| abstract |
The invention is directed to the functionality and performance of superdisintegrants in orally disintegrating tablets (ODT). The invention can be an aged direct compression ODT having between about 0.3% to about 2% (wt/wt) sodium croscarmellose relative to the total weight of the ODT, a polyol matrix, optionally a lubricant, and an active pharmaceutical or nutraceutical ingredient, in which after storage for four months the ODT has a disintegration time using an excess water test that is less than 30 seconds and a tensile strength greater than 0.5 MPa. The invention is also directed to a direct compression ODT, consisting essentially of about 0.5% to 2.0% sodium croscarmellose, from 0.1% to 2.0% lubricant, an API, up to 10% (wt/wt) microcrystalline cellulose, optionally one or more colorants, sweeteners, fragrances, flavor compounds, and/or flavor blockers, and the balance spray-dried mannitol. |