A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend to revert back to their crystalline state when exposed to the physical and thermal processes that are typically involved in the production of oral dosage forms. The authors have developed a novel formulation approach based on directly freeze-drying a solution of a PWSD held in a gelatin capsule. Such an in-situ approach circumvents processing instability issues and unexpectedly led to a marked increase in the dissolution of nifedipine (t1/2 = 1.88 ± 0.05 minutes) when compared to the equivalent marketed product. In this article we discuss the quality control challenges and how quality control was applied to our novel amorphous formulation platform…

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