ABSTRACT
NanoCrystal Technology was developed to meet a significant market need for delivery of poorly water-soluble drugs. This formulation problem is addressed using proprietary technology that presents drugs as extremely small-nanometer-sized
—particles. NanoCrystal particles are made by wet-milling active pharmaceutical ingredients (APIs), water, and a stabilizer to create a colloidal dispersion in the size range of 100-400nm in diameter. These NanoCrystal particles do not aggregate due to the non-covalent adsorption of stabilizing polymers onto the particle surface, which decreases the surface-free energy. The hydrophilic polymers used to stabilize the colloidal dispersions can be found in marketed products and are generally recognized as safe (GRAS) materials. These NanoCrystal particles can be further processed into all of the dosage forms traditionally used for administering drugs by oral, parenteral, inhalation, or topical routes. The applicability of this technology is defined solely by the drug candidate’s aqueous solubility and is not constrained by therapeutic category or chemical structure. The NanoCrystal milling process is fairly gentle and has been applied to proteins.
