DEVELOPMENT OF NEW OPHTHALMIC SUSPENSION PREDNISOLONE ACETATE 1%

Abstract

Formulation of a new Prednisolone acetate (1%) ophthalmic suspension to obtain a better contactibility of the drug at the site of action. The formulation was evaluated and optimized based on physiological, physicochemical and pharmaceutical parameters and prepared aseptically, keeping particle size between 1-3 µm, while viscosity enhancer, preservative, chelating agent were used to increase the transient residence time, antimicrobial preservation respectively. Isotonicity of the formulation was maintained. Buffering agents used were having buffering capacity NMT 0.05%. pH adjusted at which Prednisolone acetate was stable. The finished product subjected to stress conditions to check the physical stability of the formulation. The formulation was packed in LDPE plastic vials, and subjected to accelerated stability studies at 40o C and the kinetic and predictive method was employed for the determination of degradation rate constant and shelf life. The results showed that the development of a new ophthalmic formulation having significantly better contact time by the selection and optimization of viscosity (HPMC) that obtained (21 cps) with better stability studies. The results concluded that prednisolone acetate 1.0 per cent ophthalmic suspension is more effective than prednisolone phosphate 1.0 per cent ophthalmic solution in suppressing corneal inflammation.