Abstract: The present invention generally relates to unit dosage forms of naproxen and H2-receptor antagonists, comprising an immediate-release formulation of naproxen; an immediate-release formulation of an H2-receptor antagonist, and a delayed-burst release formulation of an H2-receptor antagonist.

Abstract: The present invention is related to an oral dosage form comprising an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, or a mixture thereof and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule.

Abstract: A pharmaceutical composition comprises multiparticulates comprising a drug, a matrix material, and swelling agent. In one aspect, the multiparticulates comprise a core comprising a drug, and a coating surrounding the core. The coating is selected from the group consisting of (i) a water-permeable, substantially drug-impermeable coating, and (ii) an anti-enteric coating.

Abstract: A sustained release solid oral dosage form for treatment of a psychotic disorder, for example schizophrenia, in a mammal is provided, which oral dosage form comprises ziprasidone in an amount effective in treating said psychotic disorder and a pharmaceutically acceptable carrier.

Abstract: A controlled release dosage form has a coated core with the core comprising a drug-containing composition and a water-swellable composition, each occupying separate regions within the core. The drug-containing composition comprises a low-solubility drug and a drug-entraining agent. The coating around the core is water-permeable, water-insoluble and has at least one delivery port therethrough. A variety of formulations having specific drug release profiles are disclosed.

Abstract: The present invention is related to an oral dosage form comprising an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, or a mixture thereof and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule.

Abstract: The present invention is related to an oral dosage form comprising an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, or a mixture thereof and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule.

Abstract: A process is described for producing drug-containing multiparticulates with improved stability, characterized by an improvement in one or more of chemical stability, physical stability, or dissolution stability.

Abstract: A process for forming drug multiparticulates having improved drug crystallinity is disclosed, comprising modifying a conventional melt-congeal process by adding a volatile cospecies either to the molten mixture or to the process atmosphere, or to both.

Abstract: Reduced levels of drug degradation in drug-containing multiparticulates are obtained by an extrusion/melt-congeal process.

Abstract: A multiparticulate for controlled release of a drug comprises crystalline drug, a glyceride having at least one alkylate substituent of at least 16 carbon atoms, and a poloxamer, wherein at least 70 wt % of the drug in the multiparticulate is crystalline.

Abstract: Azithromycin multiparticulates containing acceptably low concentrations of azithromycin esters are formed by a melt-congeal process.

Abstract: Pharmaceutical compositions of crystalline azithromycin-containing multiparticulates having low concentrations of azithromycin ester degradants and exhibiting controlled release of the drug are achieved by inclusion of dissolution enhancers having low concentrations of acid and ester substituents.

Abstract: Liquid-based processes are disclosed for forming azithromycin multiparticulates having minimal amounts of azithromycin esters.

Abstract: An oral dosage form comprising azithromycin and an effective amount of an alkalizing agent. Preferably, said oral dosage form comprises an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule. Additionally disclosed is an oral suspension comprising azithromycin, an effective amount of an alkalizing agent and a vehicle. Preferably, the azithromycin is in multiparticulate form wherein said multiparticulate comprises azithromycin, a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and a poloxamer.

Abstract: A process for forming multiparticulates of azithromycin and a controlled release dosage form comprising multiparticulates of azithromycin and a pharmaceutically acceptable excipient are disclosed. The dosage form decreases the incidence and/or severity of GI side effects relative to currently available immediate release azithromycin dosage forms that deliver an equivalent dose. The dosage forms operate by effecting azithromycin release at a rate sufficiently slow to ameliorate side effects, yet sufficiently fast to achieve good bioavailability.

Abstract: A controlled release dosage form for sertraline has a core comprising a sertraline-containing composition and a water-swellable composition wherein the water-swellable composition is in a separate region within the core. A coating around the core is water-permeable, water-insoluble, and has at least one delivery port therethrough. In one embodiment, the dosage form releases sertraline to the use environment at an average rate of 6 to 10 wt % per hour from the second to the twenth hour after introduction to a use environment and less than about 25 wt % for the first two hours and at least 70 wt % by the twelfth hour, where the percentages correspond to the mass of drug released from the tablet divided by the total mass of drug originally present in the tablet.