Compatibility of 17-α-Estradiol, Betamethasone, Finasteride, Melatonin, Prednicarbate, and Spironolactone in TrichoFoam™ - a Foaming Vehicle for Personalized Alopecia Treatments.

Abstract

Objective: This study evaluates the physicochemical compatibility of six active pharmaceutical ingredients (APIs) - 17-a-estradiol, betamethasone, finasteride, melatonin, prednicarbate, and spironolactone - in TrichoFoam™, a foaming vehicle designed for personalized alopecia treatments.

Background: Alopecia, a condition impacting around 2% of the global population, can benefit from more effective and patient-friendly treatments. TrichoFoam™ represents a personalized medicine approach that utilizes a foam base to enhance the delivery and efficacy of topical treatments.

Methods: The physicochemical compatibility was assessed using High-Performance Liquid Chromatography (HPLC) and Ultra-High Performance Liquid Chromatography (UHPLC) to ensure that the APIs remain stable and effective within TrichoFoam™. Products evaluated were: 17-a-estradiol 0.025% - 0.05%, betamethasone 0.1% - 0.2%, finasteride 0.01% - 0.25%, melatonin 0.05% - 0.5%, prednicarbate 0.1%, and spironolactone 1.0%. Forced degradation studies and stability-indicating analyses were conducted to determine the APIs' stability under various conditions.

Results: The beyond-use dates found were: 17-a-estradiol 0.025% = 120 days; 17-a-estradiol 0.05%= 14 days; Betamethasone 17-valerate 0.1% = 180 days; Betamethasone 17-valerate 0.2% = 120 days; Finasteride 0.01% to 0.25% = 120 days; Melatonin 0.05% to 0.5%= 60 days; Prednicarbate 0.1% = 60 days; Spironolactone 1.0% = 14 days. The APIs demonstrated satisfactory compatibility with TrichoFoam™, with no significant chemical interactions or stability issues observed. Stability studies showed that the APIs maintained their efficacy within the foam base over time, with acceptable recovery percentages.

Conclusion: This study can further support the use of TrichoFoam™ as a viable vehicle for delivering multiple APIs in a personalized alopecia treatment regimen. The compatibility and stability of the APIs within this formulation offer a promising advancement in tailored alopecia treatments, potentially improving patient adherence and therapeutic outcomes.