Validación de proceso de manufactura de sólidos orales con Nifuroxazida y validación de limpieza de los equipos involucrados en su elaboración, neo fármaco

Abstract

The objective of the present work was to validate the manufacturing process of oral solids with nifuroxazide and the cleaning of the equipment involved in their elaboration, in the Neopharmaceutical laboratory of Ecuador. The experimental work was carried out in two stages. First, the manufacturing process of Diarex Tablets was validated, evaluating the compliance with critical quality parameters and attributes, and its capacity index. Samples were taken in triplicate at each stage of production, which were subsequently subjected to a physicochemical analysis by spectrophotometry at 385 nm, as well as quality tests for tablets. It was determined that the process can produce 99.99% of products under specification, but it is a decentralized and out-of-specification process so in the long term there will be products out of specification. In the second part, the cleaning validation was carried out where samples were taken in triplicate from the surfaces of the equipment involved in the production. The samples were analyzed by spectrophotometry at 385 nm to determine traces of nifuroxazide, to detect the detergent. The last rinse samples were analyzed by conductimetry and pHmetry, and their capacity index was evaluated. It was determined that the cleaning was effective when NaOH 0.1N was used in the removal of nifuroxazide. As for the detergent, the process was ABLE to remove 99.99% of the detergent, but being a decentralized process, there will be results out of specification in the long term. The microbiological quality was also evaluated, where samples were taken 7 days in a row, and it was determined that there was no microbial growth. In conclusion, the manufacturing process of Diarex Tablets has been validated. More data is required to consider the cleaning method used in its production equipment validated.