ESPE Abstracts (2014) 82 P-D-1-1-198

Stability Conditions in Estradiol Matrix Patches; in vitro Studies for Application in Pediatrics

Carina Ankarberg-Lindgrena & Theo Sasb,c

aDepartment of Pediatrics, Institute of Clinical Sciences, The Sahlgrenska Academy, Göteborg Pediatric Growth Research Center, University of Gothenburg, Göteborg, Sweden; bDepartment of Pediatrics, Albert Schweitzer Hospital, Dordrecht, The Netherlands; cDepartment of Pediatric Endocrinology, Sophia Childrens’ Hospital/Erasmus Medical Center, Rotterdam, The Netherlands

Background: We have previously shown that estradiol (E2) matrix patches for adults could be cut in smaller pieces to administer low doses for pubertal induction in girls with hypogonadism. With a slow increase of the patch size during a few years, serum E2 levels in normal girls undergoing puberty can be closely mimicked.

Objective and hypotheses: To evaluate storage conditions once the patch has been cut.

Method: Evorel® 25 μg/24 h patches, containing 1.55 mg E2 (Janssen-Cilag Pharmaceutica N.V.) were used. The outer edge on the patch were cut off and discarded. Two equal 1/7 pieces were cut, following the dotted marks on its cover. The cut pieces were stored together with the remaining patch in its foil-lined sachets, either i) in a plastic bag in the fridge ii) in a plastic bag in room temperature or iii) just in room temperature. Storage for 0, 1, 2, 3, 4, and 5 days were compared. E2 concentrations were determined in the entire patch. The patch pieces were put in a solution of n-hexan+ethylacetat and put on slow shaking for 1 h. The samples were thereafter serially diluted. After totally evaporated, reconstitution was made using zero calibrator. E2 concentrations were determined by RIA with lower limit of detection 9 pmol/l and total coefficient of variation (CV) 9% for 250 pmol/l and above.

Results: In average, 1/7 pieces of a 25 μg patch contained 190 μg E2 which is 86% of the expected concentration. No difference was seen either in time of storage, the way the patches were stored or how many edges that were cut. Total CV was 3%.

Conclusion: In vitro, the patches contained the expected drug amount E2 and it was evenly distributed on the surface. After cutting the patches, E2 concentrations were stable for at least 5 days storage.

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