Feasibility to Phase I: How Early Development Decisions Save Time and Cost

Discover how to assess API suitability for oral films and transdermal patches, reduce time and cost, and optimise formulations
September 17th, 2026
16:00 CEST - 10:00 ET
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OVERVIEW

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.

Addressed Challenges

01Choosing the right delivery platform:
Determine if your API is suitable for Mucofilm® oral films or Transfilm® patches and which offers highest potential
02Generating meaningful feasibility data:
Learn what permeation studies show and how they guide cost and time-efficient formulation and excipient selection
03Choosing your development partner:
Know what to look for in a CDMO for films and patches, from feasibility assessment through Phase I and commercial supply

WHAT YOU WILL LEARN

01Assess API compatibility:
Learn how to evaluate whether your API is suitable for Mucofilm® oral films or Transfilm® patches for optimal development pathway
02Gain insights into in vitro testing:
Understand the key factors influencing API permeation and how study design guides formulation and excipient selection
03Translate feasibility results into strategy:
Learn how early data guides formulation choices and accelerates Phase I readiness while reducing development cost
Reserve Your Seat
SPEAKER
Leni Breuers
Project and Laboratory Manager R&D, AdhexPharma’s R&D competence centre in Germany
Leni Breuers is a Project & Laboratory Manager in R&D at the AdhexPharma’s R&D centre in Langenfeld, Germany. With almost 10 years’ experience in the contract development of complex dosage forms and an academic background in pharmacy focused on drug research, she joined the group in 2017 and has held roles in formulation development since 2018. Today she leads multiple customer projects with technical, timeline and budget responsibility. Leni oversees formulation development across the full lifecycle: from initial feasibility studies through the development and manufacture of clinical GMP batches to technology transfer into production. Working alongside the production team, she supports the establishment of robust processes through to commercial manufacturing.
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