Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.

Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.

Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.

Abstract: A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tmax of 4-10 hours.

Abstract: The present invention relates to an extended release formulation containing a poorly water soluble active ingredient and to a method for preparing the formulation. The formulation contains a wax-based extended release material, which provides the extended release of the active ingredient.

Abstract: This invention provides orally disintegrating pharmaceutical tablet formulations comprising per tablet the following ingredients in the following percentages by weight: olanzapine as an active ingredient in an amount from about 2.5% to about 10%; mannitol in an amount from about 75% to about 95%; a disintegrating agent in an amount from about 1.0% to about 10%; and one or more excipient in a total amount of about 0.1% to about 10%. This invention also provides a method of treating a patient in need of treatment with olanzapine which comprises administering to the patient a therapeutically effective dose of the above pharmaceutical tablet formulations. Finally, this invention provides a method of producing the above pharmaceutical tablet formulation which comprises combining the ingredients in the appropriate relative percentages by weight.

Abstract: A once-a-day oral milnacipran modified release formulation has been developed. The formulation comprises an extended release dosage unit (optionally containing the immediate release portion) coated with delayed release coating. The milnacipran composition, when administered orally, first passes through the stomach releasing from zero to less than 10% of the total milnacipran dose and then enters the intestines where drug is released slowly over an extended period of time. The release profile is characterized by a 0.05-4 hours lag time period during which less than 10% of the total milnacipran dose is released followed by a slow or extended release of the remaining drug over a defined period of time. The composition provides in vivo drug plasma levels characterized by Tmax at 4-10 hours and an approximately linear drop-off thereafter and Cmax below 3000 ng/ml, preferably below 2000 ng/ml, and most preferably below 1000 ng/ml.

Abstract: A method for coating drug-containing particles is provided comprising the steps of volatilizing a coating material and condensing the volatilized coating material onto a plurality of drug-containing particles. The method can be carried out without the use of solvents. Coated drug-containing particles as well as formulations and dosage forms containing coated particles are also described. A method for treating patients using drug-containing particles is provided as well.

Abstract: A once-a-day oral milnacipran modified release formulation has been developed. The formulation comprises an extended release dosage unit (optionally containing the immediate release portion) coated with delayed release coating. The milnacipran composition, when administered orally, first passes through the stomach releasing from zero to less than 10% of the total milnacipran dose and then enters the intestines where drug is released slowly over an extended period of time. The release profile is characterized by a 0.05-4 hours lag time period during which less than 10% of the total milnacipran dose is released followed by a slow or extended release of the remaining drug over a defined period of time. The composition provides in vivo drug plasma levels characterized by Tmax at 4-10 hours and an approximately linear drop-off thereafter and Cmax below 3000 ng/ml, preferably below 2000 ng/ml, and most preferably below 1000 ng/ml.

Abstract: A once-a-day oral milnacipran modified release formulation has been developed. The formulation comprises an extended release dosage unit (optionally containing the immediate release portion) coated with delayed release coating. The milnacipran composition, when administered orally, first passes through the stomach releasing from zero to less than 10% of the total milnacipran dose and then enters the intestines where drug is released slowly over an extended period of time. The release profile is characterized by a 0.05-4 hours lag time period during which less than 10% of the total milnacipran dose is released followed by a slow or extended release of the remaining drug over a defined period of time. The composition provides in vivo drug plasma levels characterized by Tmax at 4-10 hours and an approximately linear drop-off thereafter and Cmax below 3000 ng/ml, preferably below 2000 ng/ml, and most preferably below 1000 ng/ml.

Abstract: A pharmaceutical dosage form is provided. The dosage form is comprised of a capsule having a substantially moisture-impermeable outer surface, an enclosed interior cavity, and at least one active agent contained therein. The dosage form exhibits reduced moisture transmission. In addition, methods for reducing moisture transmission in a dosage form and methods of treating a patient are described.

