Simplex lattice optimization of superdisintegrants in the formulation of fast oral dissolving tablets of ibuprofen

Abstract

Optimization of different superdisintegrants using the simplex lattice design in the formulation of fast disintegrating tablets of ibuprofen was studied. Seven formulations (F1 to F7) were prepared by direct compression of ibuprofen as the model drug and a combination of superdisintegrants–pre-gelatinized starch, croscarmellose sodium and crospovidone–utilizing the simplex lattice design. FTIR analysis of drug and excipients was carried out. Granules and tablets formulated were evaluated for pre- and post-compression parameters. The granules were fairly free flowing with angles of repose ranging from 42 - 49°, Carr’s index < 24 %, and a Hausner’s quotient < 1.3. The tablet hardness and friability were 4.00 - 5.99 kgF and < 1 %, respectively, while wetting and disintegration times were < 160 and < 76 s, respectively. Dissolution profiles showed all the tablets released over 60 % of drug within 5 min. FTIR analysis showed no interactions between ibuprofen and excipients. The simplex lattice design revealed that combination of superdisintegrants significantly affects the wetting and disintegration times as well as drug release.

Keywords: Simplex lattice, fast disintegrating tablets, superdisintegrants