Abstract: The present invention provides for a method of treatment of IgA nephropathy, which method comprises: (i) identifying a pharmaceutically acceptable composition intended to treat IgA nephropathy comprising budesonide and one or more pharmaceutically-acceptable excipients that provide for a modified release of said budesonide after administration to the gastrointestinal tract, which composition fulfils the following requirements in a standard in vitro USP<711>/Ph.Eur. 2.9.3 dissolution test using a dissolution apparatus according to Apparatus 2 (Paddle Apparatus) of said test; (a) the composition fulfils the requirement that no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes, when the dissolution medium is aqueous and has a pH of about 1.

Abstract: The invention relates to a bioactive settable hydrogel matrix having a pore creating material, which may also carry a therapeutic agent, and methods of using the same, for example, use in promoting internal wound healing, tissue repair, tissue regeneration.

Abstract: The present invention relates to a formulation comprising a pharmaceutically active ingredient and a coating. The invention also relates to the use of the formulation in the treatment and prevention of disorders of the gastrointestinal tract. Also disclosed are methods for preparing the formulations.

Abstract: A sustained-release pharmaceutical composition of topiramate, which is free of binding agent. The sustained-release pharmaceutical composition of topiramate is a sustained-release pellet, comprising a blank pellet core, a drug layer, and a sustained-release coating layer.

Abstract: A dosage form comprises a low-solubility drug, and a precipitation-inhibiting polymer. The drug is in a solubility-improved form and in the form of particles at least partially coated with the precipitation-inhibiting polymer.

Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, an extended release polymer, and an acid. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.

Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, and an extended release polymer. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.

Abstract: The present disclosure provides improved systems and methods utilizing colloidal/ultrafine superdisintegrant-based composite particles for dispersion and/or dissolution of active pharmaceutical agents. In general, the present disclosure utilizes a surfactant-free or near surfactant-free formulation by incorporating a wet milled SDI as a dispersant in the formulation. As such, the present disclosure provides for the preparation of surfactant-free or substantially surfactant-free formulations (e.g., nano-composite micro-particle formulations) by incorporating a wet-milled superdisintegrant (SDI) as the dispersant in the formulations. The advantageous SDI particles (e.g., colloidal/ultrafine SDI particles) of the present disclosure can be used to break-up the aggregates (e.g., nanoparticle aggregates) of the active agents (e.g. poorly water-soluble drugs) in the formulations (e.g.

Abstract: A powder of cold-soluble polysaccharide and polyol, which is highly viscous in water and suitable for direct compression, and a method for preparing the powder and uses thereof are described, the powder being notably intended for preparing solid forms with controlled release of an active principle.

Abstract: The present invention refers to pharmaceutical beclomethasone dipropionate compositions in modified-release gastro-resistant microspheres and to their oral use in the treatment of inflammatory pathologies of the intestinal tract. Said compositions in microspheres comprise: a) a core consisting of a microsphere of inert material; b) a first intermediate coating comprising beclomethasone dipropionate and at least one physiologically acceptable excipient; c) a second modified-release gastro-resistant coating. The present invention also refers to a process for obtaining said compositions.

Abstract: A sustained release oral pharmaceutical form suitable for single daily dose administration has a neutral microgranule coated with a mounting layer of active ingredient and pharmaceutically acceptable binder; and a coating layer of a hydrophobic coating polymer of a non-water soluble cellulose derivative, and at least 20% of inert load in relation to dry weight of hydrophobic coating polymer. The pharmaceutical form has improved resistance to rapid release of active ingredient, particularly in the presence of alcohol.

Abstract: The present invention refers to controlled release granular compositions of mesalazine and their use in the treatment of inflammatory pathologies of the intestinal tract. The aforesaid granular compositions comprise: a) a central core comprising an inert substrate; b) an intermediate layer comprising mesalazine and one or more physiologically acceptable excipients; c) a gastro-resistant coating. The present invention then refers to a process for obtaining the aforesaid granular compositions.

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: The invention relates to a controlled release pharmaceutical composition, comprising a core, comprising a pharmaceutical active ingredient, whereby the core is coated by an ethanol resistance conferring coating layer which has the effect of conferring the release profile of the pharmaceutical active ingredient to be resistant against the influence of ethanol, whereby the ethanol resistance conferring coating layer comprises at least 70% by weight of a mixture of a polymeric portion a) and an excipients portion b), with the polymeric portion a) is consisting of a water insoluble essentially neutral vinyl polymer or vinyl copolymer and the excipients portion b) is consisting of the excipients b1) 100 to 250% by weight of a non-porous inert lubricant, b2) 1 to 35% by weight of a cellulosic compound, b3) 0.1 to 25% by weight of an emulsifier and additionally or alternatively to b3), b4) 0.

Abstract: The invention relates to a controlled release pharmaceutical composition, comprising a core, comprising a pharmaceutical active ingredient, whereby the core is coated by an ethanol resistance conferring coating layer which has the effect of conferring the release profile of the pharmaceutical active ingredient to be resistant against the influence of ethanol. The coating layer comprises a polymeric portion consisting of a water-insoluble neutral vinyl polymer or vinyl copolymer and an amino methacrylate copolymer and an excipients portion consisting of a lubricant, an emulsifier, a plasticizer and optionally a cellulosic compound.

