Film-coated and/or granulated calcium-containing compounds and use thereof in pharmaceutical compositions
Calcium-containing compounds have been at least partly film-coated and/or granulated with a water-soluble substance and a water-soluble polymeric substance and use of such coated compounds in pharmaceutical compositions. The at least partly film-coated and/or granulated calcium-containing compounds have proved suitable for the preparation of tablets having a very high load of elemental calcium and a conveniently small size. A drug load of about 96% or more is obtained in tablets of the invention that have sufficient mechanical and organoleptic properties.
1. A method for the preparation of a granulated calcium carbonate, comprising
applying a granulating composition to calcium carbonate that is in the form of particles and/or crystals, wherein the granulating composition comprises
i) xylitol, and
ii) one or more polymeric substances selected from the group consisting of povidones and copovidones, and mixtures thereof, wherein the xylitol and the one or more polymeric substances are dispersed or dissolved in a solvent;
wherein the xylitol constitutes from about 2% to about 20% of the total weight of the granulated calcium carbonate, and the one or more polymeric substances constitutes from about 0.09% to about 10% of the total weight of the granulated calcium carbonate.
2. A method according to claim 1 wherein the solvent is an aqueous or an organic solvent.
3. A method according to claim 2 wherein the solvent is an aqueous solvent.
4. A method according to claim 1 wherein the one or more polymeric substances have binding properties.
5. A method according to claim 1 wherein the one or more polymeric substances are water-soluble.
6. A method according to claim 1 wherein the povidone is selected from the group consisting of povidone K-90, K-30, K-25, K-17, K-12, and mixtures thereof.
7. A method according to claim 1 wherein the granulating composition is applied by use of fluid bed.
8. A granulated calcium carbonate obtainable by the method as defined in claim 1 .
9. A pharmaceutical or nutritional composition comprising a granulated calcium carbonate obtainable by the method as defined in claim 1 .