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Determination of Dermal PDE for Pharmaceutical Products
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Journal Article
Determination of Dermal PDE for Pharmaceutical Products
2018
Overview
[...]a two-fold higher absorption by the dermal route for nickel and platinum (Pt) justified decreasing the dPDE for each element. [...]the PDE for mercury (Hg) is 30 pg/day; thus, the daily exposure from a dermatological DP should not exceed 30% (e.g., 9 pg/day) and the concentration limit of 10 pg/g. [...]up to a posology in DP of 0.9 g/day, the dermal concentration limit for Hg (10 pg/g) must be applied; whereas above 0.9 g/day the 30% PDE (9 pg/ day) will be the applicable limit. [...]these dermal concentration limits and revised PDE are not applicable for topical DP applied on skin requiring preparations, like curettage, keratolytic pretreatment, or abrasion, for which a case-by-case evaluation should be performed, taking into account changes in dermal penetration. [...]the authors propose the establishment of dPDEs for some EIs to take into consideration differences between oral and dermal penetration levels and to set dermal concentration limits for some EIs due to their significant skin sensitization risk.
Publisher
MultiMedia Healthcare Inc
Subject
