Development and gamma scintigraphical clearance study of novel Hibiscus rosasinensis polysaccharide based mucoadhesive nasal gel of rizatriptan benzoate

One of the limiting factors for nasal delivery is mucociliary clearance, which results in reduction of drug absorption. The present study describes a novel application of polysaccharide from Hibiscus rosasinensis as a mucoadhesive excipient in nasal gel. Different batches of nasal gels were prepared by using different concentrations of polysaccharide and characterized in terms of pH, drug content, viscosity, mucoadhesion and ex-vivo permeation. Furthermore, formulation containing 1%w/v polysaccharide concentration was radiolabeled with 99mTc and characterized for nasal clearance by using gamma scintigraphy. Viscosity of nasal gel increased by increasing polysaccharide concentration and work of adhesion was found to be in the range of 0.132 ± 0.00 to 20.247 ± 0.004 Nmm. The duration of complete drug permeation from nasal gel was in the range of 150 to 225 min with drug flux (μg/cm2.min) in the range of 419.35 ± 3.27 to 652.91 ± 12.83. Results of gamma scintigraphy showed that mucoadhesive nasal gel had much longer half life (95 min) as compared to control formulation (23 min). Finally, ciliotoxicity and histopathological studies confirmed the safety profile of prepared nasal gel. The present study supports the use of an extracted plant polysaccharide as a mucoadhesive excipient for nasal delivery, thereby increasing the retention of formulation in the nasal cavity.

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