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Inventi Rapid - Advanced Dosaging

Patent Watch

  • Osteochondral repair using plug fashioned from whole distal femur or condyle formed of hydrogel composition

    A method and apparatus for repairing isolated chondral defects using synthetic implants. Lesions in articular tissue are corrected by forming a recipient socket in the tissue. A donor graft of a size corresponding to the recipient socket is harvested from a synthetic specimen made of a synthetic tissue material, such as poly (vinyl) alcohol hydrogel. The donor graft is implanted into the recipient socket.

  • Bioprosthetic tissue preparation with synthetic hydrogels

    Methods for treating xenogenic tissue for implantation into a human body including in-situ polymerization of a hydrogel polymer in tissue, and tissue treated according to those methods, where the polymerization takes place in tissue that has not been fixed with glutaraldehyde. The polymerization may only fill the tissue, bind the polymer to the tissue, or cross-link the tissue through the polymer, depending on the embodiment. One method includes free radical polymerization of a first vinylic compound, and can include cross-linking through use of a second compound having at least two vinyl groups. Another method utilizes nucleophilic addition polymerization of two compounds, one of which can include PEG and can further include hydrolytically degradable regions. In one embodiment, applicants believe the in-situ polymerization inhibits calcification, and that the polymerization of tissue un-fixed by glutaraldehyde allows for improved penetration of the polymer. The methods find one use in the treatment of porcine heart valve tissue, intended to extend the useful life of the valves by inhibiting calcification. The incorporation of degradable hydrogel regions may initially fill the tissue and reduce any initial inflammatory response, but allow for later infiltration by cells to remodel the tissue.

  • Absorbable implants and methods for their use in hemostasis and in the treatment of osseous defects

    The present application is directed to compositions and methods for mechanically controlling the bleeding of bone. The compositions comprise in intimate admixture the following Components 1, 2 and 3: (1) a finely powdered, carboxylic acid salt comprising a carboxylate anion and a metallic cation, (2) a composition comprising pyrrolidone or an N-alkyl pyrrolidone wherein alkyl is a C1-C12 alkyl radical and an optional, biocompatible liquefying agent if the composition is in solid form at room temperature, and (3) an optional analgesic, wherein the analgesic is present in a free base and salt form.

  • Plasma protein affinity tags

    Method for increasing half-life of therapeutic agents in plasma and novel polypeptide derivatives.

  • pH triggerable polymeric particles

    A drug delivery system comprising pH triggerable particles is described. The pH triggerable particles comprise and agent(s) to be delivered, which is encapsulated in a matrix comprising a pH trigger agent and a polymer. Agents including nucleic acids may be delivered intracellularly using the inventive pH triggerable particles. Upon exposure to an acidic environment such as the endosome or phagosome of a cell, the particles dissolve or disrupt due to protonation or an increase in solubility of the pH triggering agent. Pharmaceutical compositions and methods of preparing and administering these particles are also described. These particles may be particularly useful in genetic vaccination.

  • Polymalic acid-based multi-functional drug delivery system

    A structured drug system that is useful for delivering a drug payload to a specific tissue or cell type is disclosed. The system is based on purified polymalic acid. This polymer isolated from natural sources is biocompatible, biodegradable and of very low toxicity. The polymer is extremely water soluble and contains a large number of free carboxyl groups which can used to attach a number of different active molecules. In the examples disclosed N-hydroxysuccinimide esters of the carboxyl groups are used to attach such molecules. The active molecules include monoclonal antibodies to promote specific cellular uptake and specific pro-drugs such as antisense nucleic acids designed to modify the cellular metabolism of a target cell. The pro-drugs are advantageously linked by a somewhat labile bond so that they will be released under specific conditions. In addition, the system contains amide-linked valine to encourage membrane disruption under lysosomal conditions. Polyethylene glycol groups are attached to extend the drug system's circulation half-life. In addition, fluorescent reported groups can be readily included to aid in visualizing and confirming drug system targeting. The drug system can deliver treatments for a wide range of diseases and is specially advantageous for treatment of neoplasms.

  • Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use

    Microparticle compositions comprising metal ion-lipid complexes for drug delivery are described including methods of making the microparticle compositions and methods of treating certain conditions and disease states by administering the microparticle compositions. The metal ion-lipid complexes can be combined with various drugs or active agents for therapeutic administration. The microparticle compositions of the present invention have superior stability to other microparticle compositions resulting in a microparticle composition with longer shelf life and improved dispersability. The microparticle compositions of the present invention have a transition temperature T.sub.m of at least 20.degree. C. above the recommended storage temperature (Tst) for drug delivery.

  • Delivery of medicaments to the nail

    The present invention includes a method for delivering a medicament to a nail plate or nail bed that comprises providing a therapeutically effective amount of a medicament, etching the surface of the nail, and applying a medicament to the surface of the nail. A preferred embodiment of the present invention is directed to a method of treating a fungal infection of the fingernail or toenail. Also included in the present invention are the compositions (i.e., the etching compositions and/or the medicament compositions) used to treat the nail in accordance with the methods of the present invention.

  • pH-sensitive polymeric micelles for drug delivery

    Mixed micelles containing poly(L-histidine)-poly(ethylene glycol) block copolymer and poly(L-lactic acid)-poly(ethylene glycol) block copolymer are a pH-sensitive drug carrier that release the drug in an acidic microenvironment, but not in the blood. Since the microenvironment of solid tumors is acidic, these mixed micelles are useful for treating cancer, including those cancers exhibiting multidrug resistance. Targeting ligands, such as folate, can also be attached to the mixed micelles for enhancing drug delivery into cells. Methods of treating a warm-blooded animal with such a drug are disclosed.

  • DRUG DELIVERY AND DIAGNOSTIC SYSTEM FOR ORTHOPEDIC IMPLANTS

    A drug delivery and diagnostic system can include an orthopedic implant having an outer attachment surface. A conduit can be coupled to the outer attachment surface. The conduit can have an inlet and a plurality of perforations formed along a length thereof. The conduit can be adapted to pass fluid between the inlet and the perforations. A subcutaneous port can be fluidly coupled to the inlet and be adapted to communicate fluid through the inlet, along the conduit and out of the perforations around and along the outer attachment surface of the orthopedic implant.

  • TRANSDERMAL DELIVERY SYSTEMS FOR ACTIVE AGENTS

    A delivery vehicle for topical pharmaceutical formulations that include a C2 to C4 alkanol, a polyalcohol, and a monoalkyl ether of diethylene glycol present in relative amounts sufficient to provide permeation enhancement of an active agent through mammalian dermal or mucosal surfaces. Preferably, the delivery vehicle as well as the formulations that contain it are substantially free of long-chain fatty alcohols, long-chain fatty acids and long-chain fatty esters in order to avoid potential undesirable odor and irritation effects caused by such compounds during use of the formulation. Without these additives, use of the formulations is facilitated and patient compliance is greater.

