Artículo
Novel topical formulation for ischemic chronic wounds. Technological design, quality control and safety evaluation
Cabrera, Carla Agostina; Ramos Vernieri, Alberto Nicolás
; Loandos, Maria del Huerto
; Valdez, Juan Carlos; Sesto Cabral, María Eugenia
Fecha de publicación:
2016
Editorial:
Informa Healthcare
Revista:
Pharmaceutical Development And Technology
ISSN:
1083-7450
e-ISSN:
1097-9867
Idioma:
Inglés
Tipo de recurso:
Artículo publicado
Clasificación temática:
Resumen
Ulceration of the foot in diabetes is common and disabling, and frequently leads to amputation of the leg. The pathogenesis of foot ulceration is complex, clinical presentation variable and management requires early expert assessment. Despite treatment, ulcers readily become chronic wounds. Chronic wounds are those that remain in a chronic inflammatory state failing a normal healing process patterns. This is partially caused by inefficient eradication of opportunistic pathogens like Pseudomonas aeruginosa. We propose its control or eradication will promote wound healing. Lactobacillus plantarum cultures supernatants (LAPS) shows antipathogenic and pro-healing properties. The main objective was to design two pharmaceutical dosage forms by using LAPS as active pharmaceutical ingredient and to perform its quality control, in vitro activity conservation tests and human trials (safety evaluation). Both selected formulations reach the technological quality expected for 120 days, shows adequate occlusive characteristics and proper adhesion to human skin. From the in vitro release assays were found that LAPS shows adequate release from matrix and maintain its antimicrobial and anti-biofilm activity. First human trials were developed and neither edema nor erythema on healthy skin voluntaries was found. We conclude that C80 and C100 are adequate for their use in future clinical trials to demonstrate a comprehensive therapeutic effectiveness in ischemic chronic wounds.
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Articulos(CCT - NOA SUR)
Articulos de CTRO.CIENTIFICO TECNOL.CONICET - NOA SUR
Articulos de CTRO.CIENTIFICO TECNOL.CONICET - NOA SUR
Citación
Cabrera, Carla Agostina; Ramos Vernieri, Alberto Nicolás; Loandos, Maria del Huerto; Valdez, Juan Carlos; Sesto Cabral, María Eugenia; Novel topical formulation for ischemic chronic wounds. Technological design, quality control and safety evaluation; Informa Healthcare; Pharmaceutical Development And Technology; 21; 4; -1-2016; 399-404
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