Abstract: Methods and formulations for treating inflammatory bowel disease are disclosed. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of 4-aminosalicylic acid and/or 5-aminosalicylic acid to affected areas of the intestine. The methods and formulations comprise modified-release elements, providing for drug delivery to the affected or desired area. Diseases and conditions treatable with the present invention include Crohn's disease and ulcerative colitis.

Abstract: The present invention provides a composition comprising a platelet aggregation inhibitor, for example, cilostazol, or a salt or derivative thereof, useful in the treatment and prevention of ischemic symptoms. The invention provides a composition which comprises nanoparticulate particles comprising the platelet aggregation inhibitor and at least one surface stabilizer. The nanoparticulate particles have an effective average particle size of less than about 2000 nm. The invention provides also a composition that delivers a platelet aggregation inhibitor, or nanoparticles comprising the same, in a pulsatile or continuous manner.

Abstract: The present invention is directed to compositions comprising a nanoparticulate antibiotic having improved bioavailability. Preferably, the antibiotic comprises nanoparticulate cephalosporin particles with an effective average particle size of less than about 2000 nm and are useful in the treatment of bacterial infection. The invention also relates to a controlled release composition comprising a cephalosporin or a nanoparticulate cephalosporin that in operation delivers the drug in a pulsed or bimodal manner for the treatment of bacterial infection. The nanoparticulate cephalosporin particles may be formulated as a controlled release drug delivery system whereby the particles are coated one or more times with one or more natural or synthetic hydrophilic or hydrophobic polymer coating materials or dispersed throughout a natural or synthetic hydrophilic and/or hydrophobic polymer matrix.

Abstract: The present invention relates to formulations comprising a therapeutically effective amount of baclofen or (R)-baclofen, or pharmaceutically acceptable salts thereof, and methods of their use. The present formulations and methods are designed to release a therapeutic amount of baclofen in a manner that maximizes its therapeutic effect. The methods and formulations are especially suitable for treating gastroparesis and nonulcer dyspepsia.

Abstract: The present invention is directed to compositions and to methods comprising a composition comprising a therapeutically effective amount of a pharmaceutically active agent such as (R)-verapamil, a derivative thereof, or a pharmaceutically acceptable salt thereof, wherein the composition treats and/or manages at least one condition having MT1 receptor activity and releases the pharmaceutically active agent, a derivative thereof or a pharmaceutically acceptable salt thereof to exhibit a primary activity on the MT1 receptor such as, exhibiting at least five times more activity on the MT1 receptor compared with the MT2 receptor.

Abstract: The present disclosure is directed to methods and formulations for treating, modifying, and/or managing at least one upper gastrointestinal symptom. Methods of using at least one ?3 ?4 nAChR antagonist and formulations comprising at least one ?3 ?4 nAChR antagonist, or pharmaceutically acceptable salt thereof are included.

Abstract: A method of treatment for hypertension and other disease states is described, which comprises the delivery of losartan in a gastric retained dosage form.

Abstract: The present invention is directed to methods comprising administering a composition comprising a therapeutically effective amount of (R)-verapamil, a derivative thereof, or a pharmaceutically acceptable salt thereof, wherein the composition treats, prevents and/or manages at least one condition having MT1 receptor, 5-HT2B receptor and L-type calcium channel activity and releases the (R)-verapamil, a derivative thereof or a pharmaceutically acceptable salt thereof to exhibit a co-primary activity on the MT1 receptor, the 5-HT2B receptor, and the L-type calcium channel.

Abstract: The present invention is directed to methods and formulations for treating, modifying, and/or managing gastrointestinal secretion, and intestinal conditions that cause the same. Methods of using at least one ?3 ?4 nAChR antagonist and formulations comprising at least one ?3 ?4 nAChR antagonist, or pharmaceutically acceptable salt thereof, are included.

Abstract: The present invention provides a composition comprising cephalosporin useful in the treatment and prevention of a bacterial infection. In one embodiment, the composition comprises nanoparticulate particles comprising cephalosporin and at least one surface stabilizer. The nanoparticulate particles have an effective average particle size of less than about 2000 nm. In another embodiment, the composition comprises a modified release composition that, upon administration to a patient, delivers cephalosporin in a bimodal, multimodal or continuous manner. The invention also relates to dosage forms containing such compositions, and to methods for the treatment and prevention of a bacterial infection.

