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

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.