Formulation, Taste Masking and In-Vitro Evaluation of Tenofovir Disoproxil Fumarate Oral Disintegrating Tablets

Author(s): Syed Abdul Azeez Basha and Seerat Unnisa

Abstract: Orally disintegrating tablets are intended to disintegrate fast in the mouth to provide dispersion before being swallowed where the active ingredient is intended for gastrointestinal delivery and absorption. Tenofovir exhibits activity for HIV-1 infection. The bitter taste of drug should be masked in order to formulate it in a palatable form. In the current study, an attempt was made to mask the bitter taste of Tenofovir by solid dispersion technique using mannitol by Fusion method and to develop oral disintegrating tablets of Tenofovir by direct compression method using the super disintegrants like Sodium starch glycolate, Croscarmellose sodium and Crospovidone. The formulations were characterized for their pre compression and post compression evaluations. The drug and polymer interaction by FTIR and DSC studies reveal the drug excipients compatibility. The blend of all the formulations showed good flow properties. The prepared tablets were shown to have good post compression parameters and they passed all the quality control evaluation parameters as per I.P limits. The optimized formulation F6 shows 99.85% drug release within 30 mins. Disintegration time, Invitro dispersion time for F6 was found to be 21±0.83 sec, 18.08±0.48, respectively. Water absorption ratio was 90.12±0.11 and wetting time 52.25±0.01sec showing high water absorbing ability. Results from stability studies indicate that the formulated Oral disintegrating tablets are stable for a period of 45 days under two different conditions at 25±2°C / 65±5%RH and 40±2°C / 75±5%RH.

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