Abstract: A pharmaceutical composition and dosage form for the treatment of incontinence with oxybutynin and a second drug is provided. The second drug can be darifenacin or tolterodine. Depending upon the route of administration, the dosage form used, and the second drug used, the dosage form may independently include therapeutic or sub-therapeutic amounts of the oxybutynin and the second drug. Particular embodiments include a dosage form that provides a controlled release of oxybutynin and the second drug to maintain therapeutically effective levels oxybutynin and/or the second in a mammal for an extended period of time. An osmotic device containing a bi-layered core is provided. The osmotic device provides a dual controlled release of both drugs from the core. A method of treating urinary (stress or urge) incontinence with the pharmaceutical composition and dosage form is provided.

Abstract: A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.

Abstract: The present invention provides a sustained-release pharmaceutical composition, characterized in that, there are contained tamsulosin or a pharmaceutically acceptable salt thereof and a carrier for a sustained-release pharmaceutical composition and, when a dissolution test is carried out according to Japanese Pharmacopoeia Dissolution Test Method 2, the tamsulosin release after 7 hours from the start of the dissolution is about 20 to about 85%.

Abstract: A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

Abstract: The present invention relates to a tablet composed of a core and a coating; said core is formed by two or more layers, wherein at least one of them contains an active agent (3). Wherein one of said layers is formulated as a swellable composition (2), the other one (4) is composed of inert compounds retaining its size at least until the coated tablet is emptied from the stomach. The coating composition is selected from the group comprising water insoluble polymers, ph dependent polymers or mixtures thereof. The active agent is released after rupture of the coating.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

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 dosage form having sustained-release or controlled-release properties for delivering 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol from the dosage form over an extended period of time in a therapeutically responsive dose to produce antidepressant therapy.

Abstract: The invention pertains to a dosage form 10 and to administering an antidepressant medicament 16 for an extended period of time in a rate-known dose.

Abstract: The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: The present invention provides a simple and improved osmotic device that is capable of providing a controlled release of active agent contained in the core first through a preformed passageway and then through an in situ formed second passageway into an environment of use. One or both of the passageways optionally increases in size during use of the osmotic device. The preformed passageway and/or the second passageway increase the release rate of the active agent, enable the release of large particles containing active agent, and/or enable the release of active agents that are substantially insoluble in the environment of use. By virtue of the in situ formation of the second aperture, the device is able to release a greater overall percentage of active agent than it would release in absence of the second aperture.

Abstract: A film coating composition suitable for use in coating pharmaceutical formulations comprising a) an acrylic polymer dispersion, e.g. an ethylacrylate/methylmethacrylate copolymer such as Eudragit NE30D, b) a surfactant, c) sodium stearyl fumarate, and d) a water-containing liquid useful for the achievement of controlled release from pharmaceutical formulations such as tablets, pellets, etc.

Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.

Abstract: The present invention relates to a process using ultrasonic cutting for the preparation of an oral delivery device comprising a core which includes a pharmaceutically active agent covered by an outer coating which includes one or more openings communicating from the exterior of the device toward the core.

Abstract: The invention comprises a gastric device having a pouch formed from a degradable film. Preferably, the pouch contains a gas producing material. The gastric device hydrates within a patient's stomach and the gas producing material expands the device to a greater volume. Accordingly, the volume of the hydrated, expanded gastric devices occupy space in the stomach cavity and reduce the amount of food the patient will ingest before reaching the feeling of fullness. Preferably, the gastric device is made from food grade materials. The gastric device is configured to expand to a desired volume and then degrade after a residence time, allowing the device to be passed by the patient's normal digestive process.

Abstract: The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.

Abstract: A biointerface membrane for an implantable device including a nonresorbable solid portion with a plurality of interconnected cavities therein adapted to support tissue ingrowth in vivo, and a bioactive agent incorporated into the biointerface membrane and adapted to modify the tissue response is provided. The bioactive agents can be chosen to induce vascularization and/or prevent barrier cell layer formation in vivo, and are advantageous when used with implantable devices wherein solutes are transported across the device-tissue interface.

Abstract: A method of inducing the sustained release of antibodies in milk comprising the step of: a) implanting at least one antigen releasing device adjacent to, within close proximity of or within at least one supramammary lymph node, wherein in use the antigen releasing device releases an antigen into the tissue area around the supramammary lymph node which stimulates antibody secretion into a mammary gland.

Abstract: The invention is directed to sustained release formulations containing oxycodone or a pharmaceutically acceptable salt thereof which provide a mean C24/Cmax oxycodone ratio of 0.6 to 1.0 or 0.7 to 1 after oral administration at steady state to patients and methods thereof.

Abstract: The present invention relates to controlled porous osmotic pump tablets of high permeable drugs and the preparation process thereof. The controlled porosity osmotic pump tablets do not need to be drilled by laser, but provides controlled porosity for drug release by adding a suitable quantity of pore-forming agents into the semipermeable membrane. In specific embodiments, the present invention relates to controlled porous osmotic pump tablets comprising venlafaxine or metoprolol or pharmaceutically acceptable salts thereof.

