Self-microemulsifying oral fast dissolving films of vitamin D3 for infants: Preparation and characterization

Combining the advantages of self-microemulsifying technology and oral fast dissolving technology, a self-microemulsifying oral fast dissolving films (SMEOFDF) of vitamin D3 was developed in this study. The pseudoternary phase diagram of microemulsion was constructed using water titration method, and the formulation of films was optimized by orthogonal experimental design. The prepared SMEOFDF of vitamin D3 was a thin film, in which the liquid drops of self-microemulsion were embedded. It had good mechanical properties (thickness 166.7 +/- 3.30 mu m, tensile strength 38.45 +/- 3.72 MPa, elongation 23.38 +/- 4.23%, and folding endurance >200 times), and its disintegration time was about 18 +/- 1.23 s. After being redissolved in water, microemulsion could form spontaneously, with particle size of 181.2 nm and zeta potential of 16.1 mV. The release profile of vitamin D from SMEOFDF could be well described by first-order equation.