Abstract: Described are controlled release nanoparticulate formulations comprising a nanoparticulate agent to be administered and a rate-controlling polymer which functions to prolong the release of the agent following administration. The novel compositions release the agent following administration for a time period ranging from about 2 to about 24 hours or longer.

Abstract: The invention relates to a multiparticulate modified release composition that, upon administration to a patient, delivers at least one active ingredient in a bimodal or multimodal manner. The multiparticulate modified release composition comprises a first component and at least one subsequent component; the first component comprising a first population of active ingredient containing particles and the at least one subsequent component comprising a second population of active ingredient containing particles wherein the combination of the components exhibit a bimodal or multimodal release profile. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.

Abstract: The present invention is directed to a method for treating chronic constipation in a subject in need of such treatment comprising administering to the subject a dosage formulation comprising a therapeutically effective amount of acarbose, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable ingredient to control the release of the acarbose, wherein following administration, the dosage formulation releases the acarbose distal to the gastrointestinal sites at which acarbose is absorbed.

Abstract: The present invention is directed to methods and formulations for treating chronic constipation. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of metformin for treating chronic constipation and further comprise at least one pharmaceutically acceptable ingredient to control the release of the metformin, wherein following administration, the release of metformin is distal to the gastrointestinal sites to achieve systemic absorption of metformin. The invention is also directed to treating constipation as a symptom associated with other diseases and conditions such as irritable bowel syndrome.

Abstract: Methods and formulations for treating inflammatory bowel disease are disclosed. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of 4-aminosalicylic acid and/or 5-aminosalicylic acid, and pharmaceutically acceptable salts and pro-drugs thereof, to affected areas of the intestine, i.e., distal gut. The methods and formulations comprise modified-release elements, providing for drug delivery to the affected or desired area. Diseases and conditions treatable with the present invention include Crohn's disease and ulcerative colitis.

Abstract: Chronotherapeutic formulations of cardiovascular drugs are disclosed. The formulations comprise at least one cardiovascular drug that exhibits an in vivo elimination half-life of less than about 8 hours; wherein the formulation exhibits the following in vivo profile following administration to a subject: a) a delay in release of therapeutic levels of the at least one drug for about 2 to about 8 hours; b) a Tmax at about 8 to about 12 hours; c) a drug plasma level within 50% of the peak for greater than or equal to 12 hours; and d) a peak-to-trough ratio of drug plasma levels greater than or equal to about 4.

Abstract: The present invention relates to formulations comprising a therapeutically effective amount of pravastatin, or a pharmaceutically acceptable salt thereof, and methods of their use. The present formulations and methods are designed to release little or no pravastatin in the stomach but release a therapeutic amount of pravastatin in the small intestine, thereby limiting systemic exposure of the body to pravastatin and maximizing hepatic-specific absorption of the drug. The formulations and methods of the present invention are particularly useful for treating and/or preventing conditions that are benefited by decreasing levels of lipids and/or cholesterol in the body.

Abstract: The present invention relates to formulations comprising a therapeutically effective amount of pravastatin, or a pharmaceutically acceptable salt thereof, and methods of their use. The present formulations and methods are designed to release little or no pravastatin in the stomach but release a therapeutic amount of pravastatin in the small intestine, thereby limiting systemic exposure of the body to pravastatin and maximizing hepatic-specific absorption of the drug. The formulations and methods of the present invention are particularly useful for treating and/or preventing conditions that are benefited by decreasing levels of lipids and/or cholesterol in the body.

Abstract: Pharmaceutical formulation comprising at least one proton pump inhibitor structured and arranged to provide an initial pH independent time-based delayed-release, and a subsequent extended-release of the at least one proton pump inhibitor.

Abstract: The present invention relates to formulations comprising therapeutically effective amounts of at least one acid-stable, carrier-mediated transport statin, at least one poorly water-soluble, carrier-mediated transport statin, or at least one large molecular weight, carrier-mediated transport statin, such as atorvastatin and rosuvastatin, or a pharmaceutically acceptable salt thereof, and methods of their use. The present formulations and methods are designed to exhibit a controlled-release of a therapeutic amount of the statin in the small intestine, thereby limiting systemic exposure of the statin and maximizing liver-specific absorption of the drug. The formulations and methods of the present invention are particularly useful for treating and/or preventing conditions that are benefited by decreasing levels of lipids and/or cholesterol in the body.