Abstract: Coated pellets which comprise an active pharmaceutical ingredient that is poorly soluble in water, release at least 80% of the active ingredient under in vitro conditions in phosphate buffer at pH 5.0 after 30 minutes and are bioequivalent to a liquid formulation of the active ingredient under in vitro fed status test conditions and/or are coated with a composition, which includes a lipophilic component (A) and a hydrogel former (B), wherein the pure lipophilic component (A) has (i) an HLB value of ?5, and/or (ii) a melting range of ?60° C., and/or (iii) a solidification range ? of less than 35° C., and/or (iv) a density of ?0.80 g cm?3.

Abstract: The purpose of the present invention is to provide a press-coated orally-disintegrating tablet characterized by containing an inner core which has an excellent disintegratability in oral cavity and a suitable hardness as a whole tablet. The present invention relates to a press-coated orally-disintegrating tablet with an outer layer surrounding an inner core wherein the inner core has a thickness in the range of 10 to 90% per that of the whole tablet, and the outer layer comprises (a) microcrystalline cellulose, (b) an inorganic excipient, and (c) one or more particular ingredients selected from the group consisting of crospovidone, starches, low substituted hydroxypropylcellulose and carmellose.

Abstract: Pharmaceutical formulations comprising niacin in a matrix comprising a hydrophobic polymer that modifies release of niacin.

Abstract: This invention relates to sustained release pharmaceutical compositions comprising O-desmethyl-venlafaxine, in particular to sustained pharmaceutical compositions comprising O-desmethyl-venlafaxine orotate and/or O-desmethyl-venlafaxine glucuronate.

Abstract: By coating the surface of a powder comprising a silicone resin and/or an organic powder with a specific hydrophilizing agent, such powder is hydrophilized. Such coated (treated) powder has extremely great dispersibility (ease of dispersion) and very good dispersion stability (long-term dispersion stability with lapse of time) in aqueous dispersion media, particularly under acidic and alkaline conditions, specifically at pH 3 through 13. Using the surface-treated powder, additionally, a dispersion with good dispersibility (ease of dispersion) and great dispersion stability, preferably for cosmetics can be provided. The use of the surface-treated powder, or the use of the dispersion can provide further a cosmetic excellent in dispersibility and dispersion stability and further in re-dispersibility and dispersion stability with lapse of time and smooth feeling as compared to the related art when selecting aqueous cosmetic as an agent form.

Abstract: The present invention relates to an oral pharmaceutical formulation that employs: (1) a compressed core containing a decongestant or pharmaceutically acceptable salt thereof; (2) a delayed release coating on the compressed core and (3) immediate release therapeutic amounts of a decongestant and an antihistamine.

Abstract: The present invention relates to pharmaceutical compositions of DPP IV inhibitors with an amino group, their preparation and their use to treat diabetes mellitus.

Abstract: A timed or delayed release oral composition delivery system for the treatment of colonic disorders and diseases is provided. According to one aspect, a delayed release oral pharmaceutical composition includes an active core comprising a therapeutically effective amount of 5-amino salicylic acid (i.e., mesalamine); a primary coating composition disposed around the active core, wherein the primary coating composition includes an enteric polymer; and a secondary coating composition disposed around the primary coating composition, wherein the secondary coating composition includes a ratio mixture of ethyl cellulose and hydroxypropyl methylcellulose.

Abstract: The invention relates to a pharmaceutical formulation of nanonised fenofibrate, to a method for preparing same, and to the uses thereof.

Abstract: A hydromorphone composition, a hydromorphone dosage form and a method for administering hydromorphone are disclosed, indicated for the management of pain.

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 solid unit dosage form of aliskiren for oral administration in the form of a tablet having a core and an outer coating is prepared such that the core contains a therapeutically effective amount of aliskiren and the outer coating is in the form of a film-coat with taste masking properties and/or can undergo controlled release.

Abstract: Dual release oral tablet compositions of dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof and processes for the manufacture of the tablet composition and its use in the treatment of gastrointestinal disorders.

Abstract: An oral pharmaceutical formulation of aliskiren, or a pharmaceutically acceptable salt or polymorph thereof, having at least two coating layers.

Abstract: The present invention provides solid preparations having two or more colors or a pattern of two or more different colors which can solve the problems of the prior art including the complexity of production processes and the low strength of solid preparations. Specifically, an object of the present invention is to provide solid preparations coated with a continuous film coating layer having two or more different colors or a pattern of two or more different colors which preparations are obtained by irradiating a part of the film coating layer containing one or more colorants with light, a process for the preparation of such solid preparations, and a film coating agent therefor.

