New glyoxalated pre-gelatinized starch as release retardant for extended release pellets containing zaltoprofen: statistical optimization, in-vitro and in-vivo evaluation

Abstract

The aim of the present investigation is to develop zaltoprofen-loaded extended-release (ER) pellets formulation by an extrusion-spheronization technique using glyoxalated pre-gelatinized starch (GPS) complex as a novel matrix-forming polymer. The prime objective was to prepare an efficient and robust ER drug delivery system of zaltoprofen. Pellets were characterized by physicochemical, morphological, and solid-state characterization. The formulation was also analyzed for in-vitro drug release and in-vivo pharmacokinetic parameters. The FTIR analysis confirmed the GPS complex formation through the formation of the hemiacetal group while the ketone groups of glyoxal are abolished. Optimized formulation G5 containing 5:8 ratio of GPS complex and MCC showed 99.03 ± 2.12 percent cumulative drug releases in 14 h. The in-vivo study showed decreased C max and increased t 1/2 compared to bulk zaltoprofen, and hence would be a viable alternative for ER-type formulations. In the author’s opinion, the GPS-based ER pellet formulation would be an excellent delivery system for zaltoprofen.