Optimization of Sorghum-Based Orodispersible Films Containing Cetirizine HCl Using PEG 400: a Central Composite Design Approach

Starch is one of the natural biopolymers that is commonly used as a film-forming agent. It can be enzymatically cleaved to form more soluble maltodextrin (MDX), which can be produced from sorghum. One of the film-forming plasticizers used for orodispersible films (ODFs) is PEG 400. The purpose of this study was to optimize the formulation of Cetirizine HCl ODFs using MDX-sorghum for the film-forming polymer and PEG 400 as the plasticizer through Response Surface Methodology (RSM). A Central Composite Design (CCD) was used to create 14 combinations of varying amounts of MDX-sorghum and PEG 400. The films were tested for disintegration time (DT), tensile strength (TS), and elongation (EL). The optimized formulation (4.34% MDX-sorghum, 10% PEG 400) demonstrated a DT of 99.2 s, TS of 1.26 MPa, and EL of 110.7%. Compared with previous MDX-sorghum ODFs plasticized with glycerol (DT 82.95 s, TS 1.50 MPa, EL 104.26%) and triethyl citrate (DT 75.67 s, TS 1.39 MPa, EL 108.85%), the PEG 400–based films exhibited comparable mechanical strength, higher flexibility, and suitable disintegration characteristics. This confirms the potential of PEG 400 as an effective plasticizer and highlights the novelty of employing MDX-sorghum as a sustainable biopolymer source for patient-friendly ODF formulations.