Abstract: The formulation for oral administration of the present invention containing Mosapride or its salt is a double layer formulation consisting of a fast-release layer for rapid release of a drug and a sustained-release layer for slow release in order to simultaneously satisfy the rapid exhibition of pharmacological activities and sustained maintenance of pharmacological activities for 24 hours, wherein the high-viscosity hydroxypropyl methylcellulose (HPMC) and the low-viscosity HPMC are used in mixture such that the content of a high viscosity HPMC as a controlled-release matrix within the sustained-release layer has a higher content, thereby capable of controlling the dissolution rate in the regions having different pH values within the gastrointestinal tract and/or the retention time in the gastrointestinal tract.

Abstract: The present invention relates to compositions comprising a lipophilic local anaesthetic, preferably bupivacaine or a pharmaceutically active salt thereof, which are formulated for local administration to the mouth or throat of a subject. The compositions are useful in the treatment or alleviation of pain, burning or xerostomia of the oral cavity, pharynx, oral mucosa and pharyngeal mucosa or for use in providing local anesthesia of the oral cavity, pharynx, oral mucosa and pharyngeal mucosa. In particular in the treatment of pain, burning or xerostomia, which is caused by a disease such as oral mucositis, Burning Mouth Syndrome, Sjogren's syndrome, xerostomia, periodontitis, toothache, tonsillectomy, throat infection or mononucleosis, canker sores and aphthous stomatitis.

Abstract: The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.

Abstract: This invention relates to compositions for delivering one or more active ingredients, and more particularly to compositions, e.g. beads, comprising a matrix material which matrix material comprises a microorganism. In particular, the invention relates to compositions comprising a microorganism selected from live, killed, attenuated and inactivated microorganisms. The matrix material may also comprise a surfactant and may further comprise an adjuvant. The invention further relates to the manufacture and use of such compositions, and to other subject matter.

Abstract: Compositions and methods that are useful for treating a subject suffering from one or more cancers are provided herein. Such compositions and methods can contain an effective amount of magnesium threonate to be used to support or improve the mental state of a subject. The composition and methods comprising magnesium threonate can also be used to support a cancer treatment.

Abstract: The present invention is generally directed to an oral pharmaceutical tablet composition comprising a sulfate salt, for example, sodium sulfate, wherein the composition is capable of administration by direct oral ingestion and by disintegration in water prior to oral ingestion. The present invention is further directed to use of such oral pharmaceutical tablet formulations to induce laxation or to treat or prevent constipation.

Abstract: This invention provides: 1) a method of treating androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 2) a method of preventing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 3) a method of suppressing or inhibiting androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; and 4) a method of reducing the risk of developing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer, by administering to the subject a pharmaceutical composition comprising cis-clomiphene or a pharmaceutically acceptable salt thereof.

Abstract: Natural, organic, environmentally “green” biocide compositions comprising oregano oil in various natural delivery media.

Abstract: The tablets, compositions and methods of the present invention, comprising a carbonate salt of an aliphatic amine polymer and s monovalent anion can prevent or ameliorate acidosis, in particular acidosis in patients with renal disease. The tablets and compositions of the present invention maintain a disintegration time of no greater than 30 minutes at 37° C. and at pH of at least 1 for a period of at least ten weeks at 60° C. Furthermore, the tablets are stable for extended periods of time without the need for specialized storage conditions.

Abstract: The disclosure provides an extended release formulation of 5-fluorocytosine. In another aspect, a method of treating a fungal disease is provided. The method comprises administering to a subject in need thereof a fungus-treating effective amount of a composition comprising 5-fluorocytosine. In yet another aspect, a method of treating a cancer is provided. The method comprises administering to a subject in need thereof a sufficient amount of an expression vector to induce expression of cytosine deaminase which is capable of converting 5-fluorocytosine to 5-fluorourcail in cells of the cancer and a cancer-treating effective amount of a composition comprising 5-fluorocytosine.

Abstract: The present invention provides a rubber composition for tires and a pneumatic tire formed from the rubber composition, wherein the rubber composition can improve discoloration resistance and tire appearance while maintaining or improving good fuel economy and good abrasion resistance. The present invention relates to a rubber composition for tires containing a rubber component containing styrene-butadiene rubber in an amount of 30 to 100% by mass based on 100% by mass of the rubber component; a Pluronic-type nonionic surfactant; and sulfur, the rubber composition for tires having a combined amount of carbon black and silica of 20 to 140 parts by mass relative to 100 parts by mass of the rubber component.