  • INTRACOCHLEAR DRUG DELIVERY TO THE CENTRAL NERVOUS SYSTEM

    The present invention is directed to method and system for delivery of brain-targeted drugs to the cerebrospinal fluid via the perilymphatic fluid of the inner ear. The system utilizes the passage of cochlear aqueduct as a drug delivery route from the inner ear to the subarachnoid space of the brain. The delivery system includes an otological conduit which enables transfer of drugs from the auditory ear canal to the inner ear and a wearable dispenser for supplying drugs to the otological conduit. The drug composition comprises a suspension of solid lipid nanoparticles (SLN) which facilitate delivery through the cochlear aqueduct. Employing aspects of present invention, a method and system for treating chronic pain is described.

  • TREATMENT MEDIUM DELIVERY DEVICE AND METHODS FOR DELIVERY OF SUCH TREATMENT MEDIUMS TO THE EYE USING SUCH A DELIVERY DEVICE

    A device for delivering a treatment medium to an eye includes a first body portion configured to be removably inserted and secured in an opening of the eye, and a second body portion supported by the first body portion. At least the second body portion includes a treatment medium, and a coating having an opening through which the treatment medium elutes out of the device.

  • DRUG DELIVERY VEHICLES, METHODS OF MANUFACTURE, AND METHODS OF USE THEREOF

    Drug delivery vehicles that release one or more drugs, e.g., an opioid antagonist and/or an opioid, in response to changes in the chemistry of body fluids, specifically in response to changes in the partial pressure of CO.sub.2 in the environment of the hydrogel are described. The drug delivery vehicles include hydrogels that swell or shrink in response to changes in the partial pressure of CO.sub.2 in their environment, thus regulating release of an entrapped drug.

  • Drug Delivery After Biodegradation Of The Stent Scaffolding

    Disclosed herein is a stent comprising: a bioabsorbable polymeric scaffolding; and a coating comprising a bioabsorbable material on at least a portion of the scaffolding, wherein the degradation rate of all or substantially all of the bioabsorbable polymer of the scaffolding is faster than the degradation rate of all or substantially all of the bioabsorbable material of the coating.

  • WATER INSOLUBLE POLYMER: STARCH-BASED FILM COATINGS FOR COLON TARGETING

    A controlled release delivery dosage form for controlled release of an active ingredient, includes an active ingredient coated in a polymeric mixture of: at least a water insoluble polymer and a starch composition including at least one component selected from the group consisting of a starch having an amylose content of between 20 and 45%, a modified starch having an amylose content of between 50 and 80% and a legume starch. The present invention also relates to the use and method for making the same.

  • Methods of Use To Orally and Topically Treat Acne and Other Skin Conditions By Administering a 19-NOR Containing Vitamin D Analog With or Without a Retinoid

    Oral and topical pharmaceutical compositions, kits and methods of treatment thereof for treating various skin disorder including acne, psoriasis, ichthyosis, photoaging, photodamaged skin, and, skin cancer. Exemplary vitamin D analogs as active pharmaceutical ingredients include 2-methylene-19-nor-20(S)-1.alpha.-hydroxy-bishomopregnacalciferol, 19-nor-26,27-dimethylene-20(S)-2-methylene-1.alpha.,25-dihydroxyvitamin D.sub.3, 2-methylene-1.alpha.,25-dihydroxy-(17E)-17(20)-dehydro-19-nor-vi- tamin D.sub.3, 2-methylene-19-nor-(24R)-1.alpha.,25-dihydroxyvitamin D.sub.2, 2-methylene-(20R,25S)-19,26-dinor-1.alpha.,25-dihydroxyvitamin D.sub.3, 2-methylene-19-nor-1.alpha.-hydroxy-pregnacalciferol, 1.alpha.-hydroxy-2-methylene-19-nor-homopregnacalciferol, (20R)-1.alpha.-hydroxy-2-methylene-19-nor-bishomopregnacalciferol, 2-methylene-19-nor-(20S)-1.alpha.-hydroxy-trishomopregnacalciferol, 2-methylene-23,23-difluoro-1.alpha.-hydroxy-19-nor-bishomopregnacalcifero- l, 2-methylene-(20S)-23,23-difluoro-1.alpha.-hydroxy-19-nor-bishomopregnan- calciferol, (2-(3' hydroxypropyl-1',2'-idene)-19,23,24-trinor-(20S)-1.alpha.-hydroxyvitamin D.sub.3, 2-methylene-18,19-dinor-(20S)-1.alpha.,25-dihydroxyvitamin D.sub.3, a stereoisomer thereof, a prodrug thereof in oral compositions, a salt thereof, and/or a solute thereof. Compounds that activate retinoic acid receptors, such as retinoyls and retinoyl esters, include 13-cis-retinoic acid, all-trans-retinoic acid, (2E,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexeneyl)nona-2,4,6,- 8-tetraenoic acid, 9-(4-methoxy-2,3,6-trimethyl-phenyl)-3,7-dimethyl-nona-2,4,6,8-tetraenoic acid, 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-napthoic acid, 4-[1-(3,5,5,8,8-pentamethyl-tetralin-2-yl)ethenyl]benzoic acid, retinobenzoic acid, ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl]pyridine-3-carboxylate, retinoyl t-butyrate, retinoyl pinacol, retinoyl cholesterol, an isomer thereof, a prodrug thereof for oral compositions, an ester thereof, a salt thereof, and/or, a solute thereof. Combinations of such active ingredients demonstrate synergistic efficacy.

  • TRANSDERMAL DELIVERY SYSTEMS FOR ACTIVE AGENTS

    A formulation for transdermal or transmucosal administration of an active agent. The formulation includes an active agent and a delivery vehicle comprising a C.sub.2 to C.sub.4 alkanol, a polyalcohol, and a permeation enhancer of monoalkyl ether of diethylene glycol present in an amount sufficient to provide permeation enhancement of the active agent through dermal or mucosal surfaces. The formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters in order to avoid undesirable odor and irritation effects caused by such compounds during use of the formulation. Also, the active agent is testosterone that is present in an amount of about 1%, the alkanol is ethanol that is present in an amount of about 46.28% to about 47.5% of the formulation; the polyalcohol is propylene glycol that is present in an amount of about 6% of the formulation; and the permeation enhancer is diethylene glycol monoethyl ether that is present in an amount of about 5% of the formulation.

