Formulation of thermosensitive in situ otic gel for topical management of otitis media

Antibiotics and antiinflammatory agents are the primary and main therapeutic categories in the treatment of otitis media. One of the simpler and feasible approaches of minimizing the problem of repeated use and subsequent resistance is development of sustained release formulation. Therefore, the present investigation aimed to develop a sustained release in situ gel formulation containing combination of broad spectrum antibiotic and antiinflammatory agents for the management of otits media. The prolonged release is achieved by phase transition of Poloxamer 407 (in situ) from sol to gel at a physiological temperature in combination with viscosity imparting agent Natrasol 250 and Klucel HF. The formulation P3N3 (19% w/v Poloxamer 407, 1.5% w/v Natrasol 250) and P3K3 (19% w/v Poloxamer 407, 1.5% w/v Klucel HF) showed mucoadhesive strength 37.17±0.32×103 and 38.12±0.13×103 dyne/cm2, respectively, and gel strength 2.1 and 2 cm, respectively. Both these formulations indicated good drug content and viscosity besides a good gelling ability. The in vitro diffusion has demonstrated prolongation of release of both the drugs over a period of 8 h.