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The study described in the paper, “Overcoming drug impurity challenges in amorphous solid dispersion with rational development of biorelevant dissolution-permeation method,” provides a relationship between observed in vitro formulation behavior of an amorphous solid dispersion formulation with in vivo results by using the acceptor profile of side-by-side dissolution-permeation apparatus (Rainbow Dynamic Dissolution Monitor™ and MicroFlux™, Pion Inc., Billerica, MA.)
The paper concludes: “Bio-relevancy of the in vitro method was confirmed with [an] in vivo dog study and clinical study on patients, and an in vitro – in vivo correlation was established. For the investigated BCS II/IV drug, this research highlights the importance of considering supersaturation and formation of colloidal species during amorphous solid dispersion release testing to assure product quality, safety and efficacy .”
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