DEVELOPMENT AND CHARACTERIZATION OF LORATADINE LIPOSOMAL GEL USING QbD APPROACH

This study aimed to formulate, prepare and characterize a loratadine liposomal gel (LOR-L-G) using the Quality by Design (QbD) approach. The formulation variables and process parameters that influence the Critical Quality Attributes (CQAs) were identified using risk assessment. Five dependent variables were considered relevant for this study: particle size before and after extrusion, polydispersity index (PDI) before extrusion, loratadine (LOR) concentration and encapsulation efficiency (EE). A two-level full factorial design was performed in order to develop loratadine-loaded liposomes (LOR-L) with the desired Quality Target Product Profile (QTPP). Based on the results, the design space was generated and the optimum formulation was prepared. The in vitro drug release study aimed at measuring drug availability and revealed a prolonged release profile of LOR with a maximum concentration at 48 hours. LOR-L were incorporated into a Carbopol 940 gel base in order to obtain the final pharmaceutical product. The liposomal gel was characterized by viscosity, texture, spreadability and it was compared with a commercial product. The results indicated the applicability of the QbD approach in the development of LOR-L, and the obtained gel characteristics were suitable for a product useful in skin allergies.