Abstract: The present invention relates to compositions and methods for the controlled-release of pest control products into aquatic environments. The compositions comprise one or more pest control products in admixture with one or more water soluble and one or more water insoluble waxes. The compositions of the present invention are particularly useful for treating columns of water in catch basins.

Abstract: The present invention provides a delayed and/or controlled release formulation of paroxetine or a pharmaceutically acceptable salt thereof that is formulated to release a substantial portion of the active ingredient (e.g., paroxetine) in the large intestine of an individual in need thereof. In one embodiment, the present invention provides a controlled release paroxetine composition comprising paroxetine or a pharmaceutically acceptable salt thereof, in a controlled release swallow pharmaceutical formulation, that upon administration, releases the paroxetine substantially in the large intestine. For example, the controlled release paroxetine formulation may be formulated to release greater than about 50% of the paroxetine in the large intestine.

Abstract: The present invention provides a pharmaceutical dosage form for sustained release of a combination of acetaminophen and tramadol or its salts. The dosage form has an immediate release portion and a sustained release portion. The immediate release portion has about 16%-75% of the drugs. The sustained release portion includes: a. about 25%-84% of the drugs, at least one gelling polymer in an amount by weight of the total formulation of about 6% to 50%. The dosage form releases about 25% to about 60% of the drugs in the first hour, and not less than about 80% of the drugs in the first 24 hours in an intestinal fluid dissolution media using USP dissolution method II with the paddle speed between 50 rpm and 100 rpm.

Abstract: This application refers to a modified-release pharmaceutical composition containing, as the active agent, a short-acting hypnotic agent or a pharmaceutically acceptable salt thereof, comprising two sustained-release pharmaceutical entities, differentiated from each other by a different release rate of the active agent wherein the release of the active agent from one of the entities starts before the release of the active agent from the second entity.

Abstract: The present invention provides alcohol resistant oral dosage pharmaceutical forms and methods of using such oral dosage forms to avoid dose dumping if the dosage form is taken together with alcohol.

Abstract: Sustained-release microparticle composition. The microparticle composition can be formulated to provide extended release over a period of from about 7 days to about 200 days. The microparticles may be formulated with a biodegradable and biocompatible polymer, and an active agent, such as risperidone, 9-hydroxy-risperidone, and pharmaceutically acceptable acid addition salts of the foregoing.

Abstract: An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.

Abstract: The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for melt extrusion and injection moulding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form.

Abstract: Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.

Abstract: Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.

Abstract: The present invention provides a composition comprising an antioxidant, and at least one of isosorbide dinitrate and isosorbide mononitrate in therapeutically effective dosage of each of the aforementioned compounds to treat cardiovascular diseases caused by nitric oxide (NO) insufficiency. The antioxidant is a hydralazine compound.

Abstract: A dosage form is disclosed comprising a semipermeable walled container that houses a capsule, which capsule comprises a drug formulation, a piston, and an osmotic composition. The dosage form delivers the drug formulation through a passageway at a controlled rate over a sustained-release period of time up to 24 hours.

Abstract: The present invention relates to a novel controlled release dosage form that releases therapeutic amounts of a sedative or hypnotic agent rapidly after administration and maintains therapeutic levels for about eight hours after administration.

Abstract: A medical capsule having a capsule configuration of size permitting introduction in a body, adapted to be at least partially dissolved over time by remaining in the intestines for a predetermined time or more. The medical capsule includes an inner casing provided at both ends with a discharge outlet and, surrounding the periphery thereof, an outer casing with a substantially uniform thickness. The inner casing and the outer casing are made of a material dissolved in the digestive secretion of the intestines. When the medical capsule remains in the intestines by, for example, entering a narrow area of the intestines, the wall of the outer casing begins to be dissolved. By this dissolution, the inner space of the inner casing communicates through the discharge outlet with the outside of the medical capsule. Consequently, a filling, such as a dye, medicine, etc., of the inner casing flows into the intestines.

Abstract: Nucleic acid sequences containing unmethylated CpG dinucleotides that modulate an immune response including stimulating a Th1 pattern of immune activation, cytokine production, NK lytic activity, and B cell proliferation are disclosed. The sequences are also useful a synthetic adjuvant.

Abstract: Pharmaceutical safety dosage forms are provided which include a pharmaceutical and an antagonist to the pharmaceutical. The safety dosage forms are such that the antagonist has no significant bioavailability when the pharmaceutical safety dosage form is administered as intended. However, the antagonist is released and becomes bioavailable if the dosage form is disrupted. Methods of administering pharmaceuticals by providing pharmaceutical safety dosage forms are also provided.

