title: Formulation and quality control of semi-solid containing harmless bacteria by-products: chronic wounds pro-healing activity.
abstract: Chronic wounds are those that remain in a chronic inflammatory state and fail to follow normal healing process. Infection is one of the most important causes of chronicity. A frequent pathogen isolated from chronic infections is Pseudomonas aeruginosa; refractory to therapy and host immune attack in its biofilm phenotype. Lactobacillus plantarum cultures supernatants (LAPS) interfere with its pathogenic capacity. In addition, LAPS showed bacteriostatic and bactericide properties and is neither cytotoxic nor an inductor of necrosis-apoptosis. LAPSs chemical composition was determined; allowing us to propose a correlation between its constituents and their biological activity. This article shows a pharmaceutical dosage form designed by using LAPS as an API with pro-healing activity and its quality control. Pharmacotechnical and anti-microbial assays were adapted to demonstrate that the vehicle used does not modify LAPS activities. Selected formulation (F100) showed fair mechanical and technological properties. From the in vitro release assays was found an adequate release from the carrier matrix and maintains its anti-pathogenic activity for 6 months. We propose F100 for chronic wounds treatment. The use of harmless bacteria by-products, such as LAPS, to antagonize infectious pathogens that have ability to form biofilm is an efficient and economic approach to treat infected chronic wounds.
authors.affiliation: a Laboratorio de Estudios Farmacéuticos y Biotecnología Farmacéutica, Facultad de Bioquímica, Química y Farmacia , Universidad Nacional Tucumán , Tucumán , Argentina.
authors.forename: Maria Eugenia
authors.initials: ME
authors.lastname: Sesto Cabral
authors.affiliation: b Laboratorio de Estudios Farmacéuticos y Biotecnología Farmacéutica, Facultad de Bioquímica, Química y Farmacia , Universidad Nacional Tucumán , Tucumán , Argentina.
authors.forename: Alberto Nicolas
authors.initials: AN
authors.lastname: Ramos
authors.affiliation: c Faculdade de Farmácia , Universidade Federal do Rio Grande do Sul , Porto Alegre , RS , Brazil.|d Centro de Biotecnologia, Universidade Federal do Rio Grande do Sul , Porto Alegre , RS , Brazil , and.
authors.forename: Alexandre Jose
authors.initials: AJ
authors.lastname: Macedo
authors.affiliation: c Faculdade de Farmácia , Universidade Federal do Rio Grande do Sul , Porto Alegre , RS , Brazil.|d Centro de Biotecnologia, Universidade Federal do Rio Grande do Sul , Porto Alegre , RS , Brazil , and.
authors.forename: Danielle S
authors.initials: DS
authors.lastname: Trentin
authors.affiliation: c Faculdade de Farmácia , Universidade Federal do Rio Grande do Sul , Porto Alegre , RS , Brazil.|d Centro de Biotecnologia, Universidade Federal do Rio Grande do Sul , Porto Alegre , RS , Brazil , and.
authors.forename: Janine
authors.initials: J
authors.lastname: Treter
authors.affiliation: e Departamento de Farmacia, Facultad de Ciencias Químicas , Universidad Nacional de Córdoba , Córdoba , Argentina.
authors.forename: Ruben H
authors.initials: RH
authors.lastname: Manzo
authors.affiliation: b Laboratorio de Estudios Farmacéuticos y Biotecnología Farmacéutica, Facultad de Bioquímica, Química y Farmacia , Universidad Nacional Tucumán , Tucumán , Argentina.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Valdez
keywords: Bacteria by products; chronic wounds; formulation; quality control