Controle de qualidade de cápsulas manipuladas contendo 50 mg de cetoprofeno

Abstract

Ketoprofen, a drug with anti-inflammatory, analgesic, and antipyretic activity, belongs to the class of non-steroidal anti-inflammatory drugs, which inhibits the enzymes cyclooxygenase-1 and cyclooxygenase-2 in a non-selective way. Belonging to Class II of the Biopharmaceutical Classification of drugs, which means that the water solubility of the molecule in the gastrointestinal tract is the limiting step in the absorption process, so that the composition of the pharmaceutical form must be designed to optimize the solubilization kinetics of the drug in the quite. Master pharmacies produce medicines individually, with the possibility of choosing the dose and excipients. However, quality control of pharmaceutical preparations is necessary to ensure the safety and effectiveness of the compounded medicine. Quality control is essential to produce medicines, whether on an industrial scale or on a master scale, as it guarantees drug safety and efficacy. The objective of the work was to evaluate the influence of excipients in capsules containing 50 mg of ketoprofen, controlling the active pharmaceutical ingredient and capsules manipulated with different excipients. Three types of excipients were prepared, varying in composition. The three formulations were approved in the average weight, only two in the dosage and none were approved in the dissolution test. This demonstrates that the composition of the excipient interferes with the dissolution speed of Class II and IV drugs, therefore, it is of fundamental importance that compounding pharmacies standardize validated excipients to produce each drug.