Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin

Autores
Guzman, Maria Laura; Marques, Margareth R.; Olivera, Maria Eugenia; Stippler, Erika S.
Año de publicación
2016
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The United States Pharmacopeia (USP) General Chapters Dissolution 〈711〉 and Disintegration and Dissolution of Dietary Supplements 〈2040〉 allows the use of enzymes in dissolution media when gelatin capsules do not conform to dissolution specifications due to cross linking. Possible interactions between enzymes and surfactants when used together in dissolution media could result in loss of the enzymatic activity. Pepsin is an enzyme commonly used in dissolution media, and in this work, the activity of pepsin was determined in the presence of different surfactants as usually found in case of dissolution tests of certain gelatin capsule formulations.Pepsin enzymatic activity was determined according to the Ninth Edition of the Food Chemicals Codex (FCC) 9 method, in dissolution conditions: simulated gastric fluid, 37 °C and 50 rpm. Sodium dodecyl sulfate (SDS), cetyltrimethyl ammonium bromide (CTAB), polysorbate 80 (Tween 80) and octoxynol 9 (Triton X100) in concentrations above and below their critical micellar concentrations were selected. Results showed a significant reduction in the activity of pepsin at all the concentrations of SDS assayed. On the contrary, CTAB, Tween 80, and Triton X100 did not alter the enzymatic activity at of pepsin any of the concentration assayed.This data demonstrates a rational selection of the surfactant to be used when pepsin is required in dissolution test.
Fil: Guzman, Maria Laura. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Marques, Margareth R.. Pharmacopeia; Estados Unidos
Fil: Olivera, Maria Eugenia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Stippler, Erika S.. Pharmacopeia; Estados Unidos
Materia
DISSOLUTION TEST
ENZYMES
PEPSIN
SURFACTANTS
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/62988

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spelling Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: PepsinGuzman, Maria LauraMarques, Margareth R.Olivera, Maria EugeniaStippler, Erika S.DISSOLUTION TESTENZYMESPEPSINSURFACTANTShttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3The United States Pharmacopeia (USP) General Chapters Dissolution 〈711〉 and Disintegration and Dissolution of Dietary Supplements 〈2040〉 allows the use of enzymes in dissolution media when gelatin capsules do not conform to dissolution specifications due to cross linking. Possible interactions between enzymes and surfactants when used together in dissolution media could result in loss of the enzymatic activity. Pepsin is an enzyme commonly used in dissolution media, and in this work, the activity of pepsin was determined in the presence of different surfactants as usually found in case of dissolution tests of certain gelatin capsule formulations.Pepsin enzymatic activity was determined according to the Ninth Edition of the Food Chemicals Codex (FCC) 9 method, in dissolution conditions: simulated gastric fluid, 37 °C and 50 rpm. Sodium dodecyl sulfate (SDS), cetyltrimethyl ammonium bromide (CTAB), polysorbate 80 (Tween 80) and octoxynol 9 (Triton X100) in concentrations above and below their critical micellar concentrations were selected. Results showed a significant reduction in the activity of pepsin at all the concentrations of SDS assayed. On the contrary, CTAB, Tween 80, and Triton X100 did not alter the enzymatic activity at of pepsin any of the concentration assayed.This data demonstrates a rational selection of the surfactant to be used when pepsin is required in dissolution test.Fil: Guzman, Maria Laura. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Marques, Margareth R.. Pharmacopeia; Estados UnidosFil: Olivera, Maria Eugenia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Stippler, Erika S.. Pharmacopeia; Estados UnidosElsevier2016-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/62988Guzman, Maria Laura; Marques, Margareth R.; Olivera, Maria Eugenia; Stippler, Erika S.; Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin; Elsevier; Results in Pharma Sciences; 6; 3-2016; 15-192211-2863CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.rinphs.2016.02.002info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S2211286316300021info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-12-23T13:40:24Zoai:ri.conicet.gov.ar:11336/62988instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-12-23 13:40:24.847CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
title Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
spellingShingle Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
Guzman, Maria Laura
DISSOLUTION TEST
ENZYMES
PEPSIN
SURFACTANTS
title_short Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
title_full Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
title_fullStr Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
title_full_unstemmed Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
title_sort Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin
dc.creator.none.fl_str_mv Guzman, Maria Laura
Marques, Margareth R.
