Formulation of Hydrocortisone Sodium Succinate (100 mg / Vial) for I.V/ I.M Injection - تصييغ تركيبة هايدروكورتيزون صوديوم سكسنيت مسحوق( 100 ملغم / فيال) للحقن العضلي والوريدي

Abstract

Hydrocortisone sodium succinate is an anti-inflammatory adrenocortical steroid has the same metabolic action as hydrocortisone . The present study aimed to prepare a pharmaceutical formula of hydrocortisone sodium succinate sterile powder for injection equivalent to hydrocortisone base (100 mg) for intravenous (I.V) or Intramuscular (I.M) administration. The study was carried out to prepare an acceptable formula through studying the effect of various concentration of buffering agent. (sodium phosphate monobasic and sodium phosphate dibasic ,either alone or in combination) and chlorobutanol as preservative , also the formula does not contain any isotonic agent because water for injection was employed as an isotonic solvent . The pH was adjusted after reconstitution with sterile water for injection and found matching with the united states pharmacopeia (USP) specified range (6.0 to 8.0) . The acclerated stability study was carried out according to International conference Harmonization (ICH) Guidelines for six months involved different temperatures and humidity at (25 Cº/ 60 % RH , 30 Cº/ 65 % RH , 40 Cº/ 75 % RH) to reach the shelf - life. The result of stability study indicates that the prepared formula was accepted during the time of Stability period.