Influence of bromobutyl freeze drying closures treatment on the moisture content of the lyophilized injectable omeprazole 40 mg

Abstract

The stability of a lyophilized product is very sensitive to the effect of residual humidity, for that reason it is important not only to control it in every stage of the process of lyophilization, but also the preparation of the packaging material to use. The objective of the present work was to evaluate the influence of the treatment received by bromobutyl freeze drying closures on the residual moisture content of the lyophilized injectable omeprazole 40 mg. The three bromobutyl freeze-dried closures batches of 20 mm were tested, sterilized by moist heat and dried. The moisture content of three industrial batches of omeprazole was estimated using sterile and dried closures, for twelve months, by Karl Fischer technique, as well as the assay of the injectable by a chromatographic method. It were successfully demonstrated that the closure’s weight increased, as a result from the humidity absorption associated to the sterilization process. The drying process of the closures decreased the initial moisture content. The industrial batches of the freeze-dried injectable omeprazole, by using sterile and dry bromobutyl closures, kept the moisture content within the established limit, for twelve months, as well as the assay, without risks for the quality of the final product.