Avaliação da qualidade de fármacos e comprimidos de clozapina em uma cadeia de fabricação farmacêutica

Abstract

The difficulty in acquiring raw materials quality, due to lack of drug industries in Brazil, leads to problems of classification of manufacturer / supplier quality and traceability in this process. The lack of standardization of these raw materials results in variability in the final product, to result in the therapeutic effect of the drug. Clozapine, a drug chosen for this study, which belongs to the category of antipsychotic agents, mainly used for refractory schizophrenia or other severe psychiatric disorders, like medicine, is part of the Specialized Pharmaceutical Service of the Ministry of Health, is considered costly, requiring of official laboratories to manufacture targeting the chronic patient care and lower costs of these treatments. The aim of this study was thus to evaluate the quality of this active ingredient supplied by a manufacturer originating from China and dosage forms generated from this asset, attesting to the reproducibility between batches and the whole production chain drug clozapine 100 mg, produced by a official laboratory of the state of Alagoas. With the aid of analytical techniques such as infrared microscopy, thermal analysis systems and dissolution was performed to characterize and evaluate the quality of these raw materials and products originated. The results of microscopy: optical and scanning electron intrinsic dissolution and differential scanning calorimetry demonstrated that the raw materials are in the form of anhydrous crystals with dissolution characteristics of the drug class II Biopharmaceutics Classification System. The tablets of clozapine showed compatibility with standard excipients of the formulation with dissolution profiles and f2 analysis (Statistical analysis) confirmed that equivalent to reference drug. The evaluation of clozapine by dissolution profile ratified compatibility studies by thermal analysis, showing that the standard formula of this product shows no excipients that reduces the stability of the final product.