Romanian Society of Pharmaceutical Sciences
 

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FORMULATION DEVELOPMENT OF FREEZE-DRIED ZEIN-BASED NANOSTRUCTURES WITH LORATADINE INTENDED FOR PAEDIATRIC USE

ANDREEA CORNILĂ 1, SONIA IURIAN 1*, LUCIA RUXANDRA TEFAS 1, DANA-MARIA MUNTEAN 1, TIBOR CASIAN 1, LUCIAN BARBU TUDORAN 2, MARCELA ACHIM 1, IOAN TOMUȚĂ 1, ALINA SILVIA PORFIRE 1

1 Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, 41 V. Babes Street, 400012, Cluj-Napoca, Romania
2 Electron Microscopy Integrated Laboratory, National Institute for Research and Development of Isotopic and Molecular Technologies, 67-103 Donath Street, 400293, Cluj-Napoca, Romania

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The aim of this study was the development of a zein-based nanostructured formulation with loratadine that preserves its properties and API content after a freeze-drying (FD) process. This process is intended to provide long-term stability to the product, since nanostructures have a short lifespan in suspensions. Experimental design was used to obtain an optimal formulation in a timely and material-sparing manner. The nanostructures were tested with regard to particle size and polydispersity index (PdI), zeta potential (ZP), active pharmaceutical ingredient (API) concentration and encapsulated solute retention (ESR), as well as for the changes that occurred in size and ZP values during FD for each formulation. After the determination of these parameters for the freeze-dried nanosuspensions, the experimental design was fitted and the optimal formulation was established. With sizes around 300 nm and an ESR around 90% after FD, the optimal formulation characteristics were well predicted by the model, therefore the formulation was considered satisfactory. With these properties, the optimal freeze-dried nanostructure formulation has the potential to be included in paediatric-friendly oral dosage forms.