Other

Elite Laboratories, Inc.

American Home Products Corporation

Bostik, Inc.

Celgene Corporation

Bostik Findley, Inc.

Nortec Development Associates, Inc.

Celegene Corporation

Norjec Development Associates, Inc.

Atul M Mehta

Andrew L Zeitlin

Thomas W Leonard

Maghsoud M Dariani

Ronald N Warner

Michael A Neperud

Lizbeth A Bachand

Nicolas Edgard Sajot

Dominique Chiarabini

Chrisophe Morel-Fourrier

Manish S Shah

Mark D Alper

Eric Roussel

Christophe Morel-Fourrier

Nicolas E Sajot

An opioid-antagonist oral dosage form which does not release a therapeutically effective amount of the opioid antagonist when the oral dosage form is orally administered to a human being, but whereby a physical alteration of the oral dosage form results in a release of the therapeutically effective amount of the opioid antagonist. An embodiment of the oral dosage form includes an opioid-antagonist layer coated onto a biologically inert pellet, and a non-releasing membrane coated onto the opioid-antagonist layer. Optionally, the oral dosage form can also include an opioid agonist, such that a method of preventing the abuse of an oral dosage form of an opioid agonist is provided by forming the oral dosage form including an opioid agonist and an opioid antagonist.

Abuse-resistant oral dosage forms and method of use thereof

A method for packaging plastic material using a film to surround the material, and more particularly to a method for packaging hot melt adhesives, the resulting package formed thereby, and the film composition used therein. The method is preferably a coextrusion process for packaging a pressure sensitive hot melt adhesive by extruding a hot melt adhesive through a die orifice, and coextruding a wax-based polymeric film to surround the hot melt adhesive. The coated adhesive may then be formed into individual packaged units having a finite size and shape. The polymeric film comprises a composition having at least 25% by weight of a wax material, an enthalpy of fusion of at least about 100 J/g, and an elongation value at break of at least about 100%. Any type of hot melt adhesive formulation can be packaged or surrounded by the polymeric film in the process. Also, the specific enthalpy of fusion desired and/or elongation value at break desired for the polymeric film can be obtained by blending an appropriate amount of partially crystalline ethylene-based polymer together with a thermoplastic elastomeric block copolymer and/or an ethylene based or propylene-based elastomer.

Process for packaging plastic materials like hot melt adhesives

Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.

Delivery of multiple doses of medications

A dual component molding assembly for packaging hot melt adhesives wherein a mold, preferably in the form of an open top pan, includes a cavity which is lined with a thin film of plastic material. The mold has openings formed therein which communicate with the cavity to facilitate vacuum forming of the film to the cavity's interior surface. The second component is a carrier for the mold and is also preferably in the form of an open top pan. The carrier also includes a cavity for receiving the mold, and functions not only to support the mold when nested therein, but also to act as a heat sink to effectively and rapidly remove, dissipate or absorb the heat from molten adhesive dispensed into the mold. After filling the mold with a mass of adhesive, the exposed open top surface of the adhesive is covered with a second layer of thin film of plastic material which is then sealed to the first film lining the interior of the mold. After cooling, the packaged adhesive is cut adjacent the seal to form individual adhesive blocks for further processing.

Apparatus for packaging hot melt adhesives using a mold and carrier

A method and apparatus for post mixing an additive with a hot melt adhesives. The method includes the steps of providing a source of molten hot melt adhesive, feeding the hot melt adhesive to an inlet of a mixer, simultaneously feeding an additive for the hot melt adhesive to the inlet of the mixer, mixing the additive and molten hot melt adhesive in the mixer to form a homogeneous mixture, and recovering the homogenous mixture. The additive is preferably selected from wetness indicators, antimicrobial agents, pigments, dyes, ultraviolet light absorbers, antioxidants, fluorescent agents, pH indicators and fragrances. The method may be practiced either on a batch basis, or on a continuous basis. The apparatus includes a vessel containing molten hot melt adhesive, a mixer located downstream from the vessel, the mixer having an inlet and an outlet, a first pump located between the vessel and the mixer for pumping molten hot melt adhesive from the vessel to the inlet of the mixer, a source of an additive for the hot melt adhesive, and a second pump located between the source of the additive and the mixer for pumping the additive to the inlet of the mixer. The mixer may comprise either a static mixer or a dynamic mixer.

Method of post mixing additives to hot melt adhesives

A dosage formulation for once daily administration prior to sleeping is described that provides an initial delay in pharmaceutical release followed by controlled release of the pharmaceutical. There is also provided a method for preparing a time specific delayed, controlled release formulation of dosage, which method includes coating a single pellet with at least one dosage layer, which is coated by at least one seal coat and at least one outer rate controlling layer of a water soluble polymer coat. The dosage formulation of this invention provides a substantially drug free interval of about 0 to 5 hours followed by a drug delivery interval at a rate permitting bioavailability thereof for up to about 24 hours following oral administration. A method of using the formulations of the present invention for the treatment of early morning pathologies, including atrial fibrillation, is also described.

Chrono delivery formulations and method of treating atrial fibrillation

A dosage formulation for once daily administration prior to sleeping is described that provides an initial delay in pharmaceutical release followed by controlled release of the pharmaceutical. There is also provided a method for preparing a time specific delayed, controlled release formulation of dosage, which method includes coating a single pellet with at least one dosage layer, which is coated by at least one seal coat and at least one outer rate controlling layer of a water soluble polymer coat. The dosage formulation of this invention provides substantially a drug free interval of about 0 to 5 hours followed by a drug delivery interval at a rate permitting bioavailability thereof for up to about 24 hours following oral administration. A method of using the formulations of the present invention for the treatment of early morning pathologies is also described.

Chrono delivery formulations and method of use thereof

A nifedipine formulation for oral administration is described that provides controlled, constant release of the pharmaceutical for about twenty four hours after a short delay following oral administration. There is also provided a method for preparing a controlled release formulation of nifedipine, which method includes coating pellets with multiple nifedipine-containing layers, along with an outer controlled release coating comprised of a water permeable polymer and lubricant/glidant. The pellets are then cured at an elevated temperature over several days. A method of using the formulations of the present invention for the treatment of patients is also described.

Method of preparation of controlled release nifedipine formulations

Controlled-release nifedipine

Growing community of inventors

Ramsey, NJ, United States of America

Atul M Mehta