Formulation of Betamethasone Sodium Phosphate (4mg/1ml) Ampoule for Intramuscular (I.M) and Intravenous (I.V) Administration

Abstract

Betamethasone sodium phosphate is a sterile aqueous solution , used for a number of diseases including rheumatic disorders such as rheumatoid arithritis , allegic conditions such as asthma and skin diseases such as dermatitis and psoriasis. The aim of the study was to prepare and evaluate a pharmaceutical formula of Betamethasone sodium phosphate (4 mg /ml) injection for Intravenous (I.V) or Intramuscular (I.M) administration. Different formulas were prepared using sodium phosphste dibasic as buffering agent, sodium metabisulphite as antioxidant and sodium acetate as chelating agent. The studied formula was designed for ( I.V) or (I.M) administration , therefore ,the pH was adjusted and controlled to (8.5) according to United State pharmacopeia (USP) range ( 8.0 – 9.0) . Easy solublization of Betamethasone sodium phosphate in water for injection and because the vehicle contains many salts as excipients, final solution was found isotonic. The Stability study was carrid out on optimized formula according to International Conference Harmonization (ICH) Guidelines after exposure the formula to different conditions temperatures and humidity especially at (25 C°/60% RH,30C°/65% RH and 40C°/75% RH) in order to obtain a suitable and effective formula which meets with the requirements of pharmacopeial specifications . The result of stability study was indicated that, the proposed formula was stable and no any major changes were observed in physico-chemical properties.