The European Medicines Agency provided draft guidance documents focused on the quality of oral modified release products and transdermal delivery patches last week. The EMA anticipates a response by March 2013. The guidelines for patches are fixed toward developers and what they must do to ensure excipients and solvents have a faster delivery so drugs can pass through the skin without causing irritation.
The EMA defines a transdermal patch “as a flexible, multi-laminated, pharmaceutical preparation of varying size containing one or more drug substances to be applied to the skin for systematic absorption”. To guarantee the safe and effective use of transdermal patches, the drug substances should be transported at a sufficient rate through the skin and should not aggravate or sensitize the skin.
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