  • Sensing and interactive drug delivery

    An interactive drug delivery system includes a drug delivery module, an optical probe, a local controller, and an optional central controller. The drug delivery module is constructed and arranged to deliver selected amounts of a drug into a subject. The optical probe is constructed and arranged to detect in a selected tissue region of the subject a manifestation caused by the delivered drug. The local controller is constructed and arranged to receive data from or transmit data to the optical probe and the drug delivery module. The local controller is arranged to correlate optical data, received from the optical probe, to selected data and provide signals to the drug delivery module for adjusting the amounts of the drug to be delivered into the subject.

  • LUNG TARGETING DUAL DRUG DELIVERY SYSTEM

    The American Cancer Society estimated that in 2009, 1,479,350 new cancer cases would be diagnosed in the United States of which 219,440 would be lung and bronchus related. The standard treatments for NSCLC include surgery, chemotherapy, radiation, laser and photodynamic therapy, all with various success rates depending on the stage of the cancer. National Cancer Institute assesses, however, that results of standard treatment are generally poor with only a 15 percent 5-year survival rate for combined cancer stages. Challenges facing the current chemotherapy drugs include excessive toxicity to healthy tissues and limited ability to prevent metastases. A dual drug delivery system described herein selectively targets the lung to deliver anti-cancer drugs and inhibit the formation of metastases.

  • PARTIALLY MICROCELLULAR, SELECTIVELY HYDROPHILIC COMPOSITE CONSTRUCT FOR OCULAR DRUG DELIVERY

    A partially microcellular, selectively hydrophilic composite as a self-standing construct or a component of a device for ocular delivery of at least one bioactive agent, the composite comprising a highly hydrophilic microcellular foam adjoined with a flexible hydrophobic barrier polymeric film.

  • Drug Delivery After Biodegradation Of The Stent Scaffolding

    Disclosed is a stent comprising a bioabsorbable polymeric scaffolding; and a plurality of depots in at least a portion of the scaffolding, wherein the plurality of depots comprise a bioabsorbable material, wherein the degradation rate of all or substantially all of the bioabsorbable polymer of the scaffolding is faster than the degradation rate of all or substantially all of the bioabsorbable material of the depots.

  • NOVEL GASTRORETENTIVE DELIVERY SYSTEM

    A novel gastroretentive delivery system comprising a tablet comprising a pharmaceutical ingredient or diagnostic, which tablet comprises a gas releasing ingredient or a tandem of two gas releasing ingredients, an ingredient capable of unrestricted swelling in gastric fluid, an ingredient capable of limiting the unrestricted swelling and a hardening ingredient. The said system is based on the use of three different gastroretentive mechanisms: flotation, swelling and mechanical strength, the three mechanisms acting in a complimentary way. Processes for manufacturing same and methods of treatment are also disclosed.

  • HIGH SHEAR APPLICATION IN DRUG DELIVERY

    In this disclosure, methods and systems for drug delivery utilizing high shear are disclosed. In an embodiment, a method comprises (1) subjecting a therapeutic fluid containing a drug to high shear; and (2) obtaining a processed therapeutic fluid, wherein the processed therapeutic fluid contains the drug in nano-size. In an embodiment, a method comprises (1) subjecting a drug carrier and a therapeutic fluid containing a drug to high shear; and (2) obtaining a processed therapeutic fluid, wherein the processed therapeutic fluid contains the drug carrier loaded with the drug. In an embodiment, a method comprises (1) applying high shear to a drug carrier and a therapeutic fluid containing a drug; (2) obtaining a processed therapeutic fluid, wherein the processed therapeutic fluid contains the drug-loaded carrier; and (3) modifying the drug-loaded carrier with a targeting moiety to obtain a modified drug-loaded carrier.

  • Active transdermal drug delivery system and the method thereof

    The present invention relates to an active transdermal drug delivery system performing transdermal drug delivery comprising of a patch capable of being attachable to the skin of the subject; at least one electrical energy power input; a plurality of converters/energy transducers configured for converting the electrical energy to different forms of energy; and a controller including a programmable microprocessor configured for providing the intensity, sequence, nature, and timing information for the different energies supplied and thereby providing activating signals to the said converters for the transdermal drug delivery by the said patch, and a method for performing transdermal drug delivery using said electronic patch.

  • TRANSDERMAL DELIVERY PATCH

    A composition suitable for use in a transdermal delivery patch for administration of a biologically active compound, the composition comprising a phosphate compound of tocopherol and a polymer carrier.

  • THERAPEUTIC AGENT DELIVERY DEVICE FOR DELIVERY OF A NEUROTOXIN

    A therapeutic agent delivery device and method for eluting a therapeutic agent to a target location are disclosed. The therapeutic agent delivery device may comprise a first conductive element, a second conductive element, and an electrochemical layer including a neurotoxin located between the first conductive element and the second conductive element. The first conductive element and the second conductive element are adapted to be connected to a voltage source. When the first conductive element and the second conductive element are connected to the voltage source, an electrochemical reaction occurs causing the neurotoxin to release from the electroactive layer and elute to a target location.

  • DELIVERY PARTICLES

    The present application relates to encapsulated benefit agents, compositions comprising such encapsulated benefit agents and processes for making and using compositions comprising such encapsulated benefit agents. Such encapsulated benefit agents eliminate or minimize one or more of the drawbacks of current encapsulated benefit agents and thus provide formulators with additional perfume delivery opportunities.

  • DUAL-CHAMBERED DRUG DELIVERY DEVICE FOR HIGH PRESSURE INJECTIONS

    A dual-chambered drug delivery device (201) includes a first chamber (205) in which a medicament is stored. A dose setting member (213) is rotated to set a medicament dose. The dose setting member (213) being rotatable to set the medicament dose. The dose setting member (213) is not axially moveable. A second chamber (221) is in fluid communication with the first chamber (205). The medicament dose is transferred to the second chamber (221) from the first chamber (205) prior to injecting the medicament dose. A needle (203) communicates with the second chamber (221) to inject the medicament dose into an injection site.

  • OPEN AND CLOSED VALVE MEDICATION DELIVERY SYSTEM FOR HIGH PRESSURE INJECTIONS

    A dual-chambered drug delivery device (301) includes a first chamber (342) in which medicament is stored and a second chamber (331) in fluid communication with the first chamber (342). A medicament dose is transferred to the second chamber (331) from the first chamber (342) prior to injecting the medicament dose. A needle (363) communicates with the second chamber (331) for injecting the medicament dose into an injection site.

