Formulation Development of a Model Dry Injection for Reconstitution of Poorly Water Soluble Drug Using Mixed Solvency Concept and its Evaluation

In this current era of pharmaceutical research, maximum newly invented drugs are found to be very poorly soluble in water. It poses difficulties in various developmental, manufacturing and administrating processes, which lead to the high failure of clinical trials of the drug due to poor pharmacokinetics. Parenteral dosage form could be expected to be an effective tool for avoiding the oral side effects and also achieving maximum bioavailability. Poor solubility of drugs in water is currently biggest challenge and limitation in injectable formulation developments. The prime purpose of any research work should be highly efficient and most effective in the pharmaceutics field to serve the societys needs by developing a formulation after literature survey and market review. The ultimate objective of this present research was to promote the use of mixed solvency concept by formulating the model dry injection of the poorlywater soluble drug and to decrease the concentration of individual solubilizers required to produce a substantial increase in solubility and thereby resulting in expected synergistic enhancement of solubility of the drug in water. In the present work, poorly water soluble drug, ornidazole was selected as a model drug and its dry injection for reconstitution was formulated. Ornidazole is the drug which belongs to the anti-protozoal category and used to treat infections caused by amoebic and trichomonas micro-organisms. It is nitro-imidazoline derivative which partially binds to plasma and also has a sensitizing action against radiation. (BCS class II highly permeable and low soluble). Due to the poor water solubility of ornidazole, the products are available in the market in tablet form, infusion form and suspension form. In order to get expected synergistic enhancement on solubility, various blends of solubilizers can be tried thereby reducing the amount of individual solubilizer employed to achieve the desired solubility enhancement ratio. Thus, the successful completion of the research work will enable the preparation of stable dry injection for reconstitution of ornidazole.