Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures
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...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Bioscientifica
2019-03-01
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| Series: | Endocrine Connections |
| Subjects: | |
| Online Access: | https://ec.bioscientifica.com/view/journals/ec/8/4/EC-19-0025.xml |
| _version_ | 1818535814441730048 |
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| author | Carina Ankarberg-Lindgren Aneta Gawlik Berit Kriström Laura Mazzanti Elisabeth J Ruijgrok Theo C J Sas |
| author_facet | Carina Ankarberg-Lindgren Aneta Gawlik Berit Kriström Laura Mazzanti Elisabeth J Ruijgrok Theo C J Sas |
| author_sort | Carina Ankarberg-Lindgren |
| collection | DOAJ |
| description | 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 1-month stability of cut estradiol patches from four different manufacturers in
the laboratory at room temperature (+21°C) and at an elevated temperature (+35°C).
Design and methods: Estraderm MX 50 μg, Systen 50 μg and Oesclim 25 μg matrix patches were cut into eight pieces while Estradot 50 μg small patches were cut in half.The cut patches were stored in their respective pouches at +21°C or at +35°C for up to 1 month. The estradiol drug was extracted from the patch by ethyl acetate n-hexane and determined by radioimmunoassay.
Results: Storage at +21°C or +35°C up to 1 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 +21 °C, at +35°C, estradiol decreased by 57% (±1%) in cut pieces.
Conclusions: Unused Estraderm MX, Systen and Oesclim patch pieces may be stored for at least 1 month at ≤+35°C. 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. |
| first_indexed | 2024-12-11T18:29:56Z |
| format | Article |
| id | doaj.art-c1c4d21eeab84e74af9343dcd80fb7f6 |
| institution | Directory Open Access Journal |
| issn | 2049-3614 2049-3614 |
| language | English |
| last_indexed | 2024-12-11T18:29:56Z |
| publishDate | 2019-03-01 |
| publisher | Bioscientifica |
| record_format | Article |
| series | Endocrine Connections |
| spelling | doaj.art-c1c4d21eeab84e74af9343dcd80fb7f62022-12-22T00:54:56ZengBioscientificaEndocrine Connections2049-36142049-36142019-03-0184360366https://doi.org/10.1530/EC-19-0025Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperaturesCarina Ankarberg-Lindgren0Aneta Gawlik1Berit Kriström2Laura Mazzanti3Elisabeth J Ruijgrok4Theo C J Sas5Department of Pediatrics, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Pediatrics and Pediatric Endocrinology, Medical University of Silesia, School of Medicine, Katowice, PolandDepartment of Clinical Sciences/Pediatrics, Umeå University, Umeå, SwedenPediatric Endocrinology and Rare Disease Unit, Department of Medical and Surgical Science, University of Bologna, Bologna, ItalyDepartment of Pharmacy, Erasmus Medical Center – Sophia Children’s Hospital, University Medical Center Rotterdam, Rotterdam, the NetherlandsDepartment of Pediatric Endocrinology, Sophia Children’s Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands; Diabeter, National Diabetes Care and Research Center, Rotterdam, the NetherlandsObjective: 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 1-month stability of cut estradiol patches from four different manufacturers in the laboratory at room temperature (+21°C) and at an elevated temperature (+35°C). Design and methods: Estraderm MX 50 μg, Systen 50 μg and Oesclim 25 μg matrix patches were cut into eight pieces while Estradot 50 μg small patches were cut in half.The cut patches were stored in their respective pouches at +21°C or at +35°C for up to 1 month. The estradiol drug was extracted from the patch by ethyl acetate n-hexane and determined by radioimmunoassay. Results: Storage at +21°C or +35°C up to 1 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 +21 °C, at +35°C, estradiol decreased by 57% (±1%) in cut pieces. Conclusions: Unused Estraderm MX, Systen and Oesclim patch pieces may be stored for at least 1 month at ≤+35°C. 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.https://ec.bioscientifica.com/view/journals/ec/8/4/EC-19-0025.xmlestrogenhormone replacement therapypatchespubertal inductionstability |
| spellingShingle | Carina Ankarberg-Lindgren Aneta Gawlik Berit Kriström Laura Mazzanti Elisabeth J Ruijgrok Theo C J Sas Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures Endocrine Connections estrogen hormone replacement therapy patches pubertal induction stability |
| title | Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures |
| title_full | Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures |
| title_fullStr | Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures |
| title_full_unstemmed | Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures |
| title_short | Estradiol matrix patches for pubertal induction: stability of cut pieces at different temperatures |
| title_sort | estradiol matrix patches for pubertal induction stability of cut pieces at different temperatures |
| topic | estrogen hormone replacement therapy patches pubertal induction stability |
| url | https://ec.bioscientifica.com/view/journals/ec/8/4/EC-19-0025.xml |
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