Formulation optimization and evaluation of metformin hydrochloride orally disintegrating tablets using spray drying and D-optimal design of experiments

Abstract Purpose Metformin hydrochloride (Met.HCl) current dosage form were found to be inconvenient for individuals with dysphagia. This situation underscores the need for orally disintegrating tablets (ODT) as an alternative dosage form. Method This research utilizes a co-spray drying method to formulate taste-masked Met.HCl optimal for ODT formulation. Formulation design and optimization were achieved using a D-optimal design of experiments (DOE) approach to obtain desired tablet properties, such as hardness and disintegration time. Results Spray drying enabled the homogenous distribution of excipients, lowered crystallinity, and improved the physicochemical characteristics of Met.HCl powder, overcoming the limitation of physical blending techniques. The optimized formulation of Met.HCl ODT exhibited outstanding tensile strength between 1.90 and 2.43 MPa, fast disintegration times of 18 to 24 seconds, and total drug release within 5 minutes. Conclusion These results demonstrate the potential of spray drying as a particle engineering technique to enhance the physicochemical and functional properties of Met.HCl powder. This improvement supports the formulation of Met.HCl ODT offers a viable alternative for T2DM patients, particularly those with dysphagia.