Uridine 10 hand-footointment and adhesive-paste For the treatment

Uridine 10% hand-footointment and adhesive-paste For the treatment of the hand-foot syndrome (PPE) and mucositis induced by of 5 -FU and its oral derivates (Capecitabine, UFT) Jürgen Barth, Essen 1

The (short) story of how it came into being • Side effects of 5 -FU (& derivates): • PPE • Mucositis • Pharmacological considerations about an „antidot“ in the 90 ies • Various substances seemed to be a possibility • Thymine • Thymidine • Uracil • Uridine • 2‘-Deoxyuridine Jürgen Barth, Essen 2

The (short) story of how it came into being • Decision: Uridine • Development of a formula in the Dept. of Pharmacy, Essen • “Clinical experience“ after a short time: IT WORKS • Since then: an “in-house-speciality” • Useful after extravasation or skin contamination • Uridin-Hand-Fußsalbe und Uridin-Haftpaste als effektive Antidota nach akzidenteller Hautkontamination mit 5 -Fluorouracil – ein Fallbericht Krankenhauspharmazie 2000; 21: 625 -628 • Evidence based data concerning efficacy (by systematical inquiry): NONE Jürgen Barth, Essen 3

The formulae • • Uridine 10% hand- & foot ointment Uridin 10 g Propylene glycol q. s. Basiscreme DAC ad 100 g - Uridine is mixed with a small amount of propylene glycol. - This dispersion is then added to DAC basic cream. - DAC basic cream is monographed in the Deutscher Arzneimittel Codex (German drug codex), representing a collection of drug monographs besides the European and German Pharmacopoeia. - DAC basic cream is an amphiphile nonionic cream. • • • Uridine 10% adhesive-paste Uridin 1 g Subliquid paraffin 6, 65 g Carbopol 934 2, 35 g Spearmint oil 1 gtt. - Uridine is added to a hydrophobic adhesive-paste composed of subliquid paraffin and Carbopole 974 P, a type of polyacrylic acid. - The paste is flavoured with spearmint oil. Jürgen Barth, Essen 4

Aim of an ESOP study • Systematical data collection to evaluate the efficacy of the ointment and –if possible- the adhesive (mucous membrane) paste • How? ESOP will make the formulae (instructions how to prepare a drug) available to any interested pharmacist who feels able to prepare these medication and offer it to physicians who treat patients with 5 -FU, Capecitabine or UFT • Data will be collected by the individual pharmacist • Summary and evaluation by ESOP Jürgen Barth, Essen 5

ESOP study Evaluation sheet (and this presentation) will be downloadable @ the ESOP homepage: http: //www. esop. li/ Jürgen Barth, Essen 6

ESOP study Evaluation sheet http: //www. esop. li/ Jürgen Barth, Essen 7