title: On variability in test results of current in vitro dissolution tests.
abstract: An analysis of theoretical cumulative mass dissolved-time profile curves represented by Weibull distributions serves to illustrate a dependency of variability in test results of current in vitro dissolution tests, on slope of a profile curve and amount of a cumulative time-shift, at any given point of a dissolution process. As a result of the dependency, a case of high variability can be shown to be an exaggerated reflection of variability in an initial delay in onset of dissolution of a product (due to, e.g., needed dissolution of a gelatin shell or coating, disintegration, and/or wetting etc.), rather than a true reflection of variability of the product in rate of dissolution (subsequent to, e.g., the dissolution of a gelatin shell or coating, disintegration, and/or wetting etc.). The high variability would not be of a clinical significance.
authors.affiliation: BioKinet Inc, PO Box 269035, Indianapolis, Indiana 46226-9035, USA. ZengWB@sbcglobal.net
authors.forename: William B
authors.initials: WB
authors.lastname: Zeng
mesh_terms: D005780:Gelatin; D008962:Models, Theoretical; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012995:Solubility; D013997:Time Factors; D014906:Wetting Agents / Q000737:chemistry
chemical_list: D004364:Pharmaceutical Preparations; D014906:Wetting Agents; D005780:Gelatin