title: Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products.
abstract: The ICH Q1B guidance and additional clarifying manuscripts provide the essential information needed to conduct photostability testing for pharmaceutical drug products in the context of manufacturing, packaging, and storage. As the previous 2 papers in this series highlight for drug products administered by injection (part 1) and drug products administered via topical application (part 2), there remains a paucity of guidance and methodological approaches to conducting photostability testing to ensure effective product administration. Part 3 in the series is presented here to provide a similar approach and commentary for photostability testing for oral drug products. The approach taken, as was done previously, is to examine "worst case" photoexposure scenarios in combination with ICH-defined light sources to derive a set of practical experimental approaches to support the safe and effective administration of photosensitive oral drug products.
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Allain
authors.affiliation: Baertschi Consulting LLC, Carmel, Indiana 46033.
authors.forename: Steven W
authors.initials: SW
authors.lastname: Baertschi
authors.affiliation: GlaxoSmithKline Pharmaceuticals, Ware SG12 0DP, UK. Electronic address: david.clapham@ntlworld.com.
authors.forename: David
authors.initials: D
authors.lastname: Clapham
authors.affiliation: Gilead Sciences, Foster City, California 94404.
authors.forename: Chris
authors.initials: C
authors.lastname: Foti
authors.affiliation: College of Pharmacy, Purdue University Indianapolis, Indiana 46202.
authors.forename: Wendy M
authors.initials: WM
authors.lastname: Lantaff
authors.affiliation: Aradigm Corporation, Hayward, California 94545.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Reed
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486. Electronic address: allen_templeton@merck.com.
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: D000284:Administration, Oral; D000818:Animals; D004348:Drug Labeling / Q000379:methods* / Q000592:standards; D004349:Drug Packaging / Q000379:methods / Q000592:standards; D004355:Drug Stability; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism*; D055668:Photochemical Processes; D010782:Photolysis
chemical_list: D004364:Pharmaceutical Preparations
keywords: oral drug delivery; photochemistry; photodegradation; solid dosage form; stability; stabilization; tablet