QUALITY OF SIBUTRAMINE CAPSULES MANIPULATED BY THREE COMPOUNDING PHARMACIES IN BELO HORIZONTE, MG, BRAZIL

Abstract

Sibutramine is indicated as an anorectic drug of choice for the treatment of obesity. Due to lack of pharmacopoeia monographs for analysis and quality control of this drug and that sibutramine has classification biopharmaceutical I, the authors of this study proposed physical-chemical tests of quality and evaluation of the influence of excipients in dissolving sibutramine capsules 10 mg manipulated in three compounding pharmacies of Belo Horizonte, MG. The general methods described in the Brazilian Pharmacopoeia 5th ed were applied and was made co-validation of UV spectrophotometric method. The results indicate that only one of the three samples fulfilled all quality specifications.