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: Venlafaxine besylate is formulated into an extended release tablet in high loading rates by use of a coating that contains ammonio methacrylate copolymer(s).

Abstract: A depot formulation comprising iloperidone and a biodegradable, biocompatible polymer. Preferably, the polymer is a star polymer.

Abstract: The present invention relates to the pharmaceutical dosage forms which enable a controlled and/or a targeted delivery of an active substance to the selected regions of gastrointestinal tract of humans or animals. The pharmaceutical dosage forms preferably comprises the active substance N-(2(2-phthalimidoethoxy)-acetyl)-L-alanyl-D-glutamic acid (designated as LK 423). Methods of treatment of chronic inflammatory diseases of gastrointestinal tract of humans and/or animals by using the pharmaceutical dosage forms of the invention are disclosed.

Abstract: A method of forming a tablet includes the steps of pre-blending an active pharmaceutical ingredient susceptible to tackiness and a blending additive with a first mixing effort to form a pre-blend mixture, wherein the first mixing effort and a second mixing effort, resulting from mixing at least one excipient with the pre-blend mixture, form a blend suitable for direct compression and compressing the blend to form the tablet. One way of achieving the first mixing effort is to pre-blend for an extended period of time. The method allows for directly compressing the blend without the need for a granulation step or roller compression. One such active pharmaceutical ingredient susceptible to tackiness is ibuprofen.

Abstract: The present invention relates to a process for the preparation of a medicament containing vardenafil hydrochloride trihydrate in solid form, in which vardenafil hydrochloride trihydrate is processed with suitable pharmaceutical auxiliaries at a temperature of from approx. 20° C. to approx. 45° C.

Abstract: Solid controlled-release oral dosage forms comprising a therapeutically effective amount of an opioid analgesic or a salt thereof which provide an extended duration of pain relief of about 24 hours, have a dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm at 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37° C. of from about 12.5% to about 42.5% (by wt) opioid released after 1 hour, from about 25% to about 65% (by wt) opioid released after 2 hours, from about 45% to about 85% (by wt) opioid released after 4 hours, and greater than about 60% (by wt) opioid released after 8 hours, the in-vitro release rate being substantially independent of pH and chosen such that the peak plasma level of said opioid analgesic obtained in-vivo occurs from about 2 to about 8 hours after administration of the dosage form.

Abstract: The present invention relates to pharmaceutical compositions of diclofenac or pharmaceutically acceptable salts thereof and misoprostol or pharmaceutically acceptable salts thereof. The invention also relates to processes for the preparations of such compositions.

Abstract: The present invention refers to a solid dosage form comprising an inner coating located between a core containing a pharmaceutically active ingredient and an outer enteric coating; wherein said inner coating comprises a partially neutralized anionic polymeric material, and at least a carboxylic acid having 2 to 16 carbon atoms the salts thereof or mixtures of said acid and its salt; wherein said outer coating comprises an anionic polymeric material which is less or not at all neutralized than the material of the inner coating.

Abstract: Pharmaceutical compositions comprising micronized fenofibrate, a surfactant and a binding cellulose derivative as a solubilization adjuvant, wherein said compositions contain an amount of fenofibrate greater than or equal to 60% by weight and methods of producing fenofibrate compositions.

Abstract: The present invention relates to the supply and production of an animal medicine consisting of a substrate in pellet or tablet form, which is attractive to livestock and domestic animals, in which fine-grained particles of a neutral-tasting, physiologically compatible, solid carrier material are embedded, which is characterised in that said fine-grained particles of carrier material have an average diameter of 0.09 to 0.8 mm and are coated with an active substance from veterinary medicine, and said active substance layer is covered with a protective layer of a physiologically compatible polymer matrix, and to the production of this animal medicine. It also relates to the usage of said double-coated, fine-grained particles of carrier material in the production of a preparation for veterinary medicine.

Abstract: A controlled release dosage forms comprising zolpidem or a salt thereof to release zolpidem to induce rapid onset of sleep, and continue to release zolpidem in a controlled manner to maintain effective plasma concentrations over an extended period of time to improve sleep maintenance. The pharmaceutical controlled-release dosage form of zolpidem or a salt thereof having a dissolution profile when measured in a type I or II dissolution apparatus according to the U.S. Pharmacopoeia in 0.01M hydrochloric acid buffer at 37° C., such that less than 40% is released at the end of 30 minutes.

Abstract: The present invention provides various pharmaceutical compositions comprising an S1P receptor modulator, e.g. an S1P receptor agonist. In one aspect, there is provided a pharmaceutical composition having a coating. In other aspects, rapid disintegrating compositions are provided. In a further aspect, a pharmaceutical composition which is free of sugar alcohols is provided. In another aspect, the invention provides a pharmaceutical composition comprising a coating comprising an S1P receptor modulator.

