Compatibility of Different Formulations in TrichoConceptTM Vehicles for Hair Treatments

Hudson Polonini,Clark Zander,Sarah Taylor

doi:10.3390/scipharm90010016

Abstract

The wide variety of potential pathogeneses for alopecia and the wide variety of active pharmaceutical ingredients (APIs) to treat and manage those pathogeneses highlight the importance of the development of stable and effective topical treatments. Topical options for alopecia on the market remain limited and oral products may result in unwanted systemic adverse effects. This study is meant to fill the gap by determining compatibility in terms of beyond-use date (BUD) of APIs with theoretical or demonstrated benefits for topical use for alopecia. The compatibility of seven formulations was tested: F1 = clobetasol 0.05% in TrichoWashTM; F2 = ketoconazole 2% in TrichoWashTM; F3 = spironolactone 1% in TrichoWashTM; F4 = latanoprost 0.1% in TrichoCreamTM; F5 = pyridoxine HCl 0.5%, vitamin A acetate 1%, and vitamin E succinate 12.1 IU in TrichoCondTM; F6 = Caffeine 2%, menthol 1%, and pyridoxine HCl 0.5% in TrichoWashTM; F7 = Latanoprost 0.1%, minoxidil 5%, and finasteride 0.25% in TrichoSolTM. All formulations presented a BUD of 6 months, except for F4 and F7, which showed compatibility for 3 months. This validates the compatibility of the APIs with the TrichotechTM vehicles, and that they are highly convenient for compounding pharmacies.

Highlights

Alopecia is a pervasive issue around the world
We explored the compatibility of several active pharmaceutical ingredients (APIs) in bases designed to be used for patients with alopecia, including TrichoWashTM, TrichoCondTM, TrichoCreamTM
Finasteride for topical use has been well studied at a variety of strengths for androgenetic alopecia; the topical use allows the successful treatment of alopecia while avoiding higher systemic levels associated with oral use [8–10]. Spironolactone is another anti-androgenic drug that has been studied for topical use to avoid unwanted adverse effects that may be associated with oral use, such as those associated with its mechanism of action as a diuretic [11]

Summary

Introduction

Alopecia is a pervasive issue around the world. One study of men between the ages of 18 to 49 years, found that 42% of men had moderate to extensive hair loss. The chosen APIs were caffeine, clobetasol propionate, finasteride, ketoconazole, latanoprost, menthol, minoxidil, pyridoxine hydrochloride, spironolactone, vitamin A acetate, and vitamin E succinate. Spironolactone is another anti-androgenic drug that has been studied for topical use to avoid unwanted adverse effects that may be associated with oral use, such as those associated with its mechanism of action as a diuretic [11] Other options such as latanoprost or minoxidil have a history of topical use but may not be available at the appropriate strength for use on the scalp, such as in the case of latanoprost or, as is the case with minoxidil, are often available in hydroalcoholic vehicles or vehicles that contain propylene glycol, which may cause drying or irritation of the scalp or even contact dermatitis [12,13]. HCl, vitamin E, and vitamin A, as well as caffeine, menthol, and pyridoxine, and lastly, a combination of latanoprost, minoxidil, and finasteride were evaluated as combination formulations to demonstrate compatibility in bases well-suited for use for alopecia

Preparation of Active Pharmaceutical Ingredients Cream Samples

Chromatographic Conditions

Results

Conclusions