Abstract: This invention relates to a pharmaceutical dosage form for the phase-controlled and chronotherapeutic delivery of at least one and, preferably, several pharmaceutically active ingredients. The dosage form has a carrier platform which,—preferably, is a polymer having known biodegradable characteristics. The platform may include a pharmaceutically active ingredient'which is released over a predetermined period of time as the platform polymer degrades. At least one pharmaceutically active ingredient in the form of a disc is embedded in the platform and, once the polymer of the platform has degraded, the disc is released and releases its ingredient in the same location as that of the platform or it travels to another region of the body where it releases its ingredient.

Abstract: The invention relates to a dosage form for oral administration comprising a carrier tablet, wherein the carrier tablet is at least partially (preferably partially) covered by a film comprising 1-isopropyl-4-{[4-(tetrahydro-2H-pyran-4-yloxy)phenyl]carbonyl}hexahydro-1H-1,4-diazepine or a pharmaceutically acceptable salt thereof, such as the mono-maleate salt thereof. In particular embodiments, the film, which at least partially covers the carrier tablet, comprises a stabiliser (e.g. citric acid), and/or a film former (e.g. hydroxypropylcellulose). The film is preferably present in a recess on the carrier tablet. The invention also relates to a method of producing said dosage form.

Abstract: This invention relates to a pharmaceutical dosage form for the site specific delivery of more than one active pharmaceutical ingredient to different sites in the human or animal body in the gastrointestinal tract. The dosage form has an outer polymeric layer incorporating a first active pharmaceutical ingredient which reacts to stimuli specific in the stomach, degrades, and releases the first active pharmaceutical ingredient in the stomach for absorption. The dosage form also has at least one inner polymeric layer incorporating a second active pharmaceutical ingredient which, once the outer layer has degraded, passes into the intestine where the polymers of the second layer degrade to release the second active pharmaceutical ingredient. The dosage form may have additional layers each incorporating active pharmaceutical ingredients for release in different portions of the intestine depending on the nature of the polymers.

Abstract: This disclosure relates to pharmaceutical compositions comprising bazedoxifene and an antioxidant such as vitamin E, vitamin E TPGS, propyl gallate, citric acid, or BHA/BHT, substantially free of ascorbic acid, as well as methods of making such compositions. Also provided are methods of enhancing dissolution stability and/or enhancing bioavailability of bazedoxifene in a formulation containing an antioxidant, and methods of reducing interactions of at least one of bazedoxifene and hydroxymethyl cellulose with at least one of ascorbic acid and one or more degradant products of ascorbic acid in such compositions.

Abstract: The invention relates to coated tablets comprising the pharmaceutically active substance diclofenac. Said tablets further comprise a single film coating.

Abstract: Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed herein are solid oral dosage forms which can be administered as a capsule or tablet, or alternatively as a sprinkle form with the patient experiencing little or no bitter taste. The dosage forms provide immediate release in vitro and in vivo.

Abstract: Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed herein are solid oral dosage forms which can be administered as a capsule or tablet, or alternatively as a sprinkle form with the patient experiencing little or no bitter taste. The dosage forms provide immediate release in vitro and in vivo.

Abstract: A film coating which is an oxygen barrier is applied to a pharmaceutical dosage form to protect the dosage form from atmospheric oxygen. The coating comprises a polymeric binder, an anti-tackifying agent, and an optional dissolution enhancing agent, where the polymeric binder is sodium carboxymethylcellulose, the anti-tackifying agent is talc, and the optional dissolution enhancing agent is sucrose, sodium bicarbonate, or a mixture thereof.

Abstract: A pharmaceutical composition for oral administration comprising a core and a film coating on the core that exhibits enhanced disintegration characteristics is disclosed. The film coating comprises a film forming polymer, an organic solvent, a super-disintegrant and, optionally, an acid labile material.

Abstract: A sugar-coated agent that includes a core, a film layer that mainly includes a film component, the outer surface of the core being coated with the film layer, a sugar coating layer that mainly includes a sugar coating component, the outside of the film layer being coated with the sugar coating layer, and a middle layer that includes a film component and a sugar coating component and is provided between the film layer and the sugar coating layer, wherein within the middle layer, the concentration of the sugar coating component at the interface between the middle layer and the sugar coating layer is higher than the concentration of the sugar coating component at the interface between the middle layer and the film layer.

Abstract: Intraorally rapidly disintegrating tablets which, when ingested, disintegrates in the oral cavity rapidly without presenting unpleasant taste, can be quickly absorbed in the digestive tract and express efficacy are provided. The intraorally rapidly disintegrating tablets contain a drug being hardly water-soluble under neutral or alkaline conditions and being highly water-soluble under acidic conditions yet presenting unpleasant taste, which tablets can be prepared by combining the medicinal substance with a water-soluble acidic substance, coating either or both of the substances with a water-soluble coating agent being insoluble in alcoholic solvent, further adding a water-soluble binding agent being soluble in alcoholic solvent and a water-soluble saccharide, subjecting the resultant mixture to compression, and treating the products with an alcoholic solvent.