Abstract: A method of preparing a glycol mono-ether or mono-acetate, or carbonate involving either one of two pathways from alkylene glycols, HMF or its reduction derivative products (i.e., FDM, bHMTHFs), is provided. In particular, according to one pathway, the alkylene glycol, HMF or FDM, bHMTHFs are reacted with a dialkyl carbonate in the presence of a deprotonating agent, in substantial absence of an extrinsic catalyst, to produce an ether, and subsequently reacting the ether with an acid base. According to the other pathway, alkylene glycols are reacted with an acetate donor in the presence of an acid, base, to generate an alkylene mono-acetate, and etherified with a carbonate in the presence of a deprotonating agent.

Abstract: The present invention provides methods of lyophilizing a pharmaceutical substance involving a primary drying step executed at a product temperature at or above the collapse temperature. The invention also provides pharmaceutical substances lyophilized at or above the collapse temperature.

Abstract: A tablet comprising a core containing an active agent, and a coating, the core being disposed within the coating such that the coating has a thickness about a longitudinal axis (X-Y) of about 4.85 to 4.95 mm. The position of the core within the coating dictating that the active agent is released rapidly after a lag time during which time no active agent is released.

Abstract: The invention relates to an oral pharmaceutical dosage form providing resistance against dose dumping in aqueous ethanol and comprising a pharmacologically active ingredient embedded in a matrix material, wherein the matrix material comprises an alkyl cellulose and a heteropolysaccharide; and wherein the relative weight ratio of heteropolysaccharide to alkyl cellulose is within the range of from 1:20 to 20:1; and wherein the total content of alkyl cellulose and heteropolysaccharide is at least 35 wt.-%, relative to the total weight of the dosage form. A process of producing the dosage form and methods of using the dosage form, for example to treat pain, are also disclosed.

Abstract: In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

Abstract: The present invention relates to a capsule composition of raloxifene comprising multiparticulates comprising a) a core comprising raloxifene, and b) a taste-masking coating present in amount of from about 0.5% to about 50% w/w based on the core weight.

Abstract: The site-specific expression of selectins on endothelial cells of blood vessels during angiogenesis provides an opportunity to target anti-cancer drugs to the vascular endothelium to extend the range of the therapeutic effect. This invention describes an innovative drug targeting strategy for the selective delivery of the anticancer drugs to endothelial cells by means of polymer-drug conjugates modified with a carbohydrate ligand for the vascular selectins. A model chemotherapeutic drug, doxorubicin, and the E-selectin ligand, sLex, are attached to a biocompatible polymer (HPMA). The selective binding, cellular uptake, intracellular fate, and cell cytotoxicity of the polymer-bound drug are investigated in human endothelial cells.

Abstract: In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

Abstract: The invention relates to a pharmaceutical composition comprising a first pharmacologically active ingredient selected from (1r,4r)-6?-fluoro-N,N-dimethyl-4-phenyl-4?,9?-dihydro-3?H-spiro[cyclohexane-1,1?-pyrano[3,4,b]indol]-4-amine and the physiologically acceptable salts thereof, and a second pharmacologically active ingredient which is a salicylic acid component selected from the group consisting of acetylsalicylic acid, salicylic acid, salicylamide, ethenzamide, salsalate, dipyrocetyl, benorilate, diflunisal, guacetisal, and the physiologically acceptable salts thereof.

Abstract: An oral dosage form to deliver diphenhydramine through the sublingual or buccal mucosa. The oral dosage form can contain diphenhydramine, or a pharmaceutically acceptable salt thereof, a permeability enhancer, and a buffering agent. The buffering agent can achieve a pH of about 7.0 to about 8.0. The diphenhydramine can completely dissolve within about 2 minutes.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: Embodiments of the invention relate generally to the use of formulations comprising DMSO and MSM to treat arthritis (such as osteoarthritis), pain, inflammation, and/or degeneration. DMSO and MSM formulations are administered orally and/or topically in several embodiments and provide effective treatment of both chronic and acute symptoms of arthritis (e.g., osteoarthritis), pain, inflammation, and/or degeneration. Solid forms of DMSO are provided in several embodiments.

