Directly compressible acetaminophen compositions
AssigneeRhodia Inc.
InventorsAjay Hasmukhlal Upadhyay, Wayne Camarco
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Abstract
Acetaminophen compositions are disclosed which are capable of being directly compressed, without addition of other components, into an tablet dosage form, and which include, based on the total weight of the dry components of the composition, from about 80 percent by weight to about 98 percent by weight acetaminophen, a fluidizing agent, a binder compound, a starch, a disintegrant and a lubricant.
Claims8
An acetaminophen composition capable of being directly compressed into an acetaminophen tablet, said composition comprising from about 80 to about 95 wt % acetaminophen, from about 1 to about 4 wt % essentially water-insoluble tablet/capsule disintegrant, from about 0.5 to about 5.0 wt % polyvinylpyrrolidone, from about 0.5 to about 5.0 wt % totally pregelatinized starch, about 0.25 to about 3.0 wt % of a fluidizing agent, from about 0.25 to about 3.0 wt % of a lubricant, and optionally up to about 10 wt % of a co-active ingredient, the weight percents being based on the total weight of the dry components of the composition, the composition also comprising a moisture content of up to about 1.5 wt % based on the total weight of the dry components of granulation composition, wherein the composition comprises free flowing granules, said granules comprising an acetaminophen blend and a binder coating the blend, said acetaminophen blend comprising the acetaminophen, the disintegrant, a minor portion of the starch, at least a portion of the fluidizing agent and, optionally, a portion of the lubricant, and said binder comprising polyvinylpyrolidone, the remaining starch and the remaining lubricant.
Dependencies are inferred from the claim text.