Abstract: An orally disintegrable tablet, of the present invention, which comprises (i) fine granules having an average particle diameter of 400 ?m or less, which fine granules comprise a composition coated by an enteric coating layer, said composition having 10 weight % or more of an acid-labile physiologically active substance and (ii) an additive, has superior disintegrability or dissolution in the oral cavity so that it can be used for treatment or prevention of various diseases, as an orally disintegrable tablet capable of being administered to the aged or children and easily administered without water. Also, because the tablet of the present invention contains fine granules having the average particle diameter such that it will not impart roughness in mouth, it can be administered easily without discomfort at the administration.

Abstract: A compressible extended release tablet or tablet layer having a drug release profile that is not strongly dependent on tablet hardness may be prepared by dry blending a pharmaceutically active ingredient with hydroxypropyl methylcellulose, wherein the hydroxypropyl methylcellulose has a bimodal or multimodal number average molecular weight distribution that includes at least one mode over 20,000 Daltons and at least one mode under 10,000 Daltons. An additional advantage of the invention is that the tablet formulations may be prepared without resort to wet granulation.

Abstract: A pharmaceutical composition containing the active substance atorvastatin in the form of oblong-shaped tablets with the length of 5 to 22 mm and the width of 2 to 11 mm or round tablets with the diameter of 3 to 16 mm, the core of which is constituted of compressed granulate and contains: i. Atorvastatin and/or at least one physiologically acceptable salt thereof in the quantity of 5 to 10% by weight, related to pure atorvastatin; ii. An organic or inorganic base selected from meglumine or an alkali metal hydroxide or their combination in the quantity of 0.01 to 7% by weight; iii. A pharmaceutically acceptable filler in the quantity of 20 to 90% by weight; iv. A disintegrant in the quantity of 0.5 to 50% by weight; provided with a coat that makes up 1 to 15% of the weight of the core, the selected base being uniformly distributed in the tablet core by means of spraying the same on the solid mixture in the granule production process.

Abstract: The invention provides an oral dosage form for the anti-cancer drug picoplatin comprising a core and a coating, the dosage form being free of redox-active metal salts. The core of the tablet is a substantially dry powder comprising about 10 to 60 wt % picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant. The dosage form can further include a dispersant.

Abstract: An aqueous liquid laundry detergent containing methylcarboxymethyl cellulose having a degree of methylation in the range from 0.01 to 0.3, surfactant, and at least one typical ingredient of laundry detergents. The detergent inhibits graying of textile fabrics during the washing of the fabrics.

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 tablet characterized by comprising 5-methyl-1-phenyl-2-(1H)-pyridone as the main ingredient and, based on the main ingredient, 10 to 50 wt. % excipient, 5 to 40 wt. % disintegrator, 1 to 10 wt. % binder, 0.5 to 5 wt. % lubricant, 2 to 6 wt. % coating basis, and 0.05 to 3 wt. % light-shielding agent, wherein the odor or bitterness of the 5-methyl-1-phenyl-2-(1H)-pyridone is masked and the light stability is improved.

Abstract: A controlled release melatonin tablet having a slow release nucleus of melatonin, hydroxypropyl methylcellulose, a lubricant, a volume excipient and a glidant, wherein 95% of the melatonin is released within 5 hours in an oscillating tray containing gastric/intestinal juice at 37° C. and a fast release cortex coating on said nucleus of melatonin, hydroxypropyl methylcellulose and a volume excipient, wherein at least 95% of the melatonin is released within 10 minutes in an oscillating tray containing gastric/intestinal juice at 37° C.

Abstract: The invention relates to dosage forms and formulations comprising the novel crystal modification A of the compound I-(2, 6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide, wherein crystal modification A is characterized by characteristic lines with interplanar spacings (d values) of 10.5 ?, 5.14 ?, 4.84 ?, 4.55 ?, 4.34 ?, 4.07 ?, 3.51 ?, 3.48 ?, 3.25 ?, 3.19 ?, 3.15 ?, 3.07 ?, and 2.81 ?, determined by means of an X-ray powder pattern. Dosage forms of crystal modification A of the compound I-(2, 6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide may be for oral or parenteral administration, in the form of a solid or liquid, and in a dosage range of 20 mg to less than 500 mg. Solid dosage forms comprise a tablet or capsule, and further comprise a pharmaceutically-acceptable carrier and film-coat.

Abstract: Enteric coated capsules or tablets for oral delivery of a protein, polypeptide or peptide drug, in particular for oral delivery of insulin, are provided, comprising microparticles of the protein, polypeptide or peptide drug, microparticles of a protease inhibitor and, optionally, microparticles of an absorption enhancer. The protease inhibitor and the absorption enhancer may be together in the same microparticles. The microparticles of each component are embedded in an enteric polymer matrix.

