In life-cycle management of pharmaceutical products, novel drug delivery technologies that offer positive differentiation over first-generation products provide an important means for staying competitive in today’s business environment. This article will briefly discuss a proven and scalable solid dispersion approach based on spray-drying that is suitable for Biopharmaceutical Classification System (BCS) (Figure 1) Class II active pharmaceutical ingredients (APIs) and new chemical entities (NCEs).1-4
Many existing APIs and NCEs are poorly water soluble and subsequently have low oral bioavailability if formulated in unmodified form. Traditional approaches to overcoming this include (1) improvement of water miscibility by employing self-emulsification, lipid-based techniques, solubilization into micellar cores, or alternatively complexation with cyclodextrins; (2) reduction of particle size to nano-scale via mechanical milling or high-shear processing accompanied by particle stabilization; and (3) impacting
crystal lattice energy using polymorphs or co-crystals, or through the creation of solid dispersions of drug in inert carriers or matrices.5-11.