Multimechanism oral dosage forms fabricated by three dimensional printing.

ABSTRACT

Four types of complex oral drug delivery devices have been fabricated using the three dimensional printing process. Immediate-extended release tablets were fabricated which were 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 composed of three sections. An interior fast-eroding section separating two drug-releasing sub-units eroded in 30-45 min in simulated gastric fluid. Enteric dual pulsatory tablets were constructed of one continuous enteric excipient 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 tablets were also fabricated. These samples were composed of two erosion based excipient sections of opposite pH based solubility. One section eroded immediately during the acid dissolution stage releasing diclofenac during the first 30 min, and the second section began eroding 5 h later during the high pH stage.