title: Pharmaceutics, Drug Delivery and Pharmaceutical Technology: A New Test Unit for Disintegration End-Point Determination of Orodispersible Films.
abstract: No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up. Precision was compared using commercial ODF products in different media. Agreement between the two measurement methods was analysed. The DTU showed improved repeatability and reproducibility compared to the USP disintegration system with tighter standard deviations regardless of operator or medium. There is good agreement between the two methods, with the USP disintegration test giving generally longer disintegration times possibly due to difficulty in end-point determination. The DTU provided clear end-point determination and is suitable for quality control of ODFs during product developmental stage or manufacturing. This may facilitate the development of a standardized methodology for disintegration time determination of ODFs. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3893-3903, 2015.
authors.affiliation: AbbVie Pte. Ltd. Singapore, Singapore 138667; Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore 117543.
authors.forename: Ariana
authors.initials: A
authors.lastname: Low
authors.affiliation: AbbVie Pte. Ltd. Singapore, Singapore 138667.
authors.forename: Si Ling
authors.initials: SL
authors.lastname: Kok
authors.affiliation: AbbVie Pte. Ltd. Singapore, Singapore 138667.
authors.forename: Yuetmei
authors.initials: Y
authors.lastname: Khong
authors.affiliation: Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore 117543. Electronic address: phacsy@nus.edu.sg.
authors.forename: Sui Yung
authors.initials: SY
authors.lastname: Chan
authors.affiliation: AbbVie Pte. Ltd. Singapore, Singapore 138667. Electronic address: rajeev.gokhale@abbvie.com.
authors.forename: Rajeev
authors.initials: R
authors.lastname: Gokhale
mesh_terms: D002214:Capsules / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems; D023381:Endpoint Determination / Q000379:methods*; D004867:Equipment Design; D005079:Excipients / Q000032:analysis; D006801:Humans; D015203:Reproducibility of Results; D012995:Solubility; D013607:Tablets / Q000032:analysis*; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods*; D014867:Water
chemical_list: D002214:Capsules; D005079:Excipients; D013607:Tablets; D014867:Water
keywords: US Pharmacopeia (or USP); analysis; buccal; physical characterisation; transmucosal drug delivery