QUALITY CONTROL OF COMPOUNDED CAPSULES CONTAINING ATORVASTATIN CALCIUM: QUALITY OF CAPSULES OF ATORVASTATIN CALCIUM

• Autor(a) principal: Gomes, Ana Julia Pereira Santinho
• Data de Publicação: 2020
• Outros Autores: Ribeiro, Diego da Silva, Silva, Nayra Mendes da
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Colloquium Vitae
• Texto Completo: http://revistas.unoeste.br/index.php/cv/article/view/3496

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 exceptional dispensing 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 in compounding pharmacies in Divinópolis-MG. Fourier Transform Infrared spectroscopy (FTIR) was used to identify the ATC. Tests for weight determination (WD), content uniformity (CU) and dissolution were carried out. The FTIR confirmed the authenticity of ATC. All batches were approved in relation to WD, however only 67 % were approved in relation to 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 behavior can 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, as well as the effectiveness of the approval criteria used to date has been demonstrated.