  • MULTI-STROKE DELIVERY PUMPING MECHANISM FOR A DRUG DELIVERY DEVICE FOR HIGH PRESSURE INJECTIONS

    A dual-chambered drug delivery device (201) includes a cartridge (211) having a first chamber (212) for storing a medicament and a second chamber (211) in fluid communication with the first chamber (212). A dose setting member (241) is used to set a medicament dose to be injected at an injection site. A piston (281) is disposed in the second chamber (221). An upward stroke of the piston (281) draw a portion of the medicament dose into the second chamber (221) and a downward stroke of the piston (281) expels the portion of the medicament dose. A needle (205) communicates with the second chamber (221) for sequentially injecting the portions of the medicament dose into the injection site.

  • LIQUID CANNABINOID FORMULATIONS

    Oral cannabinoid formulations, including an aqueous-based oral dronabinol solution, that are stable at room or refrigerated temperatures and may possess improved in vivo absorption profiles with faster onset and lower inter-subject variability.

  • Camptothecin Conjugates of Anti-CD22 Antibodies for Treatment of B Cell Diseases

    Disclosed herein are compositions and methods of use comprising combinations of anti-CD22 antibodies with a therapeutic agent. The therapeutic agent may be attached to the anti-CD22 antibody or may be separately administered, either before, simultaneously with or after the anti-CD22 antibody. In preferred embodiments, the therapeutic agent is an antibody or fragment thereof that binds to an antigen different from CD22, such as CD19, CD20, CD21, CD22, CD23, CD37, CD40, CD40L, CD52, CD80 and HLA-DR. However, the therapeutic agent may an immunomodulator, a cytokine, a toxin or other therapeutic agent known in the art. More preferably, the anti-CD22 antibody is part of a DNL complex, such as a hexavalent DNL complex. Most preferably, combination therapy with the anti-CD22 antibody or fragment and the therapeutic agent is more effective than the antibody alone, the therapeutic agent alone, or the combination of anti-CD22 antibody and therapeutic agent that are not conjugated to each other. Administration of the anti-CD22 antibody and therapeutic agent induces apoptosis and cell death of target cells in diseases such as B-cell lymphomas or leukemias, autoimmune disease or immune dysfunction disease.

  • FORMULATIONS CONTAINING LARGE-SIZE CARRIER PARTICLES FOR DRY POWDER INHALATION AEROSOLS

    A dry powder inhaler may include a drug chamber configured to contain a formulation including carrier particles and working agent particles, a mouthpiece configured to direct flow of working agent particles to a user, and a retaining member proximal the mouthpiece. The retaining member be sized and arranged to prevent flow of substantially all carrier particles to the user while permitting flow of working agent particles to a user. The inhaler may include a formulation including carrier particles for delivering working agent to the pulmonary system of a patient. The carrier particles may have an average sieve diameter greater than about 500 .mu.m. The carrier particles may be one of polystyrene, PTFE, silicone glass, and silica gel or glass.

  • FORMULATIONS CONTAINING LARGE-SIZE CARRIER PARTICLES FOR DRY POWDER INHALATION AEROSOLS

    A dry powder inhaler may include a drug chamber configured to contain a formulation including carrier particles and working agent particles, a mouthpiece configured to direct flow of working agent particles to a user, and a retaining member proximal the mouthpiece. The retaining member be sized and arranged to prevent flow of substantially all carrier particles to the user while permitting flow of working agent particles to a user. The inhaler may include a formulation including carrier particles for delivering working agent to the pulmonary system of a patient. The carrier particles may have an average sieve diameter greater than about 500 .mu.m. The carrier particles may be one of polystyrene, PTFE, silicone glass, and silica gel or glass.

  • RADIOACTIVE THERAPEUTIC FASTENING INSTRUMENT

    An instrument used for brachytherapy delivery in the treatment of cancer by radiation therapy including a handle having first and second handle actuators; an end effector; and an instrument shaft that connects the handle with the end effector. The end effector has first and second adjacent disposed staple mechanisms that each retain a set of staples. The first mechanism is for holding standard staples in a first array, and dispensing the standard staples under control of the corresponding first handle actuator. The second mechanism is for holding radioactive source staples in a second array, and dispensing said radioactive source staples under control of the corresponding second handle actuator. A holder is for receiving the first and second mechanisms in a substantially parallel array so that the standard staples close the incision at a surgical margin while the source staples are secured adjacent thereto.

  • Systems, devices, and methods including implantable devices with anti-microbial properties

    Systems, devices, methods, and compositions are described for providing an actively controllable implant configured to, for example, monitor, treat, or prevent microbial growth or adherence to the implant.

  • IMPLANTABLE DRUG DELIVERY DEVICES

    The invention relates generally to implantable drug delivery devices. Devices having a single drug chamber configuration, a divided drug chamber configuration and a compact dual-drug configuration are described. The devices have features to prevent clogging of the dispensing catheter and the creation of a local vacuum caused by the dispensing of the drug fluid. Also provided are features of a failsafe refilling process, automatic refill notification, and performance verification process. The divided drug chamber configuration enables frequent or continuous minute doses. A dual-drug chamber configuration uses self-locking refill containers to prevent mismatching between refill containers and drug chambers.

  • Insulin Delivery Safety

    Embodiments of the present disclosure are directed to systems, devices/apparatuses and methods for assessing a residual insulin value for a user/patient. Such embodiments may be implemented by selecting a first value corresponding to a duration of insulin action; selecting a second value corresponding to a lock out time duration, selecting a first time period beginning at a time point T0 minus the first value and ending at the time point T0 minus the second value, selecting one or more boluses delivered during the first time period; for each of the one or more boluses selecting a corresponding residual insulin value estimated at the time point T0, computing the cumulative residual insulin value by summation of the corresponding residual insulin values.

  • Tamper Resistant Dosage Form Comprising An Anionic Polymer

    A pharmaceutical dosage form and method of using same, the pharmaceutical dosage form exhibiting a breaking strength of at least 500 N, said dosage form containing a pharmacologically active ingredient (A); an anionic polysaccharide (B) obtainable by introducing anionic functional groups, in protonated form or a physiologically acceptable salt thereof, into a polysaccharide; and a polyalkylene oxide (C); wherein the pharmacologically active ingredient (A) is present in a controlled-release matrix comprising the anionic polysaccharide (B) and the polyalkylene oxide (C).

  • DISPERSIONS OF RASAGILINE CITRATE

    The subject invention provides a solid dispersion of rasagiline citrate, a composition and a process for the manufacture thereof.

  • ANTIVIRAL TREATMENTS

    The invention provides unit dosage forms, kits, and methods useful for treating viral infections.advantageously on the skin.

