Avaliação de qualidade de cápsulas manipuladas de Diacereína 50 mg em farmácias magistrais da cidade de Fortaleza e região metropolitana

Abstract

Osteoarthritis (OA) is a degenerative joint multifactorial disease that is highly prevalent in the adult population and especially in the elderly, responsible for the individual's functional incapacity, which ends up leading to a decrease in the quality of life. Usually the treatment used is an association between treatment nonpharmacological and pharmacological, among which stands out the use of diacerein, whose manipulation is very widespread in magistral pharmacies. With this in mind, this study aims to evaluate the quality of diacerein 50mg manipulated capsules in some magistral pharmacies in Ceará and the reference medicament. For this, about 30 capsules of each of the 4 formulations used in the study were used for the make the physical-chemical control tests (mean weight, dose uniformity by content, disintegration, dissolution and loss by desiccation), microbiological test and DSC analysis. In the formulation 1 got in the mean weight test a RSD of 5.45%. In the dissolution test, all formulations were approved according to the limits of the Hindu pharmacopoeia. However, in the point-to-point comparison (f1 and f2) only formulation 2 showed similarity to the reference drug getting f2 = 64 and f1 = 7. All formulations were approved in the tests of the content uniformity, disintegration and microbiological test. In view of the results obtained, stands out the importance of a greater rigor in the elaboration of tests already performed in routine in the magistral pharmacies, as in the case of the average weight, as well as the necessity of elaboration of tests of dissolution to guarantee to the individual a treatment of quality with like effect to that which would be obtained with the use of the reference medicine. It is also important stands out the need to draw up official compendiums on diacerein capsules