Abstract: A sustained-release pharmaceutical composition in a form of an orally deliverable tablet containing reboxetine, or a pharmaceutically acceptable salt thereof, dispersed in a matrix containing a hydrophilic polymer and a starch, wherein the starch has a tensile strength of at least 0.15 kN cm?2 at a solid fraction of 0.75 to 0.85.

Abstract: The present invention is directed to an extended release multiparticulate formulation of a therapeutic agent, wherein coated core multiparticulate particles of the therapeutic agent are overcoated with a binder-dispersing agent, such as povidone or cross-povidone. The invention is also directed to compressed tablets of the extended release multiparticulate formulation of the invention, and to a method of oral administration of compressed tablets of clindamycin to a subject to treat or prevent a gram-positive bacterial infection therein. The binder-dispersing agent in the formulations of the present invention ensure that compressed tablets formed therefrom will remain intact through oral administration, and dissolve shortly thereafter, enabling the multiparticulates to release the therapeutic agent contained therein over an extended period of time.

Abstract: The present invention is directed to oral dosage forms for extended release, including a dosage form for pH independent extended release, of at least one drug to a subject. The present invention is also directed to methods of making and using the dosage forms to treat or prevent a subject for various conditions. Specific extended release formulations of crystalline clindamycin free base are also provided. The crystalline clindamycin free base oral formulations of the present invention provide a means for treating or preventing gram-positive bacterial infections with a minimal number of treatments per day, potentially, as little as once or twice per day.

Abstract: A method of preparing a coated solid dosage form is disclosed wherein a solid dosage form, such as a compressed tablet with active agent dispersed therein, is coated at least twice with a coating solution comprising a water-insoluble coating polymer and a water-soluble pore former, and cured after at least the first coating step. The method of the present invention allows for the production of cured coated solid dosage forms using very short curing times. Coated solid dosage forms produced according to the present invention have been found to have long extended release characteristics.

Abstract: A pharmaceutical tablet is provided comprising an intraorally disintegratable core and an excipient coating adherent thereto, wherein the coating comprises gellan gum. The tablet is suitable for intraoral administration, for example for delivery of a drug contained in the core of the tablet to a subject, at least in part by absorption of the drug via oral mucosa of the subject.

Abstract: A pharmaceutical tablet is provided comprising a core and a coating adherent thereto, wherein (a) the core comprises solid particles of a water-soluble dye distributed in a matrix, and (b) the coating comprises gellan gum. The tablet is suitable for peroral or intraoral administration, for example for delivery of a drug contained in the core of the tablet to a subject. The tablet has a speckled appearance that renders the tablet readily identifiable.

Abstract: The present invention relates to zero-order sustained release solid dosage forms suitable for administration of a wide range of therapeutically active medicaments, especially those that are water-soluble, and to a process of making same. The solid dosage form comprises (a) a matrix core comprising ethylcellulose and the active agent and (b) a hydrophobic polymer coating encasing the entire matrix core.

Abstract: The present invention is directed to an oral dosage form for multiple-pulsed delivery of at least two fractions of clindamycin to a subject, one in an immediate-release form and the other in an extended release form. The oral dosage forms of the present invention provide a means for treating or preventing gram-positive bacterial infections with a minimal number of treatments per day, potentially, as little as once or twice per day.

Abstract: A method is disclosed for producing coated compressed tablets, using at least one upper punch. The upper punch can be a single punch with a hollow shaft containing a movable rod with a tip that is extended or retracted as the rod moves within the shaft. Alternatively, two solid upper punches are used, one with an extended tip and the other with a retracted tip. An upper punch with an extended tip is designed to produce cup-shaped compacts of excipient and/or polymeric tablet coating material, when inserted into the die. Core material is inserted into each cup. Additional coating material is then placed on top of the cup and core, within the die, and compressed with an upper punch with a retracted tip. The method and device of the present invention enables one to produce tablets from poorly compactable substances.