Trimodal, precision-timed pulsatile release tablet

A trimodal, pulsatile release tablet for oral administration of a stimulant comprising:

• (a) a first stimulant layer comprising (i) a first pulse of about 30% to about 40% of the total stimulant in the tablet, wherein the first pulse is released within about 10 to about 45 minutes after oral administration of the tablet to a patient, (ii) calcium sulfate, (iii) microcrystalline cellulose, (iv) colloidal silicon dioxide, (v) sodium starch glycolate, and (vi) sodium stearyl fumarate;
• (b) a second stimulant layer comprising (i) a second pulse of about 40% to about 50% of the total stimulant in the tablet, wherein release of the second pulse begins about 3 to about 5 hours following oral administration of the tablet to a patient, and release of the second pulse is sustained for about −30 to about 135 minutes, (ii) calcium sulfate, (iii) hypromellose, (iv) microcrystalline cellulose, (v) colloidal silicon dioxide, (vi) sodium starch glycolate and (vii) sodium stearyl fumarate;
• and
• (c) a third stimulant layer comprising (i) a third pulse of about 15% to about 25% of the total stimulant in the tablet, wherein the third pulse is delayed in release until about 5 hours to about 10 hours following oral administration of the tablet to a patient, (ii) calcium sulfate, (iii) microcrystalline cellulose, (iv) colloidal silicon dioxide, (v) sodium starch glycolate, and (vi) sodium stearyl fumarate;
• wherein the tablet is structured such that the first stimulant layer is positioned as a surface of the tablet and on an outer erosion barrier layer, the second stimulant layer is positioned between the outer erosion barrier layer and an inner erosion barrier layer such that it is surrounded by the outer and inner erosion barrier layers, and the third stimulant layer is positioned at the center of the tablet and surrounded by the inner erosion barrier layer;
• wherein the first stimulant layer comprises 2.5 w/w % to about 25 w/w % of stimulant, about 1 w/w % or less of calcium sulfate and about 75 w/w % to about 98 w/w % cumulatively of microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and sodium stearyl fumarate;
• the second stimulant layer comprises about 5 w/w % to about 50 w/w % of stimulant, about 1 w/w % or less of calcium sulfate, about 4 w/w % to about 10 w/w % of hypromellose, and about 40 w/w % to about 90 w/w % cumulatively of microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and sodium stearyl fumarate;
• the third stimulant layer comprises 2.5 w/w % to about 25 w/w % of stimulant, about 1 w/w % or less of calcium sulfate, and about 75 w/w % to about 98 w/w % cumulatively of microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and sodium stearyl fumarate;
• wherein the outer and inner erosion barrier layers each comprise about 35% to about 45% by weight of glyceryl behenate, about 15% to about 25% by weight of LH-21, about 25% to about 35% by weight of LH-32 and about 4% to about 8% by weight of hydroxypropyl cellulose;
• wherein the thickness of the outer erosion barrier layer is about 574 to 888 microns and the thickness of the inner erosion barrier layer is about 862 to 1071 microns;
• and
• wherein the stimulant is methylphenidate or a pharmaceutically acceptable salt thereof.