Abstract: The invention is for a method and composition for preparing a controlled release pharmaceutical formulation which can be used to administer Hydralazine hydrochloride over a 24 hours time frame, and for controlled release oral dosage forms of Hydralazine hydrochloride in the form of a tablet and a capsule.

Abstract: The present invention includes controlled release dosage forms and methods of designing and manufacturing dosage forms to obtain specific release profiles, for example, zero-order release profiles, escalating release profiles or decreasing release profiles. The dosage forms of the present invention can include spatial variation of API concentration in the dosage form and can include nested regions. Dosage forms according to the present invention may be manufactured by any appropriate method for obtaining the internal structure as disclosed herein for producing zero-order release profiles and increasing or decreasing release profiles. The invention further includes methods of manufacturing such dosage forms, such as by three-dimensional printing, possibly also including compression of the dosage form after three-dimensional printing. The invention further includes methods of designing such dosage forms.

Abstract: A dosage form comprises at least one active ingredient, a first portion which comprises an exterior surface and one or more cavities defining at least one interior surface having indentations and an exterior surface, and a second molded portion which is inlaid into the cavities of the first portion and has an exterior surface. The first and second portions are in contact at an interface, the second portion comprises a solidified thermoplastic material, and the second portion resides substantially conformally upon the indentations of the first portion. In another embodiment, a dosage form comprises at least one active ingredient, a core having an outer surface and a shell residing on at least a portion of the core outer surface, wherein the shell comprises a first shell portion and a second molded shell portion which is inlaid into the first shell portion.

Abstract: A dosage form is disclosed comprising means for delaying the delivery of drug from the dosage form following the administration of the dosage form to a patient in need of drug therapy.

Abstract: The present invention refers to a tablet-shaped osmotic release system providing, in a controlled way, active principles which solubility depends on the pH of the medium, simultaneously providing appropriate solubilization throughout the gastrointestinal tract. The pharmaceutical osmotic release system comprises of a pharmaceutical layer, which contains at least one active principle in a solid solution, a propelling layer, which contains at least one osmopolymer and at least one osmoagent, a semipermeable coating involving both layers, and at least one orifice in the semipermeable coating at the side of the pharmaceutical layer.

Abstract: A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

Abstract: Disclosed is a controlled release formulation comprising valproic acid, pharmaceutically acceptable salt thereof, amide thereof, or derivative thereof.

Abstract: The present invention is a new type of microporous film. The micoporous film can be applied to use as coating material of controlling drug release. The present invention also relates to a preparation of the microporous film.

Abstract: Enteric film coating systems for orally ingestible substrates such as pharmaceutical tablets and dietary supplements are disclosed. In preferred aspects, the enteric film coatings include an ethylcellulose dispersion and a substantially gastro-insoluble pore former such as sodium alginate.

Abstract: The invention concerns a floating pharmaceutical composition consisting of at least a first phase comprising at least a high dose active principle combined with one or several carriers and at least a second phase comprising at least a gas-generating system. The invention also concerns tablets comprising such a pharmaceutical composition and a method for preparing such tablets.

Abstract: The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.

Abstract: The invention provides a dosage form comprising at least one active ingredient, and first core and second cores surrounded by and separated by a shell. The dosage form provides a delay of at least one hour between the initial release of active ingredient contained in said first core and the initial release of active ingredient contained in said second core after contacting of the dosage form with a liquid medium.

Abstract: A controlled release formulation of pramipexole for once-a-day administration to a mammalian subject, which formulation releases pramipexole along a pre-determined release profile, is provided.

Abstract: Provided are pharmaceutical dosage forms within structures such as hollow capsules, gelcaps, or sachets, adapted to allow ingestion of a whole dose or a preferably predetermined fraction of said dose when desired.

Abstract: A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

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: This invention pertains to a multi-layered tablet for a triple combination release of active agents to an environment of use. More particularly, the invention pertains to a multi-layered tablet (1) comprising two external drug-containing layers (2 and 3) in stacked arrangement with respect to and on opposite sides of an oral dosage form (4) that provides a triple combination release of at least one active agent. In one embodiment of the invention the dosage form is an osmotic device. In another embodiment of the invention the dosage form is a gastro-resistant coated core. In yet another embodiment of the invention the dosage form is a matrix tablet. In a different embodiment the dosage form is a hard capsule.

Abstract: A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

Abstract: A system and method for manufacturing oral osmotic drug delivery devices including the use of a mathematical model in deriving relationships between parameters used in manufacturing the devices for a desired release rate of the active drug substance contained therein. The derived relationship is then used to control the parameters so that the active substance within the device is delivered at a desired rate. Methods of administering the oral osmotic drug delivery devices are also provided. Use of a mathematical model in deriving relationships between parameters used in the drug granulation process for a desired range of percentage fines of the drug granulation substance. The derived relationship is then used to control the parameters in the drug granulation process so that the desired percentage fines are obtained in the drug granulation substance.

Abstract: A method of treatment for hypertension and other disease states is described, which comprises the delivery of losartan in a gastric retained dosage form.

