Development and Qualification of a Physiologically Based Pharmacokinetic Model of Finasteride and Minoxidil Following Scalp Application

February 2021 in “ Journal of Pharmaceutical Sciences ”

Arpar Ngampanya, Udomsak Udomnilobol, Pakawadee Sermsappasuk, Natapol Pornputtapong, Boonsri Ongpipattanakul, Nikunjkumar Patel, Suree Jianmongkol, Thomayant Prueksaritanont

finasteride minoxidil dihydrotestosterone physiologically based pharmacokinetic model scalp physiology pharmacokinetics Multi-Phase and Multi-Layer Mechanistic Dermal Absorption Simcyp Simulator topical formulations Propecia Rogaine DHT PBPK model MechDermA Simcyp

TLDR The model can help predict how finasteride and minoxidil work when applied to the scalp.

The study developed and qualified a physiologically based pharmacokinetic (PBPK) model for scalp application of finasteride and minoxidil, incorporating parameters related to scalp physiology, drug pharmacokinetics (PK), and formulations. The model used the Multi-Phase and Multi-Layer (MPML) Mechanistic Dermal Absorption (MechDermA) framework within the Simcyp® Simulator V17. For finasteride, the model linked its effect on dihydrotestosterone (DHT) levels using an indirect response model, and its predictions were verified against clinical data. The minoxidil model was developed using the same scalp parameters and was satisfactorily qualified with independent clinical datasets. The results indicated that the PBPK model could be useful for other topical formulations for scalp application.

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