RESUMEN
OBJECTIVE: To investigate the effect of the critical quality attributes of hypromellose (HPMC) on the release profile of diclofenac sodium sustained-release tablets in vitro. METHODS: The characteristics including appearance, particle size, density, compression and specific surface area of HPMC K15M from three manufacturers (A, B and C) were studied and evaluated comprehensively. The compression data of HPMC K15M were non-linear fitted via the pressure-tensile strength curve method, Kawabe equation and Hasano equation. Sustained-release tablets were prepared by using diclofenac sodium as the active ingredient with different HPMC as gel matrix, and the in vitro release behavior of the tablets was determined in order to identify the critical quality attribute of HPMC that affect the in vitro release profile of diclofenac sodium sustained-release tablets. RESULTS: The release rate of diclofenac sodium sustained-release tablets was correlated with the substitution type of HPMC, viscosity, density and specific surface area, but less affected by particle size. CONCLUSION: Substitution, viscosity, density and specific surface area of HPMC are the CQAs factors influencing the release profile of diclofenac sodium sustained- release tablets.