FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS OF SALBUTAMOL SULPHATE
Anupama A. Vardai*
ABSTRACT
Background: Mouth dissolving film becomes a novel approach to oral drug delivery system as it provides convenience and ease of use over other dosage forms such as orally disintegrating buccal tablets and sublingual tablets. Mouth dissolving film was developed on the basis of technology of transdermal patch. These are thin solid dosage forms which when placed in the oral cavity; dissolve within few seconds without chewing and intake of water. The oral buccal mucosa being highly vascularized, drugs can absorbed directly and can enter the systemic circulation without undergoing firstpass hepatic metabolism. These films offer convenient way of dosing medication to pediatric, geriatric and bedridden patients. The sublingual and buccal delivery of a drug via thin film has the potential to improve the onset of action, lower the dosing and enhance the efficacy and safety profile of medicament. Material and methods: Fast dissolving oral films were prepared by solvent casting method using hydroxyl propyl methyl cellulose in varying ratios and evaluated for in vitro disintegration/ dissolution time, Tensile strength, Percent of elongation at break (% E), Folding endurance, Thickness of film, Drug content of film, Stability study. Optimized fast dissolving oral films were tested for its in vitro drug release study and Stability studies. Results: Formulated fast dissolving oral films showed improved bioavailability of salbutamol sulphate when compared to its oral route. Conclusion: Salbutamol sulphate loaded fast dissolving oral films could serve as better alternative to existing marketed formulation in terms of bioavailability.
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