  • USE OF POLYMORPHIC FORMS OF RIFAXIMIN FOR MEDICAL PREPARATIONS

    The present invention relates to Rifaximin polymorphic forms .alpha., .beta. and .gamma., to their use in medicinal preparations for the oral or topical route and to therapeutic methods using them.

  • UNIT DOSE DRY POWDER INHALER

    An inhaler includes a first body member and a second body member fit closely together to form an inhaler body, and an outlet. The first body member has a medicament chamber containing a unit dose of powdered medicament. A seal such as a foil strip seals the medicament chamber and extends outwardly of the inhaler body. In use, one end of the seal can be grasped by a user and withdrawn, fully or partially, from the inhaler body, to release the powdered medicament from the medicament chamber. The second body member includes a medicament collection well in which the medicament is collected upon its release from the medicament chamber. The medicament collection well forms part of an airway connecting into the outlet. In use, air can be drawn by inhalation at the outlet to entrain the powder medicament in the collection well for inhalation by a user.

  • Multi-Dose Drug Delivery Device and Method

    Drug delivery devices and methods are provided. The device included two or more housing units connected together end-to-end in a fixed, linear orientation, the exterior surfaces of the connected housing units defining a sidewall of the device; discrete drug dose units disposed within the housing units; degradable timing members connected to the housing units and separating the discrete dose units from one another; first and second end pieces defining opposed ends of the device such that the discrete dose units are located between the first and second end pieces within each of the housing units, wherein the device is configured to release in vivo a first of the discrete dose units following rupture of the first or second end piece, and subsequently to release in vivo a second of the discrete dose units following rupture of the degradable timing member separating the first discrete dose unit from the second discrete dose unit.

  • USE OF HIGH-DOSE OXAZAPHOSPHORINE DRUGS IN COMBINATION WITH MONOCLONAL ANTIBODIES FOR TREATING IMMUNE DISORDERS

    The present invention relates to methods of treating an autoimmune disorder, using a lymphocytotoxic but hematopoeitic cell sparing high-dose pulsed amount of an oxazaphosphorine drug in combination with immune therapeutics such as, for example, monoclonal antibodies that selectively bind B-cell specific antigens.

  • METHODS AND UNIT DOSE FORMULATIONS FOR THE INHALATION ADMINISTRATION OF AMINOGLYCOSIDE ANTIBIOTICS

    A patient suffering from an endobronchial infection is treated by administering to the patient for inhalation a dose of less than about 4.0 ml of a nebulized aerosol formulation comprising from about 60 to about 200 mg/ml of an aminoglycoside antibiotic, such as tobramycin, in a physiologically acceptable carrier in a time period of less than about 10 minutes. Unit dose devices for storage and delivery of the aminoglycoside antibiotic formulations are also provided.

  • LOW-DOSE DOXEPIN FOR TREATMENT OF SLEEP DISORDERS IN ELDERLY PATIENTS

    Methods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe for elderly individuals.

  • CONTROLLED RELEASE DOSAGE FORMS FOR HIGH DOSE, WATER SOLUBLE AND HYGROSCOPIC DRUG SUBSTANCES

    Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

  • GASTRORENTENTIVE ORAL HIGH DOSE ZINC PREPARATIONS

    A method of providing zinc to a subject in need of treatment includes administering to the subject an effective amount of a sustained-release zinc composition.

  • LARGE DOSE RIBAVIRIN FORMULATIONS

    The present invention is related to pharmaceutical dosage forms of ribavirin which are designed to increase patient compliance to a ribavirin therapy. Examples of such dosage forms include 400 mg to 600 mg tablets. These dosage forms are bioequivalent to multiple doses of tablets containing small amounts of ribavirin.

  • PHARMACEUTICAL COMPOSITIONS FOR REDUCING ALCOHOL-INDUCED DOSE DUMPING

    A pharmaceutical composition is disclosed. The composition comprises a core comprising an active substance or a salt thereof; a separating layer comprising at least one sugar; and a functional layer comprising at least one pharmaceutically acceptable polymer, wherein the composition is resistant to dose dumping in presence of alcohol.

  • Stable, non-corrosive formulations for pressurized metered dose inhalers

    Pharmaceutical pressurized metered dosing inhalers (MDIs) are disclosed containing at least one dissolved halide substance, a suspended drug substance and a co-solvent, stabilized chemically and also against metal corrosion by the addition of an acid, an unsaturated suspending agent and water.

  • Unit Dose Capsules and Dry Powder Inhaler

    Described is a dry powder inhaler comprising an intake section; a mixing section, and a mouthpiece.

  • DOSE SETTING MECHANISM FOR PRIMING A DRUG DELIVERY DEVICE

    A method and system for priming a drug delivery device are provided. The drug delivery device includes a dose dial sleeve and an internal housing portion. The dose dial sleeve is coupled to the internal housing. The dose dial sleeve rotates on a substantially circumferential rotational path during priming of the drug delivery device. Further, the dose dial sleeve rotates on a helical path during dose setting of the drug delivery device.

  • SOLID PHARMACEUTICAL FIXED DOSE COMPOSITIONS COMPRISING IRBESARTAN AND AMLODIPINE, THEIR PREPARATION AND THEIR THERAPEUTIC APPLICATION

    The present invention is directed to solid stable pharmaceutical fixed dose compositions comprising irbesartan, amlodipine besilate and pharmaceutically acceptable excipients, to their preparation and to their therapeutic application.

  • Dose Reset Mechanism

    A dose reset mechanism for a medicament delivery device with a housing and a medicament container includes a dose setting member in the housing for setting a dose when it is rotated and for resetting the dose when it is rotated in the opposite direction. The dose setting member has a drive member connected to a plunger rod such that when the drive member rotates, the rod moves axially; and a connection member between the dose setting member and the drive member. A ratchet mechanism enables the connection member to rotate when the dose setting member rotates for setting a dose but not to move in the opposite direction. At least one dose reset member and at least one blocking member are connected to the ratchet mechanism such that the connection member and drive member are released when a dose knob is turned in the opposite direction.

  • ANGIOGENICALLY EFFECTIVE UNIT DOSE OF FGF-2 AND METHOD OF USE

    The present invention provides a unit dose composition comprising 0.2 .mu.g/kg to 48 .mu.g/kg of an FGF-2 of SEQ ID NO:2, or an angiogenically active fragment or mutein thereof in a pharmaceutically acceptable carrier. Also provided is a method for treating a human patient for coronary artery disease, comprising administering into one or more coronary vessels or a peripheral vein of said patient a safe and angiogenically effective dose of a recombinant FGF-2, or an angiogenically active fragment or mutein thereof. Also provided is a pharmaceutical composition comprising a therapeutically effective amount of FGF-2, alone or in combination with heparin, in a therapeutically effective carrier.

  • Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens

    The present invention provides ascending-dose extended cycle regimens in which a female is administered an estrogen and a progestin for a period of greater than 30 or 31 consecutive days, optionally followed by a hormone-free period or by a period of administration of estrogen. The disclosed regimens can be administered to a female to provide contraceptive and non-contraceptive benefits

  • PTH-CONTAINING THERAPEUTIC/PROPHYLACTIC AGENT FOR OSTEOPOROSIS, CHARACTERIZED IN THAT PTH IS ADMINISTERED ONCE A WEEK IN A UNITDOSE OF 100 TO 200 UNITS

    A method of treating osteoporosis by PTH that has excellent safety and high efficacy is disclosed, along with a method for inhibiting/preventing bone fractures by PTH that has excellent safety, as well as providing a drug to do this. A drug containing PTH as the active ingredient is disclosed, characterized in that a unit dose of PTH of 100 to 200 units is administered weekly in the above method.

  • PTH-CONTAINING THERAPEUTIC/PROPHYLACTIC AGENT FOR OSTEOPOROSIS, CHARACTERIZED IN THAT PTH IS ADMINISTERED ONCE A WEEK IN A UNITDOSE OF 100 TO 200 UNITS

    A method of treating osteoporosis by PTH that has excellent safety and high efficacy is disclosed, along with a method for inhibiting/preventing bone fractures by PTH that has excellent safety, as well as providing a drug to do this. A drug containing PTH as the active ingredient is disclosed, characterized in that a unit dose of PTH of 100 to 200 units is administered weekly in the above method.

  • METHOD AND APPARATUS FOR DOSE MEASUREMENT

    The present disclosure relates to devices for use in conjunction with a syringe in measuring a dose using the syringe. In certain embodiments, a clip is provided that includes an elongated portion for insertion into a barrel of a syringe and a locking portion that locks onto a feature of the syringe. Once inserted, the clip physically prevents retraction of a plunger of the syringe past a certain point corresponding to a desired dose.

  • METHOD AND APPARATUS FOR DOSE MEASUREMENT

    The present disclosure relates to devices for use in conjunction with a syringe in measuring a dose using the syringe. In certain embodiments, a clip is provided that includes an elongated portion for insertion into a barrel of a syringe and a locking portion that locks onto a feature of the syringe. Once inserted, the clip physically prevents retraction of a plunger of the syringe past a certain point corresponding to a desired dose.

  • METHODS OF USING LOW-DOSE DOXEPIN FOR THE IMPROVEMENT OF SLEEP

    Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).

  • Dose Display Mechanism for a Drug Delivery Device

    This invention relates to a dose display mechanism for a drug delivery device that allows the user to select multiple doses of an injectable drug and for the dispensing of the set dosage of the drug and applying said drug to a patient, preferably by injection.

  • SINGLE UNIT ORAL DOSE PHARMACEUTICAL COMPOSITION COMPRISING LEVODOPA, CARBIDOPA AND ENTACAPONE OR SALTS THEREOF

    There is provided a single unit oral dose pharmaceutical composition comprising a) levodopa or salts thereof from about 50 mg to about 300 mg in extended release form, b) carbidopa or salts thereof from about 10 mg to about 100 mg in extended release and c) entacapone or salts thereof from about 100 mg to about 1000 mg in immediate release form, optionally with other pharmaceutically acceptable excipients. The invention also relates to process of preparation of such compositions.

  • MULTI-DOSE NUTRITIONAL SUPPLEMENTS FOR THE PROMOTION OF BONE HEALTH

    Multi-dose packages of nutritional supplements are provided that are designed for regular and continuous use by a specific target (i.e., consumer) over a reoccurring predetermined period of time. The multi-dose packaging of nutritional supplements contains supplements that vary in dosage and that are each intended to be taken at a specific time during the predetermined period of time. Each supplement in the series is tailored to contain unit dosages of nutritional supplements that are designed to address specific needs of the intended consumer during the predetermined period of time at which the supplement is intended to be ingested.

  • Universal Domed Closure to Supply Dose

    The present invention relates to a universal closure capable of fitting various sized container openings in sealed engagement. The present invention also relates a universal dispensing closure capable of fitting various sized container openings in sealed engagement and used to house a secondary supply or dose of product and when the closure is activated dispense the secondary product or dose into a receiving vessel to which it is attached.

  • Universal Domed Closure to Supply Dose

    The present invention relates to a universal closure capable of fitting various sized container openings in sealed engagement. The present invention also relates a universal dispensing closure capable of fitting various sized container openings in sealed engagement and used to house a secondary supply or dose of product and when the closure is activated dispense the secondary product or dose into a receiving vessel to which it is attached.

  • Universal Domed Closure to Supply Dose

    The present invention relates to a universal closure capable of fitting various sized container openings in sealed engagement. The present invention also relates a universal dispensing closure capable of fitting various sized container openings in sealed engagement and used to house a secondary supply or dose of product and when the closure is activated dispense the secondary product or dose into a receiving vessel to which it is attached.

  • UNIT DOSE BREAKABLE VIAL WITH INTEGRATED BRUSH APPLICATOR

    A disposable sterile breakable vial includes a handle section and a vial section which are completely separable in response to a manually applied separation force. The vial section includes a sterile void dimensioned to contain a unit dose of a sterile therapeutic topical agent. An elongated member comprises a proximal portion supported by the handle section and a distal portion provided with a sterile applicator element, such as a brush. At least the applicator element is completely enclosed within the vial section with the applicator element immersed within the therapeutic topical agent. A hermetic seal between the handle and vial sections maintains sterility of at least the vial section prior to handle and vial section separation. Complete separation of the handle section and the vial section exposes the elongated member and the applicator element for topical application of the therapeutic agent saturating the applicator element.

  • UNIT DOSE BREAKABLE VIAL WITH INTEGRATED BRUSH APPLICATOR

    A disposable sterile breakable vial includes a handle section and a vial section which are completely separable in response to a manually applied separation force. The vial section includes a sterile void dimensioned to contain a unit dose of a sterile therapeutic topical agent. An elongated member comprises a proximal portion supported by the handle section and a distal portion provided with a sterile applicator element, such as a brush. At least the applicator element is completely enclosed within the vial section with the applicator element immersed within the therapeutic topical agent. A hermetic seal between the handle and vial sections maintains sterility of at least the vial section prior to handle and vial section separation. Complete separation of the handle section and the vial section exposes the elongated member and the applicator element for topical application of the therapeutic agent saturating the applicator element.

