[The size of nanoparticles after incorporation into gastroresistant spheroids]

Nanoparticles can be used as an attractive carrier for the controlled delivery of drugs by the oral route. This nanoparticular delivery system can protect an active ingredient from enzymatic degradations and enhance its absorption from the intestinal mucosa. We studied the development of a gastroresistant dosage form for the oral administration of nanoparticles. Fast disintegrating pellets were used for the administration of nanoparticles and for their transit to the site of absorption. A gastroresistant film was applied onto the pellets to protect the nanoparticles and/ or the active substance from the acid gastric environment. The integrity of the nanoparticle size was assessed after two critical manufacturing steps: the extrusion/spheronisation process and the coating process. The determination of the nanoparticles size distribution was performed by photon correlation spectroscopy (PCS). The comparison of the PCS results between the original nanoparticles and the nanoparticles incorporated in the pellets shows a very low aggregation. Moreover the coating process was not a critical step since it was not responsible for an additional agglomeration of the nanoparticles. In conclusion, our manufacturing process allows the redispersion of the nanoparticles with a little change of the size distribution. In a next study we well try to quantify the release of the nanoparticles from the pellets.