Abstract: The present invention is directed to surface functionalization of polymeric fibers. Surface biofunctionalization is achieved by covalent conjugation of biofunctional igands and/or cell growth factors that are crucial for cell attachment, proliferation and functions. Biofunctional fibers could be fabricated into three-dimensional scaffolds. Polymer fibers described here comprise of biocompatible polymers that are either biodegradable ornon-biodegradable. This patent also describes a series of new biodegradable polyphosphoramidates for the processing of biodegradable fibers. Scaffolds made of non-biodegradable functional fibers could be used for in vitro cell culture (for example, ex vivo cell expansion), while biodegradable functional fibers could be fabricated into tissue engineering scaffolds.

Abstract: A method for treating Attention Deficit/Hyperactivity Disorder (ADHD) in humans and the symptoms associated therewith, inattentiveness, and hyperactivity with impulsivity, using eltoprazine and related compounds is provided.

Abstract: Microbial growth on the surface of a valve of a voice prosthesis and optionally the cartridge or ring supporting the valve, is inhibited by providing antimicrobial activity at a level sufficient to retard growth of a microbial film by dispersing an inorganic antimicrobial agent such as silver oxide or an organic antimicrobial agent such as triclosan or butyl paraben dispersed in a medical grade silicone elastomer. The valve, ring or cartridge is in contact with body fluids containing microorganisms and nutrients therefor. The antimicrobial surface can interfere with or inhibit the growth of a biofilm, bacterial layer or a yeast layer. The body of the prosthesis may also contain an antimicrobial surface as long as it is non-toxic to the tissue it contacts.

Abstract: This invention relates to an oral composition for treatment or prevention of atherosclerosis comprising a low-dose aspirin and a low-dose of statin wherein the aspirin and statin are in a slow-release formulation. The invention also relates to a method of treatment or prevention of atherosclerosis using such a composition.

Abstract: Nucleic acids containing unmethylated CpG dinucleotides and therapeutic utilities based on their ability to stimulate an immune response and to redirect a Th2 response to a Th1 response in a subject are disclosed. Methods for treating atopic diseases, including atopic dermatitis, are disclosed.

Abstract: A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

Abstract: A formulation and dosage form for enhancing the bioavailability of orally administered hydrophilic macromolecules includes a permeation enhancer, a hydrophilic macromolecule, and a carrier such as a nonionic surfactant that exhibits in-situ gelling properties. The formulation is delivered within the GI tract as a liquid having at least some affinity for the surface of the GI mucosal membrane. Once released, it is believed that the liquid formulation spreads across one or more areas of the surface of the GI mucosal membrane, where the carrier of the formulation then transitions into a bioadhesive gel in-situ. As a bioadhesive gel, the formulation presents the hydrophilic macromolecule and the permeation enhancer at the surface of the GI mucosal membrane at concentrations sufficient to increase absorption of the hydrophilic macromolecule through the GI mucosal membrane over a period of time.

Abstract: A unit dose sustained-release oral dosage form containing a plurality of melt-extruded particles, each consisting essentially of a therapeutically active agent, one or more retardants, and an optional water-insoluble binder is disclosed. The particles have a length of from about 0.1 to about 12 mm and can be of varying diameters and each unit dose provides a release of therapeutically active agents over at least about 8 hours. Methods of preparing the unit doses as well as extrusion processes and methods of treatment are also disclosed.

Abstract: The present invention provides solid pharmaceutical compositions for improved delivery of a wide variety of pharmaceutical active ingredients contained therein or separately administered. In one embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier including a substrate and an encapsulation coat on the substrate. The encapsulation coat can include different combinations of pharmaceutical active ingredients, hydrophilic surfactant, lipophilic surfactants and triglycerides. In another embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier being formed of different combinations of pharmaceutical active ingredients, hydrophilic surfactants, lipophilic surfactants and triglycerides. The compositions of the present invention can be used for improved delivery of hydrophilic or hydrophobic pharmaceutical active ingredients, such as drugs, nutritional agents, cosmeceuticals and diagnostic agents.

Abstract: A sustained-release formulation is provided comprising a solid dispersion composition comprising a tricyclic compound or a pharmaceutically acceptable salt thereof in a mixture comprising a water-soluble polymer and a water-insoluble polymer and an excipient.

Abstract: A solid dosage form for oral administration comprising azithromycin in an amount below that which causes gastrointestinal side effects, which dosage form is a controlled release dosage form.

