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AssigneeNational Starch and Chemical Investment Holding Corporation
InventorsEric M. Weisser, Judith K. Whaley, Amos Enabosi, Himanshu Shah, Prankaj Rege
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This invention relates to a method of using compressible polysaccharides having a tap density of less than 0.4 g/ml as a filler/binder for tablets prepared by direct compression, excipient blends including said polysaccharides, a method of tableting an active ingredient therein from the excipient blends and the tablets produced therefrom. More particularly, this invention relates to the use of low-density starches as binders for tablets prepared by direct compression, excipient blends, and methods of tableting an active ingredient therein from such starches. Further, this invention describes a starch-based excipient composition having a tap density of less than 0.4 g/ml, which has excellent moisture resistance.
A polysaccharide having a tap density of less than about 0.05 g/ml.
A polysaccharide having a tap density of less than about 0.2 g/ml which, when used in an binding effective amount in a tablet, prevents the crushing strength of the tablet from decreasing more than about a 20% decrease in crushing strength when exposed to 95% relative humidity at 25° C. for 3 hours wherein the crushing strength is measured according to Procedures 1 or 2, herein.
A directly compressible tablet comprising a polysaccharide having a tap density of less than about 0.4 g/ml, and an active agent.
A directly compressible tablet comprising a polysaccharide, an excipient, and an active agent, wherein a mixture of the polysaccharide and the excipient has a tap density of less than about 0.4 g/ml.
A method of making a tablet comprising directly compressing a polysaccharide having a tap density of less than about 0.4 g/ml and/or a porosity of no more than about 0.7, and an active agent.
A method of making a tablet comprising directly compressing a polysaccharide, an excipient, and an active agent, wherein a mixture of the polysaccharide and the excipient has a tap density of less than about 0.4 g/ml.
Dependencies are inferred from the claim text.