Vivelle dot can it be cut

Certified reference material was purchased from Sigma-Aldrich. The assay procedure has been described previously and validated accordingly 15 , This combined result confirmed the validity of the study design. Storage at room temperature for up to 1 month did not affect the E 2 concentration in any of the tested patches. All data fell within analytical variability of 4. Storage in a plastic bag yielded similar results Fig.

Evaluation of stability of four different E 2 matrix patches. Half of the tested patches were stored in the original pouch square symbols and the other half in the pouch inside a small sealed airtight plastic bag circle symbols. E 2 , estradiol. No difference in E 2 concentration was observed between storage in a plastic bag or in the pouch only.

Storage in airtight plastic bags gave similar results as storage in the pouch only. They were covered with a protective liner that was larger than the patch itself by a generous margin Fig. Oesclim was a thicker patch compared to the others, rectangular in shape and very easy to cut and handle. Square-shaped patches with rounded corners were easier to cut into equal wedges than into perfect rectangles Fig.

For the purposes of this study, we cut the patches to a practical size that would ensure accuracy. These patches adhered well on the filter paper after cutting and storage.

The Estradot patch was a miniature rectangular patch, which was too small to be properly cut into small pieces. The protective liner had no extra space surrounding the patch itself Fig. Only the pieces surrounding the incision could easily be separated from the protective liner.

The substance of the content on the Estradot patch surface was thicker and more glutinous compared to the other brands. When the Estradot patch was cut with scissors, a small amount of this content leaked out. However, the patch adhered well on the filter paper after cutting and storage. In the extraction procedure, the drug contents turned gray in the solvent phase, which did not occur with the other three products.

This is the first report on the utility and stability of E 2 matrix patches in cut pieces as well as the impact of storage in higher temperatures. This study showed that the E 2 drug amount was uniformly distributed over the tested E 2 matrix patches Systen, Estraderm MX and Oesclim, and we therefore consider it safe to cut these patches into smaller pieces.

The Estradot patch is very small and can be safely cut in half; however, it did not meet our stability criteria. Pediatricians will, in general, prefer to use registered and licensed products.

Nevertheless, in the absence of very-low-dose E 2 patches, cutting patches of one of the three studied brands Systen, Estraderm MX and Oesclim will reliably deliver the correct dose when used directly after cutting into pieces or after storage of up to 1 month.

This study indicates that E 2 matrix patches with similar size and shape will behave in the same manner. Consequently, we expect that more pediatricians in different countries with different climates will be encouraged to choose transdermal E 2 treatment according to the guidelines for girls with hypogonadism 6 , 7.

Traveling with patches will not be an issue as those patches were found to be relatively resistant to higher temperatures. However, controlled trials are still needed in order to determine which regimen provides the best clinical outcomes. This study brings us one step closer to future clinical studies involving cut pieces of transdermal E 2 matrix patches.

Three of the patches, Systen, Estraderm MX and Oesclim, were relatively large and covered with a generously sized protective liner which made them easy to cut. In this study, the patches were cut into eight pieces for practical reasons.

Nonetheless, cutting into sixteen pieces is possible and has been used in clinical practice 12 ; this would not have changed the results in this experimental study. The least stable patch was the Estradot patch. This miniature E 2 patch is cosmetically preferable for adult women, but it was too small to properly cut into small pieces. We assume that in order to obtain the same delivery criteria on a small area, the content on the Estradot patch surface was thicker compared to the others.

Smaller pieces were impractical to handle, and cutting such small patches would be prone to inaccuracies. Only the pieces surrounding the incision could easily be removed from the release liner, which leads us to suspect that users in many cases have to discard the unusable patch fractions.

Nonetheless, it seems that some users manage to cut even smaller pieces For this reason, the Estradot patch is not applicable for pubertal induction in the youngest girls with the lowest weight.

The inter-individual variation has been reported to be less with transdermal E 2 patches three-fold compared to transdermal gel seven-fold Although only four brands of E 2 matrix patches were tested in this study, we assume that the results are applicable to other similar E 2 matrix patches.