Abstract: A complex coacervate delivery system is provided which encapsulates lipophilic nutrients such as, for example, fish oils high in omega-3 fatty acids. The complex coacervate delivery system protects the lipophilic nutrient from degradation, e.g., oxidation and hydrolysis, and also reduces or eliminates the unpleasant taste and odor of the lipophilic nutrient. The complex coacervate delivery system upon ingestion is operative to substantially release the lipophilic nutrient in the lower gastrointestinal tract in a pH-controlled manner. The complex coacervate delivery system may be included in a food or beverage product having a pH value within the range of about 1.5 to about 5.0.

Abstract: A novel sleep regulating pharmaceutical formulation is introduced, typically implementing two principal drugs having actions which are reversive to one another, yet incorporated into a unitary solid dosage, and prepared for oral administration before bedtime. Usually, structure is configured to initially release a calmative or other sleep-compatible substance by prompt dissolution. The initial release is followed by a specific period of delay, which in basic formulations entails no release of any drug, and which allows a nominal interval of sleep. At the terminus of the delay, a final agent is released to induce wakeup. Incorporation of agents of opposite action within a unitary dosage form renders utility which is uniquely appropriate to the invention. In a preferred embodiment, delay of release and final delivery of wakeup agent are arranged by a dialysis membrane which eventually bursts as a result of osmotic pressure generated by a hydrophilic core.

Abstract: A method for treating a medical condition for which quetiapine is indicated in a subject comprises comprising orally administering to the subject quetiapine or a pharmaceutically acceptable salt thereof in a daily dosage amount effective to treat said condition; wherein the quetiapine or salt thereof is administered in one to a plurality of dosage forms collectively comprising (a) a major quetiapine component in immediate-release form in a sedative effective amount, administered not earlier than about 3 hours prior to the start of a sleep period; and (b) either (i) a minor quetiapine component in extended-release, delayed extended-release or delayed pulsed-release form, wherein time of administration and release properties of the minor component provide substantial onset of release of quetiapine therefrom not earlier than about 6 hours after the start of the sleep period, or (ii) a plurality of minor quetiapine components in immediate-release form, administered sequentially during a waking period following th

Abstract: A once-a-day, extended-release formulation of lamotrigine, exhibiting a significantly similar release rate throughout the GI tract irrespective of the pH of the environment, is provided. The formulation comprises lamotrigine, an organic acid, a release enhancing polymer and a release controlling polymer. The use of the formulation for the treatment of the neurological disorders is also disclosed.

Abstract: The present invention relates to co-extruded pharmaceutical compositions and dosage forms including an active agent, such as an opioid agonist, and an adverse agent, such as an opioid antagonist. Such compositions and dosage forms are useful for preventing or discouraging tampering, abuse, misuse or diversion of a dosage form containing an active pharmaceutical agent, such as an opioid. The present invention also relates to methods of treating a patient with such a dosage form, as well as kits containing such a dosage form with instructions for using the dosage form to treat a patient.

Abstract: The invention is directed to controlled release formulations containing drugs which are preferably considered sparingly soluble to insoluble and which are suitable for administration to a patient in need of treatment related thereto, and methods of manufacturing the same.

Abstract: Controlled release and taste masking compositions containing one or more active principles inglobated in a three-component matrix structure, i.e. a structure formed by successive amphiphilic, lipophilic or inert matrices and finally inglobated or dispersed in hydrophilic matrices. The use of a plurality of systems for the control of the dissolution of the active ingredient modulates the dissolution rate of the active ingredient in aqueous and/or biological fluids, thereby controlling the release kinetics in the gastrointestinal tract.

Abstract: Stable formulations of imidazolylalkyl-pyridines, including controlled-release formulations.

Abstract: Controlled-release preparations of oxcarbazepine and derivatives thereof for once-a-day administration are disclosed. The inventive compositions comprise solubility- and/or release enhancing agents to provide tailored drug release profiles, preferably sigmoidal release profiles. Methods of treatment comprising the inventive compositions are also disclosed.

Abstract: A controlled release dosage form of venlafaxine that comprises an immediate release pellet and an extended release pellet.

Abstract: Bioadhesives coatings increase the gastrointestinal retention time of orally-ingested medicaments. Certain bioadhesive coatings producing a fracture strength of at least 100 N/m2, as measured on rat intestine, when applied to at least one surface of a pharmaceutical dosage form for oral delivery of a drug, result in a gastrointestinal retention time of at least 4 hours in a fed beagle dog model, during which the drug is released from the dosage form. Multi-layer tablets, particularly those including hydrophobic excipients, are useful in administering hygroscopic and/or deliquescent drugs. In addition, varying the amount of drug in multi-layer tablets allows the release rate of the drug to be controlled.

