High-amylose maize starch as a novel film former to develop oral films with excellent mechanical properties: A preliminary study
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.
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Salbutamol sulfate IP was gifted by Medopharm, Bangalore, Karnataka. HPMC E50 was procured from LobaChemie laboratory reagents, Mumbai, India. HAMS was gifted by Roquette Pharma ltd, Mumbai, India. Glycerin and D-sorbitol from LobaChemie Pvt. limited, Mumbai, citric acid from Hi-pure Chem industries, Chennai. Crospovidone (CP) was obtained from yarrow Chem products, Mumbai, India. Distilled water was utilized all over the experiment.
Savitha Sriram, Vijayalakshmi Sankaranarayanan, Lavanya Ramesh, Pandiaraj Murugesan, Suresh Murugesan
International Journal of Green Pharmacy • Jan-Mar 2022 • 16 (1) | 132