CONICET | Buscador de Institutos y Recursos Humanos

Purpose: The aim of this work was to develop an extemporaneous 1% BNZ suspension, with masked taste and adequate stability starting from available commercial tablets. The quality of compounding was evaluated though content uniformity measurement and physical and microbiological stability evaluation, under different storage conditions during 90 days. Methods: Six batches of 1 % BNZ suspension were prepared using safe excipients currently available in a galenic area of Hospital Pharmacy, and then stored at 5 and 25 °C for 90 days. The BNZ content was determined by UV-spectrophotometry. Physical stability was defined as the absence of color, odor and/or flavor changes and the re-suspension of solid phase by a reasonable amount of simple 15-second shaking. The compliance with microbiological attributes of non-sterile pharmaceutical products was also evaluated. Results: An oral liquid suspension, containing 1 % of BNZ, was developed from commercially available BNZ tablets. The formulations stored during 90 days were easily re-dispersed after a simple 15-second shaking, ensuring the pouring of a liquid volume containing the desired dose of BNZ. All samples were within the acceptable range of BNZ concentration with minimal standard deviations. There were no detectable changes in color, odor, viscosity, pH and microbial growth, complying with official quality requirements. The quality attributes were not affected by storage, room or refrigeration conditions or by the frequent opening or closing of the multi-dose containers. Conclusion: Pediatric oral liquid suspension containing 1.0 % of BNZ was easily prepared starting from commercial tablets, being an interesting alternative for optimizing the pediatric treatment of Chagas disease.