NOVEL DIVISIBLE TABLET DESIGNS FOR SUSTAINED-RELEASE FORMULATIONS

Novel divisible tablet designs have been developed, which minimize the formation of new surface area upon division and thereby provide a means of administering a portion of the sustained release dose without appreciably altering the rate of drug release. A U.S. patent has been issued, claiming these divisible tablets for fractional dosing of sustained release medications [1]. Basic design features include lateral grooves on the top and bottom tablet surfaces at each line of division, which may be of variable depth, and a tablet shape that produces deep transverse grooves on the side of the tablet. Tablet shape, as well as the depth and angle of the dividing grooves, may be varied depending on the number of divisions desired, tablet size, weight, mechanical strength, and other formulation considerations. Distinctive features of oval bi-dosage tablets, oval tri-dos-age tablets, and elliptical bi-dosage tablets are examined. Divisible oval bi-dosage sustained released 400 mg Motrin tablets were evaluated. Cleavage resulted in tablet segments containing half the dosage of the whole tablet (within <0.2%). An increase in surface area, upon division, of only 2.49% was observed. In vitro drug release rates for the Motrin half tablets were essentially equivalent to those of the whole tablets. © 1990.