Formulation and In-vitro-evaluation of Isotretinoin Tablets

Isotretinoin (13-cis-Retinoic acid) is a poor water soluble drug, commonly used in the treatment of severe cases of acne. The aim of this project is to formulate isotretinoin in form of tablet and enhance its solubility and dissolution rate; by the use of formulations containing either surfactant (SLS and Tween20) or HP-β-CD. The critical micelle concentration for each surfactant was determined. Surfactant enriched tablets were prepared by physical mixture and co-precipitation method. Binary system of the drug with HP-β-CD was prepared using different ratios and techniques. The freeze drying technique gave the best drug-HP-β-CD complexation. The in-vitro dissolution study for the prepared mixtures and the prepared tablets was performed. Binary system of molecular ratio 1: 5 of the drug to HP-β-CD gave the highest solubility and dissolution rate for isotretinoin in comparison with other formulae. Therefore, it could be concluded from the study that, incorporation of surfactant and HP-β-CD in the formulation of isotretinoin tablets significantly improved Isotretinoin solubility.