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Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures

Nyhet: 2019-04-16

Ankarberg-Lindgren C, Gawlik A, Kristrom B, Mazzanti L, Ruijgrok EJ, Sas TCJ. Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures. Endocr Connect. 2019. Epub 2019/03/10.

Abstract

OBJECTIVE:
Transdermal estradiol patches are primarily designed for adult women. No low-dose patches are licensed for pubertal induction in hypogonadal girls. Low doses can be achieved by cutting a matrix patch into smaller pieces. However, the manufacturers do not guarantee stability or utility of cut estradiol patches. The aim of the study was to assess one-month stability of cut estradiol patches from four different manufacturers in the laboratory at room temperature (+21ºC) and at an elevated temperature (+35ºC).

DESIGN AND METHODS:
Estraderm MX 50µg, Systen 50µg, and Oesclim 25µg matrix patches were cut into eight pieces while Estradot 50µg small patches were cut in half. The cut patches were stored in their respective pouches at +21ºC or at +35ºC for up to one month. The estradiol drug was extracted from the patch by ethyl acetate n-hexane and determined by radioimmunoassay.

RESULTS:
Storage at +21ºC or +35ºC up to one month did not reduce the estradiol concentration in Estraderm MX, Systen, and Oesclim patches. However, although the estradiol in Estradot patches was not affected by storage at +21ºC, at +35ºC estradiol decreased by 61% (±5%) in cut pieces.

CONCLUSIONS:
Unused Estraderm MX, Systen, and Oesclim patch pieces may be stored for at least one month at ≤+35ºC. Where estradiol patches for children are not available, cut pieces of these or similar patches can be used for pubertal induction. The Estradot patch was too small to properly cut into low doses and not stable in elevated temperatures.
 

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