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 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.

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: 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: Methods comprising administering compositions comprising therapeutically effective amounts of the (R)-isomer of 2-(3,4-dimethoxyphenol)-2-isopropyl-6-azaheptanitril, a derivative thereof, or a pharmaceutically acceptable salt thereof, wherein the composition treats or prevents at least one condition having serotonin transporter activity in a subject in need thereof, and releases the (R)-isomer of 2-(3,4-dimethoxyphenol)-2-isopropyl-6-azaheptanitril, a derivative thereof, or a pharmaceutically acceptable salt thereof to exhibit an activity on the serotonin transporter.

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

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.