Abstract: The presently disclosed subject matter is directed to a granule, wherein the granule has an active agent and a wax dispersed therein, and the granule exhibits excellent friability when compressed to form a pharmaceutical composition. The subject matter disclosed herein is also directed to methods of preparing the granules and the pharmaceutical compositions comprising the granules. The compositions and methods disclosed provide granules and pharmaceutical compositions for immediate release of the active agent and do not substantially prolong the release of the active agent from the granule.

Abstract: A solid pharmaceutical dosage form, e.g., a tablet, is disclosed which comprises (a) a sustained released matrix core containing i) an at least sparingly water soluble active pharmaceutical ingredient, ii) a hydrophilic polymer, iii) an optional hydrophobic polymer, iv) an optional wax component, and v) optional diluent; and (b) a semi-permeable functional film coating surrounding the core, wherein the dosage form is substantially resistant to dose dumping when administered in the presence of ethanol. A method for making the dosage form is also provided in which the dosage form is coated with a semi-permeable coating.

Abstract: The presently disclosed subject matter is directed to a granule, wherein the granule has an active agent and a wax dispersed therein, and the granule exhibits excellent friability when compressed to form a pharmaceutical composition. The subject matter disclosed herein is also directed to methods of preparing the granules and the pharmaceutical compositions comprising the granules. The compositions and methods disclosed provide granules and pharmaceutical compositions for immediate release of the active agent and do not substantially prolong the release of the active agent from the granule.