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Methotrexate for topical application in an extemporaneous preparation
Johannes Wohlrab1,2, Reinhard H H Neubert2,3, Julia Michael2
1University Hospital for Dermatology and Venereology, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
Summary
Topical methotrexate in "Basiscreme DAC" is stable up to 0.5% and provides local skin bioavailability without significant systemic absorption. This formulation offers a safe and effective option for topical dermatological treatments.
Area of Science:
- Dermatology
- Pharmacology
- Pharmaceutical Compounding
Background:
- Methotrexate is an antifolate agent used systemically for cancer and inflammatory diseases.
- Previous topical applications showed success in mycosis fungoides and lymphomatoid papulosis.
- No approved topical preparations or compounding guidelines existed.
Purpose of the Study:
- To develop and evaluate a stable topical methotrexate formulation for dermatological use.
- To assess the pharmaceutical quality, stability, and safety of the new preparation.
Main Methods:
- Developed and tested galenic formulations for topical methotrexate.
- Established HPLC methods for active substance determination.
- Preclinically evaluated vehicle stability, drug release, pharmacokinetics, and safety.
Main Results:
- Methotrexate is stable in "Basiscreme DAC" up to 0.5% concentration.
- The formulation ensures adequate local skin bioavailability.
- No significant systemic absorption or safety risks were observed with limited topical application.
Conclusions:
- The developed prescription for topical methotrexate is stable and of pharmaceutical quality.
- It meets regulatory requirements for extemporaneous pharmaceutical preparation.
- This provides a viable option for topical dermatological therapy.