Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model

Autores
Sanchez, Maria Florencia; Luciani Giacobbe, Laura Carolina; Barbieri, Fiamma; Olivera, Maria Eugenia
Año de publicación
2024
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The management of wounds primarily revolves around pain relief, effective infection control and the promotion of tissue regeneration to prevent complications like chronic skin wounds. While polymeric bioactive films are innovative alternatives to conventional wound dressings, there exists a dearth of guidance regarding their quality control. This underscores the imperative need to establish precise critical quality attributes, a task undertaken within this study using an antibiotic-anesthetic film as a model. The aim was to establish the influence of critical composition and process parameters and optimize the formula.First, the quality target product profile was defined, and critical quality attributes were identified. Our material selection included ciprofloxacin hydrochloride (an antimicrobial), lidocaine hydrochloride (an anesthetic), as well as excipients, such as sodium alginate, sodium hyaluronate, carbomer and glycerol. The critical components were identified through a risk assessment matrix, and their influence on film composition was determined by experimental verification using Design-Expert® software. A full factorial design was employed to assess the effects of sodium hyaluronate, carbomer and glycerol (as independent variables) on transparency, homogeneity, folding capacity and handling. Following this, an optimized formulation was achieved and subjected to further characterization.These optimized antibiotic-anesthetic films exhibited uniform micro-distribution of components, ensuring dosage uniformity. Both ciprofloxacin hydrochloride and lidocaine hydrochloride displayed sustained release profiles, suggesting potential therapeutic benefits for skin wounds. Furthermore, the resistance and elongation properties were similar to those of human skin.Utilizing a QbD approach, we successfully developed an optimized antibiotic-anesthetic film that adhered to the essential critical quality attributes. This films exhibits potential utility as a wound dressing. The findings presented in this study establish a fundamental framework for delineating the critical quality attributes of dressing films and refining their formulation to optimize wound treatment.
Fil: Sanchez, Maria Florencia. 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: Luciani Giacobbe, Laura Carolina. 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: Barbieri, Fiamma. 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: 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
Materia
quality by design
polymeric wound dressings
film
polyelectrolytes
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:11336/262285
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/262285
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a modelSanchez, Maria FlorenciaLuciani Giacobbe, Laura CarolinaBarbieri, FiammaOlivera, Maria Eugeniaquality by designpolymeric wound dressingsfilmpolyelectrolyteshttps://purl.org/becyt/ford/3.5https://purl.org/becyt/ford/3The management of wounds primarily revolves around pain relief, effective infection control and the promotion of tissue regeneration to prevent complications like chronic skin wounds. While polymeric bioactive films are innovative alternatives to conventional wound dressings, there exists a dearth of guidance regarding their quality control. This underscores the imperative need to establish precise critical quality attributes, a task undertaken within this study using an antibiotic-anesthetic film as a model. The aim was to establish the influence of critical composition and process parameters and optimize the formula.First, the quality target product profile was defined, and critical quality attributes were identified. Our material selection included ciprofloxacin hydrochloride (an antimicrobial), lidocaine hydrochloride (an anesthetic), as well as excipients, such as sodium alginate, sodium hyaluronate, carbomer and glycerol. The critical components were identified through a risk assessment matrix, and their influence on film composition was determined by experimental verification using Design-Expert® software. A full factorial design was employed to assess the effects of sodium hyaluronate, carbomer and glycerol (as independent variables) on transparency, homogeneity, folding capacity and handling. Following this, an optimized formulation was achieved and subjected to further characterization.These optimized antibiotic-anesthetic films exhibited uniform micro-distribution of components, ensuring dosage uniformity. Both ciprofloxacin hydrochloride and lidocaine hydrochloride displayed sustained release profiles, suggesting potential therapeutic benefits for skin wounds. Furthermore, the resistance and elongation properties were similar to those of human skin.Utilizing a QbD approach, we successfully developed an optimized antibiotic-anesthetic film that adhered to the essential critical quality attributes. This films exhibits potential utility as a wound dressing. The findings presented in this study establish a fundamental framework for delineating the critical quality attributes of dressing films and refining their formulation to optimize wound treatment.Fil: Sanchez, Maria Florencia. 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: Luciani Giacobbe, Laura Carolina. 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: Barbieri, Fiamma. 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: 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; ArgentinaElsevier2024-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/262285Sanchez, Maria Florencia; Luciani Giacobbe, Laura Carolina; Barbieri, Fiamma; Olivera, Maria Eugenia; Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model; Elsevier; Heliyon; 10; 22; 11-2024; 1-192405-8440CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2405844024157970info:eu-repo/semantics/altIdentifier/doi/10.1016/j.heliyon.2024.e39766info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-11-26T09:10:21Zoai:ri.conicet.gov.ar:11336/262285instacron: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:34982025-11-26 09:10:21.579CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
title Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
spellingShingle Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
Sanchez, Maria Florencia
quality by design
polymeric wound dressings
film
polyelectrolytes
title_short Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
