharmaceutical ingredient (API) are the driving forces behind bioavailability. In order to avoid development challenges and delays, it is critical to fully explore these parameters when developing formulations to enhance and maximise oral bioavailability. Lipid-based drug delivery systems offer a way to effectively deliver poorly soluble or bioavailable drugs in both preclinical and human studies. The physicochemical characteristics of the API determine if lipid delivery is an appropriate approach for dosage form design.

Understanding how lipid molecules are classified, in what circumstances they can be utilized and how to design an effective lipid-based drug delivery formulation is complex. Once a formulation has been established in preclinical studies and is proven for effective administration, translation to a lipid-based drug formulation first-in-human (FIH) studies requires further consideration and can pose new challenges.

This webinar will cover the rationale for dosage form design of lipid-based formulations to ensure successful project delivery, including:

• Considerations for why lipid approaches are successful and appropriate for assessment
• The theoretical basis for classification of lipid-based systems
• Design and characterisation of lipid-based systems
• Associated analytics required to ensure product robustness and clinical safety
• Examples of challenges associated with API recovery from complex matrices

As products translate to human studies, it is essential to consider the requirements of a target product profile, with particular focus on aiding patient compliance. The featured speakers will share examples on approaching product design and scale up for various dosage forms and case studies to show the various project stages and duration of activities associated with developing successful formulations for FIH studies.

Register to learn about improving dosage form design in lipid-based drug delivery systems, from preclinical to first-in-human studies.

Speakers

Dr. Mike Frodsham, Chief Technical Officer, SGS Quay Pharma

Dr. Mike Frodsham applies more than 22 years product development experience to his role as CTO at SGS Quay Pharma where he provides technical oversight of development projects and manufacturing operations. Dr. Frodsham has been involved in more than 300 different development projects, involving a wide range of non-sterile dosage forms including solid dose, liquid and topical products.

The breadth of Dr. Frodsham’s experience ranges from small molecule developments to the development of products containing live biotherapeutics and antibodies for targeted oral delivery, as well as supporting IMPD/IND submissions. He is named as inventor on a range of patents, covering various products, including paediatric oral liquids, targeted delivery of polypeptides and the use of penetration enhancers to improve buccal absorption.

Dr. Frodsham earned a PhD in pharmaceutical sciences from Liverpool John Moores University where his research focused on the conversion of lipid liquid systems into solid dosage forms. He also earned a Master of Science degree in Industrial Pharmaceutical Sciences from the University of Manchester.

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Rober Habashy, MSc, Group Technical Manager, SGS Quay Pharma

With 15 years of pharmaceutical experience and a proven record of developing enabling formulations for dosing into different species and translating lead candidate formulations for first-in-human (FIH) studies, Mr. Rober Habashy leads SGS Quay Pharma’s Pre-Clinical Group, overseeing development activities including solid state characterization and analytical method development services, as well as leading the development and supply of formulations for preclinical evaluation.

Mr. Habashy has held several roles in multinational organizations covering concept to commercialization. He earned a Master of Science degree in Industrial Pharmaceutics at University of Central Lancashire where he also worked as a Senior Researcher specializing in and publishing research on novel natural coating technologies and 3D printing approaches for product development.

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