Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: A dosage form comprises: (a) at least one active ingredient: (b) a core having a first surface portion upon which resides a first coating and a second surface portion which is substantially free of the first coating; and (c) a shell which resides upon at least a portion of the second surface portion, wherein the shell comprises a different material from the first coating. In another embodiment, the dosage form comprises: (a) at least one active ingredient; (b) a core comprising a center portion having an exterior surface and an annular portion having an exterior surface and an interior surface, wherein the annular portion interior surface is in contact with at least a portion of the center portion exterior surface, and a coating resides on at least a portion of the annular portion exterior surface; and (c) a shell which resides upon at least a portion of the exterior surface of the center portion, wherein the shell comprises a different material than the impermeable coating.

Abstract: 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.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: This invention relates to a pharmaceutical composition comprising a combination of phentermine in an immediate-release form and topiramate in an extended-release form. Further, it relates to processes for the preparation of the composition and a method of using the composition.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to bilayer tablet formulations comprising metformin extended release (XR) or reduced mass metformin XR formulation as the first layer, an SGLT2 inhibitor formulation as the second layer, and optionally a film coating. The present invention provides methods of preparing the bilayer tablet formulations and methods of treating diseases or disorders associated with SGLT2 activity employing the bilayer tablet formulations.

Abstract: The present invention relates to an oral controlled release pharmaceutical composition in the form of a unit dosage form comprising: (a) a highly soluble high dose active ingredient consisting essentially of therapeutically effective amount of levetiracetam or a pharmaceutically acceptable derivative thereof, and (b) a rate controlling means comprising a rate-controlling agent and/or a coating selected from (i) a active ingredient permeable coating surrounding the unit dosage form, and (ii) an active ingredient impermeable coating covering one or more surfaces but not all the surfaces of the unit dosage form, wherein the composition is in the form of a compact tablet and the levetiracetam or a pharmaceutically acceptable derivative thereof is present in an amount ranging from about 55% to about 90% by weight of the tablet.

Abstract: A magnesium-based system suitable for use in skincare comprises (a) a first magnesium source in the form of a progressive-release oral tablet exhibiting in vitro, after 2h in 0.1N HCl medium, a rate of dissolution (?) of the magnesium contained therein of less than or equal to 60% by weight relative to the total weight of the Mg provided by the first magnesium source, and (b) a second magnesium source in a topical preparation. A method for treating skin for stress, fatigue or skin barrier deficiencies, as well as for stratum corneum hydration, includes orally and topically administering magnesium sources (a) and (b), respectively.

Abstract: A solid oral pharmaceutical composition in the form of at least one tablet, the tablet consisting of a core including at least one bicarbonate salt as active ingredient and at least one prolonged-release matrix, and of a coating including at least one coating agent, the composition allowing continuous release in vivo over a period from after a quarter of an hour and up to twelve hours after taking a single dose, for use thereof as a medicament, in particular in the treatment and/or prevention of urinary lithiasis and related diseases, occurring at a physiological pH and/or during urinary acidosis and/or during hypobicarbonatemia and/or during hypocitraturia and/or during hypercalciuria and/or during hyperoxaluria.

Abstract: Solid dosage formulations of nitazoxanide or a nitazoxanide analogue are provided that comprise a controlled release portion and an immediate release portion. The pharmaceutical composition is typically in the form of a bilayer solid oral dosage form comprising (a) a first layer comprising a first quantity of nitazoxanide or analogue thereof in a controlled release formulation; and (b) a second layer comprising a second quantity of nitazoxanide or analogue thereof in an immediate release formulation. Method of using the formulations in the treatment of hepatitis C are also provided.

Abstract: A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.

Abstract: A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Abstract: Deeply scored pharmaceutical tablets are disclosed, along with pharmaceutical tablets with a score in a segment that adjoins a segment lacking a pharmacologically effective dose of any drug.

Abstract: The present invention relates to pharmaceutical compositions of calanolides, their derivatives and analogues, and process for producing the same having enhanced solubility and bioavailability for oral or parenteral administration. The invention further provides for a method of using the disclosed compositions for the treatment and prevention of retroviral diseases such as human immunodeficiency, specifically HTV-1 and mycobacterial diseases especially tuberculosis infections in mammals, particularly humans.

