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

摘要

A 2(4) full factorial analysis was used to study the individual and interactive effects of binder type, X-1; binder concentration, X-2; relative density, X-3 and tabletting technique, X-4, 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 Entandophragma 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 X-2 > X-3 > X-1 > X-4, on TS; X-3 > X-2 > X-1 > X-4 and on MT; X-2 > X-1 > X-4 > X-3. The effects of changing the binder from hydroxypropylcellulose to ENTA led to an increase in DT and decrease in TS, BFI and MT. Changing X-2 and X-3 to higher values increased the DT and TS. The interaction between X-1, and X-2 had the highest influence on BR and MT, while interaction between "X-3 and X-4", and "X-2 and X-3" 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.