Desenvolvimento farmacotÃcnico e desenvolvimento de estabilidade de comprimidos à base de captopril / Pharmacotechnician development and a study based on the stability of tablets with captopril

AUTOR(ES)
DATA DE PUBLICAÇÃO

2006

RESUMO

Hypertension is a public health problem considered by the Worldwide Health Organisation (OMS) as the third death cause in the world, overpassing only by unsafe sex and malnutrition. In the world, there are 600 million hypertensive people. In which of these, 500 million need an immediate medical intervention. In Brazil, there are about 30 million infected by this disease, that can reach more than 50% of the elderly. The OMS foresees that by the year 2010, the cardiovasculars disease will be the main cause of deaths in developing countries (OMS-2003). Captopril was the first drugs inhibitor of the Angiotensine of Enzyme Conversion (ECA), served as an useful tool in high blood pressure and insufficient congestive cardiac treatment, due to the effect of reducing the Angiotensine II production. It is a very sensitive substance that is submitted to the alteration by being exposed to moist suffering a degrading oxidation to captopril disulphide and is in favor the main active to dimish, an impurity elevation of captopril disulphide , above the permitted index and the strong odor. The studies on captopril advanced in the last decade, however, a scientific research left an achknowledged gap relating to the degrading captopril disulphide. The issue is not cleared yet in all aspects, taking in addition the scientific reasoning to reality that presents as a very comprised field for the present study, giving the possibility to achknowledge a more complete above all the factors related to the captopril disulphide. The objective of this work was to evaluate the excipents influence (lubricant and diluent) in four different tablet formulas of the active and conditional in blister packaging with molding film made of vinil ployclorect crystal (PVC) and polyvinilden clorect (PVDC) reinvested by PVC in crystal colors and red. A stability study was done following the required rules ade by ANVISA (National Sanitary Surveillance Agency) (RE nÂ. 1, July 29, 2005). The samples were submitted to testing defining in official summary. It was verified that the formulation F-2 and F-4, whose lubrification used was of estearic acid, applying to all the especifications from the Brazilain Pharmacopoeia 4Â ed. presented a lower concentration of captopril disulphide of 3%. It showed a little influence of studied diluents (anhydrous lactose and lactose spray-dried). The best results were obtained in moist conditional tablets and gases in general. Several factors as moist, packaging, storage and transportation were in favor of degrading captopril and resulted in an increase of captopril disulphide, being necessary an evaluation of these during the pharmacotechnician development of the preparation with the active captopril

ASSUNTO(S)

captopril policloreto of vinila comprimidos captopril cloreto of poliviniledeno policloreto de vinila dissulfeto de captopril estabilidade cloreto de poliviniledeno captopril disulphide stability farmacia tablets

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