.

ISSN 2063-5346
For urgent queries please contact : +918130348310

FORMULATION DEVELOPMENT AND EVALUATION OF DOLUTEGRAVIR ORAL DISINTEGRATION TABLETS USING THE STARCH PHTHALATE

Main Article Content

Spoorthy Valusa, Rajiv Kukkar
» doi: 10.53555/ecb/2022.11.11.83

Abstract

The rationale of the current work was to formulate and evaluate Oral disintegrating tablets of Dolutegravir by direct compression technique with a vision to augment patient compliance and rapid onset of action. Methods: Elven oral disintegrating formulations of Dolutegravir were formulated by direct compression method using starch phthalate, Microcrystalline cellulose and starch glycolate sodium 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. Results: Based on the results obtained, formulation F10 containing 20 mg of starch Phthalate and 100 mg of Micro crystalline cellulose 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 F10 disclosed no significant changes in the drug content at 30±2°C and 75% RH 40±2°C with 75% RH was found to be 98.68 ±0.87 and 98.28 ±0.37 after 1 and 6 months respectively , and drug release after 6 months After 5 min, the percentage drug release of F10 was found to be 30±2°C and 75% RH 40±2°C with 75% RH Were found to be 96.14 ± 0.42 and 96.24 ± 0.42respectively after 1 and 6 months , respectively. Conclusion: Oral disintegrating tablets of Dolutegravir sodium were formulated successfully by employing direct compression technique. From the investigation, it can be reasonably concluded that F10 batch Oral disintegrating tablets of propranolol with 20 mg of starch Phthalate and 100 mg of Micro crystalline cellulose exhibited maximum cumulative drug release in 5 min.

Article Details