Salbutamol Oral Films: Design, Preparation and Evaluation Using Blends of Pectin and Mucilage of Dioscorea alata

Background and Objective: Salbutamol sulphate is indicated in the management of respiratory disorders such as asthma and bronchitis. However, how it is delivered can affect the onset of action, therapeutic effect obtained and patients’ adherence. This work prepared salbutamol sulphate oral dispersible films using blends of water yam mucilage (WYM) and pectin and compared its drug release profile to immediate release tablets of a commercial brand. Materials and Methods: The WYM was prepared from Dioscorea alatatubers and characterized but the pectin purchased. Preliminary compatibility test was done between the WYM, pectin and salbutamol sulphate using Fourier Transform infrared (FTIR) spectroscopy. Simple admixture blends of WYM with pectin in weight ratios (1:1, 1:4, and 2:3) were used as the film-forming polymer to produce oral films of salbutamol sulphate by the solvent evaporation method. The obtained films were evaluated for mechanical properties, disintegration time and drug release profile. The films were later re-evaluated after 10 months of storage in room conditions. The drug release profiles from the films were compared with oral tablets of marketed salbutamol sulphate. Results: The results showed that the moisture content and folding endurance of the oral films reduced after storage for 10 months, but the disintegration time increased. Both the oral films and the commercial tablet released all the drug content in 60 min. While the films followed zero-order release kinetics, the first-order kinetics best described the commercial tablet. After 10 months of storage, there was no significant difference in the release profile of the films except that F11 was now described by first-order kinetic. Conclusion: The WYM-pectin blends showed good potential as an oral film, providing an alternative delivery system for salbutamol, especially for patients with swallowing difficulty. The films possessed good mechanical properties, a stability profile and a drug release profile comparable to the oral tablets.