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.
Friday, December 13, 2013
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