Abstract: A multi-particulate oral dosage form, comprising a plurality of pellets, the pellets comprising a core having disposed thereon a core composition layer, the core composition layer comprising an active agent, and a sustained-release coating disposed on the core composition layer, wherein the sustained-release coating comprises a first polymer comprising a copolymer of acrylic and methacrylic esters comprising quaternary ammonium groups and having a ratio of quaternary ammonium groups to neutral meth(acrylic) esters of 1:40 and optionally a second polymer comprising a copolymer of acrylic and methacrylic esters comprising quaternary ammonium groups and having a ratio of quaternary ammonium groups to neutral meth(acrylic) esters of 1:20, wherein the ratio of the first polymer to the second polymer is about 50:50 to about 100:0, and wherein the first and second polymer comprise about 20 wt % to about 90 wt % of the total weight of the sustained-release coating; and about 10 wt % to about 50 wt % of colloidal sili

Abstract: Disclosed herein are methods and compositions suitable for providing zero-order release of active agents. Disclosed herein is a multiparticulate oral dosage form comprising a plurality of pulsed-release pellets, wherein the dosage form releases the active agent at a substantially constant rate following a lag time. The dosage form comprises a combination ensemble of pellets produced by combining 2 to 8 individual ensembles of pulsed-release pellets having a particular T50 and dissolution profile.

Abstract: A method of optimizing a dissolution profile for a selected active agent dosage form, comprises combining a first amount of a first ensemble of pulsed-release pellets having a first dissolution profile with a first T50 and a second amount of a second ensemble of pulsed-release pellets having a second dissolution profile with a second T50 to produce a combination ensemble of pellets having a combination dissolution profile of a combination slope, wherein the combination slope corresponds to a single phase release, and wherein the combination slope is greater than 10% lower than the slope of the first dissolution profile and greater than 10% lower than the slope of the second dissolution profile, and wherein the first ensemble of pellets and the second ensemble of pellets comprise a core having disposed thereon a core composition layer, the core composition layer comprising the active agent, and a pulsed-release coating disposed on the core composition layer.

Abstract: The present invention relates to a taste-masked pharmaceutical composition. In particular the invention relates to suspensions of microcapsules taste-masked as a function of a polymer coating and the pH of a suspending medium. Surprisingly, a polymer considered permeable maintains taste masking in this media whereas a polymer considered impervious by the industry does not. There is provided a taste masked oral pharmaceutical composition including: a pharmaceutically active ingredient having a pH-dependent solubility; a polymer encapsulating said pharmaceutically active ingredient, said polymer having a quaternary ammonium functionality; a suspending medium for suspending the encapsulated pharmaceutically active ingredient, said medium adjusted to a predetermined pH at which the pharmaceutically active ingredient remains substantially insoluble; and wherein the pharmaceutically active ingredient is taste masked by the combination of the polymer and suspending medium.

Abstract: Disclosed is a method for the therapeutic treatment of pain related to wind up in a human or animal. The method of the invention is practiced by administering to the subject an effective amount of an analgesic pharmaceutical composition which includes a NMDA receptor antagonist in an immediate release form combined with an NMDA receptor antagonist in a sustained release form. The immediate release form and sustained release forn are present in sufficient amounts to diminsh or abolish wind up.

Abstract: A controlled absorption diltiazem pellet formulation for oral administration comprises a core having diltiazem or a pharmaceutically acceptable salt thereof as the active ingredient. The core is surrounded by a coating which has only a single layer which is comprised of a relatively major proportion of talc and relatively minor proportion of sodium lauryl sulfate admixed with a minor proportion of a pharmaceutically acceptable film-forming, first polymer permeable to water and diltiazem, and a major proportion of a pharmaceutically acceptable film-forming, second polymer that is less permeable to water and diltiazem than the first polymer. The core and the coating layer both exclude organic acids. The composition of the coating layer as well as the proportion of core to coating layer are effective to permit release of the diltiazem allowing controlled absorption following oral administration.

Abstract: A pelletized sustained release pharmaceutical composition including a core element including approximately 0.1 to 95% by weight, based on the total weight of the core element, of an active ingredient of low aqueous solubility; approximately 0.1 to 55% by weight of a core seed; and a core coating for the core element, including approximately 30 to 97% by weight, based on the total weight of the core coating, excluding filler, of an enteric polymer; approximately 3 to 50% by weight of an insoluble polymer; and 0 to approximately 50% by weight of plasticizer, the enteric polymer comprising at least approximately 70% by weight of the total weight of the enteric polymer and insoluble polymer; the core coating being such that the active ingredient is released in a controlled fashion over an extended period in the intestine but substantially no release occurs in the acid environment of the stomach and blood levels of active ingredient are maintained within the therapeutic range over an extended period of time.