Abstract: The present invention comprises methods and compositions for the reduction of oxalate in humans, animals and plants. For example, the invention provides methods and compositions for the delivery of one or more oxalate-reducing pharmaceutical compositions to the intestinal tracts of persons and animals. The methods and compositions can be used in treating and preventing oxalate-related conditions.

Abstract: The invention relates to a solid oral dosage form comprising a pharmaceutically active ingredient in combination with an enhancer which enhances the bioavailability and/or the absorption of the active ingredient. Accordingly, a solid oral dosage form comprises a drug and an enhancer wherein the enhancer is a medium chain fatty acid ester, ether or salt or a derivative of a medium chain fatty acid, which is, preferably, solid at room temperature and which has a carbon chain length of from 6 to 20 carbon atoms. Preferably, the solid oral dosage form is controlled release dosage form such as a delayed release dosage form.

Abstract: This invention pertains to an orally disintegrating multilayer tablet wherein it comprises at least two discrete layers, one of which comprises at least one active agent that promotes the oxidation of opioids, preferably acetaminophen, and the other of which contains granules including an inert core which is coated with at least one opioid and at least one binder, wherein said opioid coating is coated with a subcoat comprising a compound soluble in gastric fluids, said subcoat being coated with a taste-masking coating comprising a polymer or copolymer comprising dialkylaminoalkyl(meth)acrylate units and optionally a pore-forming agent.

Abstract: A film-coated preparation having excellent storage stability, which contains a compound represented by the formula (I) below or a pharmacologically acceptable salt thereof, having a film layer containing one or more film coating base agents selected from polyvinyl alcohol, sodium carboxymethyl cellulose and pullulan.

Abstract: The present invention provides composition of comprising a therapeutically effective amount of at least one peptide, polypeptide, analog or derivative thereof and a sufficient amount of at least one stabilizing agent to improve the stability of the peptide, polypeptide, an analog or derivative thereof, wherein at least one stabilizing agent is a medium chain fatty acid salt, an ester, an ether, or a derivative of a medium chain fatty acid and has a carbon chain length of from about 4 to about 20 carbon atoms or is a surface active agent. The method for preparation of a composition of a peptide, polypeptide, protein, an analog and/or derivative thereof is also provided.

Abstract: The present invention provides a novel tablet with improved tablet appearance and improved swallowability. The tablet contains a pharmaceutically acceptable anion exchange resin represented by colestimide as an active ingredient, and has a visibility-resolved tablet edge.

Abstract: A pharmaceutical dosage form comprising diphenhydramine, or a pharmaceutically acceptable salt thereof, and ibuprofen, wherein the dosage form provides both diphenhydramine and ibuprofen in a single monolayer tablet, and processes for preparation of dosage forms.

Abstract: Dosage forms for the oral administration of the magnesium salt of pantoprazole are described.

Abstract: Provided are multilayer compressed oral dosage forms comprising naproxen or a pharmaceutically acceptable salt thereof and sumatriptan or a pharmaceutically acceptable salt thereof. Processes of making and using the oral dosage forms also are described.

Abstract: An enteric sustained-release coated core includes a drug-containing core and a coating film. The coating film includes 20%˜80% by weight of a hydrophobic polymer and 10%˜70% by weight of an enterosoluble material. The dissolution rate of the medical component in the drug-containing core is approximately less than 10% in hydrochloric acid solution of pH 1˜3 after 2 hours. The dissolution of the medical component in the drug-containing core sustains more than 5 hours in phosphate buffer solution of pH 5˜8.

Abstract: Disclosed are formulations which are designed to release rasagiline mesylate while maintaining specific pharmacokinetic properties.

Abstract: Disclosed herein is an extended release pharmaceutical formulation suitable for once daily administration, comprising a highly water soluble core consisting essentially of about 30 to about 40% by weight of venlafaxine hydrochloride, about 50 to about 80% by weight of water soluble diluent and about 2 to about 10% of water soluble binder and a coating layer having an effective combination of rate controlling polymers comprising water-soluble polymer and water insoluble, water permeable polymer.

Abstract: The invention relates to a stable solid dosage form comprising olmesartan medoxomil and amlodipine or a pharmacologically acceptable salt thereof. In particular, it relates to solid dosage forms free from reducing sugars. The stable solid dosage form may optionally further comprise hydrochlorothiazide or a pharmacologically acceptable salt thereof.

