Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.

Abstract: The present invention relates to a process for spray-freeze-drying (SFD) a dispersion of polyelectrolyte complex (PEC) nanoparticles loaded with a protein drug, which yields a powdered product with adequate flowability properties that may readily be processed further into solid dosage forms such as tablets or capsules. The mean particle size of PEC nanoparticles obtained after redispersion of SFD powder or pharmaceutical compositions made from said powder in water is preserved in the nanometer range (<1000 nm), and so is the protein biological activity.

Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.

Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.

Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a process for preparing dosage forms containing ezetimibe, comprising the steps of: a) providing a composition comprising ezetimibe, b) sieving a composition comprising a composition of step (a), c) shear mixing of the composition after step (b), preferably the mixing of the composition is carried out by high shear mixing, d) formulation into a dosage form. The present invention also relates to dosage forms containing ezetimibe and ezetimibe and simvastatin, which have been prepared according to the process according to the invention.

Abstract: Self-microemulsifying drug delivery systems and microemulsions used to enhance the solubility of pharmaceutical ingredients comprising a polyoxyethylene sorbitan fatty acid ester emulsifier; a fatty acid ester co-emulsifier and an oil.

Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a process for preparing dosage forms containing ezetimibe, comprising the steps of: a) providing a composition comprising ezetimibe, b) sieving a composition comprising a composition of step (a), c) shear mixing of the composition after step (b), preferably the mixing of the composition is carried out by high shear mixing, d) formulation into a dosage form. The present invention also relates to dosage forms containing ezetimibe and ezetimibe and simvastatin, which have been prepared according to the process according to the invention.

Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a process for preparing dosage forms containing simvastatin and ezetimibe, comprising the steps of providing a first composition containing simvastatin, providing a second composition containing ezetimibe, and forming a dosage form comprising at least two separate compartments, wherein one compartment is formed using either the first or the second composition and another compartment is formed using the other composition. The present invention also relates to a process for preparing dosage forms containing simvastatin and ezetimibe, wherein the process involves a direct compression step. Furthermore, the present invention belongs to a dosage form obtained by this process, comprising at least two separate compartments, wherein one compartment contains simvastatin and one compartment contains ezetimibe.

Abstract: The invention provides a microcapsule having a shell and a liquid core incorporating a self-microemulsifying system or a microemulsion, wherein the core comprises a lipophilic substance, at least one surfactant, an active agent, a gelling agent and optionally a cosolvent. Furthermore, a method for producing such microcapsules and pharmaceutical formulations comprising such microcapsules is provided.

Abstract: A method for preparing nanoparticles is provided, which comprises the steps of dissolving a polymer and, optionally, at least one additional ingredient, in an organic solvent, passing the solution through a vibrating nozzle and dropping the solution through the electrical field into an aqueous solution, which is stirred, such that nanoparticles are formed by the rapid diffusion of the solvent.

Abstract: The present invention relates to a controlled release preparation of tamsulosin hydrochloride comprising hydroxypropylcellulose and polyethylene oxide, and the process for making such pharmaceutical composition.

Abstract: Self-microemulsifying drug delivery systems and microemulsions used to enhance the solubility of pharmaceutical ingredients comprising a polyoxyethylene sorbitan fatty acid ester emulsifier; a fatty acid ester co-emulsifier and an oil.

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: The present invention provides a method of making solid micropellets of which at least 75% by weight have a diameter less than 500 ?m comprising (i) melting one or more binders; and (ii) combining the one or more binders melted in step (i) with a pharmaceutically active ingredient to form solid micropellets. Solid micropellets obtainable by this method are also provided. The invention has particular utility for improving the solubility of poorly water-soluble pharmaceutically active ingredients.

Abstract: Lovastatin, pravastatin, simvastatin, mevastatin, atorvastatin, and derivatives and analogs thereof are known as HMG-CoA reductase inhibitors and are used as antihypercholesterolemic agents. The majority of them are produced by fermentation using microorganisms of different species identified as species belonging to Aspergillus, Monascus, Nocardia, Amycolatopsis, Mucor or Penicillium genus, and some are obtained by treating the fermentation products using the methods of chemical synthesis or they are the products of total chemical synthesis. The aforementioned active substances may be destabilized by the environmental factors, their degradation may also be accelerated by interactions with other pharmaceutical ingredients, such as fillers, binders, lubricants, glidants and disintegrating agents, therefore the pharmaceutical ingredients and the process for preparation of the pharmaceutical formulation should be meticulously chosen to avoid the aforementioned undesired interactions and reactions.

Abstract: The present invention relates to a novel modified release pharmaceutical composition comprising the coated capsule body, coated or uncoated capsule cap, at least one tablet and granulate comprising active substance.

Abstract: Stabilized pharmaceutical compositions comprising polymorphs of active pharmaceutical ingredients susceptible to conversion to alternate polymorph forms are prepared by a process of wet granulation in which the ratios of active, fillers, and granulating liquid are controlled in order to avoid polymorphic interconversions.

Abstract: The present invention relates to a novel composition, e.g. of mycophenolic acid, a salt or a prodrug thereof, in a modified release form.

Abstract: The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and/or environmental humidity by coating.

Abstract: The present invention relates to the formed particles comprising amoxicillin and clavulanic acid, the particles being obtained wet granulation. The invention also relates to the procedure for the preparation of these particles and to the pharmaceutical compositions comprising them.