Estudio comparativo de los perfiles de disolución entre comprimidos y cápsulas de omeprazol 20 mg.
Fecha
2025
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Universidad Nacional San Luis Gonzaga
Resumen
El omeprazol es un antiulceroso, inhibidor de la bomba de protones, posee un amplio margen
terapéutico por lo cual es un medicamento de primera elección frente a enfermedades del sistema
digestivo lo que es motivo de su constante dispensación en el sistema de salud por su seguridad y
eficacia, por todo esto se encuentra tanto en forma de medicamentos genéricos como de marca
registrada. El objetivo del presente trabajo fue comparar los perfiles de disolución en
comprimidos y capsulas de omeprazol 20 mg, para lo cual se realizó un estudio de diseño
experimental que consistió en la comparación de medicamentos genéricos de omeprazol 20 mg
frente a Norprazole ® 20 mg como medicamento de referencia. En el proceso de disolución se
hicieron seis tiempos de muestreo con 12 unidades por cada lote y mediante el modelo
independiente se desarrolló el cálculo del factor de similitud (f2) para determinar la existencia de
equivalencia terapéutica. También se desarrolló el proceso de disolución de Ometab®, por ser el
único comprimido distribuido en el mercado nacional, del cual hicieron seis tiempos de muestreo
con 12 unidades. Se analizaron las muestras en dos niveles diferentes de pH (1.2 y 6.8), realizando
la cuantificación mediante espectrofotometría UV-Vis.
Se realizo el perfil de disolución de comprimidos de omeprazol de diferentes laboratorios con el
mismo principio activo é igual concentración y forma farmacéutica, estos medicamentos fueron
elegidos por presentar mayor cantidad de reportes en el observatorio peruano de productos
farmacéuticos (OPPF) de la DIGEMID. Los resultados permitieron calcular como factor de
similitud en el laboratorio A, un valor de 29.31, mientras que de loslaboratorios “B” Y “C” fueron
de 25.23 y 24.28, respectivamente y las constantes de disolución fueron de 1.5, 1.29, 0.75 y 1.47
para Norprazole ® y los laboratorios A, B y C. De acuerdo con los resultados del comprimido,
Ometab® mostró una disolución rápida habiéndose completado antes de los 10 minutos,
registrando una constante de disolución de 0.10. Los valores del factor de similitud (f2) permiten
concluir que no es posible la bioequivalencia entre Norprazole® y los medicamentos genéricos
estudiados debido a que los valores de f2 fueron menores que 50.
Omeprazole is an anti-ulcer drug and proton pump inhibitor with a broad therapeutic margin, which makes it a first-line treatment for digestive system disorders. Its safety and efficacy account for its constant dispensing within the healthcare system. For these reasons, it is available in both generic and branded forms. The objective of the present study was to compare the dissolution profiles of 20 mg omeprazole tablets and capsules. An experimental design study was carried out, which involved comparing three generic 20 mg omeprazole products against Norprazole® 20 mg as the reference product. The dissolution process included six sampling times with 12 units per batch, and the similarity factor (f2) was calculated using the model-independent approach to determine therapeutic equivalence. The dissolution profile of Ometab®, the only omeprazole tablet distributed in the national market, was also evaluated with six sampling points and 12 units per batch. Samples were analyzed at two pH levels (1.2 and 6.8), and quantification was performed using UV-Vis spectrophotometry. Dissolution profiles were obtained for omeprazole tablets from different laboratories with the same active ingredient, concentration, and pharmaceutical form. These medications were selected based on the higher number of records reported in the Peruvian Observatory of Pharmaceutical Products (OPPF) of DIGEMID. The similarity factor (f2) calculated for Laboratory A was 29.31, while values for Laboratories B and C were 25.23 and 24.28, respectively. The dissolution rate constants were 1.5, 1.29, 0.75, and 1.47 for Norprazole® and Laboratories A, B, and C, respectively. According to the results, Ometab® showed rapid dissolution, completing the process in under 10 minutes, with a dissolution constant of 0.10. The f2 similarity factor values indicate that bioequivalence between Norprazole® and the generic drugs studied is not achievable, as all f2 values were below 50.
Omeprazole is an anti-ulcer drug and proton pump inhibitor with a broad therapeutic margin, which makes it a first-line treatment for digestive system disorders. Its safety and efficacy account for its constant dispensing within the healthcare system. For these reasons, it is available in both generic and branded forms. The objective of the present study was to compare the dissolution profiles of 20 mg omeprazole tablets and capsules. An experimental design study was carried out, which involved comparing three generic 20 mg omeprazole products against Norprazole® 20 mg as the reference product. The dissolution process included six sampling times with 12 units per batch, and the similarity factor (f2) was calculated using the model-independent approach to determine therapeutic equivalence. The dissolution profile of Ometab®, the only omeprazole tablet distributed in the national market, was also evaluated with six sampling points and 12 units per batch. Samples were analyzed at two pH levels (1.2 and 6.8), and quantification was performed using UV-Vis spectrophotometry. Dissolution profiles were obtained for omeprazole tablets from different laboratories with the same active ingredient, concentration, and pharmaceutical form. These medications were selected based on the higher number of records reported in the Peruvian Observatory of Pharmaceutical Products (OPPF) of DIGEMID. The similarity factor (f2) calculated for Laboratory A was 29.31, while values for Laboratories B and C were 25.23 and 24.28, respectively. The dissolution rate constants were 1.5, 1.29, 0.75, and 1.47 for Norprazole® and Laboratories A, B, and C, respectively. According to the results, Ometab® showed rapid dissolution, completing the process in under 10 minutes, with a dissolution constant of 0.10. The f2 similarity factor values indicate that bioequivalence between Norprazole® and the generic drugs studied is not achievable, as all f2 values were below 50.
Descripción
Palabras clave
Omeprazol, Factor de similitud, Equivalencia terapéutica, Intercambiabilidad, Similarity factor