Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia
The objective of the study was to determine the equivalence of two multisource drug products of metformin tablets using in vitro testing. The in vitro dissolution profiles were done in phosphate buffer (pH 6.8), acetate buffer (pH 4.5), hydrochloric acid (pH 1.2) and two dissolution apparatus were u...
- Autores:
-
Pérez Guzmán, Milena
Orobio Lerma, Yenifer
Baena Aristizábal, Yolima
- Tipo de recurso:
- Article of journal
- Fecha de publicación:
- 2013
- Institución:
- Universidad Nacional de Colombia
- Repositorio:
- Universidad Nacional de Colombia
- Idioma:
- spa
- OAI Identifier:
- oai:repositorio.unal.edu.co:unal/49325
- Acceso en línea:
- https://repositorio.unal.edu.co/handle/unal/49325
http://bdigital.unal.edu.co/42782/
http://bdigital.unal.edu.co/42782/2/
- Palabra clave:
- metformina
multifuente
equivalencia
disolución in vitro
bioexención
metformin
multisource
equivalence
in vitro dissolution
biowaiver
- Rights
- openAccess
- License
- Atribución-NoComercial 4.0 Internacional
| id |
UNACIONAL2_f3f39babe2e7604673cb2cff4c55b959 |
|---|---|
| oai_identifier_str |
oai:repositorio.unal.edu.co:unal/49325 |
| network_acronym_str |
UNACIONAL2 |
| network_name_str |
Universidad Nacional de Colombia |
| repository_id_str |
|
| dc.title.spa.fl_str_mv |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia |
| title |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia |
| spellingShingle |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia metformina multifuente equivalencia disolución in vitro bioexención metformin multisource equivalence in vitro dissolution biowaiver |
| title_short |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia |
| title_full |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia |
| title_fullStr |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia |
| title_full_unstemmed |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia |
| title_sort |
Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia |
| dc.creator.fl_str_mv |
Pérez Guzmán, Milena Orobio Lerma, Yenifer Baena Aristizábal, Yolima |
| dc.contributor.author.spa.fl_str_mv |
Pérez Guzmán, Milena Orobio Lerma, Yenifer Baena Aristizábal, Yolima |
| dc.subject.proposal.spa.fl_str_mv |
metformina multifuente equivalencia disolución in vitro bioexención metformin multisource equivalence in vitro dissolution biowaiver |
| topic |
metformina multifuente equivalencia disolución in vitro bioexención metformin multisource equivalence in vitro dissolution biowaiver |
| description |
The objective of the study was to determine the equivalence of two multisource drug products of metformin tablets using in vitro testing. The in vitro dissolution profiles were done in phosphate buffer (pH 6.8), acetate buffer (pH 4.5), hydrochloric acid (pH 1.2) and two dissolution apparatus were used. Multivariate analysis for repeated measures design was employed to compare the percentage dissolved of the drug products. According to Food and Drug Administration (FDA) guidance for dissolution data equivalence, model independent approach was applied. This involves the use of difference factor (f1) and similarity factor (f2). The drug release from drug products was analyzed by various mathematical models such as zero order, firs order and Higuchi. The results showed that there were significant differences between the drug products, and for this reason it was not possible to demonstrate equivalence based in vitro assays. |
| publishDate |
2013 |
| dc.date.issued.spa.fl_str_mv |
2013 |
| dc.date.accessioned.spa.fl_str_mv |
2019-06-29T08:35:33Z |
| dc.date.available.spa.fl_str_mv |
2019-06-29T08:35:33Z |
| dc.type.spa.fl_str_mv |
Artículo de revista |
| dc.type.coar.fl_str_mv |
http://purl.org/coar/resource_type/c_2df8fbb1 |
| dc.type.driver.spa.fl_str_mv |
info:eu-repo/semantics/article |
| dc.type.version.spa.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
| dc.type.coar.spa.fl_str_mv |
http://purl.org/coar/resource_type/c_6501 |
| dc.type.coarversion.spa.fl_str_mv |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.content.spa.fl_str_mv |
Text |
| dc.type.redcol.spa.fl_str_mv |
http://purl.org/redcol/resource_type/ART |
| format |
http://purl.org/coar/resource_type/c_6501 |
| status_str |
publishedVersion |
| dc.identifier.uri.none.fl_str_mv |
https://repositorio.unal.edu.co/handle/unal/49325 |
| dc.identifier.eprints.spa.fl_str_mv |
http://bdigital.unal.edu.co/42782/ http://bdigital.unal.edu.co/42782/2/ |
| url |
https://repositorio.unal.edu.co/handle/unal/49325 http://bdigital.unal.edu.co/42782/ http://bdigital.unal.edu.co/42782/2/ |
| dc.language.iso.spa.fl_str_mv |
spa |
| language |
spa |
| dc.relation.spa.fl_str_mv |
http://revistas.unal.edu.co/index.php/rccquifa/article/view/45115 |
| dc.relation.ispartof.spa.fl_str_mv |
Universidad Nacional de Colombia Revistas electrónicas UN Revista Colombiana de Ciencias Químico Farmacéuticas Revista Colombiana de Ciencias Químico Farmacéuticas |
| dc.relation.ispartofseries.none.fl_str_mv |
Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 169-189 0034-7418 1909-6356 |
| dc.relation.references.spa.fl_str_mv |
Pérez Guzmán, Milena and Orobio Lerma, Yenifer and Baena Aristizábal, Yolima (2013) Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia. Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 169-189 0034-7418 1909-6356 . |
| dc.rights.spa.fl_str_mv |
Derechos reservados - Universidad Nacional de Colombia |
