Open AccessCONTROLE DE QUALIDADE DE CÁPSULAS MANIPULADAS CONTENDO ATORVASTATINA CÁLCICA
Author(s) -
Ana Julia Pereira Santinho Gomes,
Diego da Silva Ribeiro,
Nayra Mendes da Silva
Publication year - 2020
Publication title -
colloquium vitae
Language(s) - English
Resource type - Journals
ISSN - 1984-6436
DOI - 10.5747/cv.2020.v12.n2.v297
Subject(s) - compounding , excipient , dissolution , solubility , dissolution testing , biopharmaceutics classification system , dosage form , active ingredient , immediate release , pharmacology , chemistry , materials science , medicine , organic chemistry
Atorvastatin calcium (ATC) is one of the most used drugs in the treatment of dyslipidemia. The compounding of capsules containing ATC has often been requested as it is an exceptionaldispensing drug (continuous use and high cost). ATC presents low solubility and high permeability, therefore, pharmaceutical ingredients are capable of interfering with its solubility. The aim of this work was to evaluate the quality of ATC capsules prepared incompoundingpharmacies in Divinópolis,Brazil.Fourier Transform Infrared spectroscopy (FTIR) was used to identify the ATC. Tests for weight determination (WD), content uniformity (CU) and dissolution were also carried out. The FTIRconfirmed the authenticity of ATC. All batches were approved in relation to the WD, however only 67% were approved in relation to the CU, although all have been approved for acceptance value.It was also observed that 1/3 of the products did not display the specified dissolution rate. This is due to the excipient composition impacting on a significantly slower dissolution profile compared to the others. It was noted that the choice of a specific excipient for ATC together with an appropriate encapsulation procedure play key roles in ensuring the quality of an exceptional dispensing drug, whose dissolution behaviorcan influence oral absorption. In conclusion, the importance of monitoring the compounding process was demonstrated, expanding the relevance of the constant evaluation of the quality of pharmaceutical dosage forms, bringing to light the difficulties of the compounding sector, as well as the effectiveness of the approval criteria employed to date.