Development and Characterization of Fast Dissolving Oral Films of Orciprenaline Sulphate

Introduction: From past few decades there has been a massive change in designing various drug delivery systems to achieve rapid onset of action to treat sudden surprising disorders like hypertensive reactions. Fast dissolving oral films enhance the efficacy of APIs by dissolving within a minute in oral cavity after the contact with less saliva without chewing and need of water for administration. Orciprenaline Sulfate belongs to the category of bronchodilators, beta-adrenergic agonist. It is very essential that the drug is released rapidly and hence fast dissolving oral films were designed. Objective: Present study was undertaken with a view of enhancing the bioavailability and to achieve a rapid onset of action as well as to provide better patient compliance especially in pediatric and geriatric patients. Method: The accurately weighed quantity of polymers was kept for soaking overnight in a beaker containing 10 ml of distilled water. The polymeric solution was then stirred for 2 hrs on a magnetic stirrer; Propylene glycol was used as the plasticizer in the concentration of 10%w/w of the polymer concentration. In another beaker weighed quantities of citric acid & sodium saccharine were added and dissolved in sufficient quantity of distilled water and was stirred for another 30 min on a magnetic stirrer. Then the polymeric solution and the drug solution with other excipients was mixed together to get a homogenous solution. Further the solution was casted on the glycerine lubricated petridish and was kept for sweltering in an oven at 700C. Results: The surface pH of all the formulations F1 to F8 was found to be neutral in the range of 6.47- 6.82 concluding that films might not cause any potential irritation to the mucosa. All the films showed good disintegration time. Formulation F1 showed the least disintegration time compared to other films. The percentage drug content of all the formulations was found to be in the acceptable range of 94.3-97.9 percent. In vitro drug release study showed that all the films released more than 70 percent of drug within 15 min. From all the formulations F1 containing HPMC E15 as the film forming polymer showed the highest and the best drug release of 98.4 percent within 15 minutes. Conclusion: The results obtained after formulation oral fast dissolving films of Orciprenaline sulfate clearly indicate that it has improved bioavailability and rapid release rate. The formulation is tested for stability and the results are positive hence the formulation is stable.