Formulation Development and Evaluation of Fast Dissolving Theophylline Tablets

Over the past three decades, FDT has gained much attention as a preferred alternative to conventional oral dosage forms such as tablets and capsules. FDT is a solid dosage form that disintegrates and dissolves in the mouth (either on or beneath the tongue or in the buccal cavity) without water. In the present work, 10 formulations of fast dissolving tablets of theophylline (F1 to F9) using three different superdisintegrants namely crospovidone, sodium starch glycolate and pregelatinized starch with three concentrations (2%, 3% and 5%) and a control F10 (without superdisintegrant) were prepared by direct compression method. The final blend of the drug and excipients were evaluated for powder flow properties, bulk density, tapped density, compressibility index and hausner's ratio. All the formulations were evaluated for weight variation, disintegration time, hardness, friability, wetting time and water absorption ratio. Formulation F3 showed the lowest disintegration time and more water absorption ratio. In vitro dissolution studies revealed that formulation F3 showed 97.83% percent drug release at the end of 30 minutes. The stability studies for the formulation F3 showed no significant change in disintegration time, drug content and percentage of drug released when stored at 45°C±2°C/75% RH for a period of 90 days. These results revealed that the formulation F3 containing crospovidone (5%) as superdisintegrant was better one which satisfied all the criteria as a fast dissolving tablets.