Development and Optimization of Nano Topical Formulation for Treatment of Atopic Dermatitis

Abstract

Atopic Dermatitis (AD) is a constantly occuring , Itchy , reoccuring inflammation causing disorder , due to disruption of stratum corneum barrier,with wide range of severity it is one of the most common skin illness in developed regions, affecting about 25% of childrens and 3% of adulrs.Symptoms like eczematous plaque, as well as their repercussions like sleep difficulties, commonly affect the quality of life of patient. Topical corticosteroid, calcineurin inhibitors, Emollients, phototherapy, antiallergic agents are being widely used for management of disease..Delivery via nanoparticles has gained much more importance in dermatological diseases. Currently nanoformulation are being used for topical delivery of the drug in order to improve local bioavailability and to minimize drug related toxicity. Nanocarriers like nanoemulsion,nanoparticles,polymeric, lipidic, dendritic, vesicular carriers have been explored by the researchers for dermal drug delivery . Betamethasone falls under the first line treatment for AD. However it belongs to BCS Class II and shows poor water solubility Zinc is also the adjuvant drug prescribed for improvement in the condition of AD. In the present Study an attempt was made to formulate and optimize nanocrystals of betamethasone dipropionate – Zinc sulphate using wet bead milling technique as it is simple, economic and reproducible. Screening of stabilizers was carried out for selection of stabilizer .At a concentration of 0.8 percent w/v, polysorbate 80 shows a significant reduction in particle size. Nanocystals were optimized by varying process parameters of media milling technique Preliminary trials have revealed that media milling can effectivelty reduce the particle size of drug and solubility is being enhanced. The process and formulation parameters were systematically optimized using DOE approach. Optimized batch was prepared and measured for particle size and zeta potentials Results shown size of particles and solubility in acceptable limits.The Arithmetic mean of particle size was found to be 345.1(nm) with a ploydispersibility index of 0.319 with wet bead milling at 1000rpm for 16 hrs.The optimised nanocrystal suspension was then formed into a nanogel with Carbopol 940, wich had a viscosity of 82.42± 3.05 pa s at 25ºC and improved nanocrystal application ease, The pH range was 6.99±0.06which was found to be biocompatible for dermal application.further in-vitro diffusion studies were carried out in comparison with available marketed formulation with same composition which revealed that the prepared nanogel formulation serve the purpose of providing sustained release thus reducing the frequency of doses with once a day application. Thus the study results proved that the developed nano