Abstract: The present invention provides a composition comprising ziprasidone useful in the treatment and prevention of schizophrenia and similar psychiatric disorders. In one embodiment, the composition comprises nanoparticulate particles comprising ziprasidone 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 ziprasidone 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 schizophrenia and similar psychiatric disorders.

Abstract: The present invention is directed to a composition comprising a nanoparticulate cyclosporine having improved bioavailability. The nanoparticulate cyclosporine particles of the composition have an effective average particle size of less than about 2000 nm in diameter and are useful in the prevention and treatment of organ transplant rejection and autoimmune diseases such as psoriasis, rheumatoid arthritis, and other related diseases. The invention also relates to a controlled release composition comprising a cyclosporine or a nanoparticulate cyclosporine that in operation delivers the drug in a pulsed or bimodal manner for the prevention and treatment of organ transplant rejection and autoimmune diseases such as psoriasis, rheumatoid arthritis, and other related diseases.

Abstract: The present invention provides a composition comprising nilvadipine, or a salt, derivative, prodrug, or polymorph thereof, useful in the treatment and prevention of hypertension or related cardiovascular disorders. In one embodiment, the composition comprises nanoparticulate particles comprising nilvadipine, or a salt, derivative, prodrug, or polymorph thereof, 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 nilvadipine, or a salt, derivative, prodrug, or polymorph thereof, 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 hypertension or related cardiovascular disorders.

Abstract: The invention relates to a multiparticulate modified release composition that, upon administration to a patient, delivers famciclovir in a bimodal, multimodal or continuous 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. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition, and to a method for the treatment or suppression of viral infections.

Abstract: A composition of a triptan and particles of a NSAID. The NSAID particles having an effective average particle size of less than 2000 nm and at least one surface stabilizer adsorbed on the surface thereof. The NSAID component of the composition, in a comparative pharmacokinetic testing with a non-particulate NSAID in the same dosage strength and form, exhibits a shorter time to Tmax when compared to the time to Tmax of the non-nanoparticulate NSAID.

Abstract: Described are nanoparticulate formulations of a benzodiazepine, such as lorazepam, that does not require the presence of polyethylene glycol and propylene glycol as stabilizers, and methods of making and using such formulations. The formulations are particularly useful in aerosol and injectable dosage forms, and comprise nanoparticulate benzodiazepine, such as lorazepam, and at least one surface stabilizer. The formulations are useful in the treatment of status epilepticus, treatment of irritable bowel syndrome, sleep induction, acute psychosis, and as a pre-anesthesia medication.

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 invention relates to a multiparticulate modified release composition that, upon administration to a patient, delivers ticlopidine in a bimodal, multimodal or continuous 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. The invention also relates to a solid oral dosage form containing such multiparticulate modified release composition, and to methods for inhibiting platelet aggregation, inhibiting blood clotting, and reducing risk of stroke in a patient.

Abstract: The invention relates to a modified release composition comprising loxoprofen or a salt or derivative thereof that in operation delivers the drug in a pulsatile or continuous manner for the treatment of pain and/or inflammation. The composition may comprise a first loxoprofen component and one subsequent loxoprofen component, wherein the first loxoprofen component comprises an immediate release component and the subsequent loxoprofen component comprises a modified release component.

Abstract: The present invention is directed to compositions comprising an acylanilide, such as bicalutamide, having improved solubility in water. The bicalutamide particles of the composition have an effective average particle size of less than about 2000 nm, and are useful in the treatment of prostate cancer.

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 is directed to compositions comprising a nanoparticulate prostaglandin derivative, preferably limaprost or a salt or derivative thereof, having improved bioavailability. The nanoparticulate prostaglandin derivative particles of the composition have an effective average particles size of less than about 2000 nm and are useful in the treatment of ischemic symptoms. The invention also relates to a controlled release composition comprising a prostaglandin derivative, such as limaprost alfadex, or a nanoparticulate prostaglandin derivative, such as limaprost or a salt or derivative thereof, that in operation delivers the drug in a pulsed or bimodal manner for the treatment of ischemic symptoms.

Abstract: The invention provides an oral formulation for administering to a subject comprising an imatinib compound and an enteric matrix or enteric coating or a combination thereof, whereby at least 80% of the imatinib compound is released in the small intestine of the subject. Methods of using such formulation is also provided.

Abstract: Nanoparticulate compositions comprising anidulafungin are described, as well as methods of making such compositions. Also described are methods for treatment of fungal infections.

Abstract: Provided are methods of determining a resistance-adjusted dosage regimen of an anti-infective agent for treatment of an infection of a mammal by a resistant infective organism, wherein an effective dosage regimen of the anti-infective agent is known for treatment of an infection of the mammal by a susceptible strain of the infective organism. Methods of treating a cefepime resistant bacterial infection in a patient are also provided.

Abstract: Described are injectable formulations of particulate olanzapine that produce a prolonged duration of action upon administration, and methods of making and using such formulations. The injectable formulations comprise particulate olanzapine.

Abstract: Methods and kits are provided enabling a twice daily dosing regimen that achieves daily patient blood levels of active pharmaceutical ingredient comparable to a dosing regimen requiring the same active ingredient to be administered three times a day.

Abstract: The present invention is directed to benzothiophene compositions, preferably nanoparticulate raloxifene hydrochloride compositions having improved pharmacokinetic profiles, improved bioavailability, dissolution rates and efficacy. In one embodiment, the raloxifene hydrochloride nanoparticulate composition have an effective average particle size of less than about 2000 nm.

Abstract: The present invention is directed to compositions comprising a nanoparticulate modafinil compositions, or a salt(s), or an enantiomer(s), or a prodrug(s), or a polymorph(s) or derivative thereof, having improved bioavailability. The nanoparticulate modafinil composition formulation particles of the composition have an effective average particle size of less than about 2000 nm and are useful in the treatment of dyssomnias, including but not limited to, narcolepsy, chronic fatigue, eating disorders, compulsive behaviors, ADHD, addictions, substance abuse, sleepiness, nervous system diseases, conditions, syndromes, and symptoms and related diseases, conditions, and symptoms.

Abstract: The present invention provides a composition comprising a cefditoren, or a salt, derivative, prodrug, or other form thereof, for example, cefditoren pivoxil, useful in the treatment and prevention of infections and related conditions. The invention provides a composition which comprises nanoparticulate particles comprising the cefditoren, or a salt, derivative, prodrug, or other form thereof 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 cefditoren, or a salt, derivative, prodrug, or other form thereof, or nanoparticles comprising the same, in a pulsatile or continuous manner.