Preparation and Evaluation of a New Salbutamol Fast-Dissolving Oral Film for Asthma Treatment

Abstract

Background: 300 million people are suffering from asthma worldwide. Since some patients have difficulty swallowing tablets and capsules, oral films stepped into the market. This drug form is easily consumed without the need for drinking water. Additionally, fast-dissolving oral films release their drugs more rapidly. Ondansetron, folic acid, zolmitriptan, dextrometorphan and loratadin are some examples of this kind of formulation. Methods: In this study, the salbutamol oral films were made by sodium carboxymethylcellulose, hydroxypropyl methylcellulose and polyvinyl alcohol as the base polymer and glycerin as the plasticizer by casting method. The prepared films were evaluated for pharmaceutical properties such as thickness, disintegration time, assay, and drug release. The Design-Expert 7.1.5 software (Stat-Ease, Inc., USA) was used for designing and evaluating the formulations. Design was validated by extra design checkpoint formulations. Findings: The survey of the films shows that the formulation containing polyvinyl alcohol and sodium carboxymethylcellulose had desirable pharmaceutical properties and was selected as the optimum formulation with desirability factor of 0.884. This formulation began to disintegrate within 60 seconds and 93 percent of drug was released within 150 seconds. The release kinetic of this formulation best fitted the Non-Fickian profile. Conclusion: According to the desirable specifications of fast-dissolving salbutamol oral film comprising immediate drug release and being comfortable to use, the compliance of patients in asthma treatment would greatly improve. Keywords: Salbutamol, Drug delivery systems, Asthma, Polyvinyl alcohol, Carboxymethylcellulose sodium