Evaluación de la equivalencia farmacéutica in vitro en comprimidos de paracetamol (500mg) de tres industrias farmacéuticas multinacionales y tres industrias farmacéuticas ecuatorianas.

Abstract

The research is based on the pharmaceutical equivalence "in vitro" in the paracetamol 500 mg tablets, the National Pharmaceutical Industries and the Multinational Pharmaceutical Industry. The information that was applied was experimental, descriptive, comparative, observational, transversal and prospective, in the pharmaceutical forms, in the different pharmacies of Ecuador. weight,dimensions, hardness, dose uniformity, disintegration, profile of production, determination of active principle and friability, all the parameters of the agricultural policy of the United States (USP 30). The evaluable results showed that the National comprises passed 489.64 mg of active principle and the Multinationals tablets published 491.96 mg of active principle, as well as all the solid dosage forms subjected to a study have an equal as it was found that all these drugs at 15 minutes obtained an 85% release of the drug in the bio-exemption tests, thus fulfilling the requirements of the pharmacopoeia. Through the application of the test of equivalence of means (t-student), referring to the variables Study time, disintegration time, dose uniformity, activity principle,work profile and friability, means of communication and the standard deviation are equivalent. , calculated at the “p” value of all these tests was <0.05. It is important for us to determine all the 500 mg paracetamol tablets of the six commercial houses under study are pharmaceutical equivalents. The quality of the drugs distributed at the level of Ecuador will be made known, which will provide greater satisfaction and tranquility to the client.