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

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. Rezumat RezumatObiectivul acestui studiu a fost dezvoltarea formulrii unor nanostructuri din zein cu loratadin ncapsulat care i pstreaz proprietile n urma unui proces de liofilizare (FD).Acest proces este folosit pentru a crete stabilitatea pe termen lung a nanostructurilor, care au o durat de via limitat n suspensie.Metoda planurilor experimentale a fost utilizat pentru a deduce factorii de formulare i de proces care au un efect asupra proprietilor nanostructurilor i pentru a obine o formulare optim din acest punct de vedere.Nanostructurile au fost analizate din punctul de vedere al mrimii particulelor, indicelui de polidispersie (PdI), potenialului zeta (ZP), concentraiei substanei active (API) i reteniei solutului ncapsulat (ESR), precum i din punctul de vedere al schimbrilor mrimii particulelor i PZ n timpul procesului de FD.n urma determinrii acestor parametri pentru nanosuspensiile liofilizate dup redispersare, planul experimental a fost fitat i formularea optim a fost stabilit.Cu dimensiuni ale particulelor de aproximativ 300 nm i ESR de 90% dup FD, caracteristicile optime ale formulrii au fost prezise corespunztor de ctre modelul matematic, deci formularea a putut fi considerat satisfctoare.Cu aceste proprieti, formularea optim are potenial pentru a fi inclus n forme farmaceutice pentru pacieni pediatrici.