Abstract: The present invention provides an enteric coated composition for oral administration of a chloride channel opener which can provide improved pharmaceutical activity with reduced adverse side effect such as nausea.

Abstract: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: Drugs are formulated as oral dosage forms for controlled release in which the release rate limiting portion is a shell surrounding the drug-containing core. The shell releases drug from the core by permitting diffusion of the drug from the core. The shell also motes gastric retention of the dosage form by swelling upon imbibition of gastric fluid to size that is retained in the stomach during the postprandial or fed mode.

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 invention is directed to an extended release formulation comprising pramipexole or a pharmaceutically acceptable salt thereof.

Abstract: An antifungal product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for the antifungal product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, as well as two or more delayed release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.

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: Methods and compositions for treating inflammatory bowel disease involve the use of targeted antibiotics in combination with probiotic formulations. The probiotics mitigate many of the deleterious side effects associated with antibiotic use and permit the antibiotic to be administered at a higher dose and for a longer duration than would otherwise be possible in the absence of the probiotic. The practice of the invention may reduce or eliminate the use of immunosuppressants in the treatment and management of IBD.

Abstract: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: The present invention relates to a conformable and semi-permeable biopolymeric membrane suitable for tissue repair and protection. This membrane contains a first layer made from randomly oriented, reconstituted biopolymer fibers and, on top of the first layer, a coating layer made from biopolymer fibers.

Abstract: A controlled release pharmaceutical composition for oral use is provided in the form of a coated matrix composition, the matrix composition comprising i) a mixture of a first and a second polymer that have plasticizing properties and which have melting points or melting intervals of a temperature of at the most 200° C.

Abstract: A pharmaceutical composition with an active pharmaceutical ingredient including a pomegranate fruit polyphenol extract. The pomegranate fruit polyphenol extract includes at least about 3% combined punicalagin A and punicalagin B by weight, less than about 5% ellagic acid and their derivatives by weight, and less than about 1% anthocyanins by weight.

Abstract: Multilayer functionally coated tablets for oral administration of one or more active pharmaceutical ingredients containing one or more quick release layers and one or more modified release layers separated by an inert layer are provided. Also provided are methods for formulation and use of these tablets.

Abstract: The present invention concerns a method for coating granules comprising mesalazine, with a coating mixture comprising two polymers, polymer I and polymer II; said polymer I being selected to allow formation of a closing membrane around said granules in the absence of said polymer II, and said polymer II being selected to act as a water-soluble pore former in said coating mixture; wherein a) the amount of polymer I is adjusted to provide a closing membrane in the absence of polymer II, and b) the amount of polymer II in said coating mixture is adjusted to obtain coated granules which exhibit controlled release of mesalazine. The invention further concerns a product obtainable by the coating method.

Abstract: The present invention is concerned with a system for spatially and temporally programmable delivery of an active agent. When administered orally, the System can be retained in the gastric region for a prolonged period of time. It comprises of a core (I), one or more layers (II, IV, V) coated over the core and a preformed hollow space (III). The invention also concerns with a process for preparation of the System and a method for treating/preventing diseases, by administering to a subject in need thereof, the System of the invention.

Abstract: An oral dosage form for administration to an animal comprising a biologically utilizable form of calcium and a extended release system that maintains the calcium level in the animal's bloodstream at a substantially beneficial level for a defined period of time.

Abstract: A pharmaceutical matrix film tablet with controlled release of natural mixtures of conjugated estrogens which have been obtained from the urine of pregnant mares.

Abstract: 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.

Abstract: The present invention relates to a multilayer orodispersible tablet and to the process for preparing it.

Abstract: The present invention relates to pharmaceutical compositions of antihistamine-decongestant combination. Specifically the invention relates to bilayered tablet formulation comprising antihistaminic decongestant combination. More specifically present invention relates to the novel polymorph of fexofenadine or pharmaceutically accepted salts thereof, with at least one decongestant in the form of bilayered tablet. The preferred polymorphs are polymorph A and polymorph X of fexofenadine hydrochloride.

