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Objective . The objective of this work encompasses the application of the response surface approach in the development of buccoadhesive pharmaceutical wafers of Loratadine (LOR).  Methods . Experiments were performed according to a 3 2  factorial design to evaluate the effects of buccoadhesive polymer, sodium alginate ( A ), and lactose monohydrate as ingredient, of hydrophilic matrix former ( B ) on the bioadhesive force, disintegration time, percent (%) swelling index, and time taken for 70% drug release ( t   70% ). The effect of the two independent variables on the response variables was studied by response surface plots and contour plots generated by the Design-Expert software. The desirability function was used to optimize the response variables.  Results . The compatibility between LOR and the wafer excipients was confirmed by differential scanning calorimetry, FTIR spectroscopy, and X-ray diffraction (XRD) analysis. Bioadhesion force, measured with TAXT2i texture analyzer, showed that the wafers had a good bioadhesive property which could be advantageous for retaining the drug into the buccal cavity.  Conclusion . The observed responses taken were in agreement with the experimental values, and Loratadine wafers were produced with less experimental trials, and a patient compliant product was achieved with the concept of formulation by design.

Design Expert Supported Mathematical Optimization and Predictability Study of Buccoadhesive Pharmaceutical Wafers of Loratadine