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Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base

Author(s):  Spennacchio Antonio, Lopedota Angela Assunta, Lopalco Antonio, Dibenedetto Maria Teresa, la Forgia Flavia Maria, Fontana Sergio, Franco Massimo, Denora Nunzio

Issue:  May/Jun 2023 - Volume 27, Number 3
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Page(s):  256-262

Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base Page 1
Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base Page 2
Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base Page 3
Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base Page 4
Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base Page 5
Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base Page 6
Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base Page 7

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Abstract:  Minoxidil is a vasodilator drug generally employed for the treatment of various forms of alopecia. In this article, the authors propose an alternative to the formulation reported in the British Pharmacopoeia for the realization of topical minoxidil -based solutions using ALOPLUS FAST. This liquid vehicle is an ethanol- and propylene glycol-free base which allows the complete solubilization of minoxidil, thanks to the presence of hydroxypropyl-ß-cyclodextrin. Solubility and chemical stability studies of the active ingredient in the formulation at a concentration of 5% w/w and physical stability studies of this extemporaneous preparation are reported. Incorporation tests of various active pharmaceutical ingredients that can be combined with minoxidil for alopecia synergic treatment have been carried out. Analyses were performed by using a high-pressure liquid chromatography analytical method. The results showed that the intrinsic solubility of the drug in the liquid base was 62.37 mg/mL ± 0.85 mg/mL (5.24 w/w ± 0.07% w/w) at 25°C; minoxidil was chemically stable in ALOPLUS FAST; and the formulation was physically stable for more than six months, under different storage conditions. Incorporation tests of several active pharmaceutical ingredients in 2% to 4% w/w minoxidil formulations were successful as well. 

Related Keywords: Antonio Spennacchio, PhD Student in Pharmaceutical Technology, Angela Assunta Lopedota, PhD in Pharmaceutical Technology, Antonio Lopalco, PhD in Pharmaceutical Technology, Maria Teresa Dibenedetto, Master's degree in Pharmaceutical Chemistry and Technology, Flavia Maria la Forgia, MS in Pharmacy, Sergio Fontana, MS in Pharmacy, Massimo Franco, PhD in Pharmaceutical Technology, Nunzio Denora, PhD in Pharmaceutical Technology, topical preparations, minoxidil, alopecia, chemical stability, physical stability, ALOPLUS FAST vehicle, Galenic formulations, cyclodextrins, excipient compatibility

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS

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