Abstract: In one aspect, the present invention features a tablet including a first drug layer and a second drug layer, wherein: (i) the first drug layer includes first drug particles including naproxen and third drug particles including cetirizine, where the first drug particles and/or the third drug particles are coated with an immediate release coating; and (ii) the second drug layer including 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.

Abstract: In one aspect, the present invention features a tablet including a first drug layer, a second drug layer, and a third drug layer, wherein (i) the first drug layer includes naproxen; (ii) a second drug layer including pseudoephedrine; and (iii) the third drug layer includes cetirizine; wherein the first drug layer is in contact with the second drug layer, the third drug layer is in contact with the second drug layer, and the first drug layer is not in contact with the third drug layer, and wherein the 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.

Abstract: Aqueous drug coatings including at least one insoluble drug, wherein the insoluble drug accounts for about 85 wt % to about 97 wt % of the drug coatings are described. Such drug coatings may include only one insoluble drug, two or more insoluble drugs, or one or more insoluble drugs in combination with one or more soluble drugs.

Abstract: The present invention provides immediate release and modified release oral dosage forms. Specifically, the invention provides modified and immediate release pharmaceutical dosage forms containing memantine that exhibit an enhanced release profile and provide reliable absorption. The dosage forms may be used to treat mild, moderate or severe Alzheimer's disease or neuropathic pain.

Abstract: A pharmaceutical composition in the form of a tablet including a first portion and a second portion, wherein said first portion includes guaifenesin having an immediate release profile and a second drug having a sustained release profile, and wherein the second portion includes guaifenesin having a sustained release profile. The second drug can be in the form of a drug-resin complex. The second drug can be either an anti-tussive or a decongestant. The drug-resin complex includes a drug complexed to an ion exchange resin. The ion exchange resin can be a polystyrene sulfonate resin, polacrilex resin, polacrilin potassium, cholestyramine resin, or a colestyramine resin. The drug-resin complex can be provided with a coating, the coating thickness being selected to obtain the desired release profile. The drug-resin complex can be provided with a coating level of from 5% to 50%. The coating level can be from 10% to 35%.

Abstract: Methods and compositions are provided which comprise effective amounts of analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.

Abstract: A pharmaceutical composition, comprising a thiazolidinedione, such as Compound (I), metformin hydrochloride and a pharmaceutically acceptable carrier, wherein the thiazolidinedione and metformin hydrochloride are each dispersed within its own pharmaceutically acceptable carrier in the pharmaceutical composition and the use of such a composition in medicine.

Abstract: A pharmaceutical tablet adapted for accurate division of a dose of a drug into two or more smaller doses, which tablet has two or more segments.

Abstract: The present invention provides a hydrostatic delivery system including a hydrostatic couple and an agent of interest. The hydrostatic couple includes at least one hydrodynamic fluid-imbibing polymer, and at least one hydrostatic pressure modulating agent. This delivery system has the ability to control the release of one or more agents of interest within a fluid environment following zero-order kinetics.

Abstract: This invention relates to a oral pharmaceutical formulation for methylphenidate or its analogs, derivatives, isomers or enantiomers, including d-threo-methylphenidate.

Abstract: The present invention is directed to aqueous drug coatings that include at least one insoluble drug, wherein the drug accounts for about 85 wt % to about 97 wt % of the drug coatings. A drug coating according to the present invention may include only one insoluble drug, two or more insoluble drugs, or one or more insoluble drugs in combination with one or more soluble drugs. The present invention also includes drug coating formulations suitable for providing drug coatings according to the present invention and dosage forms that include a drug coating according to the present invention.

