Solid pharmaceutical formulations for slow zero order...

Details Solid pharmaceutical formulations for slow zero order... Solid pharmaceutical formulations for slow zero order...

A - Human Necessities

61

K

167/164

A61K 9/20 (2006.01)

Patent

CA 1158979

ABSTRACT OF THE DISCLOSURE A new class of solid pharmaceutical formulations enables the attainment of slow, zero order in vivo release of a wide range of phar- maceutically active ingredients upon oral administration, without the pharmaceutical composition having layers, beads or enteric materials, and without relatively insoluble polymers, waxes or gums. A broad range of release rates can be preselected by suitable adjustments of tablet properties. The formulations are based upon control of active ingredient release from the surface of the tablet via a controlled surface erosion mechanism. These compositions comprise: (a) an effective amount in the range of 10-90 wt % of a pharmacologically active compound having a water solubility (20°C) of ? - ? (w/w); (b) 1-40 wt % of a surface controlling compound which is pharmaceutically acceptable in oral com- positions and has a water solubility (20°C) of 1/1 - 1/40 (w/w); (c) 2-20 wt % of an erosion controlling compound which is pharmaceutically acceptable in oral compositions and has a water solubility (20°C) of 1/1 - 1/10 (w/w); (d) an amount in the range of 0.05 - 1.0 wt % of a dis- integrating agent for pharmaceutical compositions, at which amount the compound is ineffective as a disintegrating agent; (e) 0.1-2.0 wt % of a surfactant which is pharmaceutically acceptable in oral compositions; and, as necessary for tablet manufacturing purposes, (f) 1-20 wt % of a binder which is pharmaceutically acceptable in oral compositions; or (g) 0.5-5.0 wt % of a die wall lubricant which is pharmaceutically acceptable in oral compositions.

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