Abstract: The present invention relates to a particulate material and a solid dosage form notably tablets comprising a regularly shaped calcium-containing compound such as a calcium salt as a therapeutically and/or prophylactically active substance and a pharmaceutically acceptable sugar alcohol such as, e.g., sorbitol and/or isomalt that has a micro structure as evidenced by SEM. The invention also relates to a process for the preparation of the particulate material and solid dosage form. The process involves agglomeration of the calcium-containing compound and the pharmaceutically acceptable sugar alcohol by means of roller compaction. The particulate material obtained by roller compaction is suitable for use in the further processing of the particulate material into e.g. tablets such as chewing tablets.

Abstract: The present invention relates to a method for the preparation of a tablet comprising at least 50% w/w of calcium carbonate, the method comprising i) providing a particulate composition comprising a) calcium carbonate, b) a binding sugar alcohol selected from sorbitol or isomalt, or combinations thereof, c) a non-binding sugar alcohol selected from mannitol, maltitol or xylitol, or combinations thereof, and ii) compressing said composition using a tabletting machine equipped with at least one pair of punches and dies, wherein the pair of punches and die before filling the die with said particulate composition is sprayed with a composition comprising a lubricant selected from magnesium stearate, calcium stearate or stearic acid or combinations thereof.

Abstract: The present invention relates to a method for the preparation of a tablet comprising at least 50% w/w of calcium carbonate, the method comprising i) providing a particulate composition comprising a) calcium carbonate, b) a binding sugar alcohol selected from sorbitol or isomalt, or combinations thereof, c) a non-binding sugar alcohol selected from mannitol, maltitol or xylitol, or combinations thereof, and ii) compressing said composition using a tabletting machine equipped with at least one pair of punches and dies, wherein the pair of punches and die before filling the die with said particulate composition is sprayed with a composition comprising a lubricant selected from magnesium stearate, calcium stearate or stearic acid or combinations thereof.

Abstract: The present invention relates to a method for the preparation of a tablet comprising at least 50% w/w of calcium carbonate, the method comprising i) providing a particulate composition comprising a) calcium carbonate, b) a binding sugar alcohol selected from sorbitol or isomalt, or combinations thereof, c) a non-binding sugar alcohol selected from mannitol, maltitol or xylitol, or combinations thereof, and ii) compressing said composition using a tabletting machine equipped with at least one pair of punches and dies, wherein the pair of punches and die before filling the die with said particulate composition is sprayed with a composition comprising a lubricant selected from magnesium stearate, calcium stearate or stearic acid or combinations thereof.

Abstract: A pre-compacted materiel comprising one or more calcium-containing compounds and one or more sugar alcohols, wherein the calcium-containing compound having a polycrystallic porous structure. The pre-compacted material is preferably obtained by roller compaction and is suitable for use in the further processing of the pre-compacted material into composition like e.g. tablets.

Abstract: A novel method for the preparation of a tablet comprising a calcium-containing compound, the method involves a melt granulation process by which a sugar alcohol is melted and embeds the calcium-containing compound so that a sufficient taste masking of the chalkiness is substantially achieved and an unpleasant mouth feel of the calcium-containing compound is substantially avoided, while at the same time obtaining a low tablet volume. The method of the invention is especially suitable for the manufacturing of tablets having a high load of a calcium-containing compound.

Abstract: The present invention relates to a novel process for the preparation of a granulate comprising a calcium-containing compound as an active substance. The method comprises a method for the preparation of a granulate comprising a calcium-containing compound as an active substance, the method comprising, i) feeding a granulation chamber with a composition comprising the calcium-containing compound, ii) wet-massing the composition with a granulation liquid optionally comprising a pharmaceutically acceptable binder for a time period of at the most 30 sec to obtain a wet granulate, iii) drying the thus obtained wet granulate. A granulate obtained by the present method is especially suitable in the preparation of solid dosage forms, in particular in the preparation of tablets.

Abstract: The present invention relates to a method for the preparation of a tablet comprising at least 50% w/w of calcium carbonate, the method comprising i) providing a particulate composition comprising a) calcium carbonate, b) a binding sugar alcohol selected from sorbitol or isomalt, or combinations thereof, c) a non-binding sugar alcohol selected from mannitol, maltitol or xylitol, or combinations thereof, and ii) compressing said composition using a tabletting machine equipped with at least one pair of punches and dies, wherein the pair of punches and die before filling the die with said particulate composition is sprayed with a composition comprising a lubricant selected from magnesium stearate, calcium stearate or stearic acid or combinations thereof.

Abstract: A pre-compacted materiel comprising one or more calcium-containing compounds and one or more sugar alcohols, wherein the calcium-containing compound having a polycrystallic porous structure. The pre-compacted material is preferably obtained by roller compaction and is suitable for use in the further processing of the pre-compacted material into composition like e.g. tablets.

Abstract: Novel controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The novel compositions are designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained followed by a prolonged and relatively constant plasma concentration of desglymidodrine. The novel compositions may be designed for administration once or twice daily, i.e. a therapeutically effective concentration of desglymidodrine is maintained for a period of at least 10-16 hours followed by a wash out period of about 8-12 hours in order to avoid the well-known midodrine related side effect with respect to supine hypertension. The therapeutically effective concentration of desglymidodrine is regarded as a plasma concentration of desglymidodrine of at least about 3 ng/ml.

Abstract: The invention provides a novel pharmaceutical kit comprising a controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The controlled release composition is designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained, followed by a prolonged and relatively constant plasma concentration of desglymidodrine. The invention also provides a method for treating orthostatic hypotension and/or urinary incontinence, the method comprising administration to a patient in need thereof of an effective amount of midodrine and/or desglymidodrine in a kit.

Abstract: Novel phannaceutcal kit comprising a controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine and a relatively fast onset composition. The controlled release compositions are designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained followed by a prolonged and relatively constant plasma concentration of desglymidodrine.

Abstract: Novel pharmaceutical compositions comprising desglymidodrine or a pharmaceutically acceptable salt thereof as an active drug substance. Desglymidodrine is the active metabolite of the prodrug midodrine. The pharmaceutical composition may be presented in a suitable dosage form for oral, parenteral, mucosal, nasal, sublingual, buccal, topical, vaginal, rectalor ocular etc. administration. A pharmaceutical composition of the invention may be in the form of an immediate and/or modified release composition or it may be designed to release the active drug substance, desglymidodrine, in a relatively fast manner in order to enable a relatively fast onset of the therapeutic effect. The compositions have a suitable shelf-life, i.e. the desglymidodrine contained in the composition is not subject to a significant degradation under storage conditions normally acceptable for pharmaceuticals.

Abstract: Novel controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The novel compositions are designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained followed by a prolonged and relatively constant plasma concentration of desglymidodrine.