High-amylose maize starch as a novel film former to develop oral films with excellent mechanical properties: A preliminary study

Abstract

Aim: The study involved the development and optimization of the fast-dissolving oral films of salbutamol sulfate
using high-amylose maize starch (HAMS) as a novel film former by comparison with the HPMC E50 (hydroxy
propyl methyl cellulose) films. The high aqueous solubility, low dose, and low molecular weight of salbutamol
sulfate make it best suited for oral dissolving films, thereby possible to enhance patient compliance in pediatrics
and geriatrics. Materials and Methods: The HPMC E50 and HAMS films were prepared by solvent-casting
technique. The casted films were optimized using the design of experiments employing 22 factorial designs with
replicates separately. The concentration of HAMS/HPMC and crospovidone were considered as independent
variables and the responses being tensile strength (TS), percentage elongation at break, and disintegration
time. Results and Discussion: HAMS films exhibited good mechanical properties due to high TS and greater
percentage elongation than the HPMC E50 films. Both the films disintegrated within a minute with no significant
differences. X-ray diffraction studies exposed that starch with high-amylose content has a greater crystalline
domain and this may be attributed to the maximum TS of the formulated HAMS oral films. In vitro drug dissolution
profiles of HAMS and HPMC E50 films at the end of 10 min were found to be 96.98% and 88.25%, respectively.
Conclusion: From this study, it is evident that HAMS can be utilized as the promising film-forming polymer in
the development of fast-dissolving oral films.