Abstract: New pharmaceutical compositions in unit dosage form are disclosed for both intraoral and oral administration to a patient, said unit dosage form configured to be placed intraorally of said patient, which comprises: (a) as a first portion, at least one discrete molded triturate tablet comprising a therapeutically effective amount of at least one pharmaceutically active ingredient capable of intraoral administration; and (b) as a second portion located around the said first portion, a therapeutically effective amount of at least one pharmaceutically active ingredient capable of oral administration and which is releasable and orally ingestible by the patient after the molded triturate tablet has disintegrated or has dissolved intraorally.

Abstract: Apparatuses and methods for pumping fluids such as fluid medications are disclosed. Embodiments of the invention provide an osmotic pump fluid delivery apparatus including elements designed to control the fluid delivery rate. Typical embodiments of the invention include an arrangement of elements such as solute reservoirs that can manipulate the solute concentrations within an inner osmotic compartment or compartments of an osmotic pump so as to control fluid delivery from the pump. Other embodiments include sealed electro-osmotic pumps that do not discharge ions into the surroundings or require water from an external source. These embodiments of the invention provide new ways to control fluid delivery in apparatuses that employ osmotic processes to function.

Abstract: A nifedipine controlled release composition is provided comprising a drug-layer and a push-layer at a ratio of 1:0.5˜3 by weight. The drug-layer contains nifedipine and 40˜99 percent by weight of the drug-layer of hydrophilic polyvinylpyrrolidone homopolymer and/or copolymer carrier. The push-layer comprises about 10 to 80 percent by weight of the push-layer of osmopolymers, about 10 to 80 percent by weight of the push-layer of water-insoluble polymers, and about 5 to 50 percent by weight of the push-layer of osmagents. The composition is used in osmotic pump tablets for controlled release of nifedipine useful for administration once a day.

Abstract: A drug core composition is described for enhancing controlled delivery of pharmaceutical active agents with low solubility in water. The drug core composition contains at least a drug-layer and a push-layer. The drug-layer contains at least a pharmaceutical active agent with low solubility in water and a hydrophilic polymer carrier. The push-layer contains at least osmopolymers, water-insoluble polymers and osmagents. An osmotic pump system containing the drug core composition is described wherein a semi-permeable membrane is coated outside of the drug core composition. The drug core composition provides drug release at a controlled rate particularly adaptable for release of therapeutic dosages over a period of 24 hours when administered once a day.

Abstract: The invention encompasses novel salts of topiramate, and pharmaceutically acceptable polymorphs, solvates, hydrates, dehydrates, co-crystals, anhydrous, or amorphous forms thereof, as well as pharmaceutical compositions and pharmaceutical unit dosage forms containing the same. In particular, the invention encompasses pharmaceutically acceptable salts of topiramate, including without limitation topiramate sodium, topiramate lithium, topiramate potassium, or polymorphs, solvates, hydrates, dehydrates, co-crystals, anhydrous, and amorphous forms thereof. The invention further encompasses novel co-crystals or complexes of topiramate, as well as pharmaceutical compositions comprising them. The invention also encompasses methods of treating or preventing a variety of diseases and conditions including, but not limited to, seizures, epileptic conditions, tremors, cerebral function disorders, obesity, neuropathic pain, affective disorders, tobacco cessation, migraines, and cluster headache.

Abstract: An osmotic pump device for delivery of tamsulosin or a pharmaceutically acceptable salt thereof to the gastrointestinal tract is provided. The device is a two-layer device comprising a drug containing layer containing as a carrier about 10 to 99 percent by weight of the first layer a polyvinylpyrrolidone polymer and/or copolymer, and a second layer comprising about 10 to 80 percent by weight of the second layer of water-insoluble volume-swellable polymers, about 80 to 10 percent by weight of the second layer of osmopolymers, and about 5 to 50 percent by weight of the second layer of osmagents.

Abstract: An immediate release compressed pharmaceutical tablet that has two or more segments and a top and a bottom and has a height that exceeds the width of the tablet. The height is measured vertically from the top to the bottom of the tablet while it is in the tablet die in which it is fully compressed, after compression has been completed. The width is measured as the greatest horizontal dimension of the tablet at a location halfway between the top and the bottom of the tablet, except that when the horizontal cross-section of the tablet is substantially rectangular, the width is defined by locating the two shorter sides of the perimeter of the horizontal cross-section, and measuring the length of a line that is at right angle to the shorter sides.

Abstract: An immediate release compressed pharmaceutical tablet that has two or more segments and a top and a bottom and has a height that exceeds the width of the tablet. The height is measured vertically from the top to the bottom of the tablet while it is in the tablet die in which it is fully compressed, after compression has been completed. The width is measured as the greatest horizontal dimension of the tablet at a location halfway between the top and the bottom of the tablet, except that when the horizontal cross-section of the tablet is substantially rectangular, the width is defined by locating the two shorter sides of the perimeter of the horizontal cross-section, and measuring the length of a line that is at right angle to the shorter sides.