  • PHARMACEUTICAL COMPOSITIONS FOR REDUCING ALCOHOL-INDUCED DOSE DUMPING

    A pharmaceutical composition is disclosed. The composition comprises a core comprising an active substance or a salt thereof; a separating layer comprising at least one sugar; and a functional layer comprising at least one pharmaceutically acceptable polymer, wherein the composition is resistant to dose dumping in presence of alcohol.

  • LOW-DOSE DOXEPIN FOR TREATMENT OF SLEEP DISORDERS IN ELDERLY PATIENTS

    Methods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe for elderly individuals.

  • COMBINATION THERAPY USING LOW-DOSE DOXEPIN FOR THE IMPROVEMENT OF SLEEP

    A composition comprising doxepin, or a pharmaceutically acceptable salt, or prodrug thereof, and a compound that enhances sleep onset, sleep maintenance or reduces early morning awakenings. These compositions are useful for treating multiple manifestations of insomnia.

  • LOW DOSE LITHIUM IN THE TREATMENT OR PROPHYLAXIS OF PARKINSON'S DISEASE

    In various embodiments methods of delaying the onset of and/or mitigating the severity of one or more symptoms of Parkinson's disease in a mammal are provided. In certain embodiments the methods involve administering to a mammal diagnosed as having or as at risk for Parkinson's disease a chronic low dose of lithium (e.g., a subtherapeutic dose). In certain embodiments the low dose lithium is administered in conjunction with another agent (e.g., L-DOPA).

  • PROGESTERONE CONTAINING ORAL DOSAGE FORMS AND KITS

    The present invention provides for progesterone containing pharmaceutical oral dosage forms, pharmaceutical kits, and related methods. In one embodiment, an oral dosage form formulated for on-going administration is provided. The oral dosage form includes an amount of progesterone and a pharmaceutically acceptable carrier. The oral dosage form is formulated such that upon single dose administration to a non-pregnant woman in follicular phase, the oral dosage form provides a serum progesterone C.sub.24h of at least 0.20 ng/mL.

  • ORAL CONTROLLED RELEASE DOSAGE FORM

    A dosage form that provides a controlled release solid dosage form for the oral administration of a central nervous system stimulant, preferably methylphenidate hydrochloride.

  • UNIT DOSAGE OF APADENOSON

    The present invention provides a unit dosage of Apadenoson, a pharmacological stress agent, and use of the same as a pharmacologic agent for myocardial perfusion imaging.

  • ADMINISTRATION METHODS AND PACKAGINGS FOR DOSAGE UNITS

    Packagings for holding dosage units and methods for administering dosage units from a packaging. The packaging includes a cover and a body with compartments each configured to hold at least one of the dosage units. The compartments have a circular arrangement on the body. The packaging further includes a cover with a plurality of strips attached to the body for confining the dosage units in the compartments. Each of the strips is positioned relative to a respective one of the compartments and configured to be individually manipulated for releasing the dosage unit from the respective one of the compartments. The method includes manipulating one of the strips to unblock an opening to one of the compartments and removing the dosage unit from the compartment through the unblocked opening.

  • MODIFIED RELEASE FORMULATIONS OF MEMANTINE ORAL DOSAGE FORMS

    The present invention provides pharmaceutical compositions given once daily containing at least one therapeutically active ingredient selected from the group consisting of memantine and a pharmaceutically acceptable salt of memantine, and a pharmaceutically acceptable polymeric matrix carrier. The dosage forms of the invention sustain the release of the therapeutically active agent from about 4 to about 24 hours when said dosage form is exposed to aqueous solutions, following entry of said form into a use environment, wherein said dosage form has a dissolution rate of more than about 80% after passage of about 6 hours to about 12 hours following said entry into said use environment.

  • HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS AND THEIR USE TO TREAT BACTERIAL VAGINOSIS

    The present disclosure provides mucoadhesive aqueous-based gel formulations of metronidazole useful for a variety of purposes, including intravaginal application as a therapeutic approach towards the treatment of individuals suffering from and/or diagnosed with bacterial vaginosis.

  • Solid Pharmaceutical Dosage Formulation

    The present invention provides a pharmaceutical dosage formulation, and more particularly, a pharmaceutical dosage formulation comprising an HIV protease inhibitor.

  • QUININE DOSAGE FORMS AND METHODS OF USE THEREOF

    Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed are methods of using quinine and informing a user of information, including potential adverse effects, the effect of food on quinine's pharmacokinetics, effect of dosing various strengths of quinine, effect of maximum plasma concentrations of quinine in a patient as it relates to adverse events, effects of deviating from the prescribed dosage, etc.

  • LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS

    Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2 methylpropyl)-1H-imidazo[4,5 c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for Aldara.RTM. 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration ("FDA"), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration ("FDA") for Aldara.RTM. 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.

  • LIQUID NASAL SPRAY CONTAINING LOW-DOSE NALTREXONE

    Liquid formulations for administration of naltrexone at low concentrations by the nasal route are described.

  • LOW-DOSE DOXEPIN FOR TREATMENT OF SLEEP DISORDERS IN ELDERLY PATIENTS

    Methods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe for elderly individuals.

  • LOW DOSE LITHIUM IN THE TREATMENT OR PROPHYLAXIS OF PARKINSON'S DISEASE

    In various embodiments methods of delaying the onset of and/or mitigating the severity of one or more symptoms of Parkinson's disease in a mammal are provided. In certain embodiments the methods involve administering to a mammal diagnosed as having or as at risk for Parkinson's disease a chronic low dose of lithium (e.g., a subtherapeutic dose). In certain embodiments the low dose lithium is administered in conjunction with another agent (e.g., L-DOPA).

  • AUTOMATIC INJECTION DEVICE WITH TORSIONAL SPRING

    A semi-automatic "fixed" dose injection device is disclosed containing a reservoir of medicament, where a trigger controls the unwinding of a torsional spring to cause a predetermined injection of medicament from the reservoir through a disposable needle.

  • METHODS OF TREATING PEDIATRIC PATIENTS USING DEXMEDETOMIDINE

    The presently disclosed subject matter relates to methods of administering an effective amount of dexmedetomidine to a pediatric patient in order to reduce the incidence of neurological damage. More particularly, the presently disclosed subject matter relates to methods of providing sedation or analgesia to a pediatric patient by administering a dexmedetomidine infusion and optionally a loading dose. The dexmedetomidine can be administered before, during, or after surgery.

  • VACCINE FORMULATIONS

    An immunogenic composition comprising a plurality of capsular polysaccharides from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to a carrier protein, and further comprising at least one preservative, preferably 2-phenoxyethanol (2-PE). The preservative-containing immunogenic compositions of the invention confer resistance to one or more micro-organisms and are useful for producing multi-dose vaccine formulations having advantageous properties with respect to long term stability of the different antigenic determinants in the immunogenic composition of choice. Related compositions and methods for measuring the efficacy of one or more preservatives in a vaccine formulation are also provided.

