Extemporaneous Topical Minoxidil Solutions for the Treatment of Androgenetic Alopecia- Stability Studies and Incorporation Tests of Active Pharmaceutical Ingredients in Aloplus Total Base

Int J Pharm Compd. 2024 Jan-Feb;28(1):68-73.

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.

MeSH terms

  • Administration, Topical
  • Alopecia / drug therapy
  • Bulk Drugs*
  • Humans
  • Minoxidil* / therapeutic use
  • Solubility
  • Treatment Outcome

Substances

  • Minoxidil
  • Bulk Drugs