Influence of alternative presentation formats of amoxicillin 500 mg capsules on its quality

Abstract

Amoxicillin is considered an essential medicine and of frequent use in the Cuban Basic Table of Medicines. It is presented in hard gelatin capsules in a green-white format with a 500 mg dose. The objective of the present work was to evaluate the influence of alternative presentation formats of amoxicillin 500 mg capsules on its quality. Industrial batches of amoxicillin capsules were made using three presentation formats: green, red and scarlet. The tests carried out were: description, average weight, disintegration, evaluation, uniformity of dosage units, dissolution test and dissolution profiles. Simultaneously, the performance of the spectrophotometric method for the quantification of the analyte in three dissolution media was verified. To evaluate the drug release kinetics, different mathematical models were applied, determining the dissolution efficiency, mean dissolution time and area under the curve. The behavior of the dissolution was analyzed under conditions of shelf life stability. According to the technological and chemical evaluation carried out, the established quality specifications were met, regardless of the capsule presentation format used. The spectrophotometric method was shown to meet the established criteria for the intended purpose. The release of the drug in each of the batches was adjusted to the Weibull model. The capsule format used does not interfere with the dissolution behavior, for 24 months, under shelf life conditions. The industrial batches of amoxicillin capsules in the alternative presentation formats, complied with the established specifications, as well as the dissolution for 24 months, without risks to the quality of the finished product.