Abstract: Formulations of sparingly water-soluble active ingredientscomprising carrier particles provided with active ingredient-containing coatings, the sparingly soluble active ingredients being embedded in coatings composed of amphiphilic copolymers, and the coatings being applied in the form of a solvent-free melt.

Abstract: The present invention deals with a multiparticulate tablet, which disintegrates in the mouth containing: i) a proton pomp inhibiting agent, in particular of the benzimidazole type, in the form of enteric coated microgranules, which enteric coated granules are overcoated with at least one barrier coating, such as for instance a methacrylic copolymer-based protective film; ii) at least one antacid in the form of granules, for instance based on CaCO3 and/or Mg(OH)2 and/or Al(OH)3; and, iii) a mixture of excipients comprising at least one disintegrating agent, one diluent agent, a lubricant, and optionally a swelling agent, a permeabilising agent, sweeteners, flavourings and colours. Furthermore, the present invention is directed to processes for the manufacture of the tablet and its use in the treatment of gastrointestinal disorders.

Abstract: The object of the present invention is to minimize the risks of dose dumping associated with the concomitant consumption of alcohol and certain modified-release pharmaceutical or dietetic forms. The invention relates to an oral form comprising microparticles of the reservoir type for the modified release of at least one active principle (AP), characterized in that it is resistant to immediate dumping of the dose of AP in the presence of alcohol. In particular, the oral form according to the invention is characterized in that the time taken to release 50% of the AP in an alcoholic solution is not reduced more than 3-fold relative to the time taken to release 50% of the AP in an alcohol-free aqueous medium. The form comprises an agent 13, which is a pharmaceutically acceptable compound whose hydration or solvation rate or capacity is greater in an alcohol-free aqueous medium than in alcoholic solution.

Abstract: A pharmaceutical form, contains an active compound-containing core, which is covered with a coating layer of a gastric juice-resistant, intestinal juice-soluble (meth)acrylate copolymer, a separating layer situated between said core and said coating layer, the separating layer containing a film-forming water-soluble polymer, wherein the separating layer contains at least two layers: an inner layer containing a water-repellent substance, and thereon a layer comprising the film-forming water-soluble polymer.

Abstract: The invention disclosed herein relate to an oral vaccine in which the vaccine composition and adjuvant(s) are carried on a solid fast-dispersing dosage form. The vaccines are targeted toward mucosal tissue and the adjuvant serves to ensure sufficient residence time for the vaccine composition on the mucosal tissue to facilitate its absorption thereby. The fast-dispersing oral solid vaccine dosage form of the invention is particularly useful to administer the vaccine to patients that have difficulty swallowing medications. In one embodiment, the invention provides a fast disintegrating oral solid vaccine dosage form comprising: an immunogenic amount of an antigenic preparation, the antigenic preparation comprising a microsphere-antigen complex; an adjuvant, wherein the adjuvant enhances the absorption of the antigen or potentiates the immunogenic response; a mucoadhesive substance; and a low density dosage form matrix.

Abstract: Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising HPMC and xanthan gum, carrageenan, and mixtures thereof, or HPMC and castor oil or maltodextrin.

Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, an extended release polymer, and an acid. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.

Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, and an extended release polymer. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.

Abstract: A pharmaceutical form, contains an active compound-containing core, which is covered with a coating layer of a gastric juice-resistant, intestinal juice-soluble (meth)acrylate copolymer, a separating layer situated between said core and said coating layer, the separating layer containing a film-forming water-soluble polymer, wherein the separating layer contains at least two layers: an inner layer containing a water-repellent substance, and thereon a layer comprising the film-forming water-soluble polymer.

Abstract: Pharmaceutical compositions useful for treating autoimmune diseases in a mammal comprising as an active ingredient a therapeutically effective amount of Copolymer 1, and microcrystalline cellulose are disclosed. Processes for the manufacture of such compositions are also disclosed.

Abstract: Among the conventional processes for producing solid dispersion, the solid dispersion obtained by a solvent method is excellent in terms of solubility and bioavailability of a poorly soluble drug. However, due to frequent uses of organic solvents in the solvent method, problems have arisen such as organic solvent residue in products, environmental pollution and operational safety as well as corporate problems such as capital investment and the like required to avoid such events. The present invention provides a process for preparing pharmaceutical solid preparations without use of organic solvents frequently used in conventional solvent methods.

Abstract: A process for the production of encased, spherical granular grains comprising spraying grains which consist of a prostane derivative and a cyclodextrin vehicle, forming together a prostane-cyclodextrine-clathrate, with an aqueous polymer dispersion of ethyl cellulose and/or poly(methyl)acrylic acid ester in a fluidized or boiling bed is disclosed. The polymer dispersion is applied in a thickness equivalent to 1-5% (w/w) of the total mass of the encased grains. The coated grains are cured for at least 24 hours. Grains produced according to this method have a pharmaceutical active ingredient release profile which remains unchanged over the storage time.

Abstract: The pharmaceutical composition of the invention, which comprises a benzimidazole compound of the formula 1