بررسي تاثير ميزان دارو بر خصوصيات فيزيكومكانيكي و آزادسازي دارو از پلت هاي ايبوپروفن تهيه شده به روش استروژن و اسفرونايزيشن

Effect of drug loading on physicomechanical and release properties of Ibuprofen pellets prepared by Extrusion-Spheronization

The need for high levels of Avicel (as an ideal excipient) to achieve suitable pellets is the main limitation for production of pellets with high load of drug. The aim of this study was to evaluate the effect of drug loading on release behaviour and physicomechanical properties of Ibuprofen pellets. The pellets were prepared by Extrusion-Spheronization based on full factorial design. Independent variables were % Ibuprofen (40, 60, 80) and % PVP (1, 3, 5). Adequate amount of water was added to all formulations and kneaded until proper wet mass was resulted. The evaluated responses were Mean Dissolution Time (MDT), Surface characteristics, Sphericity, Aspect Ratio, Elastic Modulus and Crushing Strength. Regression and response surface modeling were used for analyzing results. It was shown that the amount of water required to prepare proper wet mass was affected by composition of formulations; the amount of water decreased with increasing of drug load and percent of PVP. Increasing percent of PVP slightly decreased MDT and Elastic Modulus but had negligible effect on Crushing Strength. Increasing percent of Ibuprofen up to 60 had no effect on MDT but beyond that decreased MDT. Increasing percent of Ibuprofen also decreased Crushing strength and Elastic Modulus of pellets. The results showed that in case of Ibuprofen, proper pellets with high load of drug could be prepared successfully.