Abstract: The invention provides pills and tablets having lubricious coating deposited over the outer surface of the pills and the tablets.

Abstract: Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.

Abstract: A novel solid oral dosage form comprising a therapeutically effective amount of hydrophobic pharmacological active ingredient and at least one particle separating agent preferably selected from a class of wetting agents, prepared without or with minimum amount of a disintegrating agent. The hydrophobic pharmacological active ingredient active ingredient belongs to the class of angiotensin receptor blocking agents preferably is valsartan optionally in combination with hydrochlorothiazide. The active ingredient may also be a class of 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors preferably atorvastatin. The ratio of hydrophobic active ingredient to particle separating agent is about 20:1 to about 1:20. The process for the preparation of the novel solid oral dosage form comprises treating a hydrophobic active ingredient with at least one particle separating agent, and incorporating the treated hydrophobic active ingredient into a solid dosage form.

Abstract: The invention at hand concerns trofosfamide containing film-coated tablets for oral application and a procedure for their production.

Abstract: The invention relates to the combination of polyvinyl acetate and water-insoluble, acid-insoluble, or alkali-insoluble polymers used for producing film coatings for forms of administration in which agents are released in a controlled manner, and methods for the production thereof. The controlled-release properties can be specifically adjusted by means of said combinations, resulting in films having excellent mechanical stability and storage stability. In particular, agents are released independent of the pH by means of the inventive forms of administration.

Abstract: In a solid pharmaceutical preparation containing 1) a basic medicinal component having an unpleasant taste; 2) a saccharide; 3) a polyanionic polymer; 4) a corrigent; and 5) carboxymethylcellulose, the unpleasant taste of the basic medicinal component having an unpleasant taste can be satisfactorily masked and excellent properties such as quick disintegration, appropriate preparation strength and high storage stability over a long period of time, etc., can be achieved. Further, a quickly disintegrating solid pharmaceutical preparation containing a medicinal component, a sugar alcohol and carboxymethylcellulose has excellent properties such as quick disintegration, appropriate preparation strength, high storage stability over a long period of time, etc.

Abstract: A process for preparing an orally dispersible solid pharmaceutical form comprises the following steps: a) coating the active ingredient with at least one hydrophilic carboxylate polymer, b) granulating the coated active ingredient obtained in step (a) with at least one lipid compound having a melting point lower than that of the active ingredient, c) mixing the granulate obtained in step (b) with at least one hydrophilic natural polymer having high molecular weight, and d) mixing the granulate obtained in step (c) with ingredients suitable for obtaining an orally dispersible solid pharmaceutical form. An orally dispersible solid pharmaceutical form comprises an active ingredient coated with at least one hydrophilic carboxylate polymer and at least one lipid compound, in which the said coated active ingredient is embedded in a matrix comprising at least one hydrophilic natural polymer having high molecular weight.

Abstract: Disclosed are oral dosage forms comprising an effective amount of mesalamine, wherein the dosage form has a dissolution profile such that greater than 5 wt % of the total weight of the mesalamine in the dosage form is released during a pH 6.0 portion of a dissolution test, the dissolution test comprising stirring in a pH 6.0 solution for 1 hour, followed by stirring in a pH 7.2 solution for an additional hour. In some embodiments, the dosage form releases less than all of the mesalamine to the right side of the colon. Release of less than all of the mesalamine dosage form to the right side of the colon may be determined by the in vitro dissolution profile of the dosage form.

Abstract: The invention discloses a pharmaceutical composition useful for treatment and prevention of medical disorders and ailments. The aforesaid composition comprises active ingredients comprising; Turmeric extract, Turmeric powder, optionally, Selenium or source of Selenium, especially Selenomethionine, optionally, Green tea extract. The pharmaceutical composition further comprises enteric coating encapsulating the same. The disclosed pharmaceutical composition is especially adapted for treatment of inflammatory bowel disease (IBD) and colorectal cancer (CRC).

Abstract: Pharmaceutical compositions comprising mesalamine, wherein the compositions are free of a liphophilic matrix, and processes for preparing pharmaceutical compositions comprising mesalamine and being free of a liphophilic matrix.

Abstract: The present invention relates to a tablet comprising a tabletted core comprising a triglyceride granulate, and an enteric coating surrounding said tabletted core. The invention particularly relates to a tablet wherein the tabletted core contains esterified omega-3 fatty acids such as eicosapentaenoic acid and/or docosahexaenoic acid.

