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 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 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 is directed to compositions comprising nanoparticulate heterocyclic amide derivative and preferably zafirlukast nanoparticles, also collectively referred to as “active ingredient,” having improved solubility in water. The nanoparticles of the composition have an effective average particle size of less than about 2,000 nm, and are useful in the treatment of asthma. The invention also relates to a multiparticulate modified release composition comprising the active ingredient that in operation delivers the drug in a pulsed or bimodal manner for the treatment of asthma. The controlled release composition comprises an immediate release component and a modified release component.

Abstract: The present invention is directed to a formulation comprising a narcotic analgesic and a non-narcotic analgesic, methods of use and methods of preparing thereof.

Abstract: Nanoparticulate compositions comprising docetaxel or a salt, derivative, conjugate or analogue thereof, wherein the compositions are terminally sterilized via gamma radiation, are described, as well as methods of making and using such compositions.

Abstract: The invention relates to a multiparticulate modified release composition that, upon administration to a patient, delivers a combination of carbidopa, levodopa and entacapone 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 of Parkinson's disease.

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: The invention relates to a multiparticulate modified release composition comprising a fluorocytidine derivative, preferably capecitabine, and a modified release component comprising a modified release coating, a modified release matrix material, or both. Following oral delivery, the composition in operation delivers the fluorocytidine derivative in a pulsatile manner at about six to about twelve hours after administration.

Abstract: This invention relates to proteins (e.g., peptides) that are capable of facilitating transport of an active agent through a human or animal gastro-intestinal tissue, and derivatives (e.g., fragments) and analogs thereof, and nucleotide sequences coding for said proteins and derivatives. The proteins of the invention have use in facilitating transport of active agents from the lumenal side of the GIT into the systemic blood system, and/or in targeting active agents to the GIT. Thus, for example, by binding (covalently or noncovalently) a protein of the invention to an orally administered drug, the drug can be targeted to specific receptor sites or transport pathways which are known to operate in the human gastrointestinal tract, thus facilitating its absorption into the systemic system.

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: A once daily controlled-release pharmaceutical formulation which contains therapeutic amounts of topiramate and which is capable of being administered to specific regions along the gastrointestinal tract used to treat various types of conditions, for example, partial seizures with or without secondarily generalized seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox Gastaut Syndrome, migraines, and obesity.

Abstract: The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.

Abstract: A syringe comprises a barrel containing an internal cylindrical body containing a liquid and communicating with a delivery needle. The needle is covered before use by a removable sheath, and after the sheath is removed, the needle is concealed by a displaceable sleeve. In use the sleeve is pressed against the skin by applying pressure while holding the barrel. The sleeve is thereby retracted into the barrel allowing the needle to penetrate the skin. The movement of the sleeve also activates a gas generator which expels the liquid from the needle. When delivery is complete and the syringe is taken from the skin, a coil spring moves the sleeve back to the starting position again concealing the needle. The coil spring is torsionally biased before use and causes a rotational movement of the sleeve relative to the barrel when the sleeve moves into and out of the barrel. This rotational movement engages a locking mechanism which prevents further movement of the sleeve and thereby permanently conceals the needle.

Abstract: The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.

Abstract: The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.

Abstract: The present invention relates to a novel membrane translocating full-length peptide sequence, fragment, motif, derivative, analog or peptidomimetic thereof (MTLPs), to nucleotide sequences coding therefor, and to compositions comprising a MTLP-active agent complex and a MTLP-active particle complex. The MTLP or the nucleotide sequence coding therefor enhance movement of the active agent or of the active particle across a lipid membrane. More particularly, the present invention relates to a MTLP-active agent complex and a MTLP-active particle complex, wherein the MTLP enhances uptake of the active agent into a cell, into or out of an intracellular compartment and across a cell layer. Methods of making and methods of using MTLPs also are included.

Abstract: The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.

Abstract: This invention relates to proteins (e.g., peptides) that are capable of facilitating transport of an active agent through a human or animal gastro-intestinal tissue, and derivatives (e.g., fragments) and analogs thereof, and nucleotide sequences coding for said proteins and derivatives. The proteins of the invention have use in facilitating transport of active agents from the lumenal side of the GIT into the systemic blood system, and/or in targeting active agents to the GIT. Thus, for example, by binding (covalently or noncovalently) a protein of the invention to an orally administered drug, the drug can be targeted to specific receptor sites or transport pathways which are known to operate in the human gastrointestinal tract, thus facilitating its absorption into the systemic system.

Abstract: The invention provides an antibody or antibody fragment specific to a domain of a GIT targeting agent, such as a polyclonal antibody, monoclonal antibody, chimeric antibody, single chain antibody, a Fab fragment or a Fab expression library. In particular, the invention provides an antibody or antibody fragment, wherein the GIT targeting agent is selected from the group consisting of ZElan033 (PAX2 15 mer), ZElan088 (HAX42-2 20 mer) or ZElan053 (P31 D-form 16 mer). Numerous methods using these GIT targeting agent specific antibodies are disclosed.