EFFECT OF FORMULATION AND PROCESS VARIABLES ON THE RELEASE, MECHANICAL AND MUCOADHESIVE PROPERTIES OF IBUPROFEN TABLET FORMULATIONS.

A 2(4) full factorial analysis was used to study the individual and interactive effects of binder type, X1; binder concentration, X2; relative density, X3 and tabletting technique, X4, on disintegration time (DT), brittle fracture index (BFI), tensile strength (TS) and mucoadhesion time (MT) of ibuprofen tablets formulated by direct compression (DC) and wet granulation (WG), and containing Entandophragnia angolense gum (ENTA) as binder, in comparison with hydroxypropylcellulose. The result of the FTIR and UV peaks suggests the absence of any interaction between ENTA and ibuprofen. Interactions between the polymers and ibuprofen were determined using FTIR and UV determinations. The ranking of the individual effects on DT and BFI was X2 > X3 > X1 > X4, on TS; X3 > X2> X1 > X4 and on MT; X2> X > X4 > X3. The effects of changing the binder from hydroxypropylcellulose to ENTA led to an increase in DT and decrease in TS, BFI and MT. Changing X2 and X3 to higher values increased the DT and TS. The interaction between X1 and X2 had the highest influence on BEI and MT, while interaction between "X3 and X4", and "X2 and X3" had the highest influence on DT and TS, respectively. Ibuprofen tablets prepared by wet granulation method and containing Entandophragma angolense gum showed lower capping/lamination tendencies and better mucoadhesive drug release profiles.