Pharmacotherapy of the tuberculosis (TB). Assessment of the quality of anti-TB drugs provided by the national TB control program

ROMAÑUK CB; CATANI YA,; MANZO RH; OLIVERA ME

Córdoba - Argentina

Congreso; 1ª Reunión Internacional de Ciencias Farmacéuticas; 2010

Facultad de Ciencias Químicas, Universidad Nacional de Córdoba y Facultad de Ciencias Bioquímicas y Farmaceúticas Universidad Nacional de Rosario

Introduction Although there are potentially curative treatments since more than half a century, the TB is even today the most important cause of avoidable deaths and is a very important problem in developing countries1.One of the biggest problems facing the TB is that the established set of rules is not fulfilled2,3. In Argentina, anti-TB treatments supplied by the National TB Control Program are dispensed by pharmacists in public hospitals. There is no information easily available neither about the quality of the anti-TB products, nor if it is maintained after the long supply chains4. Objective To determine the quality of formulations of anti-TB agents supplied in public hospitals for use in national TB control program. In vitro assays of solid dosage forms containing isoniazid (ISO), rifampicin (RIF), pyrazinamide (PIR) and ethambutol (ETA) as single units and also ISO/RIF Fixed Dose Combination were performed. Materials and methods Rifampicin (capsules 300 mg), isoniazid (tablets 300 mg), pirazinamide (tablets 250 mg), ethambutol (tablets 400 mg) and RIF/ISO Fixed Dose Combination (tablets 300/150 mg). Twelve units of each product were tested according to their individual USP monographs5, with in vitro dissolution test and quantification by HPLC and UV-Vis methods. Dissolution profiles were constructed. Results and discussion The quality of products containing antibiotics is one of the basic elements to guarantee the treatment success. In the case of anti-TB treatment, the lack of quality can result in both effectiveness decrease and side effects occurrence. The tablets containing RIF, ISO, and PIR greatly exceeded the established values of Q. However, those containing ETA presented a dissolved percentage at the lower limit. In contrast, Q times for products containing RIF and ISO in the fixed drug combination do not meet the codified requirements. This could result in drug unloading which would seriously compromise the treatment effectiveness in in vivo situations. It is known that RIF exhibits variable bioavailability from solid oral dosage forms and this problem is more apparent when it is formulated as fixed dose combination, in presence of other first-line anti-TB drugs. Pharmacist must be aware of the patient?s risks. Clinical follow- up is encouraged. Conclusions Formulations of anti-TB agents supplied as single units successfully passed in vitro evaluation. However, the RIF/ISO fixed drug combinations do not. This non compliance can compromise drug effectiveness. The obtained results will be reported to the National Health Authority.