Background: The Turner syndrome (TS) Working Group of the ESPE intends to start an international study comparing transdermal estradiol (E2) vs oral E2 in Europe in girls with TS. For this, stable and reliable products for children are needed, for use in different countries with different climates. It has previously been shown that E2 matrix patches for adults can be cut in smaller pieces to administer low doses for pubertal induction in girls. The Turner Working Group plan to extend the knowledge of the use of the (cut) patches for children, as no pharmacological company will perform this important work. Consequently, in vitro studies are necessary before going further to the clinical study. After this study, we expect to have the knowledge and experience to ask to the pharmacist to cut different patches in a standardized way and we can give advices to patients and parents about the storage conditions in different countries with different temperatures during the year.
Objective and hypotheses: Assess the consequences of cutting the patch on the distribution of E2 over the surface and storage conditions of cut pieces.
Method: The study will include five patches from different manufacturers in Europe. E2 concentrations in patches stored in sealed sachets and cut pieces after storage in +30C and +35C for up to 4 weeks will be determined in parallel with storage in +2123C.
Results: In a pilot study, one of the E2 matrix patches after cutting into pieces were stored together with the remaining patch in its foil-lined sachets, either in a plastic bag in the fridge i) in a plastic bag in room temperature ii) or just in room temperature iii). Storage for 0, 1, 2, 3, 4 and 5 days were compared. Our in vitro study showed that the patches contained the expected drug amount E2 and it was evenly distributed on the surface. After cutting the patches, E2 concentrations were stable in 22 C for at least 1 week in its sachet.
Conclusion: The ESPE TS Working Group hopes to get the possibility to perform this in vitro study in order to obtain more knowledge about storage conditions of cut pieces from different estrogen matrix patches, and consequently a better way to induce puberty in TS.
01 - 03 Oct 2015
European Society for Paediatric Endocrinology