Formulation Development and Evaluation of Dry Powder Injection for Reconstitution

This study focuses on the formulation development and evaluation of a dry powder injection for reconstitution of candesartan cilexetil, a poorly water-soluble drug.The primary aim was to enhance the solubility of candesartan cilexetil through physiologically compatible solubilizers, enabling the formulation of a stable and effective parenteral preparation.Preformulation studies confirmed the drug's physicochemical properties, including a melting point of 159-163C and UV absorption maximum at 305 nm.Solubility studies revealed significant enhancement in selected mixed blends, with Blend F-2 showing a solubility enhancement ratio of 1326.6.Formulations were developed using a geometric dilution method and evaluated for parameters including drug content, pH, clarity, and reconstitution time.The optimized formulation, DPF1, demonstrated a drug content of 7.21 mg, a pH of 8.94, and a reconstitution time of 1 minute 5 seconds.Stability studies conducted at room temperature and 2-8C over 12 weeks showed 90.20% and 90.90% residual drug content, respectively.The developed formulation exhibited clear solutions without precipitation upon reconstitution, demonstrating its potential as a viable parenteral preparation of candesartan cilexetil.