ABSTRACT
RESUMEN Los medicamentos de mayor consumo en el mundo son los analgésicos antiinflamatorios no esteroideos (AINEs), debido a su capacidad para aliviar el dolor, condición común a muchas patologías. Uno de los AINEs de gran utilización en Colombia es el ibuprofeno. Con el fin de evaluar la conformidad de los productos y determinar su equivalencia biofarmacéutica, se adquirieron y evaluaron un total de 10 productos comerciales. Estos se compraron en establecimientos comerciales de cuatro de las principales ciudades del país: Cartagena, Barranquilla, Bogotá y Cali. Para ello, se evaluaron las características físicas, químicas y biofarmacéuticas de las tabletas, tales como variación de peso, dureza, desintegración, prueba de disolución, perfil de disolución, eficiencia de la disolución y valoración de principio activo a partir de metodologías validadas. Los ensayos farmacopeicos se evaluaron según lo establecido en la USP 39. Los resultados permitieron establecer que todos los productos evaluados cumplieron con las especificaciones de la Farmacopea, con respecto a contenido de ingrediente activo y prueba de disolución. En cuanto al comportamiento biofarmacéutico, pese a que todas las marcas cumplen con las especificaciones farmacopeicas, solo tres de las 10 marcas evaluadas son biofarmacéuticamente equivalentes con el innovador. Los resultados de este trabajo permiten proponer a la comunidad científica la determinación de la equivalencia biofarmacéutica como elemento de apoyo en la toma de decisiones de compra en el servicio farmacéutico.
SUMMARY The most widely used drugs in the world are non-steroidal anti-inflammatory analgesics (NSAIDs), because of their ability to relieve pain, a condition common to many pathologies. One of the widely used NSAIDs in Colombia is Ibuprofen. To assess the conformity of products and determine their biopharmaceutical equivalence, a total of 10 commercial products were purchased and evaluated. These were bought in commercial establishments of four of the main cities of the country: Cartagena, Barranquilla, Bogota and Cali. For this purpose, the physical, chemical and biopharmaceutical characteristics of the tablets were evaluated, such as weight variation, hardness, disintegration, dissolution test, dissolution profile, dissolution efficiency and active ingredient titration from validated methodologies. The pharma-copoeial tests were evaluated according to USP 39. The results allowed to establish that all evaluated products met the specifications of the pharmacopoeia with respect to content of active ingredient and test of dissolution. Regarding biopharmaceutical behavior, although all brands comply with pharmacopoeial specifications, only three of the ten brands evaluated are biopharmaceutically equivalent to the innovator. The results of this work allow proposing to the scientific community, the determination of biopharmaceutical equivalence as an element of support in making purchasing decisions in the pharmaceutical service.
ABSTRACT
Objective To evaluate the similarity of dissolution behavior in vitro of self-made and reference listed drug (RLD) of esomeprazole magnesium enteric tablets. Methods The dissolution test method and HPLC method were established according to Chinese pharmacopoeia. The HPLC method was validated according to ICH guidance. The dissolution behavior of the 3 batches of the self-made drug and RLD were compared in dissolution medium of pH 1.2 HCl solutuion, pH 4.5 phosphate buffer, pH 6.8 phosphate buffer, pH 1.2 HCl solutuion (2 h) and pH 6.0 phosphate buffer, pH 1.2 HCl solutuion (2 h) and pH 6.8 phosphate buffer, and purified water with different rotation rates. Results The HPLC validation results for linearity, repeatability, recovery, etc. all met the requirement. The similarity factors F2 between the self-made drug and RLD were greater than 50 in different dissolution mediums. Conclusion The dissolution behaviors of the self-made drug and RLD are similar.
ABSTRACT
OBJECTIVE:To explore the similarity of dissolution profiles of self-development and original preparation of Solife-nacin succinate tablet,and provide reference for the prescription and process screening of the former one and the quality similarity evaluation of the latter one. METHODS:The paddle method was adopted with rotational speed of 50 r/min,using water,pH1.2 hy-drochloric acid solution,pH4.0 acetate buffer solution and pH6.8 phosphate buffer solution as dissolution media,HPLC was used to determine the cumulative dissolution of main components of self-development and original preparation of Solifenacin succinate tablet at different time points,dissolution profile was drew,then f2 was used to evaluate its similarity. RESULTS:In the 4 dissolu-tion media,the f2 of both self-development and original preparation of Solifenacin succinate tablet was higher than 50,which indi-cated that the dissolution profiles showed similarity. CONCLUSIONS:The established HPLC is suitable for the dissolution determi-nation of Solifenacin succinate tablet;the dissolution profiles of the self-development and original preparations are basically simi-lar,which indicates the prescription and technology of self-development preparation are feasible.
ABSTRACT
Objective To evaluate the similarity of dissolution behavior in vitro of self-made and reference listed drug(RLD) of esomeprazole magnesium enteric tablets. Methods The dissolution test method and HPLC method were established according to Chinese pharmacopoeia. The HPLC method was validated according to ICH guidance. The dissolution behavior of the 3 batches of the self-made drug and RLD were compared in dissolution medium of pH 1.2 HCl solutuion,pH 4.5 phosphate buffer,pH 6.8 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.0 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.8 phosphate buffer,and puri?fied water with different rotation rates. Results The HPLC validation results for linearity,repeatability,recovery,etc. all met the re?quirement. The similarity factors F2 between the self-made drug and RLD were greater than 50 in different dissolution mediums. Con?clusion The dissolution behaviors of the self-made drug and RLD are similar.
ABSTRACT
Objective:To establish a real time dissolution determination method for furosemide tablets and compare the similarity of dissolution curves of furosemide tablets from 11 generic drug manufacturers and the original research drug manufacturer in four kinds of dissolution media to evaluate the overall situation of dissolution process of furosemide tablets in our country. Methods:A fiber-optic medicine dissolution process real time test system was used to monitor the dissolution process of furosemide tablets from 11 generic drug manufacturers and the original research drug manufacturer. A paddle method was applied and the rotation speed was 50 r·min-1 . The dissolution medium was pH 1. 2 hydrochloric acid solution, pH 4. 0 acetate buffer, pH 6. 8 phosphate buffer and water, respectively with volume of 900 ml. The absorbance wavelength was 277 nm. The dissolution profile was drawn and f 2 factor was used to evaluate the similarity. Results:The dissolution tests were not influenced by the excipients and the dissolution media. The liner range of furose-mide was 4. 44-26. 66 μg·ml-1(r=0. 9997). The average recovery of furosemide was 101. 26% and RSD was 1. 84%(n=9). Ee-spect to 11 manufactures, there was only one of the dissolution similarity can meet the requirements. Conclusion:A simple, fast and accurate fiber-optic method for medicine dissolution process real time test is established. The method can reflect the real dissolution and provide the information on how to improve the preparation technology and monitor the stability of the preparation technology.