Abstract: Bioadhesives coatings increase the gastrointestinal retention time of orally-ingested medicaments. Certain bioadhesive coatings producing a fracture strength of at least 100 N/m2, as measured on rat intestine, when applied to at least one surface of a pharmaceutical dosage form for oral delivery of a drug, result in a gastrointestinal retention time of at least 4 hours in a fed beagle dog model, during which the drug is released from the dosage form. Multi-layer tablets, particularly those including hydrophobic excipients, are useful in administering hygroscopic and/or deliquescent drugs. In addition, varying the amount of drug in multi-layer tablets allows the release rate of the drug to be controlled.

Abstract: Pharmaceutical compositions for oral administration comprising terbinafine and a method for administering high dosages while minimizing effects associated with e.g. a high dosage load, e.g. coated tablets or multiparticulate formulations such as minitablets or pellets, e.g. in capsules.

Abstract: The present invention pertains to a sized product, which contains a drug, polyethylene oxide with a molecular weight of 2,000,000 or higher, and a specific size controlling agent for polyethylene oxide (substance with the appropriate plasticity and binding force) and wherein at least the above-mentioned specific size controlling agent is uniformly dispersed in the above-mentioned polyethylene oxide, a controlled-release pharmaceutical composition containing this sized product, and a method of manufacturing a controlled-release pharmaceutical composition containing this sized product. A controlled-release pharmaceutical composition with good uniformity of content can be presented by using powder particles of polyethtylene oxide with powder properties suitable for tableting, which is obtained by uniform dispersion of the specific size controlling agent for polyethylene oxide of the present invention.

Abstract: The present invention relates to a bioadhesive drug delivery system (BIOadhesive Rate controlled Oral Dosage (BIOROD) formulation) in which a drug containing core either alone or coated with a rate controlling membrane system is enveloped on its circumference by a bioadhesive coating, thereby yielding a monolithic system that allows for drug release in a regulated manner. Also described herein are polymers with improved bioadhesive properties and methods for improving bioadhesion of polymers.

Abstract: This invention relates to solid and stable dispersions of a hydrosoluble derivative of vinca alkaloids in at least one polyethyleneglycol with a molecular mass between 800 and 30,000.

Abstract: The invention relates to a pharmaceutical active-ingredient-containing formulation for oral administration which is coated with a single coating of a film-forming polymer, the coating comprising a mixture of at least two separating agents and no stabilizer.

Abstract: An active compound-containing pellet has a polymer coating of an anionic (meth)acrylate copolymer and a pharmaceutically active substance, embedded in a polymer matrix of one or more polymers, a particle size in the range from 300 to 1100 ?m, a friability of at most 0.1%, measured using 200 g of pellets in a screening machine having a 200 ?m screen, a screening diameter of 20 cm and 1.5 mm shaking amplitude at a shaking frequency of 50 l/sec for 10 min in the presence of six rubber cubes having a 1.8 cm edge length, with the proviso that the pellet releases no more than 10% of the active compound in a release test according to USP in artificial gastric juice at pH 1.2 after 120 min.

Abstract: A pharmaceutical composition comprising a Zolpidem hemitartrate starting material comprised of form A, the composition containing less than about 8% by weight of water. The starting material typically comprises less than about 0.1% by weight of forms of Zolpidem other than Form A.

Abstract: This invention comprises pharmaceutical compositions for administering a biologically active compound to an animal. Particularly provided are proliposomal compositions that are advantageously used to deliver biologically active compounds to the gastrointestinal tract after oral administration.

Abstract: The present invention provides a novel gastric retention system in the form of a tablet or a capsule coated with an expandable coating, more particularly, with an expandable coating comprising a film-forming polymer and an expandable component.

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

Abstract: Formulations have been developed to improve the solubility of corticosteroids such as fluticasone proprionate in a composition designed to achieve localized release of the drug in the small intestine and/or colon. In one embodiment, solid dispersions of fluticasone are prepared wherein the drug is blended with or coated onto a highly water soluble substrate such as nonpareil (sugar beads) then coated with a layer of polymer soluble in small intestinal fluid, then coated with an enteric coating. The inner polymer layer controls release of the drug, and the enteric coating, a pH sensitive polymer that is broken down in the ileum and colon, controls localized release of drug at various sites within the gastrointestinal tract. The multilayer pharmaceutical composition can be in the form of pellets, tablets compressed from pellets or pellets packed into capsules. The release profile of the drug can be manipulated by (1) altering size or shape (i.e.

Abstract: This invention comprises pharmaceutical compositions for administering a polycyclic, aromatic, antioxidant or anti-inflammatory compound to an animal. Particularly provided are proliposomal compositions that are advantageously used to deliver polycyclic, aromatic, antioxidant or anti-inflammatory compounds to the gastrointestinal tract after oral administration.