Formulation Development of Oral Fast Disintegrating Tablet of Theophylline

Abstract

Theophylline is used for the treatment of asthma, COPD and premature apnea. Conventional tablet dosage form is available for the acute and chronic treatment of such diseases. However, the oral administration of conventional tablets may be a drawback for the pediatric, elderly or psychotic patients. As such, the formulation of oral fast disintegrating tablets (ODTs) was developed to address swallowing difficulties of the conventional tablet dosage form. Thus, the objectives of this work were to develop the ODTs formulation and study the disintegration potential of various commercial super-disintegrants and natural banana starch. Materials and Methods: ODTs of Theophylline were prepared by wet granulation method using water, 50% ethyl alcohol and 95% ethyl alcohol as a binder solvents. Ac-Di- Sol^®, Exprotab^®, Kollidon^® CL -SF60, banana starch extracted with sodium hydroxide and that with sodium sulfite were used as super-disintegrats. Physical characterization of such granules and ODTs were determined. In vitro dissolution was performed using dissolution apparatus II and the dissolved drug was analyzed by UV- spectrophotometer. Results: Granules using50% ethyl alcohol as a binder solvent gave the desirable characters, excellent flowability and low moisture content. ODTs contained Exprotab® with 50% ethyl alcohol illustrated the superlative in the disintegration time approximately 53 seconds and maximum in the dissolution rate. Conclusion: The binder solution and type of super-disintegration affected the quality and dissolution of ODTs of Theophylline. The commercial super-disintegrats demonstrated the higher disintegration potential comparing with natural banana starch. It was due to the natural starchcomposed of variouscomponents in which declined the disintegration power and led to downward of drug release.