FORMULATION AND EVALUATION OF ANTIFUNGAL NANOGEL FOR TOPICAL DRUG DELIVERY SYSTEM

Objective: Ciclopirox olamine has been used as antifungal agent. It is used as topical formulation because oral route causes irritation and ulceration of GIT. In this research work, antifungal nanogel formulated to reduce size of particle, improve in-vitro release and in-vivo release. Methods: Ciclopirox olamine nanogel was prepared by homogenization technique and incorporation of gelling agent to produce nanogel. Ciclopirox olamine nanogel formulated using Carbopol 940. Results: Antigungal Nanogels (F1-F6) were subjected to FT-IR analysis and showed no interaction between the drug and excipients. The best formulation (F6) elicited the high in-vitro release of 83.42 % at 8 hours; zeta-potential and particle size, obtained values were 230 nm and -27 mV correspondingly. In-vitro release kinetic models were shown that formulation-F6 follows First-order kinetics and high regression coefficient value r2 0.9866. SEM image of the best formulation-F6 depicts that no breakage of nanogel. The differential scanning calorimetry thermogram of ciclopirox olamine was found to be 140.09.7°C. The DSC thermogram of physical mixture of carbopol 940 and Euragit-S 100 was found to be 1290C and 218 0C. DSC study of nanogel (F6) showed no interaction between drug and excipients. The best formulation-F6 was subjected to in-vivo study on mice which showed better effect in treating dermatitis. Conclusion: It would be concluded that the best formulation-F6 which elicited better in-vitro drug release and enhanced dermatitis scoring. Keywords: Ciclopirox-olamine, Eudragit-S100, Glycerol, Dermatitis, Carbopol-940, Cellophane membrane.

COMPARATIVE STUDY OF EFFICACY OF ORAL TERBINAFINE ALONE AND ORAL TERBINAFINE WITH TOPICAL 8% CICLOPIROX OLAMINE IN ONYCHOMYCOSIS

Onychomycosis is a common fungal infection of nail plate caused by dermatophytes, non dermatophyte molds & yeasts. Tinea unguium on the other hand refers specifically to infection caused by dermatophytes. Onychomycosis represents 50% of all nail disorders and 30% of all mycotic infections of skin.1 It is distributed worldwide with prevalence of 3% to 9%. It is generally considered as a disease of middle aged and elderly affecting a large and significant number of people. There has been a recent increase in the incidence as well as a spectrum of causative pathogens associated with onychomycosis. 50 patients of onychomycosis who attended our outpatient department were randomly selected. These 50 patients were equally divided into two groups A and B. Patients in group A (25) were given only oral terbinafine 250mg/once daily for 12 weeks. Patients in group B (25) were given oral terbinafine 250mg/once daily for 12 weeks along with 8% Ciclopirox Olamine nail lacquer which is applied topically once daily at night. In our present study combination therapy give high mycological cure rates than oral terbinafine monotherapy. Combination therapy (oral terbinafine 250mg daily dose with 8% ciclopirox olamine nail lacquer) showed 70 % clinical cure rate and 60 % mycological cure.

Effectiveness and safety of ciclopirox olamine in patients with dermatophytosis: a retrospective cohort analysis

<p class="abstract"><strong>Background:</strong> The current scenario of dermatophytosis is alarming, despite the availability of multiple antifungal agents the management of dermatophytosis is still challenging. Hence there is a need for a different antifungal with a novel mechanism of action for the management of dermatophytosis.</p><p class="abstract"><strong>Methods: </strong>It was retrospective cohort study where in record of patients with dermatophytosis who were candidates for topical therapy only were analysed. All the patients were treated with Ciclopirox olamine 1% twice daily for 6 weeks. The efficacy end points were complete cure rate, mycological cure rate and clinical cure rate.</p><p class="abstract"><strong>Results: </strong>613 patients were included in the final analysis. At the end of study period the complete, mycological and clinical cure rates were 73.89%, 75.37% and 77.65% respectively. Out of 613 patients included 528 patients showed treatment failure to previous topical antifungal agents while 84 patients were treatment naïve. In treatment failure patients the complete, mycological and clinical cure rates were 72.15%, 73.48, and 75.56% respectively. In treatment naïve patients the complete, mycological and clinical cure rates were 84.70%, 87.05% and 90.58% respectively. 5.70% reported adverse events. The most common adverse event was pruritus followed erythema, dryness and rash.</p><p><strong>Conclusions: </strong>Results of this study proves that ciclopirox is efficacious and safe in the management of dermatophytosis. This study also proves that ciclopirox is useful in those patients who failed to respond to other topical antifungal agents. </p>