title: Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product.
abstract: Although essential guidance to cover the photostability testing of pharmaceuticals for manufacturing and storage is well-established, there continues to be a significant gap in guidance regarding testing to support the effective administration of photosensitive drug products. Continuing from Part 1, (Baertschi SW, Clapham D, Foti C, Jansen PJ, Kristensen S, Reed RA, Templeton AC, Tønnesen HH. 2013. J Pharm Sci 102:3888-3899) where the focus was drug products administered by injection, this commentary proposes guidance for testing topical drug products in order to support administration. As with the previous commentary, the approach taken is to examine "worst case" photoexposure scenarios in comparison with ICH testing conditions to provide practical guidance for the safe and effective administration of photosensitive topical drug products.
authors.affiliation: Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, Indiana, 46285.
authors.forename: Steven W
authors.initials: SW
authors.lastname: Baertschi
authors.affiliation: GlaxoSmithKline Pharmaceuticals, Ware, SG12 0DP, UK.
authors.forename: David
authors.initials: D
authors.lastname: Clapham
authors.affiliation: Pfizer Inc, Analytical Research and Development, Eastern Point Road, Groton, Connecticut, 06340.|Gilead Sciences, Foster City California, 94404.
authors.forename: Chris
authors.initials: C
authors.lastname: Foti
authors.affiliation: GlaxoSmithKline Pharmaceuticals, King of Prussia, Pennsylvania, 19406-0940.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Kleinman
authors.affiliation: School of Pharmacy, University of Oslo, Oslo, 0316, Norway.
authors.forename: Solveig
authors.initials: S
authors.lastname: Kristensen
authors.affiliation: Celsion Corporation, Lawrenceville, New Jersey, 08648.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Reed
authors.affiliation: Merck Research Laboratories, Merck and Company, Inc., West Point, Pennsylvania, 19486.
authors.forename: Allen C
authors.initials: AC
authors.lastname: Templeton
authors.affiliation: School of Pharmacy, University of Oslo, Oslo, 0316, Norway.
authors.forename: Hanne Hjorth
authors.initials: HH
authors.lastname: Tønnesen
mesh_terms: D000287:Administration, Topical; D000818:Animals; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry; D017408:Guidelines as Topic; D006801:Humans; D010084:Oxidation-Reduction; D004364:Pharmaceutical Preparations; D055668:Photochemical Processes
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations
keywords: drug-excipient interaction; oxidation; photochemistry; photodegradation; physical stability; preformulation; solid state stability; stability; transdermal; transdermal drug delivery