Formulation and evaluation of Prednisolone Sodium Phosphate injection

Abstract

Prednisolone Sodium Phosphate (PSP) is a synthetic corticosteroid exerting potent glucocorticoid and weak mineralocorticoid activity.The present study was undertaken with an intention to develop a stable and effective parenteral formulation, containing the high concentration of drug PSP. PSP is   heat sensitive and water soluble drug but unstable upon standing at room temperature or at elevated temperature in water. So the effects of various cosolvents in the solubility of PSP have been evaluated.PSP was tried with different cosolvents such as Ethanol, Glycerine and Propylene glycol. The drug was made into injection formulation for administered as a SVP. The influence of heat, light and atmospheric oxygen on the stability of the drug was studied. Out of all trials, formulation containing propylene glycol (16.5%w/v) and glycerine (5%w/v) in combination was found to be more stable and passed all tests satisfactorily. Accelerated stability study was conducted for 3 months at 45⁰ C / 75% RH, formulation containing propylene glycol (16.5%w/v) and glycerine (5%w/v) in combination was found to pass all tests satisfactorily.