Extemporaneous Topical Minoxidil Solutions for the Treatment of Androgenetic Alopecia- Stability Studies and Incorporation Tests of Active Pharmaceutical Ingredients in Aloplus Total Base
Author(s): Spennacchio Antonio, Lopedota Angela Assunta, Lopalco Antonio, Cutrignelli Annalisa, la Forgia Flavia Maria, Fontana Sergio, Franco Massimo, Denora Nunzio
Issue: Jan/Feb 2024 - Volume 28, Number 1
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Abstract: Minoxidil is one of the most employed active pharmaceutical ingredients for the treatment of androgenetic alopecia. The authors propose a new method for production of minoxidil lotions using Aloplus Total. The latter is a propylene glycol-free liquid base in which the presence of hydroxypropyl-ß-cyclodextrin and ethanol allows the solubilization of high drug amounts. Minoxidil intrinsic solubility in the base was determined, and a comprehensive chemical and physical stability study was conducted on 8% w/w minoxidil lotions. Incorporation tests of different active pharmaceutical ingredients that can be combined to 5% w/w minoxidil were also carried out. The analyses showed that minoxidil intrinsic solubility in the new base was 85.93 mg/mL ± 4.17 mg/mL (8.64% w/w ± 0.42% w/w) at 25°C, and the topical lotions were found to be physically and chemically stable for more than 180 days when stored at 25°C or 40°C. Incorporation tests of several active pharmaceutical ingredients also were successful, indicating that Aloplus Total is a liquid vehicle also useful for the preparation of minoxidil-based topical lotions for a synergistic treatment of androgenetic alopecia.