Development of a Paediatric-Friendly Pullulan-Based Mouth Dissolving Film of Ferrous Bisglycinate Using Factorial Design and Electronic Tongue-Assisted Taste Evaluation

Background

The primary objective of this study was to develop, optimize and evaluate a paediatric-friendly, pullulan-based Mouth Dissolving Film (MDF) of Ferrous Bisglycinate as a novel iron delivery system. The work aimed at improving bioavailability, minimizing gastrointestinal side effects, and enhancing patient compliance in the management of iron deficiency anaemia, which is the one of the symptoms of malnutrition in children. Ferrous Bisglycinate has been specifically selected as the iron source due to its chelated structure with two glycine molecules, which provides superior absorption, reduced interaction with dietary inhibitors, and lower gastrointestinal irritation compared to conventional ferrous and ferric salts.

Materials and Methods

MDF was formulated using polymers [Hydroxy Propyl Methyl Cellulose (HPMC) E15, Lycoat RS^® 720, and Pullulan] and plasticizers [Poly ethylene Glycol (PEG) 400, Glycerol] by the solvent casting method. The formulated film was evaluated for various parameters like Disintegration Time (D.T), thickness, tensile strength, Young’s modulus, % elongation, % assay and pH. Further, Pullulan with PEG 400 was optimized using a 3²-factorial design. Optimized formulation was further evaluated for in vitro dissolution study, stability studies, FTIR studies, taste profiling using electronic tongue (e-tongue), taste evaluation on human volunteers and microbial contamination test for non-sterile products.

Results and Discussion

MDF with Pullulan (6%w/v) and PEG 400 (3.78%w/v) showed required characteristics including acceptable organoleptic properties confirmed by the e tongue and human volunteers study, stability over a six-month storage period, and compliance with microbial contamination limits.

Conclusion

Developing MDF for Ferrous Bisglycinate holds the potential to establish a Platform technology for other micronutrients.