New granulation technique using a spouted bed type binderless granulator and a jet mill to make PLGA nano-composite granules applicable to DPI was studied. In the method, the PLGA nano-composite granules having a spherical shape with soft granule strength can be binderlessly granulated in the spouted bed using raw materials prepared by milling and blending freeze dried PLGA nanospheres and lactose powder as an excipient with a jet mill. The prepared nano-composite granules showed good handling properties with high respirable fraction (RF) values estimated by cascade impactor in vitro. The new method proposed in the present work proved to be a useful preparation technique of PLGA nano-composite granules for DPI application.
