Formulation and characterization of novel floating in-situ gelling system for controlled delivery of ramipril
Keywords:
In-situ gel, Floating drug delivery system, Ramipril, Sodium alginate, Gellan gumAbstract
The present study mainly focuses on the novel floating in-situ gelling system for controlled delivery of ramipril. Ramipril has half-life of 2-4 hours and required dose is 10 mg day. Hence ramipril is a suitable candidate for sustained drug delivery system. A gastro retentive drug delivery system of ramipril was formulated to increase the resident time in stomach and to modulate the release behavior of the ramipril. Different formulations of ramipril were prepared by using different concentration of gelling polymer such as sodium alginate, gellan gum and calcium carbonate. Sodium citrate was used to prevent gelation outside the gastric environment. The formulation was studied for FT-IR study and DSC study to interpret the interaction between drug and polymer used. Formulation containing 0.50 % of sodium alginate, 0.50 % of gellan gum and 1.0 % of calcium carbonate showed the best gelling ability. For optimization of in-situ gelling system 32 full factorial design was employed to study the effect of independent variables, concentration of gellan gum (X1) and concentration of sodium alginate (X2) and dependent variables like viscosity, in vitro bouncy time, % drug release at 4 hr (Y3), % drug release at 6 hr (Y4) and % drug release at 8 hr (Y5). F8 batch was selected as optimized batch based on buoyancy time (71 sec), viscosity 356.9cp, drug content 99.06 % and CPR 99.80 % at 12 hrs. The controlled release of ramipril from in-situ gelling system was observed and good fit to the Zero order and Korsmeyer Peppasmodel whichshows fickian diffusion (n=0.351) mechanism. Stability revealed that there was no noticeable change in characterizations. Thus, in-situ gel formulation is promising approach for gastroretentive controlled delivery of Ramipril.
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