Multifactorial Disease Models: Their Role In De-Risking Topical Formulation Development

Topical pharmaceutical development is a high-stakes, capital-intensive process. Relying on prototype formulations and limited in vitro or animal testing can lead to costly failures or extensive reformulation work late in the development cycle. Traditional methods like In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) fall short because they fail to capture critical factors, such as a drug’s ability to partition into the skin, its bioavailability, or how the formulation affects the skin's underlying barrier properties. Furthermore, animal models are increasingly limited by ethical concerns and often lack the biological similarity to human skin required for translatable results.

The industry is now advancing toward innovative solutions that bridge this gap. By combining advancements in immunology and tissue culture, scientists are utilizing living ex vivo human skin explants to create complex, multifactorial disease models. These advanced systems incorporate key elements of human disease, such as infection and inflammatory responses, allowing researchers to accurately monitor therapeutic efficacy by tracking changes in inflammatory cytokines and antimicrobial peptides. By offering a more representative and translatable system for testing, these models are essential for de-risking the development process for all topical products. Discover the evolution of topical drug testing and the technical specifics of these next-generation models.