Multimechanism oral dosage forms fabricated by three dimensional printing (TM)

Four types of complex oral drug delivery devices have been fabricated using the three dimensional printing(TM) process. Immediate-extended release tab lets were fabricated which ware composed of two drug-containing sections of different pH-based release mechanisms. Pulsed release of chlorpheniramine maleate occurred after a lag time of 10 min followed by extended release of the compound over a period of 7 h. Breakaway tablets were fabricated compo sed of three sections. An interior fast-eroding section separating two drug -releasing sub-units eroded in 30-45 min in simulated gastric fluid. Enteri c dual pulsatory tablets were constructed of one continuous enteric excipie nt phase into which diclofenac sodium was printed into two separated areas. These samples showed two pulses of release during in vitro USP dissolution at 1 and 8 h with a lag time between pulses of about 4 h. Dual pulsatory t ablets were also fabricated. These samples were composed of two erosion bas ed excipient sections of opposite pH based solubility. One section eroded i mmediately during the acid dissolution stage releasing diclofenac during th e first 30 min, and the second section began eroding 5 h later during the h igh pH stage. (C) 2000 Elsevier Science B.V. All rights reserved.