Formulation development and evaluation of medroxyprogesterone acetate injectable suspension

The aim of the present work is to develop sustained release parenteral drug delivery system of contraceptive drug i., e medroxyprogesterone acetate. The formulation was prepared by sterile combining of API and excipient powders by rapid stirring method. Different excipients used in the formulation are PEG 3350, Poloxamer -188, Polysorbate-80, Benzyl alcohol and Sodium chloride. The prepared parenteral suspension was evaluated for all official parameters like sedimentation volume, measurement of zeta potential, pH, viscosity, osmolality, dissolution, assay, particle size determination, and stability studies. The dissolution profile was found to be more when compared with the innovator formulation. Stability studies were also conducted at 25ºC / 60% RH and 40ºC / 75% RH conditions up to 3M.All the parameters evaluated are within the specified limits. Keywords: Medroxy progesterone acetate, PEG 3350, Poloxamer-188, injectable suspension