FORMULATION AND EVALUATION OF THERMOSENSITIVE IN SITU OFLOXACIN OTIC GEL FOR THE TREATMENT OF OTITIS MEDIA

Sujith S. Nair*, Jasni K. P. and Sreena K.

ABSTRACT

Conventional otic drug delivery has the drawbacks like short residence time, leakage of medicaments from ear, inconvenient administration and less patient compliances. Thermosensitive in situ otic gel overcome all these drawbacks as they exist as free flowing aqueous sol during administration and rapidly undergo phase transition when exposed to body temperature. Otits media is a group of inflammatory disease of middle ear accompanied by pain, dizziness and partial loss of hearing. Ofloxacin is recommended as most effective antibiotic against otitis media. In situ gel was prepared by blending drug with thermosensitive gelling agent in distilled water followed by addition of suitable viscosity enhancers and undergoes continuous stirring in a magnetic stirrer. The formulations were then kept aside overnight at 4°C to allow complete hydration of polymer. Out of the 18 preparations, formulation P3K1 containing 19% Poloxamer 407 and 0.05% hydroxypropyl cellulose was selected as best formulation as it exhibited suitable satisfactory physicochemical characteristics, with optimum drug content (92.166± 0.132%) and maximum in vitro drug release (75.608± 0.012 %) for 8hrs, showing first order kinetics and Higuchi model mechanism and was stable with no adverse effect of temperature and humidity during storage over three months.

Keywords: Thermosensitive, in situ gel, otitis media, phase transition, Poloxamer, Sol-Gel transition.