Effects of processing techniques on physicotechnical parameters of Paracetamol-Diclofenac combination formulation

Musibau A. Mustapha and Michae

Abstract

Formulation of Paracetamol – Diclofenac combination tablets was designed to incorporate Diclofenac Potassium in 2 ways coded B-I (internally incorporated) and B-E (externally incorporated). Wet granulation technique was adopted and micromeritic properties were evaluated. Granules were compressed to tablets at different compression pressure and the physicotechnical parameters were then evaluated. Results showed a flow rate of ≥ 0.91 g/s, angle of repose of ≤ 15.3⁰, bulk density of 0.57 g/ml, tapped density of 0.70 g/ml, Hausner ratio of ≤ 1.245 and Carr’s index of ≤ 19.69%; all of which engendered excellent micromeritic characteristics. Minimal percentage relative standard deviation (%RSD) of ≤ 3.43 in weight variation, hardness of ≥ 9 Kp were achieved while timely disintegration was corroborated by disintegration time (DT) of 6.65 min in B-I, 3.12 min in B-E, although standard product (STD-P) failed this parameter (22.9 min). Fragmenting behaviours of the formulations resulted in high friability even though hardness/friability ratio of ≥ 6.49 was achieved suggesting that the tablets are mechanically strong. Physicotechnical parameters were better achieved in B-E compared to B-I and STD-P. Influence of increase in compression pressure was more pronounced on friability and hardness and least on DT. Although B-I and B-E consolidated by fragmentation during compaction, B-I seemed to be easier to compress than B-E giving mean yield pressures (Py) of 121.95 and 285.71 Kgfcm-2 respectively. Process capability index (CpK) demonstrated good performance only in DT and hardness and was better in B-I and B-E than STD-P.