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The present invention relates to a stable pharmaceutical composition that comprises active substance metformin or a pharmaceutically acceptable salt thereof in combination with DPP- IV inhibitor, which is preferably vildagliptin or a pharmaceutically acceptable salt thereof, which can be produced by a simple, reliable, straightforward, cost-effective process of wet granulation and use of standard pharmaceutical excipients. According to the wet granulation process of the present invention metformin granulate is obtained, to which vildagliptin portion is admixed as in drug particles or granulated form.
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The present invention relates to a stable pharmaceutical composition that comprises active substance metformin or a pharmaceutically acceptable salt thereof in combination with DPP- IV inhibitor, which is preferably vildagliptin or a pharmaceutically acceptable salt thereof, which can be produced by a simple, reliable, straightforward, cost-effective process of wet granulation and use of standard pharmaceutical excipients. According to the wet granulation process of the present invention metformin granulate is obtained, to which vildagliptin portion is admixed as in drug particles or granulated form.
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The present invention relates to a moisture-activated granulation process for the manufacture of a pharmaceutical dosage form containing at least one moisture- sensitive active substance selected from the group consisting of aliskiren and its pharmaceutically acceptable salts, esters and cocrystals, said process comprising: a) mixing the active substance (s) with one or more dry excipients in solid form, said excipient being selected in particular from the group consisting of diluents, surfactants, binders, lubricants, disintegrators, granulation aids, buffering/alkalizing agents, fillers and antioxidants; b) contacting the mixture with a granulation liquid containing water and optionally one or more excipients to form a granulate, said excipient being selected in particular from the group consisting of binders, buffering/ alkalizing agents, surfactants and antioxidants, to form a granulate wherein the ratio of the total amount of water to the total amount of all the solid ingredients including the active substance (s) and all intragranular excipients is less than 30:100, based on weight; c) further processing the mixture including the addition of further dry excipients to obtain the pharmaceutical dosage form, said excipients being in particular selected from the group consisting of diluents, disintegrants, glidants and lubricants.
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· 2019
The object of the present invention is a pharmaceutical tablet composition comprising an NSAID and a PPI and having improved stability and bioavailability. The present invention relates to a pharmaceutical tablet composition comprising: a) a multilayer tablet core comprising: i) a non-steroidal anti- inflammatory drug (NSAID) layer comprising an NSAID and at least one pharmaceutically acceptable excipient; ii) an optional middle layer; iii) a proton pump inhibitor (PPI) layer comprising multiple units of PPI coated with a protective coating; b) a barrier coating surrounding the multilayer tablet core; and c) a gastro-resistant coating surrounding the barrier coating.
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The subject of the invention includes a pharmaceutical composition comprising micronized prasugrel or its pharmaceutically acceptable salts as the active pharmaceutical ingredient, prepared in the absence of water with solvent 5 free technological methods and characterized in that it does not contain lactose.
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The present invention relates to a moisture-activated granulation process for the manufacture of a pharmaceutical dosage form containing at least one moisture- sensitive active substance selected from the group consisting of aliskiren and its pharmaceutically acceptable salts, esters and cocrystals, said process comprising: a) mixing the active substance (s) with one or more dry excipients in solid form, said excipient being selected in particular from the group consisting of diluents, surfactants, binders, lubricants, disintegrators, granulation aids, buffering/alkalizing agents, fillers and antioxidants; b) contacting the mixture with a granulation liquid containing water and optionally one or more excipients to form a granulate, said excipient being selected in particular from the group consisting of binders, buffering/ alkalizing agents, surfactants and antioxidants, to form a granulate wherein the ratio of the total amount of water to the total amount of all the solid ingredients including the active substance (s) and all intragranular excipients is less than 30:100, based on weight; c) further processing the mixture including the addition of further dry excipients to obtain the pharmaceutical dosage form, said excipients being in particular selected from the group consisting of diluents, disintegrants, glidants and lubricants.