One limitation of this study is that the effect of humidity was not tested. Although the absence of guidance from the manufacturer suggests that humidity is not an issue for storage, we do not rule out the possibility of an effect.

On the other hand, E 2 is only slightly soluble in water, and we therefore believe that humidity will have little impact on stability.

Until this is established, we recommend using an airtight plastic bag in order to avoid any effect of humidity during storage. This study yielded no difference in stability with or without a plastic bag. All cut patches adhered well on the filter paper after storage for up to 1 month.

Although we did not test the cut patches on skin, we assume that the adhesive quality would not differ. The drug amount was uniformly distributed over the surface area of the tested Estraderm MX, Oesclim, Systen and Estradot E 2 matrix patches, and we therefore consider it safe to cut the patches into smaller pieces. The Estraderm MX, Oesclim and Systen E 2 patches are large enough to easily be cut into small pieces, in order to achieve very low E 2 doses. Since E 2 patches for children are not available, cut pieces of these three brands of E 2 matrix patch can be used to induce puberty in hypogonadal girls.

The Estradot E 2 patch, however, was too tiny to properly cut into small pieces for pubertal induction and not stable for storage in a hot climate. The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported. This work was supported by Pfizer grant numbers WP No Pfizer products were involved in this study.

National Center for Biotechnology Information , U. Journal List Endocr Connect v. Endocr Connect. Published online Mar 8. Author information Article notes Copyright and License information Disclaimer. Correspondence should be addressed to C Ankarberg-Lindgren: es. Received Feb 27; Accepted Mar 8. Abstract Objective Transdermal estradiol patches are primarily designed for adult women.

Keywords: estrogen, hormone replacement therapy, patches, pubertal induction, stability. Introduction Girls with hypogonadism require estrogen replacement therapy to induce puberty and maintain secondary sex characteristics, as well as to attain peak bone mass.

Open in a separate window. Figure 1. Table 1 Description of four brands of E 2 matrix patch for potential use in pediatrics. Extending beyond the patch with dotted marks along the edge A polyester release liner with an incision. Extending beyond the patch A polyester release liner extending beyond the patch, no incision A polyester release liner with an incision.

Do not store Estradot in refrigerator. Ensuring uniformity of drug distribution and optimal E 2 extraction procedure In order to verify the uniform distribution of E 2 on the surface area of the patches and to determine the optimal extraction procedure, a pre-study was performed.

Figure 2. Stability testing of E 2 drug amount in cut patches Patches of each variety were taken out of the foil-lined pouches. Extraction of E 2 drug from patch pieces Each piece of the E 2 patches was removed from the protective liner and attached to a matched-size filter paper Whatman for newborn screening; PerkinElmer.

Figure 3. Practical experience with using the patches in this experiment Three of the patches, Systen, Estraderm MX and Oesclim, were large and easy to cut. Discussion This is the first report on the utility and stability of E 2 matrix patches in cut pieces as well as the impact of storage in higher temperatures.

Conclusions The drug amount was uniformly distributed over the surface area of the tested Estraderm MX, Oesclim, Systen and Estradot E 2 matrix patches, and we therefore consider it safe to cut the patches into smaller pieces. Declaration of interest The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.

Funding This work was supported by Pfizer grant numbers WP References 1. Cutler GB. Journal of Steroid Biochemistry and Molecular Biology A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism.

International Journal of Pediatric Endocrinology Hormone supplementation for pubertal induction in girls. Archives of Disease in Childhood Differential association of oral and transdermal oestrogen-replacement therapy with venous thromboembolism risk. Lancet Hormone therapy and venous thromboembolism among postmenopausal women: impact of the route of estrogen administration and progestogens: the ESTHER study. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose. If you miss a dose of this medicine, take it as soon as possible.

However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the patches at room temperature in a closed container, away from heat, moisture, and direct light. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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