Evaluation of anti-moisture effect of HPMC, Kollidon CL and Aerosil - 200 in hydrolysis affinity Clopidogrel-Aspirin tablet using Delta T Moister Sensor

Abstract

The combined therapeutic effect of aspirin and clopidogrel is more potent than single one. This combined formulation is not stable due to their moisture affinity toward the hydrolysis reaction. The presence of moisture is a crucial factor in any formulation and causes sticking, picking, microbial growth, stability issues, lamination, friability. This combination formulation was designed using hydroxypropylmethyl cellulose 15 cps, Kollidon CL and Aerosil 200 in a controlled clean room class-I to stop the hydrolysis reaction. The tablets were made using slug method and hardness, disintegration, friability, dissolution, drug content, water activity, moisture content was determined. Kollidon CL and Aerosil 200 showed greater moisture reduction rate than HPMC 15 cps. The better anti-moisture effect of the excipient of Kollidon CL and Aerosil 200 was assured by the calculation of water activity using delta T sensor and isotherm, hysteresis. The quantity of excipients in the tablets was demonstrated for the significant affinity to moisture. The investigated simulated amount of Kollidon CL and Aerosil 200 showed the effective lower water activity in the delta T sensor. The mean moisture specification range was considered as 0.5-4.0% while the kollidon CL and Aerosol 200 showed moisture content of 1.32% and water activity (aw)of 0.014. In this study the Delta T sensor is used due to its significant reduction of dead time from 30% to 45% and moisture variation reduced at least 30% than other models treatment.