A REVIEW ARTICLE ON STATISTICAL COMPARISON OF DISSOLUTION PROFILE

Asla C. K.*, Rashidah K. Ansari, Dr. Nishad K. M., Dr. Shijikumar P. S. and Dr. Sirajudheen M. K.

ABSTRACT

Solid dosage forms are mainly taken orally to get it's therapeutic action. After the administration the drug undergo disintegration, followed by dissolution and then diffuse into the systemic circulation. Dissolution testing is an in vitro method that deals with how an active molecule extracted out of solid dosage form. The comparison of dissolution profile can be done by model-dependent and model-independent approaches. In the model-dependent approach including zero order, first order, Hixson- Crowell, Higuchi, and Weibull models are applied to the utilization of fit factors. Model- independent approaches including ANOVA-based procedures, ratio test procedure, and pair wise procedure. The ratio test includes percentage, area under the curve, mean dissolution time, while the pair wise procedure belongs difference factor (f1), similarity factor (f2), and Rescigno index e.t.c. All this approaches are valuable in statistical and clinical aspects, supporting the objectives of current dissolution profile.

Keywords: Dissolution comparison, Model dependent and independent method, f2 similarity.