Formulation, Development, and Characterization of Lyophilized Para-Amino Salicylate Sodium Injection for an Effective Treatment for Multi-Drug Resistance-Tuberculosis

Abstract

The purpose of this study was to the development and manufacture of stable lyophilized injection formulation of Para-Amino Salicylate sodium, a drug that used in the treatment of multi-drug resistance tuberculosis. The drug was unstable in the aqueous solution and it shows high impurity level. Lyophilization technique in the pharmaceutical industries used in the formulation of thermolabile and moisture sensitive drug. For the formulation purpose, initial drug-excipients compatibility study was conducted and on the basis of percentage impurity level, present excipients were selected. Drug-Excipients compatibility study result shows that sodium metabisulphite increases the percentage of impurity level found that 0.12%, 0.15%, 0.06%, 0.09%, where the composition of API with sodium sulphite and other excipients reduces the impurities level. For the development of an effective formulation that provides stable, less impure and improved physicochemical characteristic of the model, several formulation methodologies were adopted.