Abstract: The present invention provides a controlled release pharmaceutical composition which exhibits reduced food effect.

Abstract: An oral drug delivery system comprising a coated tablet having one or more surfaces. The coated tablet further comprises a core and a coating surrounding the core. The core comprises an active ingredient composition comprising at least one active ingredient and a pharmaceutically acceptable excipient and a composition selected from a swellable composition and a reactive composition located in an immediate vicinity of one or more preselected surfaces. The coating comprising water insoluble polymer(s) and leachable component(s) is operable to be reliably removed fully from the one or more of the preselected surfaces of the tablet upon contact with an aqueous environment, but not removed from at least one of the surfaces.

Abstract: The present invention relates to granules comprising oxycodone, as well as to orally disintegrating tablets including same and optionally acetaminophen.

Abstract: Low dose pharmaceuticals can be delivered for a prolonged period using a tablet-in-tablet design wherein the drug is contained in a controlled release matrix in the outer compression coating layer but not in the inner tablet core.

Abstract: Controlled release oral dosage forms are provided for the continuous, sustained administration of a pharmacologically active agent to the upper gastrointestinal tract of a patient in whom the fed mode as been induced. The majority of the agent is delivered, on an extended release basis, to the stomach, duodenum and upper regions of the small intestine, with drug delivery in the lower gastrointestinal tract and colon substantially restricted. The dosage form comprises a matrix of a biocompatible, hydrophilic, erodible polymer with an active agent incorporated therein, wherein the polymer is one that both swells in the presence of water and gradually erodes over a time period of hours, with swelling and erosion commencing upon contact with gastric fluid, and drug release rate primarily controlled by erosion rate.

Abstract: An oral dosage form comprising a pharmaceutical tablet of one or more layers, one of which carries a biologically active substance; the formulation of said tablet includes different percentages of hydrophilic and lipophilic polymeric materials, and adjuvant substances. The tablets of the present invention show a release rate which is independent from the amounts of active substance present in the tablet.

Abstract: New pharmaceutical compositions for oral use containing Diclofenac together with alkali metal bicarbonates in amounts of from 20 to 80 by weight with respect to Diclofenac are described. These compositions are entirely palatable and free from any unpleasant taste or other side effects; in particular, these formulations permit to obtain in human patients higher Cmax of the active principle and shorter Tmax together with a lower coefficient of variation.

Abstract: The invention relates to sustained release compositions of alfuzosin or pharmaceutically acceptable salts thereof that include one or more functional layers. The functional layer includes alfuzosin or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable hydrophilic and/or hydrophobic rate-controlling polymers.

Abstract: A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.

Abstract: The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.

Abstract: Granule, fine particle or tablet of excellent leaching property, comprising a drug active ingredient in high content realized by forming a layer containing drug active ingredient on core particles through a combination of a method of dispersing and adhering an active ingredient while spraying or adding a binder with a method of spraying or adding a solution or suspension wherein an active ingredient and a binder are contained so as to effect adhesion. Further, there are provided a drug composition containing such a granule, fine particle or tablet and a process for producing the same.

Abstract: The invention relates to sustained release compositions of alfuzosin or pharmaceutically acceptable salts thereof that include one or more functional layers. The functional layer includes alfuzosin or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable hydrophilic and/or hydrophobic rate-controlling polymers.

Abstract: The invention relates to glucocorticoid replacement therapy and provides pharmaceutical compositions and kits designed to deliver one or more glucocorticoids to a subject in need thereon in a manner that results in serum levels of the glucocorticoid that essentially mimic that of a healthy subject for a clinically relevant period of time. The pharmaceutical compositions and kits are prepared in such a way that a first part of one or more glucocorticoids is substantially immediately released and a second part of one or more glucocorticoids is released over an extended period of time of at least about 8 hours. The invention also relates to a method for treating diseases requiring glucocorticoid treatment such as in subjects having a glucocorticoid deficiency disorder.

Abstract: Disclosed are pharmaceutical compositions having a portion of aspirin for intraoral release and another aspirin for gastrointestinal release. The compositions can further include niacin. Methods of using such compositions to treat diseases or conditions suitably treated by niacin are also provided which result in reduced flushing.

