Method for the preparation of granulates suited for the production of sustained release coated tablets for oral use
AssigneeIstituto Gentili S.p.A.
InventorLuciano Fontanelli
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Abstract
A method for the preparation of tablets slowly releasing the active principle, characterized in that (I) during the granulation step a solution in organic solvents of a polymer insoluble in biological juices is sprayed on a mixture containing an active principle, slightly swelling polymers and usual excipients; (II) the granulated obtained in this way is added with a highly hydroswelling colloidal polymer; (III) a solution, in organic solvents, of an entero-soluble polymer, is sprayed on the granulate; (IV) the resulting granulate is submitted to compression; (V) the obtained tablets are hardened by washing with organic solvents; and (VI) they are then optionally coated.
Claims9
A process for the preparation of tablets slowly releasing an active principle which consists essentially of preparing a mixture containing said active principle, a slightly swelling polymer and an excipient, then spraying onto said mixture in step (I) a solution in an organic solvent of a polymer insoluble in physiological fluids granulating said thus sprayed mixture to obtain a granulate;
- in step (II) adding to said granulate a hydroswelling colloidal polymer to obtain a granulate with increased swelling properties;
- in step (III) spraying a solution, in an organic solvent, of an entero-soluble polymer onto said granulate from step (II);
- in step (IV) compressing said granulate to obtain tablets;
- in step (V) hardening said tablets by washing with an organic solvent.
Dependencies are inferred from the claim text.