| dc.rights.coar.fl_str_mv |
http://purl.org/coar/access_right/c_abf2 |
| dc.rights.license.spa.fl_str_mv |
Atribución-NoComercial 4.0 Internacional |
| dc.rights.uri.spa.fl_str_mv |
http://creativecommons.org/licenses/by-nc/4.0/ |
| dc.rights.accessrights.spa.fl_str_mv |
info:eu-repo/semantics/openAccess |
| rights_invalid_str_mv |
Atribución-NoComercial 4.0 Internacional Derechos reservados - Universidad Nacional de Colombia http://creativecommons.org/licenses/by-nc/4.0/ http://purl.org/coar/access_right/c_abf2 |
| eu_rights_str_mv |
openAccess |
| dc.format.mimetype.spa.fl_str_mv |
application/pdf |
| dc.publisher.spa.fl_str_mv |
Revista Colombiana de Ciencias Químico Farmacéuticas |
| institution |
Universidad Nacional de Colombia |
| bitstream.url.fl_str_mv |
https://repositorio.unal.edu.co/bitstream/unal/49325/1/45115-216476-1-SM.pdf https://repositorio.unal.edu.co/bitstream/unal/49325/2/45115-216476-1-SM.pdf.jpg |
| bitstream.checksum.fl_str_mv |
229a1bf1b7729e8ff527077e4c9c2b32 84195d15be93da6d92e3ca917a0668ff |
| bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 |
| repository.name.fl_str_mv |
Repositorio Institucional Universidad Nacional de Colombia |
| repository.mail.fl_str_mv |
repositorio_nal@unal.edu.co |
| _version_ |
1814089320936505344 |
| spelling |
Atribución-NoComercial 4.0 InternacionalDerechos reservados - Universidad Nacional de Colombiahttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2Pérez Guzmán, Milena0ee01547-9d2f-4abf-8671-f66a5a328de5300Orobio Lerma, Yenifer2a68fa91-f658-4c15-b12f-5a6f9c1e64ec300Baena Aristizábal, Yolima98a63e1b-7f7c-4b0b-8897-a1116eb805cf3002019-06-29T08:35:33Z2019-06-29T08:35:33Z2013https://repositorio.unal.edu.co/handle/unal/49325http://bdigital.unal.edu.co/42782/http://bdigital.unal.edu.co/42782/2/The objective of the study was to determine the equivalence of two multisource drug products of metformin tablets using in vitro testing. The in vitro dissolution profiles were done in phosphate buffer (pH 6.8), acetate buffer (pH 4.5), hydrochloric acid (pH 1.2) and two dissolution apparatus were used. Multivariate analysis for repeated measures design was employed to compare the percentage dissolved of the drug products. According to Food and Drug Administration (FDA) guidance for dissolution data equivalence, model independent approach was applied. This involves the use of difference factor (f1) and similarity factor (f2). The drug release from drug products was analyzed by various mathematical models such as zero order, firs order and Higuchi. The results showed that there were significant differences between the drug products, and for this reason it was not possible to demonstrate equivalence based in vitro assays.El presente estudio se realizó con el objetivo de establecer mediante pruebas de disolución in vitro, si dos formas farmacéuticas multifuente de liberación inmediata, de administración peroral con metformina como principio activo, son equivalentes en relación con su producto de referencia. Los datos de porcentaje de disolución obtenidos en tres niveles de pH (1,2; 4,5 y 6,8) y en dos equipos de disolución diferentes, se analizaron mediante el método de modelo independiente para comparar los perfiles de disolución de los productos a través del cálculo de los factores de diferencia (f1) y de similitud (f2), según las recomendaciones de la Food and Drug Administration (FDA). Para evaluar la cinética de liberación del fármaco, se aplicaron tres modelos matemáticos (ecuación de orden cero, de primer orden e Higuchi); además, para la comparación de los productos se aplicó un método basado en análisis multivariado para un diseño de medidas repetidas. Los resultados mostraron que existen diferencias estadísticamente significativas entre los productos, razón por la cual en este estudio no se demostró la equivalencia de los productos B y C con relación al producto A, con base en pruebas de disolución in vitro.application/pdfspaRevista Colombiana de Ciencias Químico Farmacéuticashttp://revistas.unal.edu.co/index.php/rccquifa/article/view/45115Universidad Nacional de Colombia Revistas electrónicas UN Revista Colombiana de Ciencias Químico FarmacéuticasRevista Colombiana de Ciencias Químico FarmacéuticasRevista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 169-189 0034-7418 1909-6356Pérez Guzmán, Milena and Orobio Lerma, Yenifer and Baena Aristizábal, Yolima (2013) Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia. Revista Colombiana de Ciencias Químico Farmacéuticas; Vol. 42, núm. 2 (2013); 169-189 0034-7418 1909-6356 .Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombiaArtículo de revistainfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1http://purl.org/coar/version/c_970fb48d4fbd8a85Texthttp://purl.org/redcol/resource_type/ARTmetforminamultifuenteequivalenciadisolución in vitrobioexenciónmetforminmultisourceequivalencein vitro dissolutionbiowaiverORIGINAL45115-216476-1-SM.pdfapplication/pdf353747https://repositorio.unal.edu.co/bitstream/unal/49325/1/45115-216476-1-SM.pdf229a1bf1b7729e8ff527077e4c9c2b32MD51THUMBNAIL45115-216476-1-SM.pdf.jpg45115-216476-1-SM.pdf.jpgGenerated Thumbnailimage/jpeg6331https://repositorio.unal.edu.co/bitstream/unal/49325/2/45115-216476-1-SM.pdf.jpg84195d15be93da6d92e3ca917a0668ffMD52unal/49325oai:repositorio.unal.edu.co:unal/493252023-12-09 23:05:56.875Repositorio Institucional Universidad Nacional de Colombiarepositorio_nal@unal.edu.co |