Abstract: Methods are provided for producing a bioscaffold from natural tissues by oxidizing a decellularized tissue to produce a bioscaffold having pores therein. The pore size and porosity is increased to better accommodate intact cells so that live cells can better infiltrate and inhabit the bioscaffold. The bioscaffold may be freeze-dried or lyophilized, sterilized and (optionally) aseptically packaged for subsequent use. A further aspect of the present invention is a bioscaffold produced by the processes described herein. Methods of treatment using the bioscaffold as a graft or as a biomedical implant for implantation are also provided. Also provided are methods of seeding a bioscaffold with mammalian cells, wherein the seeding carried out either in vitro or in vivo, and wherein a bioscaffold produced as described herein is utilized for said seeding.

Abstract: The present disclosure is directed to a method for treating a disease or disorder in a patient at risk of developing an NSAID-associated ulcer by administering to the patient in need thereof a pharmaceutical composition in unit dosage form comprising aspirin, or a pharmaceutically acceptable salt thereof, and an acid inhibitor to the at risk patient and thereby decreasing the patient's risk of developing an ulcer.

Abstract: The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing drug-induced hepatotoxicity, myopathy, or rhabdomyolysis.

Abstract: The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.

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 present invention provides pharmaceutical compositions for oral administration comprising a therapeutically effective amount of a selective factor Xa inhibitor or a pharmaceutically acceptable salt thereof and an enhancer, wherein the enhancer is a medium chain fatty acid or a salt, ester, ether, or derivative of a medium chain fatty acid and has a carbon chain length of from 4 to 20 carbon atoms. The present invention also provides a method for obtaining a reproducible bioavailability of selective factor Xa inhibitor in a subject after oral administration comprising orally administering a pharmaceutical composition as described above.

Abstract: The present invention is directed to multi-layered compositions for oral administration having at least one orally disintegrating layer and capable of maintaining layer cohesion. The present invention is also directed to methods of manufacturing such compositions.

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: Multilayer minitablets for oral administration of an active pharmaceutical ingredient which release the active pharmaceutical ingredient at different pH ranges and/or in different release profiles are described.

Abstract: The present invention relates to an orally administrable preparation comprising a quinolone antibiotic which releases the active compound with a delay.

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: A bilayer solid composition comprising (a) an immediate release first layer comprising an anti-allergic effective amount of desloratadine and at least one pharmaceutically acceptable excipient and (b) a sustained release second layer comprising an effective amount of a nasal decongestant, e.g. pseudoephedrine sulfate and a pharmaceutically acceptable sustained release agent wherein the composition contains less than about 2% of desloratadine decomposition products is disclosed. A solid composition comprising an anti-allergic effective amount of desloratadine and at least one, and preferably two pharmaceutically acceptable antioxidants is also disclosed.

Abstract: A controlled release pharmaceutical composition comprising Milnacipran or pharmaceutically acceptable salts thereof and hydrophobic release controlling agent. The composition releases 90% of the total amount of Milnacipran or pharmaceutically acceptable salts thereof between 8 to 20 hours when dissolution is carried out in 900 ml 0.1N HCl, USP apparatus Type I (Basket) at 100 rpm for 2 hrs, followed by 900 ml Phosphate buffer pH 6.8 USP apparatus Type I (Basket) at 100 rpm.

Abstract: A unit multiparticulate dosage form for delivering one or more basic, active pharmaceutical ingredients into the body in need of such medications to achieve target PK (pharmacokinetics) profiles is described. The dosage form comprises one or more multicoated drug particles (beads, pellets, mini-/micro-tablets) having a barrier coating and a lag-time coating. Each Timed Pulsatile Release (TPR) bead population exhibits pre-determined lag-time followed by differing release characteristics. The composition and thickness of the barrier coating, composition and thickness of the lag-time coating, ratio of IR beads to one or more TPR bead populations and total dose may be varied depending on the alkalinity, pH-dependent solubility and elimination half-life of the active ingredients to achieve target PK profiles (suitable for a once or twice daily dosing regimen) in patients in need of such medications.

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 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: A zolpidem tablet having modified release is designed as a tablet-in-tablet dosage form.

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

Abstract: The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.

Abstract: Methods and compositions are provided which comprise effective amounts of analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.