Design and Development of Pediatric Formulations of Second line Antituberculosis Medications

Abstract

Tuberculosis poses a significant worldwide health problem for children, and the occurrence of multi-drug-resistant (MDR) tuberculosis in children is on the alarming rise. Traditional adult oral immediate release tablets are often impractical for kids, leaving a scarcity of child-friendly formulations. This research seeks to mitigate the potential hazards of blocking associated with the orally taken conventional dosage forms, thereby enhancing safety, administration convenience, bioavailability, and achieving a rapid onset of action. In this study, three dosage forms were formulated which include, granules, chewable tablets, and dispersible tablets of Moxifloxacin. The research study includes different steps which include preformulation as an initial step. Preformulation was done to determine the compatibility between API and excipients. Every parameter checked for preformulation were found within limit and hence no incompatibility was observed in the Moxifloxacin and other excipients used the formulation. newlineUsing the wet granulation method, granules were created by combining taste-masking agents with excipients like mannitol 160 C, aspartame as taste masking agent, and Lemon flavor as a flavoring agent. Flow properties of the granules were checked and found within limit for formulation F6. For optimized formulation, a variety of dissolution media, including 0.1 N HCl, phosphate buffer at pH 6.8 and 7.4, and acetate buffer at pH 4.5, were used for the in vitro dissolution investigation. It was found 100 % release at 12 min in 0.1N HCl. Also, other analysis were done like FTIR, DSC, XRD for which results collectively demonstrated that Moxifloxacin existed in a crystalline form in optimized formulation. In taste masking evaluation desirable results were achieved. In chewable tablets also, direct compression method was utilised and all the physicochemical parameters for tablets were determined which were found satisfactory. Several dissolve media, such as 0.1 N HCl, phosphate buffer pH 6.8 and pH 7.4, and acetate buffe