Engineering Oral Solid Dosage Forms to Enhance Therapeutic Efficiency & Patient Acceptability
About This Presentation
Oral solid dosage development involves far more than getting a molecule to dissolve. Pharmacokinetic variability, food effect, high pill burden and swallowability all influence whether a drug actually works in a real patient, and each one has to be accounted for in the formulation design. Variability in particular is something formulators have to live with. The goal is not to eliminate it but to understand it well enough to design around it.
A big part of that starts with biology. The GI tract moves a dosage form through environments with very different pH levels, enzymes and microbial activity, and the formulation has to account for what happens at each stage. An acid-labile drug that releases too early degrades before it can be absorbed. A drug that is a substrate for enzymes in the lower intestine gets metabolized there if the release is not controlled. Getting the delivery platform right means understanding the biology first and selecting the technology second.
The developability classification system brings structure to that decision. By mapping a molecule’s solubility and permeability, the framework helps teams select from a range of strategies, from simple solutions and particle size reduction through to amorphous solid dispersions built by spray drying or hot melt extrusion, or lipid-based carriers for the most challenging molecules. Combined with PBPK modeling and biorelevant dissolution testing, teams can predict how a formulation will behave in the body before it reaches a clinical study, which matters both for speed and for patient safety.
Why Watch This Webinar
- Real case studies, not theory
- See how formulation decisions affect patient adherence
- Understand how PBPK modeling de-risks extended release development
- Relevant for formulation, CMC, regulatory and BD teams
What You Will Learn
- How to use a developability classification system (DCS) to select the right formulation platform
- How a pH-sensitive amorphous dispersion can eliminate a food effect
- How PBPK modeling helped convert a three-times-daily drug to once-daily
- What chronotherapeutics is and how it applies to formulation design
- Why biorelevant dissolution methods better predict clinical performance
- How to address swallowability for pediatric and geriatric patients
Topical Drug Delivery in Preclinical Research: Navigating Promise and Complexity
Topical drug delivery presents a promising strategy in drug development, offering direct access to the site of action while bypassing the gastrointestinal tract and hepatic first-pass metabolism. This targeted approach reduces systemic exposure and minimizes adverse effects. Despite its advantages, the discovery of drug candidates suitable for topical administration involves complex ADME challenges, including transdermal absorption and the need for simple formulations for screening NCEs.
In one of our integrated drug discovery programs, we employed a topical delivery system as a mitigation strategy to address toxicity concerns. This approach not only enhanced safety profiles but also demonstrated the practical utility of topical administration in early-stage drug development.
Why Watch the Webinar?
- Learn from real-world case studies in topical drug delivery
- Understand the ADME complexities in preclinical models
- Gain insights into formulation strategies that drive clinical success
- Interact with industry leaders and ask your questions live
Speakers Panel
Vivek Kumaravel, Ph.D
Vivek Kumaravel has over 20 years of research experience, specializing in oral solid dosage forms, complex generics, and end-to-end CMC development across both human and animal health. He has led cross-functional teams delivering programs from early development through registration to commercialization. Vivek has contributed to 12 patent applications and authored 4 international research publications, partnering with global pharma and biotech companies to translate innovation into scalable drug delivery solutions.
