Formulation and Evaluation the Transungual Drug Delivery System of Fluconazole with Penetration Enhancer: Iresine Herbestii

The present study was to formulate a transungual drug delivery formulation. We targeted to formulate and evaluate fluconazole film for the nail fungal infection using extracted natural and evaluated penetration enhancer (PE). Model drug fluconazole was formulated with the natural extracted penetration enhancer with different ratios. The solvent for PE extraction was methanol and that extracts were air dried. The cadaver nail plates for study were collected from the same volunteer for negligence in the thickness and chemical composition concentration in the nail plate. The extracted PE (Iresine herbestii) was inspected in the respect of stability before formulation. The human cadaver nail plates were treated with the formulation with and without the extracted PEs. Ex-vitro drug penetration rate was evaluated by Franz diffusion cells using cadaver human nail plate upto 36 hours. The drug filmability was best with the polymer HPMC K4M, Ethyl cellulose and hydroxyl propyle cellulose in the ratio of 1:1:1, mixture of propanol and butanol in 7:3 as solvent and 30% w/w DBP as plasticizer. The formula FT25AI4 shows 89% drug entrapment and 47% more drug penetration across the nail plate when compare to the same formulation but without any penetration enhancer. The " p " value (0.0011) of drug penetration was less than 0.05. INTRODUCTION Two main diseases affect the nail unit: onychomycosis and psoriasis. Treatments of these two diseases usually lead to poor patient compliance. Indeed, due to the lack of penetration of topically applied drugs into the nails, long term systemic treatments resulting in side effects or painful injections in the nail folds are the usual alternatives 1,2. Fungal infections in the nail plate are a very inadequate type of condition for a person. Nail fungal infections treatment are difficult to treat effectively because of insufficient concentration reach to the site of action. For making the nail fungal infection treatment more effective we tried to make a transungual formulation for the treatment with a effective penetration enhancer 3. The introducing conception which has all the vantage of the patch system, but with no weakness, nail plate is an effective route for systemic administration for a wide range of therapeutically active substance with mode of application. Nail also have the advantage that the delivery through them is not complicated by the presence of hair follicles and sweat glands, as in the skin, nor the very broad version in the permeability of stratum corneum a unlike …