Primary Study About Formulation of Methyl Prednisolone Acetate (40 mg/1 ml) as Aqueous Injectable Suspension for Intramuscular (I.M) Use دراسة أولية عن تصييغ تركيبة صيدلانية مثيل بريدنيزولون أسيتيت) 40 ملغم/ مل( معلق مائي للحقن العضلي

Abstract

Methyl prednisolone acetate suspension is used for intramuscular administration in allergy, dermatological disease, endocrine disorders, respiratory disease and rheumatic disorders.. etc .The aim of the study was to develop a new pharmaceutical formula of methyl prednisolone acetate 40 mg / ml as an active ingredient and other materials. Different formulations were carried out using several preservatives, buffering agents, different tonicity and solubilizing agents to reach to the more appropriate formula and comply with united state pharmacopeia (USP) specifications. Many formulas were carried out for methyl prednisolone injectable suspension containing benzyl alcohol as preservative and analgesic. Sodium chloride was added to adjust tonicity. When necessary pH was adjusted with sodium hydroxide and/or hydrochloric acid to remain the pH of finished product within USP range (3.5 - 7.0). Stability study was carried out according to ICH condition at (25ºC/60% RH, 30ºC/65 RH, and 40ºC/75%RH) in order to reach the shelf life of the product.