"Evaluation Of Alternate Organic Solvents As A replacement Of Halogenated Solvents For Manufacturing Of Drug Products

Abstract

Halogenated solvents, which are commonly used in manufacturing and laboratory processes have been associated with human carcinogenesis. Halogenated solvents can pose major problems when they are released into the environment. Reducing their use by using other suitable and non halogenated solvents can consequently reduce the health and environmental threats associated with use of Halogenated solvents. Therefore the aim of this project is to bring together research efforts in the quest to find "green" replacements for halogenated solvents and to direct efforts to change solvent system based on halogenated solvent to non halogenated solvents to protect the environment and health as well as industrial safety. Based upon regulatory, health and environmental aspects, solubility characteristics of the polymer used and by conducting the series of solubility trials, alternate solvents were selected. Solution properties of the alternate solvent system i.e. appearance, viscosity were compared to that of reference system. Film forming properties of the polymers in these alternate solvents were also checked by conducting film casting trials and were compared to the reference system. Films prepared were evaluated for physical and mechanical properties like appearance, thickness, tensile strength, % elongation and folding endurance and results of both the system were compared. Selected alternate solvents were further tried in coating process. By conducting various coating trials tablets were coated using reference (with using halogenated solvent) as well as alternate system and evaluated further for physical parameters. Almost in all the cases alternate solvents selected show better or comparable results; therefore we can replace these halogenated solvents with alternative solvents used as vehicle or solvent. But before implementing these solvents further suitability in actual products and stability studies are necessary.