DEVELOPMENT AND EVALUATION OF ETHANOL FREE READY TO USE INJECTION OF GEMCITABINE HYDROCHLORIDE

Abstract

Cancer known medically as a malignant neoplasm, is a broad group of various diseases, all involving unregulated cell growth. Cancer is one of the most life-threatening diseases. The mortality rate due to cancer is increasing even after presence of many chemotherapeutic agents in market. So, the ultimate objective of the present work was to developed Gemcitabine Hydrochloride aqueous injectable solution which is widely used as antineoplastic antimetabolite. Since, the Gemcitabine Hydrochloride is soluble in water as confirmed from the solubility studies, hence, formulated as an aqueous injectable solution for i.v. administration. The present work is to formulate novel injectable formulation of Gemcitabine Hydrochloride using WFI as the only vehicle by ready to use technique. Marketed injectable formulation of Gemcitabine Hydrochloride has ethanol as its major excipient. Gemcitabine Hydrochloride is given in combination therapy either with platinum derivatives as Cisplatin or Carboplatin and Paclitaxel etc. for various cancer treatments. As both aqueous injectable formulation of Gemcitabine Hydrochloride and Paclitaxel have Ethanol as major excipient. However, when both are given in combination therapy the daily exposure of Ethanol to patients exceeds its limit and shows its side effects. The present work is envisaged to overcome the above limitations by formulating it into a stable ethanol free formulation.