Challenges and Opportunities in Oral Formulation Development
Over 60% of new chemical entities that are poorly soluble qualify either as BCS Class II or Class IV and they provide challenges as well as opportunities to scientists working in formulation development [1]. The conventional solubilization approaches such as physical modifications of drug crystals (surface alteration of API, micronization or micro-milling) usually lead to a limited dissolution and solubility enhancement, but when developing a medium or high dosed formulation, the non-conventional formulation approaches are often required particularly when dealing with almost water-insoluble compounds usually characterized by a high melting point and/or very high lipophilicity[2].
Source: https://www.americanpharmaceuticalreview.com/Featured-Articles/126887-Challenges-and-Opportunities-in-Oral-Formulation-Development/