ABSTRACT:
The objective of the present study was to formulate and evaluate the Rapid disintegrating tablets (RDTs) of Labetalol hydrochloride by direct compression method and revealing the effect of various super disintegrates and binders on the performance of tablets. Fourteen different formulations (F1–F14) were prepared using Crospovidone and Sodium Starch Glycolate as the super disintegrants, HPMC E5 and PVP K-30 as binders. All powder blends were found suitable for direct compression, as revealed by pre-compression studies of the flow properties. The weight variation, hardness, friability, thickness, disintegration time, wetting time, drug content and in vitro drug release of the compressed tablets were evaluated. The mechanical strength and uniformity of the drug content of all formulations fulfilled the pharmacopeial requirements. The disintegration values were found to be between 32 and 85 seconds and the drug content was 98.2 to 99.8%. In vitro dissolution tests demonstrated rapid release of the drug from all the formulations with the drug release ranging from 88.4% to 99.7% within 600 seconds. Overall, formulation F12 showed good powder flow, along with good hardness (4.60±0.14kg/cm2), low friability value (0.38%), high drug content (99.8%) and acceptable disintegration parameters with maximum cumulative drug release (99.7%). It was found that the optimized formulation was developed using Sodium Starch Glycolate and HPMC E5 which was suitable for immediate release oral drug delivery with suitable mechanical properties, rapid disintegrating tablets and better dissolution