Three Dimensional Printing(TM) is a novel technique used in the fabrication
of complex oral dosage delivery pharmaceuticals. It is possible to enginee
r devices with complicated internal geometries, varying densities and diffu
sivities, and multiple actives and excipients. Samples were fabricated usin
g this technique using standard pharmaceutical materials. Erosion mechanism
delayed-release tablets were constructed with varying polymer content from
8.9 to 17.9%. Lag times varied between 25 and 50 min with a corresponding
decrease in release rate as polymer content increased. Diffusion mechanism
tablets were constructed with varying polymer content from 9.0 to 16.7%. Th
e peak release rate decreased and the time to exhaustion increased with pol
ymer content, whereas lag time was not affected. Active delivery studies wi
th fluorescein indicated that Three Dimensional Printing is capable of accu
rately constructing dosage forms with active content as low as 10(-12) mole
s per tablet. Hardness and friability testing indicated that samples fabric
ated with this technique are comparable to other standard pharmaceutical pr
oducts. (C) 2000 Elsevier Science B.V. All rights reserved.