ABSTRACT
The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES.
Subject(s)
Drug-Eluting Stents , Ultrasonics , Chromatography, High Pressure Liquid , Everolimus/chemistry , Everolimus/pharmacokinetics , Microscopy, Atomic Force , Microscopy, Electron, Scanning , Polyglactin 910 , Surface PropertiesABSTRACT
We report the fabrication of membranes hundreds of micrometers thick that demonstrate efficient electron conduction and proton transport through vertically aligned arrays of multiwalled carbon nanotubes (NTs) impregnated by epoxy. Electrical transport was Ohmic with a conductivity of 495 mS cm(-1). Protons traversed the membrane through the NT bore with a current of 5.84 × 10(-6) A. Good electron and proton transport, chemical robustness, and simple fabrication suggest NT membranes have potential in artificial photosynthesis applications.
