Formulation and Evaluation of Transferosomal Gel of Isotretinoin for Severe Acne

Isotretinoin (13-cis-Retinoic acid) is a poor water soluble drug, commonly used in the treatment of severe cases of acne. The aim of present work was to formulate isotretinoin in the form of transferosomal gel and sustain the drug release, enhance the drug availability at the site of action and minimize the side effects by the use of formulations containing Phospholipon 90 H and surfactant. The transfersomes were formulated by lipid film hydration technique using Rotary vacuum Evaporator. The prepared transfersomes were optimized for type and concentration of edge activator and converted into suitable gel formulation then it was evaluated for their characteristics. The prepared transferosomes were evaluated for Particle size, Size distribution, Deformability, % Entrapment efficiency and % Drug release kinetic modeling for 24 hrs. The excipients compatibility was performed by using Differential scanning calorimetry and it was found compatible with each other. The vesicular surface morphology was studied using Transmission electron microscopy (TEM). Then gel was evaluated for characteristics like pH, viscosity and spreadability, skin irritation study and skin permeation study. The stability studies performed for 6 months at 4°C and room temperature as per ICH guideline. In vitro drug release studies showed desirable results based on linearity, the drug permeation data fit well to Higuchi equation plot (R2=0.943) indicating the diffusion rate limited drug permeation mechanism was found as Fickian diffusion. Transferosomal gel prepared showed all the desired properties and complied within the range of results.