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Characterization of Kuvan tablets involved thorough analysis of physical, chemical, and dissolution properties. Formulation development encompassed pre-formulation studies, feasibility trials, and process optimization. Kuvan tablets demonstrated variability in sapropterin dihydrochloride concentration but rapid dissolution across different media. Consistent mechanical strength, low impurity levels, and appropriate pH values were observed, ensuring efficacy, safety, and reliability.
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Jena et al. (2024) studied this question.
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