MEAN WEIGHT AND CONTENT UNIFORMITY OF RANITIDINE CAPSULES

Abstract

Brazilian compounding pharmacies should follow good manufacturing practices defined by Anvisa to ensure the efficacy, safety and credibility of medicines dispensed to the population. The pharmacopoeial analyzes have limited
application in compounding pharmacies. However, minimal tests, as weight determination of capsules, are required for the quality control of medicines preparations. Other tests are applicable in cases of minimum stock or periodical
analysis, to monitoring the manufacturing process. In this study, of mean weight and uniformity of dosage forms were evaluated for ranitidine capsules from six different compounding pharmacies in Belo Horizonte, MG, Brasil.
The dosage forms were analyzed according to Brazilian Pharmacopoeia and National Formulary. Only one pharmacy presented capsules with an unsatisfactory result in the mean weight test. In uniformity of dosage forms, all analysed capsules were disapproved in the test criteria. The results showed that capsules with uniformity of weight do not necessarily present a uniformity distribution of the drug. The control of manufacturing process is essential for ensuring quality, effective and safe products.