Complex dosage forms, such as oral thin films or transdermal and topical patches, have become increasingly important in modern pharmaceutical development, offering attractive alternatives to conventional drug delivery systems. By bypassing first-pass metabolism, these administration routes can significantly improve bioavailability, particularly for NCEs, peptides, hormones and opioids. Additional benefits include reduced gastrointestinal burden, improved stability of sensitive molecules, controlled drug release, prolonged therapeutic effects, and enhanced patient adherence, especially in geriatric, paediatric, and palliative care settings.
Despite these advantages, the successful development of oral films and transdermal or topical patches requires a thorough understanding of both the active pharmaceutical ingredient (API) and the formulation challenges associated with these dosage forms. Early development decisions have a major impact on project timelines, resource requirements, and development costs. Therefore, identifying the right development pathway at an early stage is critical.
A key milestone in this process is the Lab Feasibility assessment. Following an initial paper-based evaluation and confirmation that the chemical and physicochemical properties of the API are fundamentally suitable for a complex dosage form technology such as Mucofilm® or Transfilm®, laboratory studies provide the first experimental verification of whether theoretical assumptions can be translated into robust and reproducible results.
This webinar explores the critical decision-making points within feasibility studies that guide the development of oral films and transdermal patches. Participants will learn how API suitability is assessed, how permeability and release studies are designed and interpreted, and how these results support formulation optimization and excipient selection. Special attention will be given to established testing approaches, including Franz cell studies with porcine mucosa and skin-mimicking membranes, as well as supporting investigations such as API characterization, solubilization testing, and accelerated compatibility studies. Through these examples, the webinar provides practical insights into making informed development decisions and reducing risks in early-stage product development.
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