Clotrimazol und Ciclopiroxolamin jeweils in Kombination mit Methylprednisolonaceponat in magistralen Rezepturen

Abstract

The combination of topical fungicide and glucocorticoids has been proven as a successful therapy of cutaneous mycoses with accompanying inflammatory reactions, particularly when used at an early stage. Various national and international therapeutic guidelines recommend this practice. In this context, two individually manufactured formulations have been developed and tested for stability: the combination of methylprednisolone aceponate-a topical glucocorticoid with the therapeutic index of 2.0-with clotrimazole and with ciclopirox olamine, respectively. This has been conducted in compliance with the requirements for quality controlled extemporaneous formulations and the legal framework of the German Pharmacy Working Regulations (Apothekenbetriebsordnung). There are now two formulations for clinical use that are microbiologically, physically, and chemically stable, which combine methylprednisolone aceponate-a glucocorticoid with a good risk-benefit ratio-with the broad-spectrum fungicides clotrimazole and, for the first time, ciclopirox olamine.

S2k guidelines for the use of topical preparations on the skin

“…For illustration purposes, examples of suitable standardized extemporaneous preparations for common clinical treatment scenarios are listed in Table . Additional suggestions for preparations may be obtained from other sources, such as: – German Drug Codex ( Deutscher Arzneimittel Codex, DAC )/New formulary of extemporaneous preparations ( Neues Rezepturformularium, NRF ) , – German Pharmacopoeia ( Deutsches Arzneibuch, DAB ), – scientific literature .…”

S2k‐Leitlinie zum Gebrauch von Präparationen zur lokalen Anwendung auf der Haut (Topika)

“…Zur Veranschaulichung sollen für häufige klinische Behandlungssituationen Vorschläge für geeignete standardisierte Magistralrezepturen exemplarisch aufgelistet werden (Tabelle ). Als Quelle für weitere Rezepturvorschläge seien folgende weitere Beispiele erwähnt: – Deutscher Arzneimittel Codex (DAC)/Neues Rezepturformularium (NRF) , – Deutsches Arzneibuch, – wissenschaftliche Fachliteratur .…”