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: Provided are an orally disintegrating tablet that quickly disintegrates when it is placed in the mouth or put into water, provides favorable taste, has a sufficient hardness in general production, transportation and use and is excellent in terms of storage stability, and a process for the production of the same which is excellent in terms of industrial production. An orally disintegrating tablet containing a drug, a crystalline cellulose having a bulk density of 0.23 g/cm3 or less (preferably from 0.10 g/cm3 to 0.23 g/cm3), a sugar alcohol and a pregelatinized starch.

Abstract: Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

Abstract: The invention is a pharmaceutical tablet formulation comprising between about 12.5 mg and 100 mg losartan potassium, between about 6.25 mg and about 50 mg chlorthalidone, and sodium bicarbonate in an amount between about 1.0% and about 10.0% by weight.

Abstract: The present invention relates to an oral pharmaceutical fixed dose composition in a form of a dispersible tablet for use in the treatment of tuberculosis, said oral pharmaceutical composition comprising: a) granules comprising isoniazid and at least one intragranular excipient, b) granules comprising rifapentine and at least one intragranular excipient, and c) at least one extragranular excipient, and to its process of preparation.

Abstract: Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

Abstract: In a delayed release formulation comprising a core containing a drug and a delayed release coating for providing intestinal release, release of the drug in the colon is accelerated by including an isolation layer between the core and the delayed release coating. The delayed release coating comprises an inner layer and an outer layer. The outer layer comprises a pH dependently soluble polymeric material which has a pH threshold at about pH 5 or above. The inner layer comprises a soluble polymeric material which is soluble in intestinal fluid or gastrointestinal fluid, said soluble polymeric material being selected from the group consisting of a polycarboxylic acid polymer that is at least partially neutralised, and a non-ionic polymer, provided that, where said soluble polymeric material is a non-ionic polymer, said inner layer comprises at least one additive selected from a buffer agent and a base.

Abstract: An edible energy tablet containing at least 80 weight % carbohydrates for consumption during exercise, is fabricated by a process including providing tablet material free of hydrophobic and/or PEG lubricants and free of CO2 sources. The tablet material includes a sucrose and dextrose mixture of 77-95 wt. %, maltodextrin of 2-13 wt. %, an edible soluble oil of 0.2-2.0 wt. %, and an edible acid of 1-4 wt. %. The tablet material is introduced to a tablet press that alternately moves first and second punches towards and away from one another to compress the tablet material to form and release a tablet. A punch cleaner engaged with the first and second punches removes tablet material from the punches after tablet release. The tablet has a diameter of 1.2 to 3.8 cm, a thickness of 0.6 cm to 2.3 cm, and a resistance to breakage forces of 8.5 to 30 kilopounds.

Abstract: A process for the preparation of an oral disintegrating tablet comprising the antihypertensive telmisartan and the tablet obtained by the process.

Abstract: The invention relates to the compounds of formula I and formula Ia or its pharmaceutical acceptable polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof. The pharmaceutical compositions comprising an effective amount of formula I or formula Ia; and methods for treating or preventing epilepsy, seizures and convulsions may be formulated for oral, buccal, rectal, topical, transdermal, transmucosal, intravenous, parenteral administration, syrup, or injection. Such compositions may be used to treatment of epilepsy, seizures and convulsions.

Abstract: A mesalamine pharmaceutical composition with reduced delivery variability for delivery of mesalamine to the colon that includes multiple dosage elements, and each dosage element includes mesalamine and an enteric coating. The enteric coating of each different dosage element differs so the release point of the mesalamine in the GI tract is varied. In one embodiment, a first dosage element releases about 30% to about 60% by weight of the total mesalamine in the composition after 60 minutes at a pH of about 6.6 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm and a second dosage element releases about 40% to about 70% by weight of the total mesalamine after 60 minutes at a pH of about 7.2 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: A drug dosage form is provided in the form of a solid tablet which is greater than 50% by weight the local anesthetic agent. The local anesthetic agent may be selected from the group consisting of an aminoamide, an aminoester, and a combination thereof. The drug tablet may be in the form of a mini-tablet which is greater than 70 wt % drug, with the balance being excipient. For example, the anesethetic agent may include lidocaine, in a salt or base form, combined with binder and lubricant excipients. Implantable drug delivery devices including the tablets are also provided, e.g., one or more of the drug tablets may be contained in a biocompatible housing. The drug tablets may be substantially cylindrical with flat end faces, and the device may have from 10 to 100 drug tablets aligned in the housing with the flat end faces of adjacent tablets abutting one another.

Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

Abstract: Nanocrystals, compositions, and methods that aid particle transport in mucus are provided. In some embodiments, the compositions and methods involve making mucus-penetrating particles (MPP) without any polymeric carriers, or with minimal use of polymeric carriers. The compositions and methods may include, in some embodiments, modifying the surface coatings of particles formed of pharmaceutical agents that have a low water solubility. Such methods and compositions can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for administration routes involving the particles passing through a mucosal barrier.

Abstract: Disclosed in certain embodiments is a solid oral dosage form comprising: (a) an inert tamper resistant core; and (b) a coating surrounding the core, the coating comprising an active agent.

Abstract: The present invention relates to a preservative or antimicrobial compositions with broad spectrum antimicrobial activity comprising low concentrations of essential oil (and/or one or more component thereof) and a botanical extract in synergistic combination with a fruit acid and alkanediol, and optionally a solvent. The compositions of the invention may be used in personal care products such as creams or soap products.

Abstract: Cyclophosphamide containing compositions preferably in the form of solutions having extended stability are disclosed. The compositions contain cyclophosphamide, ethanol and an ethanol soluble acidifying agent such as citric acid. Ready to dilute or ready to use cyclophosphamide containing composition of the invention maintain high levels cyclophosphamide content after about 18 or 24 months at a temperature of about 5° C.

Abstract: A method for producing starch granules suitable as an excipient for an orally disintegrating tablet. Fluidized bed granulation is performed by spraying a starch paste in small amounts while a ?-starch is being fluidized using an air-fluidized bed. Subsequently, fluidized bed drying is performed at a temperature equal to or higher than the gelatinization temperature of the ?-starch. This yields starch granules having a high degree of gelatinization in comparison with the amount of ?-starch adhered to the ?-starch by the spraying of the starch paste. These starch granules alone impart satisfactory oral disintegratability and breaking strength to the tablet. Accordingly, when used as an excipient during tableting of orally disintegrating tablets, other auxiliary excipients such as saccharides or crystalline cellulose need not be added.

Abstract: The present disclosure is directed to compositions and methods for treating or preventing muscle injury or diseases through oral administration of low doses of type I and/or type III interferons. In one embodiment a composition is administered comprising interferon-alpha and trehalose.

Abstract: Methods and compositions are provided for increasing the anaerobic working capacity of muscle and other tissues. Also provided are compositions formulated for the sustained release of free beta-alanine. Also provided is a dietary supplement formulated, for example, as a solid food product, an edible suspension, liquid or semi-liquid as described herein.

Abstract: The invention discloses a composition comprising at least one long chain polyunsaturated fatty acid, at least one probiotic and a mixture of oligosaccharides, said mixture containing at least one of lacto-N-neotetraose (LNnT) and lacto-N-tetraose (LNT), at least one N-acetylated oligosaccharide different from LNnT and LNT, at least one sialylated oligosaccharide and at least one neutral oligosaccharide, for use in increasing insulin sensitivity and/or reducing insulin resistance. This composition optionally further comprises 2?-fucosyllactose (FL). This composition is particularly adapted for use in infants who were born preterm and/or who experienced IUGR, in pregnant women suffering from gestational diabetes and in children, adolescents, and adults suffering from insulin resistance and/or type II diabetes.

Abstract: The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.

Abstract: The present disclosure relates to compositions, kits, uses, systems and methods for treating overweight and obesity using naltrexone plus bupropion, preferably in combination with a comprehensive web-based and/or telephone-based weight management program, and preferably in subjects at increased risk of adverse cardiovascular outcomes.

Abstract: The novel sustained release dosage form comprising an active agent and a combination of a non-swelling pH dependent release retardant and a non swelling pH independent release retardant polymer which provides pH-independent drug release for a considerable period of time after administration.

Abstract: Disclosed are magnesium-containing oxytocin peptide formulations or compositions comprising an oxytocin peptide and a magnesium salt that produces synergistic analgesia when used in treating pain. Also disclosed are methods for the treatment of pain (such as migraine headache) comprising co-administration of an oxytocin peptide and a magnesium salt.