Olivera, Maria Eugenia
Stippler, Erika S.
author Guzman, Maria Laura
author_facet Guzman, Maria Laura
Marques, Margareth R.
Olivera, Maria Eugenia
Stippler, Erika S.
author_role author
author2 Marques, Margareth R.
Olivera, Maria Eugenia
Stippler, Erika S.
author2_role author
author
author
dc.subject.none.fl_str_mv DISSOLUTION TEST
ENZYMES
PEPSIN
SURFACTANTS
topic DISSOLUTION TEST
ENZYMES
PEPSIN
SURFACTANTS
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv The United States Pharmacopeia (USP) General Chapters Dissolution 〈711〉 and Disintegration and Dissolution of Dietary Supplements 〈2040〉 allows the use of enzymes in dissolution media when gelatin capsules do not conform to dissolution specifications due to cross linking. Possible interactions between enzymes and surfactants when used together in dissolution media could result in loss of the enzymatic activity. Pepsin is an enzyme commonly used in dissolution media, and in this work, the activity of pepsin was determined in the presence of different surfactants as usually found in case of dissolution tests of certain gelatin capsule formulations.Pepsin enzymatic activity was determined according to the Ninth Edition of the Food Chemicals Codex (FCC) 9 method, in dissolution conditions: simulated gastric fluid, 37 °C and 50 rpm. Sodium dodecyl sulfate (SDS), cetyltrimethyl ammonium bromide (CTAB), polysorbate 80 (Tween 80) and octoxynol 9 (Triton X100) in concentrations above and below their critical micellar concentrations were selected. Results showed a significant reduction in the activity of pepsin at all the concentrations of SDS assayed. On the contrary, CTAB, Tween 80, and Triton X100 did not alter the enzymatic activity at of pepsin any of the concentration assayed.This data demonstrates a rational selection of the surfactant to be used when pepsin is required in dissolution test.
Fil: Guzman, Maria Laura. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Marques, Margareth R.. Pharmacopeia; Estados Unidos
Fil: Olivera, Maria Eugenia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Stippler, Erika S.. Pharmacopeia; Estados Unidos
description The United States Pharmacopeia (USP) General Chapters Dissolution 〈711〉 and Disintegration and Dissolution of Dietary Supplements 〈2040〉 allows the use of enzymes in dissolution media when gelatin capsules do not conform to dissolution specifications due to cross linking. Possible interactions between enzymes and surfactants when used together in dissolution media could result in loss of the enzymatic activity. Pepsin is an enzyme commonly used in dissolution media, and in this work, the activity of pepsin was determined in the presence of different surfactants as usually found in case of dissolution tests of certain gelatin capsule formulations.Pepsin enzymatic activity was determined according to the Ninth Edition of the Food Chemicals Codex (FCC) 9 method, in dissolution conditions: simulated gastric fluid, 37 °C and 50 rpm. Sodium dodecyl sulfate (SDS), cetyltrimethyl ammonium bromide (CTAB), polysorbate 80 (Tween 80) and octoxynol 9 (Triton X100) in concentrations above and below their critical micellar concentrations were selected. Results showed a significant reduction in the activity of pepsin at all the concentrations of SDS assayed. On the contrary, CTAB, Tween 80, and Triton X100 did not alter the enzymatic activity at of pepsin any of the concentration assayed.This data demonstrates a rational selection of the surfactant to be used when pepsin is required in dissolution test.
publishDate 2016
dc.date.none.fl_str_mv 2016-03
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/62988
Guzman, Maria Laura; Marques, Margareth R.; Olivera, Maria Eugenia; Stippler, Erika S.; Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin; Elsevier; Results in Pharma Sciences; 6; 3-2016; 15-19
2211-2863
CONICET Digital
CONICET
url http://hdl.handle.net/11336/62988
identifier_str_mv Guzman, Maria Laura; Marques, Margareth R.; Olivera, Maria Eugenia; Stippler, Erika S.; Enzymatic activity in the presence of surfactants commonly used in dissolution media, Part 1: Pepsin; Elsevier; Results in Pharma Sciences; 6; 3-2016; 15-19
2211-2863
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1016/j.rinphs.2016.02.002
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S2211286316300021
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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