  • USE OF LOW-DOSE LADOSTIGIL FOR NEUROPROTECTION

    The subject invention provides a method of preventing a neurodegenerative disease in a subject or oxidative stress in the brain of a subject, comprising administering to the subject a less than cholinesterase-inhibitory amount or a less than monoamine oxidase-inhibitory amount of R(+)-6-(N-methyl,N-ethyl-carbamoyloxy)-N'-propargyl-1-aminoindan or a salt thereof effective to prevent the neurodegenerative disease or oxidative stress in the subject.

  • METHODS OF USING LOW-DOSE DOXEPIN FOR THE IMPROVEMENT OF SLEEP

    Methods of treating sleep disorders by administration of low doses of doxepin in individuals seeking sustained efficacy or in need of avoiding weight gain, rebound insomnia, or sedative tolerance resulting from doxepin treatment.

  • METHOD OF REDUCING CNS AND GASTROINTESTINAL SIDE AFFECTS ASSOCIATED WITH LONG-TERM, DEXTROMETHORPHAN/LOW-DOSE QUINIDINE COMBINATION THERAPY

    Pharmaceutical compositions and methods for treating neurological disorders by administering same are provided. The compositions comprise dextromethorphan in combination with quinidine. This invention also provides methods of reducing CNS and gastrointestinal side effects associated with a long term, dextromethorphan/low-dose quinidine combination therapy.

  • CLOSURE CONTAINER FOR SINGLE DOSE DISPOSABLE PHARMACEUTICAL DELIVERY SYSTEM

    Provided herein is a single dose disposable pharmaceutical delivery apparatus and methods of use and manufacture thereof. One aspect provides a single dose disposable pharmaceutical delivery apparatus that includes a needle hub seal attached to a needle hub and a bladder that can contain a pharmaceutical composition. Another aspect provides for dispensing a pharmaceutical composition from the delivery apparatus by rupturing the needle hub seal and fluidically connecting the needle and the bladder. Another aspect provides manufacturing the delivery apparatus according to steps including attaching a needle hub and a needle hub seal and combining the bladder and the needle hub, thereby forming an apparatus described herein.

  • METHOD AND APPARATUS FOR MAKING AEROSOL CANS FOR METERED DOSE INHALER

    A method and apparatus for forming aerosol cans for metered dose inhalers.

  • CYSTITIS TREATMENT WITH HIGH DOSE CHONDROITIN SULFATE

    Interstitial cystitis and related GAG-deficient conditions of the bladder and urinary tract are treated by instillation of high dose chondroitin sulfate, such as 400 mg/20 mL. The higher dose of chondroitin is effective for the rapid reduction of symptoms, particularly in patients with severe and otherwise recalcitrant cystitis.

  • Low Dose Pharmaceutical Powders for Inhalation

    The invention relates to a method of delivering an agent to the pulmonary system of a compromised patient, in a single breath-activated step, comprising administering a particle mass comprising an agent from an inhaler containing less than 5 milligrams of the mass, wherein at least about 50% of the mass in the receptacle is delivered to the pulmonary system of a patient. The invention also relates to receptacles containing the particle mass and the inhaler for use therein.

  • LOW-DOSE DOXEPIN FORMULATIONS AND METHODS OF MAKING AND USING THE SAME

    The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.

  • PHARMACEUTICAL COMPOSITIONS CONTAINING A BIGUANIDE AND A LOW DOSE ANTIDIABETIC AGENT

    The present invention relates to pharmaceutical compositions that include a combination of a biguanide present in an extended-release form and a low dose antidiabetic agent present in an immediate-release form. The present invention further relates to processes for preparing such compositions.

  • Low Dose Pharmaceutical Composition Comprising Zanamivir

    The present invention provides a pharmaceutical composition comprising a low dose of zanamivir and a process for preparing the pharmaceutical composition comprising a low dose of zanamivir. The pharmaceutical composition comprising a low dose zanamivir may be used in the treatment and/or prophylaxis of influenza. The present invention also provides a method of treatment and/or prophylaxis of influenza which comprises administering a dry powder inhaler composition comprising a low dose zanamivir. The pharmaceutical composition of the present invention comprises zanamivir and one or more pharmaceutically acceptable excipients, wherein the total daily dose of the zanamivir is less than 10 mg, preferably for administration at least once a day, and preferably wherein the composition delivers from 3 mg to 8 mg of zanamivir per administered dose.

  • Low Dose Topiramate/Phentermine Composition And Methods Of Use Thereof

    A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.

  • LOW-DOSE DOXEPIN FOR TREATMENT OF SLEEP DISORDERS IN ELDERLY PATIENTS

    Methods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe for elderly individuals.

  • HIGH-DOSE GLYCINE AS A TREATMENT FOR OBSESSIVE-COMPULSIVE DISORDER AND OBSESSIVE-COMPULSIVE SPECTRUM DISORDERS

    The present invention provides for a method of treating OCD or an Obsessive-Compulsive Spectrum Disorder (OCSD), such as BDD or ADHD, using a high-dose glycine treatment.

  • The present invention provides for a method of treating OCD or an Obsessive-Compulsive Spectrum Disorder (OCSD), such as BDD or ADHD, using a high-dose glycine treatment.

    The invention generally relates to methods of treating an overweight or obese subject, and treating overweight- or obesity-related conditions using effective of amounts of a MetAP-2 inhibitor.

  • TREATMENT OF UTERINE FIBROIDS BY INTRAVAGINAL ADMINISTRATION OF A LOW DOSE OF SELECTIVE PROGESTERONE RECEPTOR MODULATOR (SPRM), ANTI-PROGESTIN, OR ANTI-PROGESTATIONAL

    A method and intravaginal drug delivery device for reducing size of a uterine fibroid in a female in need thereof are provided. The method includes administering intravaginally to the female a therapeutically effective amount of an active agent, wherein the agent is delivered on a delivery device directly to uterine fibroid, wherein said amount is able to significantly reduce the size of the uterine fibroid, wherein the active agent is any one of selective progesterone receptor modulator (SPRM), an anti-progestin agent, and an anti-progestational agent.

  • USE OF LOW DOSE IL-2 FOR TREATING AUTOIMMUNE - RELATED OR INFLAMMATORY DISORDERS

    The present invention relates to novel therapies for treating autoimmune and inflammatory diseases. More specifically, the present invention relates to a use of low dose interleukin-2 for the treatment of type I diabetes and other autoimmune and/or inflammatory diseases.