Formulation & Evaluation Immediate Release of Clarithromycin by Using k-30 Disintegrate

Abstract

Based on solubility data 0.1 N HCL was selected as the dissolutionmedium.Bulk density was found to be 0.321 g/ml and CI was 55.07 % indicating that drug has to be granulated for the good flowproperties.Melting point was found to be 257 ⁰ C indicating that drug has less sensitivity for drying temperatures.Drug – excipient compatibility studies indicate that all excipients used in the formulation are compatible with the drug. RS(relatedsubstances) was found to be less than 0.5%. Among the 12 formulations prepared, formulation F12 was found to exhibit all the required properties. This is found to be pharmaceutically stable, once a day, robust formulation.The physical attributes of the tablet were found to be satisfactory.Typical tablet defects such as capping, chipping and picking were not observed.Thetotalweightofeachformulationwasmaintainedconstantandtheweightvariation of the tablets was within limits of5%.Hardness was found to be 8.6KPFriability was calculated as 0.15% which was within the acceptable range of 1% and indicated that tablet surfaces are strong enough to withstand mechanical shock or attrition during storage andtransportation.Assay values were found to be within acceptablelimits.The stability study for the selected formulation F12 was performed as per ICH guidelines. Stability study was carried out for 2 months at 40° C, 75% RH, according to ICH guidelines. The tablets were tested for drug release during the stability period and confirmed that results were found within thelimits. The stability data reveals tha tthe F12 showed an egligible changein drug content after storage in various conditions for two months according to ICHguidelines.