Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF NOVEL FORMULATION OF DOLUTEGRAVIR SODIUM FOR ORAL SUSPENSION

M. Sujitha*, K. Sundhar, S. K. Tamil Selvan and C. Yuvaraj Singh

ABSTRACT

Background: Dolutegravir sodium is a anti-viral drug and most widely used in the treatment of integrase inhibitor. In recent days virus is diagnosed in children but tablets may be not convenient for oral route because it difficult to swallowing. It can be overcome too prepared and evaluate the oral reconstitutable suspension of Dolutegravir sodium for treatment of children. Objectives: The main aim of this project is to prepare oral reconstitutable suspension for paediatric treatment, using Xanthan gum as a suspending agent with different concentration. Methods: The particle size of the drug was reduced and triturated with suspending agent in mortal pestle to form uniform mixture. Preservative, Colouring agent, Flavouring agent, Buffering agent, etc., are added with sufficient quantity and stirred well. Added sufficient quantity of water and make final volume. Results: The prepared suspension were evaluated for particle size, pH,
sedimentation volume, flow rate, viscosity, redispersibility. The F-VI Formulation having Xanthan gum higher concentration show better results compared to other formulations. Conclusion: The F-VI formulation have average particle size 44.4μm. So, decreased the particle size increasing sedimentation volume. The sedimentation volume near one for F-VI formulation. F-VI formulation viscosity 0.0354 poise, flow rate 2.30(ml/sec), all the formulation are optimum pH and redispersibility are No. of cycles are 5-times.

Keywords: Dolutegravir sodium, Xanthan gum, Suspension, Flow property.