title: Novel topical formulation for ischemic chronic wounds. Technological design, quality control and safety evaluation.
abstract: 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.
authors: a Laboratorio de Estudios Farmacéuticos y Biotecnología Farmacéutica , Facultad de Bioquímica, Química y Farmacia, Universidad Nacional Tucumán , Tucumán , Argentina .
authors: Carla Agostina
authors: CA
authors: Cabrera
authors: a Laboratorio de Estudios Farmacéuticos y Biotecnología Farmacéutica , Facultad de Bioquímica, Química y Farmacia, Universidad Nacional Tucumán , Tucumán , Argentina .
authors: Alberto Nicolas
authors: AN
authors: Ramos
authors: b Cátedra de Química Orgánica II - Facultad de Bioquímica, Química y Farmacia Universidad Nacional de Tucumán , Tucumán , Argentina , and.
authors: María Del Huerto
authors: Mdel H
authors: Loandos
authors: c Facultad de Bioquímica , Instituto de Microbiología, Química y Farmacia, Universidad Nacional Tucumán , Tucumán , Argentina.
authors: Juan Carlos
authors: JC
authors: Valdez
authors: a Laboratorio de Estudios Farmacéuticos y Biotecnología Farmacéutica , Facultad de Bioquímica, Química y Farmacia, Universidad Nacional Tucumán , Tucumán , Argentina .
authors: Maria Eugenia
authors: ME
authors: Sesto Cabral
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology*; D018441:Biofilms / Q000187:drug effects; D018929:Cell Culture Techniques / Q000379:methods; D017077:Culture Media, Conditioned / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology*; D006801:Humans; D048191:Lactiplantibacillus plantarum / Q000737:chemistry / Q000254:growth & development*; D011552:Pseudomonas Infections / Q000188:drug therapy*; D011550:Pseudomonas aeruginosa / Q000187:drug effects* / Q000502:physiology; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D000900:Anti-Bacterial Agents; D017077:Culture Media, Conditioned
keywords: Bacteria by products; Lactobacillus plantarum; P. aeruginosa; pharmaceutical biotechnology; pharmaceutical technology; quality control