Self-curing controlled release systems for steroids. Application of prednisolone-based polymeric systems to ear diseases.

Abstract

An injectable delivery system for prednisolone has been prepared based on a self-curing formulation comprised of poly(methyl methacrylate) particles and hydroxyethyl methacrylate as monomer. The polymerisation reaction was initiated by the redox system 4,4'-bis (dimethylaminobenzydrol)/benzoyl peroxide (BZN/BPO) and followed at 25 degrees C by measuring the time-temperature profile. A maximum temperature of 53 degrees C and a setting time of 15 min were obtained, calculated according to standard specifications. The swelling of the cured system was studied in phosphate-buffered saline (PBS) at 37 degrees C giving a hydration degree at equilibrium of 20%. The swelling kinetics fitted a fickian behaviour at the initial stages of the experiments, with a diffusion coefficient of 0.72 x 10(-7) cm2/s. The release of the drug was sustained from the beginning without an initial drug burst. The study of the wettability showed a rather hydrophilic character of the surface of the loaded system, and the biocompatibility evaluated through MTT assay revealed the absence of cytotoxicity due to the release of toxic substances.