Satyanarayan Pattnaik and Kalpana Swain
Talla Padmavathi College of Pharmacy, Kareemabad, Warangal, India
Statistical design of experiments for development and further optimization of pharmaceutical products and processes has gained a lot of importance, now a day, in the era of quality by design. In this study we demonstrate optimization of process variables for development of nanocrystals to improve dissolution rate of aceclofenac. Bottom up approach was adopted to obtain pure drug nanocrystals of aceclofenac using different polymeric stabilizers. A Box-Behnken design was used to study the influence of process variables and further optimization was carried out. The physicochemical properties were evaluated including particle size distribution, PXRD, SEM and dissolution studies. The identified process variables influenced the particle size and dissolution velocity of aceclofenac. Methylcellulose (MC) and hydroxypropyl methylcellulose (HPMC) were found very effective in preventing growth of crystals and improving the dissolution of aceclofenac. The optimized aceclofenac nanocrystals showed improved dissolution and reduced particle size.