Formulation, Optimization and Evaluation of Niosomal Gel of Alitretinoin

Alitretinoin is used in treatment of AIDS related Kaposi’s sarcoma in concentrations of 0.1%. Alitretinoin is very effective but it causes skin erythema on the applied area. The Niosomes seems to be promising drug delivery in modern drug delivery systems. The main benefit over liposome is that the lipids are replaced by non-ionic vesicles and hence the preparation is totally non-antigenic. The non-ionic surfactants like SPANs and TWEENs are obtained from synthetic sources and hence the quality is maintained same all the time. The Alitretinoin was incorporated into niosomes using SPAN 60 and cholesterol. Various ratios of SPAN 60 and cholesterol were tried and optimized for the preparation of niosomes. Various process parameters were also optimized for the rotary flask evaporation method. The niosomal dispersion was incorporated in to carbopol 971NF gel. The gel was kept for 6 weeks accelerated stability studies. The niosomal dispersion was evaluated for various parameters like vesicle size, shape and morphology by Scanning electron microscopy (SEM) and Transmission electron microscopy (TEM). In-vitro and ex-vivo studies were carried out. The drug release pattern from gel was evaluated on the basis of in-vitro studies and skin irritation studies on rat skin. The in-vitro study shows sustained release gel effects whereas the ex-vivo study shows no signs of irritation on the applied skin area.