Abstract: An orally administrable pharmaceutical formulation is provided that combines, as active agents, a cholesterol-lowering agent, an inhibitor of the renin-angiotensin system, aspirin, and optionally at least one of vitamin B6, B12, and folate; the active agents are each present in a unit dose appropriate for once-daily dosing, and at least one of the active agents is contained in a dosage unit within the dosage form that physically separates it from the other active agents. The formulation is provided as a simple and convenient therapy to reduce the risk of cardiovascular events in individuals who are at elevated cardiovascular risk, including individuals who have systemic lupus erythematosus. The formulation is also therapeutic for individuals during or immediately following an occurrence of acute myocardial infarction.

Abstract: Novel pharmaceutical dosage forms provide for pulsatile delivery of methylphenidate, i.e., release encapsulated drug in spaced apart “pulses.” The dosage forms are comprised of first, second and optionally third dosage units, with each dosage unit having a different drug release profile. The dosage forms may comprise capsules housing compressed tablets or drug-containing beads or particles, or may comprise a single tablet with the first, second and optionally third dosage units each representing an integral and discrete segment thereof. Methods of treatment using the pharmaceutical dosage forms are provided as well.

Abstract: An orally administrable pharmaceutical formulation is provided that combines, as active agents, a cholesterol-lowering agent, an inhibitor of the renin-angiotensin system, aspirin, and optionally at least one of vitamin B6, B12, and folate; the active agents are each present in a unit dose appropriate for once-daily dosing, and at least one of the active agents is contained in a dosage unit within the dosage form that physically separates it from the other active agents. The formulation is provided as a simple and convenient therapy to reduce the risk of cardiovascular events in individuals who are at elevated cardiovascular risk, including individuals who have systemic lupus erythematosus. The formulation is also therapeutic for individuals during or immediately following an occurrence of acute myocardial infarction.

Abstract: An anti-inflammatory pharmaceutical formulation for the oral administration of a nonsteroidal anti-inflammatory drug (NSAID) is provided, wherein the NSAID an anti-inflammatory naphthalene derivative such as nabumetone, 6-methoxy-2-naphthylacetic acid (6-MNA), a fluoronaphthylone, an amido-substituted naphthalene compound, or a nabumetone derivative comprising an acetal, enol acylate or enol ether of nabumetone. The formulation is controlled release, and a preferred formulation is an enterically coated, delayed release dosage form of nabumetone. Methods for using the novel formulation are provided as well; a preferred use is in the treatment of conditions and disorders associated with inflammation.

Abstract: Novel pharmaceutical dosage forms provide for pulsatile delivery of methylphenidate, i.e., release encapsulated drug in spaced apart “pulses.” The dosage forms are comprised of first, second and optionally third dosage units, with each dosage unit having a different drug release profile. The dosage forms may comprise capsules housing compressed tablets or drug-containing beads or particles, or may comprise a single tablet with the first, second and optionally third dosage units each representing an integral and discrete segment thereof. Methods of treatment using the pharmaceutical dosage forms are provided as well.

Abstract: Novel pharmaceutical dosage forms provide for pulsatile delivery of methylphenidate, i.e., release encapsulated drug in spaced apart “pulses.” The dosage forms are comprised of first, second and optionally third dosage units, with each dosage unit having a different drug release profile. The dosage forms may comprise capsules housing compressed tablets or drug-containing beads or particles, or may comprise a single tablet with the first, second and optionally third dosage units each representing an integral and discrete segment thereof. Methods of treatment using the pharmaceutical dosage forms are provided as well.

Abstract: Stabilized bupropion hydrochloride pharmaceutical compositions are disclosed that are free of acid additives and provide for a sustained release of the bupropion hydrochloride. The particulate bupropion hydrochloride may be coated with a membrane coating and large-size particles may also be used. Methods for treating individuals using the stabilized bupropion hydrochloride pharmaceutical compositions are also provided.