Abstract: An antibiotic product is comprised of at least three dosage forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours after the initial release of antibiotic. In one embodiment, there are two delayed release dosage forms, as well as a delayed sustained release dosage form, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.

Abstract: An antibiotic product is comprised of at least three dosage forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours after the initial release of antibiotic. In one embodiment, there are two delayed release dosage forms, as well as a delayed sustained release dosage form, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours after the initial release of antibiotic. In one embodiment, there is a delayed release dosage form, as well as two or more delayed sustained release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.

Abstract: Compositions and methods for making robust pellets that contain a high percentage, by weight, of active drug agent, and which also contain additional components that enhance the absorption and solubility of the active drug agent within the gastrointestinal tract (GI tract) without diminishing the robust nature of the pellet, are disclosed.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, a delayed release dosage form, and a sustained release dosage form, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, a sustained release dosage form, and a delayed release dosage form, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, as well as two or more sustained release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.

Abstract: An osmotic system for delivering a pharmaceutically active agent which comprises a core portion, a layer portion enclosing the core portion, and a semipermeable wall portion enclosing the core portion and the layer portion. The core portion includes the pharmaceutically active agent at a first concentration. The pharmaceutically active agent is present in the layer portion at a second concentration. The second concentration is greater than the first concentration. Such a system provides for the osmotic release of the pharmaceutically active agent in release profile other than a zero order release profile, and wherein the release profile is similar to or approaches or reaches a first order release profile.

Abstract: Methods for triggering immunogenic responses and for eliciting improved immunogenic responses to immunogens in humans or animals through pulsatile transdermal delivery of antigens and adjuvants to the Langerhans cells of the skin, are disclosed.

Abstract: Drug formulations having reduced abuse potential which contain one or more of (1) a bittering agent, (2) a bright deterrent/indicator dye and (3) fine insoluble particulate matter. The bittering agent and dye are in a form which does not affect proper administration of the drug, but the bittering agent creates a bitter side effect when the dosage form is crushed or chemically extracted and nasally, orally, buccally or sublingually administered and the dye produces a bright color when crushed and contacted. The fine insoluble particulate matter hinders extraction of the drug from the dosage form and, when crushed, can deter intravenous injection because of the presence of the insoluble particles or hinder injection by blocking an intravenous needle. The bright color of the dye, when extracted, also has a psychologically deterrent effect on intravenous abusers.

Abstract: Disclosed is an osmotic pharmaceutical delivery system comprising (a) a semi-permeable wall that maintains its integrity during pharmaceutical delivery and which has at least one passage therethrough; (b) a single, homogeneous composition within said wall, which composition consists essentially of (i) a pharmaceutically active agent, (ii) at least one non-swelling solubilizing agent which enhances the solubility of the pharmaceutically active agent; (iii) at least one non-swelling osmotic agent and (iv) a non-swelling wicking agent dispersed throughout the composition which enhances the surface area contact of the pharmaceutical agent with the incoming aqueous fluid.

Abstract: A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

Abstract: A pharmaceutical composition comprising at least one pharmaceutically active agent that is pH dependent, at least one non-pH dependent sustained release agent, and at least one pH dependent agent that increases the dissolution rate of the at least one pharmaceutically active agent at a pH in excess of 5.5. Such compositions have minimized pH-dependent dissolution profiles or pH-independent dissolution profiles.

Abstract: A pharmaceutical composition comprising a solid carrier containing a liquid selected from the group consisting of a liquid active agent, a liquid enhancer, or a combination thereof.

Abstract: A fibrate self-emulsifying oral formulation with improved bioavailability when compared to commercially available formulations containing a therapeutically effective dose of fenofibrate, derivative of fenofibrate or mixtures thereof dissolved in a fibrate solubilizer selected from N-alkyl derivative of 2-pyrrolidone, mono- or di- or polyethylene glycol monoethers, C8-12 fatty acid mono- or di-esters of propylene glycol, or combinations thereof, one or more surfactants and optionally one or more stabilizers useful in the treatment of hypercholesterolaemia or hypertriglyceridaemia in mammals in the fed or fasted state.

Abstract: A pharmaceutical composition comprising at least one pharmaceutically active agent that is pH dependent, at least one non-pH dependent sustained release agent, and at least one pH dependent agent that increases the dissolution rate of the at least one pharmaceutically active agent at a pH in excess of 5.5. Such compositions have minimized pH-dependent dissolution profiles or pH-independent dissolution profiles.

Abstract: A pharmaceutical composition comprises a once-a-day sustained release formulation of at least one amphetamine salt which provides mean plasma concentration profile aspects in human ADHD patients which are substantially the same as that provided by ADDERALL XR® type pulsatile formulations.

Abstract: Disclosed is a beadlet comprising (i) a hydrophobic long chain fatty acid or ester material; (ii) a surfactant; and (iii) a therapeutic agent which in admixture form a solid solution at room temperature. The hydrophobic material preferably has a melting point of about 40 to about 100° C., and is most preferably glyceryl behenate. The surfactant is preferably a polyglycolyzed glyceride, polyoxyethylene sorbate, ethylene or propylene block copolymer or combinations thereof, and is most preferably polyoxyethylene 20 sorbitan monolaurate.

Abstract: In accordance with the present invention there is provided a pharmaceutical formulation for modified release of an active ingredient in the gastrointestinal tract comprising a plurality of irregularly shaped cores and wherein an active ingredient.

Abstract: A fibrate oral formulation with improved bioavailability when compared to commercially available formulations containing a therapeutically effective dose of fenofibrate or a fenofibrate derivative dissolved in N-alkyl derivative of 2-pyrrolidone, ethylene glycol monoether, C8-12 fatty acid ester of polyethylene glycol, fatty acids, or combinations thereof useful for the treatment of hypercholesterolaemia or hypertriglyceridaemia in mammals.