Formulation and evaluation of prednisolone sodium phosphate orally disintegrating tablets

Abstract

There is an increasing demand for more patient compliant dosage form and a novel method is the development orally disintegrating tablets which dissolve or disintegrates instantly on the patient tongue or buccal mucosa. Prednisolone is a naturally occurring glucocorticoids (hydrocortisone), it targets to corticosteroid binding globulin (it regulates Enzyme regulatory activity, Enzyme inhibitory activity and protease inhibitor activity. Used in treatment of severe inglammatory conditions including allergies, arthritis, asthma, or skin reactions. Its metabolizing enzyme is Cytochrome P450 3A4 (CYP 3A40). Hence the main objective of the study was to formulate orally disintegrating tablets of Prednisolone to achieve a better dissolution rate and further improving the bioavailability of the drug.  Orally disintegrating tablets prepared by direct compression and using super disintegrate like crospovidone, croscarmellose sodium starch glycolate designate, designated as three different groups of formulation (F-1 to F-13) respectively were prepared and evaluated for the pre-compression parameters such as bulk density, compressibility, angle of repose etc. The prepared batches of tablets were evaluated for hardness, weight variation, friability, drug content, disintegration time and in-vitro dissolution profile and found satisfactory. In present work wet granulation technique was employed to prepare tablets. Microcrystalline cellulose is used as diluents. Aspartame and mannitol is used as sweetening agents. Crospovidone XL10 as disintegrant. Prednisolone Sodium Phosphate was having bitter taste and to mask the bitter taste flavoring agent like mint flavor and taste masking agents like PEG4000, Ethyl cellulose 4cps, Eudragit EPO and Eudragit L100. Post compressional parameters hardness, friability, weight variation, disintegration time, drug content and dissolution studies are studied. All three groups of formulations released the drug at faster rates than that of marketed conventional tablets of Prednisolone.