title: High-throughput evaluation of non-swellable controlled release matrix tablets.
abstract: Drug release from controlled-release (CR) matrix tablets involves the permeation and diffusion of water through the system. In this study, a new methodology is proposed for the measurement of water permeation and simultaneous drug release from the inert, non-swellable CR matrix tablet of diltiazem (DLT) and a correlation is made between these two processes. Cylindrical matrices were readily prepared by direct compression of pellets obtained by extrusion-spheronization. Water transport was studied using tritiated water (HTO) as a permeant in a Franz-diffusion cell and simultaneously drug release was measured. Further, dissolution was performed on USP XXI/XXII dissolution apparatus I using demineralized water. Matrices showed a steady water-uptake up to 6 h and the steady state for HTO permeation lasting from 6-h to 24-h Flux of water permeated and flux of drug released correlated well. Thus, HTO permeation through the matrix tablet and the proposed methodology can be used as a tool and/or surrogate marker for evaluation of controlled release matrix tablets. This methodology can be coined as "high-throughput" in terms of amount of labor and resources required in comparison to that of dissolution.
authors.affiliation: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER) Sector 67, S.A.S. Nagar, Punjab, India. r.panchagnula@ulster.ac.uk
authors.forename: R
authors.initials: R
authors.lastname: Panchagnula
authors.forename: A
authors.initials: A
authors.lastname: Gupta
authors.forename: S
authors.initials: S
authors.lastname: Kandavilli
authors.forename: M V S
authors.initials: MV
authors.lastname: Varma
mesh_terms: D003692:Delayed-Action Preparations; D004058:Diffusion; D004110:Diltiazem / Q000737:chemistry* / Q000493:pharmacokinetics; D005079:Excipients / Q000737:chemistry; D008956:Models, Chemical; D010539:Permeability; D016062:Porosity; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D014316:Tritium; D014867:Water / Q000737:chemistry
chemical_list: D003692:Delayed-Action Preparations; D005079:Excipients; D013607:Tablets; D014867:Water; D014316:Tritium; D004110:Diltiazem