Bioequivalencia in vitro de Losartán Potásico contenido en tabletas de 50 mg multifuente comercializados en Perú
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Date
2022
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Universidad Nacional de Trujillo
Abstract
Desde el año 2018 se estableció la normativa de realizar estudios de intercambiabilidad de
medicamentos en nuestro país. Para el cual, se exigen de estudios de bioequivalencia como
requisito de los medicamentos genéricos para el registro sanitario. El objetivo de esta
investigación es determinar si existe bioequivalencia in vitro entre cinco medicamentos
multifuentes nacionales que contienen losartán potásico 50 mg en tabletas, con el producto
de referencia Cozaar®. Los criterios para el desarrollo de los perfiles de disolución fueron
los establecidos por la OMS. La equivalencia fue evaluada comparando las constantes de
velocidad de disolución, los parámetros TMD, ED y el factor de similitud f2. El modelo que
explica mejor el proceso de disolución del medicamento en los medios de disolución pH 1,2
y 6,8 fue Raíz Cúbica y Weibull para el medio disolución pH 4,5. Se encontró que los
parámetros de disolución evaluados indican que cuatro productos multifuente (B, C, D, E)
no son equivalentes al innovador, si siendo el A. Los f2 en los tres medios de disolución
fueron para el multifuente A (64,76; 99,5; 85,12); para el B (55,63; 22,84; 72,83); para el C
(41,36; 28,34; 67,70); para el D (30,26; 38,00; 67,70) y para el E (30,70; 14,38; 46,68). Se
concluye que de los cinco productos multifuente solo el A es bioequivalente in vitro y por
lo tanto intercambiable.
Since 2018, the regulations for carrying out drug interchangeability studies in our country have been established. The requirement for bioequivalence studies is introduced as a requirement for generic drugs for health registration. The objective of this research is to determine if there is in vitro bioequivalence between five national multisource drugs containing losartan potassium 50 mg in tablets, with the reference product Cozaar®. The criteria for the development of dissolution profiles were those established by the WHO. The equivalence was evaluated by comparing the dissolution rate constants, the parameters TMD, ED and the similarity factor f2. The model that best explains the drug dissolution process in the pH 1.2 and 6.8 dissolution media was the Cube Root and Weibull for the pH 4.5 dissolution media. It was found that the dissolution parameters evaluated indicate that four multisource products (B, C, D, E) are not equivalent to the innovator, if it is A. The f2 in the three dissolution media were for multisource A (64.76 , 99.5, 85.12); for B (55.63; 22.84; 72.83); for C (41.36; 28.34; 67.70); for D (30.26; 38.00; 67.70) and for E (30.70; 14.38; 46.68). It is concluded that of the five multisource products, only A is bioequivalent in vitro and therefore interchangeable.
Since 2018, the regulations for carrying out drug interchangeability studies in our country have been established. The requirement for bioequivalence studies is introduced as a requirement for generic drugs for health registration. The objective of this research is to determine if there is in vitro bioequivalence between five national multisource drugs containing losartan potassium 50 mg in tablets, with the reference product Cozaar®. The criteria for the development of dissolution profiles were those established by the WHO. The equivalence was evaluated by comparing the dissolution rate constants, the parameters TMD, ED and the similarity factor f2. The model that best explains the drug dissolution process in the pH 1.2 and 6.8 dissolution media was the Cube Root and Weibull for the pH 4.5 dissolution media. It was found that the dissolution parameters evaluated indicate that four multisource products (B, C, D, E) are not equivalent to the innovator, if it is A. The f2 in the three dissolution media were for multisource A (64.76 , 99.5, 85.12); for B (55.63; 22.84; 72.83); for C (41.36; 28.34; 67.70); for D (30.26; 38.00; 67.70) and for E (30.70; 14.38; 46.68). It is concluded that of the five multisource products, only A is bioequivalent in vitro and therefore interchangeable.
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Keywords
Cinética de disolución, Losartán potásico, Multifuentes