Journal of Pharmaceutical Research

Abstract

Antineoplastic or Anticancer drugs are the drugs that prevent or inhibit the maturation and proliferation of neoplasm. Antineoplastic agents travel the body and destroy cancer cells. The aim of present research work was to formulate aqueous injection of Bleomycin Sulphate, which can be administered via intramuscular, intravenous, subcutaneous, intra-arterial, or intrapleural routes. The stability of Bleomycin sulphate aqueous injection was increased using lyophilization technology. The process involved dissolving Bleomycin sulphate in water, measuring pH, preparing the final volume, filtering, filling to vials, and subjecting the solution to varying cycles of freezing and holding times, primary and secondary drying times, and vacuum variation. The optimized lyophilization cycle of 38.86 hours was achieved, ensuring the product met all in-vitro parameters as per IP/USP specifications. A short-term accelerated stability study confirmed the formulation's stability. The research developed a stable aqueous injection of Bleomycin Sulphate using lyophilization technology, overcoming challenges like limited stability in sodium chloride solution and hygroscopic nature in dry form. This pharmaceutical formulation is suitable for treating sensitive diseases like neoplastic diseases.

Keywords: Bleomycin, Antineoplastic, Parentral, Stability, Lyophilization