"Product on Stopper" in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern?
Sign Up to like & getrecommendations! Published in 2018 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2018.02.001
Abstract: During manufacturing of a lyophilized drug product, operator errors in product handling during loading of product filled vials onto the lyophilizer can lead to a seemingly cosmetic defect which can impact certain critical quality attributes… read more here.
Keywords: quality; cosmetic defect; product stopper; product ... See more keywords
Assessment of Patient Exposure to Leachables From Lyophilized Drug Formulations Following Reconstitution, Storage, and Administration via Polymeric Packaging/Delivery Systems.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2018.06.028
Abstract: It has been demonstrated that lyophilized drug formulations have an increased propensity to leach substances from the rubber stoppers comprising their primary packaging system when compared to aqueous liquid formulations stored in the same manner.… read more here.
Keywords: storage; drug; exposure leachables; patient exposure ... See more keywords