Comparative Study Capsules Containing Amoxicillin Obtained Some of Magistral Pharmacies

• Autor(a) principal: Paulo, Glauber dias
• Data de Publicação: 2011
• Outros Autores: Mazzuco, Ana Paula, Rodolpho, Juliana Cristina, Salgado, Hérida Regina Nunes, Moreno, Andréia de Haro
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Revista Brasileira Multidisciplinar
• Texto Completo: http://revistarebram.com/index.php/revistauniara/article/view/111
• topic: Amoxicillin capsules; Pharmacies; Quality control.; Cápsulas de amoxicilina; Farmácias magistrais; Controle de qualidade.

Amoxillin is a semisynthetic antibiotic classified as penicillin of wide action spectrum against gram-positive and gram-negative bacteria, largely used in the treatments of several infections. Besides, amoxicillin is a drug widely used in clinical treatment (the usual dosage is 500 mg). According to RDC n.87/2008, in order to monitoring the manipulation process, pharmacies must analyze their pharmaceutical formulations to assure some important quality parameters, such as average weight, dissolution time and assay, to guarantee the drug concentration and therapeutic efficacy. The objective of this work was to develop a comparative study of three pharmaceutic formulations containing amoxicillin 500 mg (capsules) and to compare the results to those obtained from the generic drug. The analysis was carried out according to Brazilian Pharmacopoeia for amoxicillin. Although the 3 magistral preparations analyzed have been approved in average weight determination, only one pharmaceutical formulation presented satisfactory results for time dissolution and assay determinations (81,30 ± 0,98% and 91,65 ± 0,72%, respectively). The results showed the necessity of a strict quality monitoring by the pharmacies to assure the correct drug dosage and its therapeutic efficacy. The selection of excipients and the weight, blend and encapsulation procedures are very important, as well as the evaluation of the purity and integrity of raw materials.