Oral Dosage Innovation for Pediatric Drug Delivery

Developing effective and patient-friendly oral dosage forms for pediatric populations presents a unique set of scientific, regulatory and practical challenges. Unlike adult formulations, pediatric dosage forms must consider a broad range of developmental, physiological and behavioral factors — from swallowing ability and taste preferences to age-specific dosing requirements and caregiver ease of use. These considerations become even more complex when dealing with poorly soluble, poorly palatable or mechanically complex drug substances.

In low-resource settings where pediatric infectious diseases are prevalent, the formulation must also meet strict standards for stability, cost-effectiveness and ease of distribution. Liquid formulations, although common in pediatrics, often suffer from poor stability and require refrigeration or the addition of preservatives, making them less practical in these environments. Solid oral dosage forms, such as mini tablets, have emerged as promising alternatives. Their small size helps children as young as 6 months to swallow them, and their modularity allows for precise, weight-based dose titration.

Through the lens of a recent collaborative pediatric formulation project, attendees will be introduced to a high-drug load mini-tablet designed for pediatric use. The case study will demonstrate practical formulation strategies employed to address challenges such as poor solubility, strict formulation requirements and poor tabletability at high drug loads. The webinar will also describe the iterative approach used to optimize blend flow, mechanical strength, disintegration and taste masking via functional coating — leveraging tools such as powder rheometry and compaction simulation to guide development.

Whether you’re involved in pediatric product development, global health initiatives or the formulation of challenging molecules, this session will provide real-world insights into creating oral dosage forms that are not only pharmaceutically robust but also suitable for the world’s most vulnerable patient populations.

Join the featured speakers to:

• Gain a behind-the-scenes perspective on developing oral dosage forms for pediatric populations
• Hear real-world insights from scientists who’ve addressed poor solubility, taste and tabletability challenges
• Understand the formulation decision-making process for high-drug load mini-tablets
• Learn how development teams balance pharmaceutical performance with real-world usability in low-resource settings

Register for this webinar to explore innovative strategies for developing oral dosage forms that meet the unique needs of pediatric patients.

Speakers

Dave Miller, PhD, Chief Scientific Officer, AustinPx

Dr. Dave Miller currently serves as the Chief Scientific Officer at AustinPx, where he leads the pharmaceutics and analytical development teams and oversees the application of the KinetiSol™ Technology. He specializes in formulation and processing technologies for improving the oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through all stages of development from early discovery to line extensions.

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Dr. Miller is the co-inventor of the pharmaceutical applications of KinetiSol Technology and continues to be a key driver of innovation for the application and expansion of the platform. Dr. Miller earned his PhD in Pharmaceutics from the University of Texas at Austin.

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Zachary Warnken, PharmD, PhD, Director, Pharmaceutical Development, Via Therapeutics, LLC

Dr. Zachary Warnken currently serves as the Director of Pharmaceutical Development at Via Therapeutics LLC, a small pharmaceutical start-up focused on delivering innovative pharmaceutical solutions. His work focuses on developing vital new treatments for underserved patient populations, including inhaled biologics and small molecules, as well as the devices that deliver the medication.

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Dr. Warnken earned his Doctor of Pharmacy in 2014 from the University of Texas at Austin and a PhD in Pharmaceutical Science in 2018. His doctoral research in the Molecular Pharmaceutics and Drug Delivery division concentrated on the complexities of nasal drug delivery and the delivery of poorly water-soluble compounds. He is a respected voice in the industry, with several peer-reviewed publications and book chapters, as well as being an inventor on multiple patent applications.

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