Lyophilized Injectables: Omeprazole and Vancomycin. Evaluation of Homogeneity of Drying

Abstract

Introduction: Among the medicines of aica+ Laboratories Company are the lyophilized injectables vancomycin 500 mg and omeprazole 40 mg, whose prescriptions were modified according to the new conditions of the entity.

Objective: To evaluate the homogeneity of the drying of omeprazole and vancomycin injectables.

Methods: For the study of homogeneity of drying, bulbs were sampled from all the plates, through the evaluation of the distribution of the data. Samples were selected from each of the industrial batches of both injectables, and the residual moisture content was determined by statistical processing to determine the existence or not of significant differences at the plate level and between batches. Quality controls were performed on all batches, including organoleptic characteristics, pH, titration, sterility and endotoxins.

Results: The values of residual moisture content of both injectables complied with the normal distribution and with the established limits. It was found that there were no significant differences between the residual moisture values of the bulbs placed on the same plate and between different plates, but not between batches, thus the drying process was considered homogeneous for the products of interest. The industrial batches, freshly processed, satisfactorily met the quality specifications established for both products.

Conclusions: The freeze-drying process performed for omeprazole and vancomycin injectables proved to be homogeneous for the conditions existing in the producing entity, under the conditions existing in the producing entity.