Abstract: A composition comprising a high molecular weight, water soluble polymer having a cloud point from about 20 to about 90° C. and at least one carrageenan is provided. The composition may be used as a component of a pharmaceutical dosage form, such as the shell of a dosage form, to provide burst release of active ingredient contained therein.

Abstract: The present invention relates to taste masked compositions of S-alkylisothiouronium derivatives, including, but not limited to, S-ethylisothiouronium diethylphosphate, in the form of a coated oral tablet having a desirable dissolution profile.

Abstract: A film-coated extended release solid oral dosage composition containing a nasal decongestant, pseudoephedrine or salt thereof, e.g., pseudoephedrine sulfate in a core effective to provide a geometric maximum plasma concentration of pseudoephedrine of about 345 ng/mL to about 365 ng/mL at a time of about 7.60 hrs to about 8.40 hrs and having two or three film-coatings on the core, the second one containing an amount of the non-sedating antihistamine, desloratadine, effective to provide a geometric maximum plasma concentration of desloratadine of about 2.15 ng/mL to about 2.45 ng/mL at a time of about 4.0 hours to about 4.5 hours, and use of the composition for treating patients showing the signs and symptoms associated with allergic and/or inflammatory conditions of the skin and airway passages are disclosed.

Abstract: The present invention provides a tablet coating composition including a cellulose polymer, a plasticiser, a sweetener, and a powdered flavour composition. The powdered flavour composition includes a flavourant associated with a solid carrier. The present invention also provides a pharmaceutical tablet including a core containing an active agent and a coating formed from the tablet coating composition.

Abstract: A pharmaceutical extended-release oral drug delivery system comprising as active ingredient Cefixime Trihydrate in combination with a hydrophilic matrix system, and optionally containing additional pharmaceutically acceptable constituents, wherein at least 20% up to but not more than 40% of Cefixime Trihydrate is released from said matrix within 1 hour from oral administration and the remainder of the pharmaceutical agent is released at a sustained rate.

Abstract: The present invention relates to a drug delivery system, in which a drug containing core, either alone or coated with a rate controlling membrane system, is enveloped on its circumference by an optionally bioadhesive coating, thereby yielding a monolithic system that allows for drug release in a regulated manner.

Abstract: A wet granulated pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof with less than about 5 weight % of an alkaline earth metal salt additive with a disintegrant which provides the atorvastatin with not more than about 3% atorvastatin lactone based on the ratio of lactone peak area compared to the total drug-related peak integrated areas, as well as said wet granulated pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof in combination with at least one other active drug, methods for preparing said compositions, kits for containing such compositions, and a method of treating hypercholesterolemia and/or hyperlipidemia, osteoporosis, benign prostatic hyperplasia (BPH), and Alzheimer's disease using a therapeutically effective amount of the pharmaceutical compositions.

Abstract: A combination product containing at least two active compounds, O-desmethylvenlafaxine or a pharmaceutically acceptable salt thereof and bazedoxifene or a pharmaceutically acceptable salt thereof is described. Also described are methods of making and using this combination product to treat a variety of conditions associated with low circulating estrogen levels or low estrogen receptor activity.

Abstract: Coated tablets of (6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine) are provided. The tablets minimize the perceived bitterness of the medicament. A method for analyzing instantaneous dissolution of sub-microgram quantities of core material is also disclosed.

Abstract: A solid pharmaceutical dosage form that is safeguarded against abuse containing at least one active substance that could be subject to abuse and at least one antagonist for the active substance, which antagonist is spatially separate from the active substance. The active substance or substances is/are present in at least one subunit (a), and the at least one antagonist is present in at least one subunit (b), and the at least one antagonist in subunit (b) is to all intents and purposes not released in the body if the dosage form is correctly administered as prescribed.

Abstract: An oral pharmaceutical dosage form comprises pharmacologically effective amounts of an acid-susceptible proton pump inhibitor and an H2 receptor antagonist in combination with at least on pharmacologically acceptable excipient which causes a delayed release and/or an extended release of the proton pump inhibitor. The H2 receptor antagonist is included in the dosage form in such a way that it is rapidly released after administration. This dosage form is suitable for the treatment of conditions associated with an excessive secretion of gastric acid and provides a suitable combination of a rapid onset and a long-lasting duration of the effect. The invention also relates to a method for manufacturing such a dosage form and to a method for the treatment of conditions associated with the secretion of gastric acid.

Abstract: The present invention relates to polypeptides having cellobiohydrolase I activity and polynucleotides having a nucleotide sequence which encodes for the polypeptides. The invention also relates to nucleic acid constructs, vectors, and host cells comprising the nucleic acid constructs as well as methods for producing and using the polypeptides.

Abstract: The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.

Abstract: A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one of a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.