Abstract: Pharmaceutical compositions and oral dosage forms of (2R)-2-phenylcarbonyloxypropyl (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoate mesylate and methods of treating diseases comprising orally administering such pharmaceutical compositions and dosage forms are disclosed.

Abstract: The present invention relates to an oral controlled release pharmaceutical composition in the form of a unit dosage form comprising: (a) a highly soluble high dose active ingredient consisting essentially of therapeutically effective amount of levetiracetam or a pharmaceutically acceptable derivative thereof, and (b) a rate controlling means comprising a rate-controlling agent and/or a coating selected from (i) a active ingredient permeable coating surrounding the unit dosage form, and (ii) an active ingredient impermeable coating covering one or more surfaces but not all the surfaces of the unit dosage form, wherein the composition is in the form of a compact tablet and the levetiracetam or a pharmaceutically acceptable derivative thereof is present in an amount ranging from about 55% to about 90% by weight of the tablet.

Abstract: The present invention relates to an oral controlled release pharmaceutical composition in the form of a unit dosage form comprising: (a) a highly soluble high dose active ingredient consisting essentially of therapeutically effective amount of levetiracetam or a pharmaceutically acceptable derivative thereof, and (b) a rate controlling means comprising a rate-controlling agent and/or a coating selected from (i) a active ingredient permeable coating surrounding the unit dosage form, and (ii) an active ingredient impermeable coating covering one or more surfaces but not all the surfaces of the unit dosage form, wherein the composition is in the form of a compact tablet and the levetiracetam or a pharmaceutically acceptable derivative thereof is present in an amount ranging from about 55% to about 90% by weight of the tablet.

Abstract: Disclosed is a controlled release nucleated tablet which is composed of an inner nucleus and an outer layer that covers the inner nucleus and is capable of maintaining the level of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid in the blood to a certain value or higher for a long period of time. The controlled release nucleated tablet is characterized in that the inner nucleus contains 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and the outer layer contains 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and a gel-forming water-soluble polymer that is in an amount of 16 (w/w) % or more relative to the weight of the outer layer.

Abstract: What is described is an implant that comprises a coating, at least in areas, in the implanted state in the surface areas that are at least directly in contact with skin and/or soft tissue. The implant is preferably characterized in that the coating comprises both a statin, such as simvastatin, in the hydrolyzed or unhydrolyzed form, or pharmaceutically compatible salts thereof, as well as at least one other component selected from the group consisting of branched or linear, substituted or unsubstituted, saturated or partially unsaturated C10-C30 alkyl, alkenyl, alkylaryl, aryl, cycloalkyl, alkylcycloalkyl, alkylcycloaryl amines or mixtures thereof and/or at least one water-soluble ionic polymer component. A method for production such an implant is also described as well as a composition that can be used in such a method.

Abstract: The invention features sublingual film formulations of dopamine agonists and methods of treating Parkinson's disease, tremors, restless leg syndrome, sexual dysfunction, and depressive disorders therewith.

Abstract: A pharmaceutical formulation of a gastric proton pump inhibitor, with the exception of omeprazole, is disclosed. The formulation is in the form of microgranules insoluble in gastric fluid having improved stability over time. The formulation comprises several hydrophobic substances chosen in order to increase the stability of the active principle while obtaining the desired dissolution profile.

Abstract: The invention relates to a controlled-release formulation for preventing and/or treating sleep disorders comprising Zaleplon or a pharmaceutically acceptable salt thereof in immediate release form and Zolpidem or a pharmaceutically acceptable salt thereof in sustained release form, wherein Zaleplon or a pharmaceutically acceptable salt thereof and Zolpidem or a pharmaceutically acceptable salt thereof are released in two phases where the first phase is a immediate release phase of Zaleplon or a pharmaceutically acceptable salt thereof and the second phase is a sustained release phase of Zolpidem or a pharmaceutically acceptable salt thereof.

Abstract: A controlled extended drug release technology for the controlled extended release of hydrophobic or hydrophilic drugs or therapeutically active agents consisting of a homogeneous blend of one or more therapeutic agents, gas generators and surrounded by one or more layers of coat made of thermoplastic water insoluble cellulose derivatives, acrylic polymers, superdisintegrants and optionally an oil, antioxidants and electrolytes. The technology platform is capable of releasing therapeutic agents via zero, first or pseudo first order release.

