CONICET | Buscador de Institutos y Recursos Humanos

Films, as dosage forms, have gained relevance in the pharmaceutical field, as novel, patient friendly, convenient products. However, there are no official standardized methods for its evaluation. To ensure quality product with desired characteristics, the aim of this study was apply Quality by Design (QbD) strategies to obtain an optimized film that can be further used as a wound dressing. The desired product quality profile was defined and its critical quality attributes (CQA) were identified. Subsequently, materials were selected: ciprofloxacin hydrochloride (antimicrobial), lidocaine hydrochloride (anesthetic) and sodium alginate, sodium hyaluronate (HNa), carbomer (Cb) y glycerol (Gly) as excipients. Then, through a risk analysis and mitigation matrix the critical components were identified, selected as study variables and subjected to experimental verification through variable-response correlation using Design-Expert® 10 software. The response variables were scored to 1 to 5, and were: transparency (absence of precipitate, T>4); homogeneity (absence of bubbles, H>4); the ease of demold (D=3) and the plasticity (P=3). The selected components allowed to develop a process of elaboration with low levels of criticality and a logical flow of operations. Only HNa, Cb and Gly showed to be critical to obtain the desired profile and were selected as study variables. The 4 variable-response obtained fitted to a R2FI model with an adequate correlation level, indicating that each model can explain the experimental changes. The 3D response surface plot of optimization showed a design space with the relative composition of the components that allows to obtain an acceptable film, and one composition that shows the best global results (desirability 0.96/1.00). The optimized anesthetic antibiotic film obtained by QbD strategies complies with the CQA and could be useful as a wound dressing.