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Abstract

An immediate flotation gastric retention drug formulation comprising at least one mineral comprising functionalized natural and / or synthetic calcium carbonate and at least one pharmaceutically active ingredient, and at least one formulation agent, wherein said carbonate of Functionalized natural or synthetic calcium is a product of the reaction of natural or synthetic calcium carbonate with carbon dioxide and one or more acids, where carbon dioxide is formed in situ by acid treatment and / or is supplied from an external source . Claim 2: A formulation according to claim 1, wherein the source of natural calcium carbonate for the preparation of functionalized calcium carbonate (FCC) is selected from the group of marble, calcite, crete, limestone or dolomite and / or mixtures thereof . Claim 3: A formulation according to claim 1, wherein the synthetic calcium carbonate for the preparation of the functionalized calcium carbonate is precipitated calcium carbonate (PCC) comprising aragonitic, vateritic or calcitic mineralogical crystalline forms, especially prismatic, rhombohedral, or scalenohedral or mixtures thereof. Claim 4: A formulation according to any one of claims 1 to 3, wherein the acids are selected from the group of hydrochloric acid, sulfuric acid, sulfurous acid, hydrosulfate, phosphoric acid, phosphoric acid in combination with acetic, formic or citric acid, or its acid salts, and mixtures thereof, preferably, is phosphoric acid. Claim 7: A formulation according to any one of claims 1 to 6, wherein at least one pharmaceutically active ingredient or inactive precursor is selected from those of synthetic, semi-synthetic or natural origin, or combinations thereof. Claim 8: A formulation according to any one of claims 1 to 7, wherein at least one formulation aid is selected from a composition and / or a film-forming compound. Claim 9: A formulation according to claim 8, wherein the film-forming composition and / or compound may be selected from hydrophilic film-forming excipients or lipophilic film-forming excipients, or combinations thereof. Claim 10: A formulation according to claim 9, wherein the hydrophilic film-forming excipients are selected from water-soluble polyethylene glycols, polyethylene oxides, polypropylene glycols, polypropylene oxides or combinations thereof, wherein said polymers have a weight average molecular weight of 2000 Da a 20,000,000 Da; chitosan, acrylic acid polymers, polyvinylpyrrolidone and its modifications (insoluble cross-linked polyvinyl pyrrolidones, homopolymers of N-vinyl-2-pyrrolidone), modified cellulose gums, starch glycolate, pregelatinized starch, low carboxymethyl sodium substitution, low carboxymethyl replacement esters of alkyl-, hydroxyalkyl-, carboxy-alkyl I-cellulose, hydroxypropyl methyl cellulose phthalate, salts of carboxymethylcellulose, alginates, ion exchange resins, gums, chitin, clays, gellan gum, copolymers of crosslinked polacrilin, agar, gelatin, laxtrins and their combinations Claim 11: A formulation according to claim 9, wherein the lipophilic film-forming excipients are selected from hydrogenated vegetables, castor oils, mineral oils, wax fatty acids and fatty acid salts with carbon chain lengths of C₆ to C₂₀, branched, unbranched, unsaturated, partially saturated and their combinations; magnesium and / or calcium stearate, paraffin, cetyl alcohol, cetyl stearyl alcohol, glyceryl monostearate, lanolin, lanolin alcohols, polyethylene glycol ethers of n-alkanols, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene stearates, sorbitan esters, stearyl alcohol, glycerol dibehenate, sodium stearyl fumarate, glycerol distearate and combinations thereof. Claim 12: A formulation according to any one of claims 1 to 11, further comprising a water soluble solid acid. Claim 13: A formulation according to claim 12, wherein the water soluble solid acid is selected from citric acid, fumaric acid, tartaric acid, or malic acid and combinations thereof. Claim 14: A method for the production of an immediate flotation gastric retention formulation, comprising the steps of: a) the provision of a mineral comprising naturalized or synthetic functionalized calcium carbonate (FCC), wherein said natural calcium carbonate or functionalized synthetic is a product of the reaction of natural or synthetic calcium carbonate with carbon dioxide and one or more acids, where carbon dioxide is formed in situ by acid treatment, and / or is supplied from an external source; b) the provision of at least one pharmaceutically active ingredient; c) the provision of at least one formulation assistant; d) the mixture of the compounds provided in steps a), b) and c); e) the granulation of the mixture obtained in step d) by means of melt, dry or wet granulation, or roller compaction. Claim 15: The method of claim 14, wherein parts of the formulation aid of step c) are first mixed with the FCC of step a) and at least one pharmaceutically active ingredient of step b), and then the remaining portion of the formulation aid is added to the mixture, followed by the granulation step e). Claim 34: Tablets, mini-tablets, granules, capsules or mini-spheres, comprising the immediate flotation gastric retention formulation of any one of claims 1 to 13.

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First Claim

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