Process for preparing oral calcium compositions
AssigneeNycomed Pharma AS
InventorsJan Yngvar Piene, Dina Dogger Schmidt
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Abstract
A process for the preparation of an orally administrable calcium composition comprising the steps of: (i) obtaining a physiologically tolerable particulate calcium compound having a mean particle size in the range of 3 to 40 μm, having a crystalline structure and having a surface area of 0.1 to 1.2 m2/g; (ii) mixing the calcium compound with a water-soluble diluent and an aqueous solution of a water soluble binder in a fluid bed granulation apparatus and dying the resulting mixture to produce a first granulate; (iii) optionally mixing the first granulate with one or more further components to produce a second granulate; and (iv) optionally compressing the first or second granulate to form tablets.
Claims16
A process for the preparation of an orally administrable calcium composition, said process comprising the steps of:
- (i) obtaining a physiologically tolerable particulate calcium compound having a mean particle size in the range 3 to 40 μm, having a crystalline structure and having a surface area of 0.1 to 1.2 m2/g;
- (ii) mixing said calcium compound with a water-soluble diluent and a water soluble binder in a fluid bed granulation apparatus and drying the resulting mixture to produce a first granulate, wherein said water-soluble diluent comprises at least one sweetener selected from the group consisting of sorbitol, xylitol, isomalt and mannitol, and wherein said first granulate has a particle size distribution of D(V,0.1=15-21 μm, D(V,0.5)=70-120 μm and D(V,0.9)=190-330 μm;
- (iii) optionally mixing said first granulate with one or more further components to produce a second granulate;
- and
- (iv) optionally compressing said first or second granulate to form tablets.
A granulate comprising a fluid bed granulation granulate product of a physiologically tolerable calcium compound, a water-soluble binder and a water-soluble diluent, wherein said calcium compound has a mean particle size in the range 3 to 40 μm, has a crystalline structure and has a surface area of 0.1 to 1.2 m2/g;
- wherein said water-soluble diluent comprises at least one sweetener selected from the group consisting of sorbitol, xylitol, isomalt and mannitol, and wherein said granulate has a particle size distribution of D(V,0.1=15-21 μm, D(V,0.5)=70-120 μm and D(V,0.9)=190-330 μm.
Dependencies are inferred from the claim text.