title_full Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
title_fullStr Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
title_full_unstemmed Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
title_sort Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model
dc.creator.none.fl_str_mv Sanchez, Maria Florencia
Luciani Giacobbe, Laura Carolina
Barbieri, Fiamma
Olivera, Maria Eugenia
author Sanchez, Maria Florencia
author_facet Sanchez, Maria Florencia
Luciani Giacobbe, Laura Carolina
Barbieri, Fiamma
Olivera, Maria Eugenia
author_role author
author2 Luciani Giacobbe, Laura Carolina
Barbieri, Fiamma
Olivera, Maria Eugenia
author2_role author
author
author
dc.subject.none.fl_str_mv quality by design
polymeric wound dressings
film
polyelectrolytes
topic quality by design
polymeric wound dressings
film
polyelectrolytes
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.5
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv The management of wounds primarily revolves around pain relief, effective infection control and the promotion of tissue regeneration to prevent complications like chronic skin wounds. While polymeric bioactive films are innovative alternatives to conventional wound dressings, there exists a dearth of guidance regarding their quality control. This underscores the imperative need to establish precise critical quality attributes, a task undertaken within this study using an antibiotic-anesthetic film as a model. The aim was to establish the influence of critical composition and process parameters and optimize the formula.First, the quality target product profile was defined, and critical quality attributes were identified. Our material selection included ciprofloxacin hydrochloride (an antimicrobial), lidocaine hydrochloride (an anesthetic), as well as excipients, such as sodium alginate, sodium hyaluronate, carbomer and glycerol. The critical components were identified through a risk assessment matrix, and their influence on film composition was determined by experimental verification using Design-Expert® software. A full factorial design was employed to assess the effects of sodium hyaluronate, carbomer and glycerol (as independent variables) on transparency, homogeneity, folding capacity and handling. Following this, an optimized formulation was achieved and subjected to further characterization.These optimized antibiotic-anesthetic films exhibited uniform micro-distribution of components, ensuring dosage uniformity. Both ciprofloxacin hydrochloride and lidocaine hydrochloride displayed sustained release profiles, suggesting potential therapeutic benefits for skin wounds. Furthermore, the resistance and elongation properties were similar to those of human skin.Utilizing a QbD approach, we successfully developed an optimized antibiotic-anesthetic film that adhered to the essential critical quality attributes. This films exhibits potential utility as a wound dressing. The findings presented in this study establish a fundamental framework for delineating the critical quality attributes of dressing films and refining their formulation to optimize wound treatment.
Fil: Sanchez, Maria Florencia. 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: Luciani Giacobbe, Laura Carolina. 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: Barbieri, Fiamma. 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: 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
description The management of wounds primarily revolves around pain relief, effective infection control and the promotion of tissue regeneration to prevent complications like chronic skin wounds. While polymeric bioactive films are innovative alternatives to conventional wound dressings, there exists a dearth of guidance regarding their quality control. This underscores the imperative need to establish precise critical quality attributes, a task undertaken within this study using an antibiotic-anesthetic film as a model. The aim was to establish the influence of critical composition and process parameters and optimize the formula.First, the quality target product profile was defined, and critical quality attributes were identified. Our material selection included ciprofloxacin hydrochloride (an antimicrobial), lidocaine hydrochloride (an anesthetic), as well as excipients, such as sodium alginate, sodium hyaluronate, carbomer and glycerol. The critical components were identified through a risk assessment matrix, and their influence on film composition was determined by experimental verification using Design-Expert® software. A full factorial design was employed to assess the effects of sodium hyaluronate, carbomer and glycerol (as independent variables) on transparency, homogeneity, folding capacity and handling. Following this, an optimized formulation was achieved and subjected to further characterization.These optimized antibiotic-anesthetic films exhibited uniform micro-distribution of components, ensuring dosage uniformity. Both ciprofloxacin hydrochloride and lidocaine hydrochloride displayed sustained release profiles, suggesting potential therapeutic benefits for skin wounds. Furthermore, the resistance and elongation properties were similar to those of human skin.Utilizing a QbD approach, we successfully developed an optimized antibiotic-anesthetic film that adhered to the essential critical quality attributes. This films exhibits potential utility as a wound dressing. The findings presented in this study establish a fundamental framework for delineating the critical quality attributes of dressing films and refining their formulation to optimize wound treatment.
publishDate 2024
dc.date.none.fl_str_mv 2024-11
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/11336/262285
Sanchez, Maria Florencia; Luciani Giacobbe, Laura Carolina; Barbieri, Fiamma; Olivera, Maria Eugenia; Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model; Elsevier; Heliyon; 10; 22; 11-2024; 1-19
2405-8440
CONICET Digital
CONICET
url http://hdl.handle.net/11336/262285
identifier_str_mv Sanchez, Maria Florencia; Luciani Giacobbe, Laura Carolina; Barbieri, Fiamma; Olivera, Maria Eugenia; Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model; Elsevier; Heliyon; 10; 22; 11-2024; 1-19
2405-8440
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2405844024157970
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.heliyon.2024.e39766
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
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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score 13.011256

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