Abstract: The invention relates to a dosage form comprising a physiologically effective amount of a physiologically active substance (A), a synthetic, semi-synthetic or natural polymer (C), optionally one or more physiologically acceptable auxiliary substances (B) and optionally a synthetic, semi-synthetic or natural wax (D), wherein the dosage form exhibits a resistance to crushing of at least 400 N and wherein under physiological conditions the release of the physiologically active substances (A) from the dosage form is at least partially delayed.

Abstract: A multiparticulate controlled release selective serotonin reuptate inhibitor (SSRI) formulation for oral administration is provided. The formulation includes particles of an SSRI or a pharmaceutically acceptable salt thereof, which are coated with a rate-controlling polymer that allows controlled release of the SSRI over a period of not less than about 12 hours after oral administration. The rate controlling polymer includes a film-forming water-insoluble polymer, or a mixture of a film-forming water-insoluble polymer and a film-forming water-soluble polymer.

Abstract: Disclosed are compositions for affecting weight loss comprising a first compound and a second compound, where the first compound is an opioid antagonist and the second compound causes increased agonism of a melanocortin 3 receptor (MC3-R) or a melanocortin 4 receptor (MC4-R) compared to normal physiological conditions. Also disclosed are methods of affecting weight loss, increasing energy expenditure, increasing satiety in an individual, or suppressing the appetite of an individual, comprising identifying an individual in need thereof and treating that individual to antagonize opioid receptor activity and to enhance ?-MSH activity.

Abstract: A controlled release dosage form comprises an immediate release portion and an enteric coated sustained release core.

Abstract: The present invention relates to a multiphase release oral pharmaceutical formulation having a dopamine agonist as an active ingredient. The multiphase composition comprises at least two different release components. The invention relates to controlled release pharmaceutical compositions of pramipexole or a pharmaceutically acceptable salt thereof for once-daily administration.

Abstract: Disclosed are amorphous carvedilol salt forms, controlled-release carvedilol compositions, and methods of preparing the forms and compositions.

Abstract: An active principle delivery device (1) comprising an inner capsule (4) within an outer capsule (2), the inner and outer capsules (4,2) containing the same active principle (5,3), with at least the outer capsule (2) being a hard capsule and the active principle (3,5) in at least one of the capsules (2,4), comprising a fluid. Also provided is a method of fabricating such a delivery device (1), as well as a method of controlling the pharmaco-kinetic profile of an active principle.

Abstract: The present invention provides a controlled absorption formulation in which modified release of active ingredient preferentially occurs in the lower gastrointestinal tract, including the colon. The formulation supports a significantly higher bioavailability of the active ingredient into the body of the subject than can be achieved from the currently used conventional formulation, such that therapeutically significant plasma levels of statin are maintained for an extended period after administration. The formulation preferably features a core over which an outer coating is layered. The core is optionally and preferentially in the form of a tablet.

Abstract: The present invention provides a therapeutic composition comprising a COX-2 selective inhibitor or a prodrug thereof and an LTB4 receptor antagonist. A method is provided for the use of such composition in the treatment, prevention, or inhibition of inflammation, an inflammation-related disorder, pain, or a pain-related disorder.

Abstract: A method for improving sleep in an individual comprising the administration of a composition comprising melatonin, lavender flower extract and Ferula extract is provided. The composition may be in a layered solid dosage form to provide controlled and sustained release of specific ingredients.

Abstract: The present invention provides storage stable, shaped particles of allotropic organic compounds. The particles of the present invention can be shaped according to the desired application. Preferred shapes of such particles are microspheres, particularly those having diameters of about 1 to about 1,000 microns. The stable shaped particles of the present invention are particularly well-suited to the fabrication of pharmaceutical formulations, particularly where sustained release and uniform bioavailability are desired. The storage stable particles are formed by a solid state crystallization of allotropic organic compounds. The solid state crystallization process of the present invention affords a means for achieving a storage stable crystalline form of said allotropic compound without loss or deterioration of the original particle dimensions.

Abstract: The invention is directed in part to oral dosage forms comprising a combination of an orally analgesically effective amount of an opioid agonist and an orally active opioid antagonist, the opioid antagonist being included in a ratio to the opioid agonist to provide a combination product which is analgesically effective when the combination is administered orally, but which is aversive in a physically dependent subject. Preferably, the amount of opioid antagonist included in the combination product provides at least a mildly negative, “aversive” experience in physically dependent addicts (e.g., precipitated abstinence syndrome).