Abstract
Objective: At present, the nail preparation to cure onychomycosis, caused by non-dermatophyte molds, is not commercially available in Thailand. The physical and chemical stability of amphotericin B (AmB) extemporaneous preparations in the presence of 30% dimethyl sulfoxide (DMSO) and their in vitro nail permeation was evaluated.
 Methods: AmB extemporaneous preparations in the presence of 30% DMSO were prepared from a commercial sterile injection product, and cream or hydrophilic ointment. Physical stability was tested at 30°C for 2 months, or using 6 heating-cooling cycles. The chemical stability and in vitro nail permeation of AmB content were analyzed using high-performance liquid chromatography (HPLC). In vitro nail permeation was performed by applying 3.5 mg/mm2 of the tested formulation on nail clippings for 5 consecutive days.
 Results: The AmB cream and ointment extemporaneous preparations containing 30% DMSO, a permeation enhancer, were homogeneous and pale yellow to yellow cream or ointment. The AmB ointment was stable for up to 60 days. The ointment preparation allows in vitro penetration through nails up to 14.17 μg/cm2. The ointment preparation allows significantly better penetration through than the cream preparation due to the presence of DMSO, sodium lauryl sulfate (SLS), and water in the ointment preparation.
 Conclusion: The AmB extemporaneous ointment was successfully compounded from a commercial sterile injection product with a beyond-use date of 60 days. The ointment preparation is currently under further investigation for in vivo efficacy.
Highlights
Onychomycosis is a fungal infection caused by dermatophytes, yeasts, and/or non-dermatophyte molds [1]
Acetonitrile, dimethyl sulfoxide, and methanol high-performance liquid chromatography (HPLC) grade were purchased from RCI Labscan Ltd., Bangkok, Thailand; ethylenediaminetetraacetic acid calcium disodium salt was purchased from Farmitalia Carlo Erba SPA, Milan, Italy, hydrochloric acid from Loba Chemie PVT
HPLC method for analysis of amphotericin B (AmB) HPLC chromatogram of AmB standard solution showed a major peak of AmB reference standard at a retention time of around 5 min (Fig. 1a)
Summary
Onychomycosis is a fungal infection caused by dermatophytes, yeasts, and/or non-dermatophyte molds [1]. The nail becomes thickened and discolored, resulting in onycholysis, along with separation of the nail plate from the nail bed [2,3]. The dermatophytes, Trichophyton rubrum and Trichophyton mentagrophytes, cause 60% and 20%, respectively, of onychomycosis worldwide. Terbinafine, Ciclopirox 8% solution, and amorolfine 5% lacquer are commercially available topical preparations for the treatment of onychomycosis caused by dermatophyte molds [4,5]. The majority of onychomycosis in Thailand is caused by non-dermatophyte molds, such as Fusarium spp. and Scytalidium spp. No effective topical antifungal drugs are commercially available to treat it
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