Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF GEMCITABINE HYDROCHLORIDE FOR INJECTION

R. Ananta Kumar*, M. Pharm, P. Sathya Narayana, M. Pharm, A. Rama Devi, M. Pharm, J. China Babu

ABSTRACT

Products are manufactured in the lyophilized form due to their instability when in solution. There are many new parenteral products, including anti-infectives, biotechnology derived products, and in- vitro diagnostics which are manufactured as lyophilized products. In the present study, the anticancer drug was formulated as lyophilized dosage form. The description, identification, assay, solubility, melting point, solution stability, pH stability, compatibility of the drug with different excipients, glass transition temperature, rubber closure compatibility were determined. From the solubility studies, it was found that API was water soluble. pH-stability profile was generated over a pH range of 2.7- 3.3 and studies showed that the drug was stable in the range and pH of 2.9 was used for the study. FTIR was used to assess the compatibility of drug with selected excipients. Based on the results of FTIR, Mannitol PFG, Lactose Monohydrate and Dextrose Monohydrate were found to exhibit no interaction with the drug. Rubber closures compatibility studies reveal the absence of loss of drug with Stelmi and West Pharma rubber closures. The drug in solution form was subjected to stability studies and suggested that the drug in solution form was stable upto 48 hours. Finally lyophilized parenteral dosage form was developed with selected excipients. Short term accelerated stability studies were also conducted and from the results, it was concluded that the optimized formulation was found to be the stable lyophilized parenteral dosage form.

Keywords: Anti-cancer drug, Freeze drying/Lyophilization, Stability, Freezing, Parenteral dosage form, Primary Drying, Secondary Drying.