Abstract
BACKGROUND: Alopecia is globally known as a distressing medical disorder that affects men and women, and current commercially available minoxidil solutions are formulated with irritant vehicles with frequent complaints of dermatologic adverse effects. OBJECTIVES: This study aimed to investigate further the compatibility of ready-to-use vehicles for the preparation of tailored formulations for alopecia treatment, namely TrichoSol™ (a ready-to-use vehicle for personalized hair solutions) and TrichoFoam™ (a ready-to-use vehicle for personalized foam formulations), in combination with minoxidil and other active pharmaceutical ingredients (APIs), to establish adequate beyond-use dates (BUD) for the given formulations. METHODS: Products under evaluation were compounded using TrichoSol™ or TrichoFoam™, with direct incorporation of the APIs into these vehicles. Samples were then stored at controlled room temperature for up to 180 days. High-performance liquid chromatography (HPLC) methods were developed and validated, and then utilized to evaluate the compatibility of the APIs in TrichoSol™ and TrichoFoam™. Forced degradation studies were conducted to assess API stability under various stress conditions, and Antimicrobial Effectiveness Testing (AET) was performed at 0 and 180 days after compounding. RESULTS: According to our results, BUDs of up to 90-180 days were obtained for the examined formulations stored at room temperature, considering a degradation of maximum 10% of the nominal concentration of the APIs within them. The formulations exhibited no discernible physical alterations throughout this period and maintained chemical stability within acceptable limits. Microbiological evaluations confirmed the efficacy of the preservative system. CONCLUSION: Products compounded with TrichoSol™ and TrichoFoam™ showed suitable stability to be used as personalized treatments for alopecia. We can then suggest that the vehicles TrichoSol™ and TrichoFoam™ present effective solutions for compounding personalized hair care treatments.