Abstract: Amorphous dispersion granules comprising an amorphous solid solution of an active pharmaceutical ingredient and a dispersing polymer, and deposited thereon a substrate comprising at least one first tableting agent, as well as oral dosage forms comprising the amorphous dispersion granules of the invention, including pharmaceutically acceptable tablets comprising the amorphous dispersion granules of the invention, and methods of preparing amorphous dispersion granules and pharmaceutically acceptable tablets manufactured therefrom.

Abstract: Pharmaceutical compositions comprised of low-solubility and/or acid-sensitive drugs and neutralized acidic polymers are disclosed.

Abstract: Pharmaceutical compositions comprised of low-solubility and/or acid-sensitive drugs and neutralized acidic polymers 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: A pharmaceutical composition comprises a solid amorphous dispersion of a cholesteryl ester transfer protein inhibitor and a concentration-enhancing polymer.

Abstract: Solid compositions with improved physical stability comprise an amorphous, low-solubility drug, a poloxamer, and a stabilizing polymer. The compositions provide good physical stability during storage and concentration enhancement of dissolved drug when administered to an aqueous environment of use.

Abstract: Pharmaceutical compositions comprised of low-solubility and/or acid-sensitive drugs and neutralized acidic polymers 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: Pharmaceutical compositions comprised of low-solubility and/or acid-sensitive drugs and neutralized acidic polymers are disclosed.

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

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.