Abstract: In one aspect, the present invention features a tablet including: (i) a first drug layer including naproxen; (ii) a second drug layer including a decongestant (e.g., pseudoephedrine) wherein said second drug layer is a sustained release layer adapted to deliver a therapeutically effective amount of pseudoephedrine for a period of at least twelve hours; and (iii) a barrier layer that does not include naproxen, wherein the barrier layer is in contact with the first drug layer; and (iv) a third drug layer including cetirizine, wherein the third drug layer is in contact with the barrier layer and is not in contact with the first drug layer.

Abstract: The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.

Abstract: A method and apparatus for assembling a plurality of independently formed solid components is provided thereby forming a single delivery vehicle for a pharmaceutical or pharmaceutical-like product. The solid components can be held and fed to the apparatus via a plurality of magazines. Pusher rods and the like can be used for positioning each of the solid components. Where the components are connected via a bonding liquid, a sprayer is provided and compression pins or the like press the components with the bonding liquid together to form the final product. A rivet or other connection structure can also be used and driven through holes in each of the solid components to form the final product.

Abstract: An extended release pharmaceutical composition comprising Paliperidone or pharmaceutically acceptable salts thereof and one or more pharmaceutical excipients and process for preparing the same. The present invention particularly relates to an extended release pharmaceutical composition comprising Paliperidone or pharmaceutically acceptable salts thereof and one or more pharmaceutical excipients wherein the core is coated with multiple coatings.

Abstract: It is intended to provide a long-acting solid pharmaceutical preparation which has an immediate release part and a sustained release part containing tramadol or a pharmaceutically acceptable salt thereof, is fast-acting and stably has an excellent release property showing little pH dependency in the initial elution. The invention relates to a long-acting solid pharmaceutical preparation characterized by having an immediate release part and a sustained release part, containing tramadol or a pharmaceutically acceptable salt thereof as an active ingredient in both parts and containing partially pregelatinized starch and an excipient as additives in the immediate release part.

Abstract: In one aspect, the present invention is concerned with a treatment where it is desired that an active agent is designed to be released in a prolonged manner at a time point some time after administration of the active agent. The present invention is particularly suited to administering an agent which may be released whilst a subject is sleeping, shortly before waking and continues to administer the drug during the early waking hours. As well as treating certain conditions by a particular regime, the invention also provides novel formulations for a delayed, followed by a prolonged release of drug.

Abstract: A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Abstract: Provided are cap layer compositions and base layer compositions, providing quick and extended release of an active ingredient, respectively, when placed in water. Further provided are dual release compositions including a base composition and a cap composition. The base composition may include a plaster and an active agent, and it may further include at least one of a water-soluble binder, a non-water-soluble binder, and a lubricant. The cap composition may include a plaster and an active agent, and it may further include at least one of a disintegrating agent, a non-water-soluble binder, and a lubricant. The compositions may be heated and mixed and formed into a tablet. Further provided are methods of making the compositions. Further provided are methods of controlling or eliminating pests and methods of increasing the potability of water. The compositions are effective for controlling or eliminating pests such as mosquitoes when applied at an application site.

Abstract: The present invention is directed to a solid dose form comprising a film coating composition encapsulating a core, wherein: (i) the core comprises an active ingredient comprising at least one of a pharmaceutical, veterinary, or nutraceutical active ingredient; (ii) the film coating composition comprises ethylcellulose and guar gum, wherein the guar gum has an apparent viscosity ?151.0 cps at a shear rate of 50 s?1 in a 1% aqueous guar gum solution measured rotationally at 20° C. after 1 minute equilibration using a 6 cm acrylic cone (1°) on a cone-plate viscometer wherein the shear is ramped up linearly from 1 to 50 s?1 in 25 steps over 29 seconds; (iii) the dose form provides controlled release of the active ingredient; (iv) the guar gum is present in an amount greater than 5 wt % based on the weight of the guar gum and ethylcellulose; and (v) the dose form is ethanol resistant.