Formulation Development and Evaluation of Tenofovir Disoproxil Fumarate Oral Disintegration Tablets Using the Starch Phthalate

The rationale of the current work was to formulate and evaluate Oral disintegrating tablets of Tenofovir disoproxil fumarate by direct compression technique with a vision to augment patient compliance and rapid onset of action. Twelve oral disintegrating formulations of Tenofovir disoproxil fumarate were formulated by direct compression method using starch phthalate& croscarmellose sodium, Avicel PH101 as the super disintegrants. The prepared formulations were evaluated for wetting time, drug content, in vitro disintegration time, dissolution time and also projected to kinetic treatment to know the pattern of drug release. Further, the discovered promising formulation was subjected to stability studies. Based on the results obtained, formulation F12 containing Avicel PH101 72.5 mg and Starch phthalate and croscarmellose sodium (1:1) 62.5 mg exhibited good wetting time, dispersion time, and disintegration time and drug release compared to Oral disintegrating tablets prepared with other super disintegrants. The stability studies piloted as per International Conference on Harmonisation guidelines on the promising formulation F12 disclosed no significant changes in the Disintegration time at Initial, 1 month , 2month, 3 months will be 5.2±0.43 5.1±0.54 5.1±0.23 5.1±0.12 min respectively. Oral disintegrating tablets of Tenofovir disoproxil fumarate were formulated successfully by employing direct compression technique. From the investigation, it can be reasonably concluded that F12 batch Oral disintegrating tablets of Tenofovir disoproxil fumarate with Avicel PH101 72.5 mg and Starch phthalate and croscarmellose sodium (1:1) 62.5 mg exhibited maximum cumulative drug release in 10 min.