Characterization of Sapropterin Dihydrochloride Tablet

  • Tapan Kumar Jena Institute of Pharmaceutical Sciences, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu, Rajasthan – 333001
  • Rakesh Kumar Jat Institute of Pharmaceutical Sciences, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu, Rajasthan – 333001

Abstract

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.


Keywords: Sapropterin dihydrochloride, Hyperphenylalaninemia, Kuvan tablets

Keywords: Sapropterin dihydrochloride, Hyperphenylalaninemia, Kuvan tablets

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Author Biographies

Tapan Kumar Jena, Institute of Pharmaceutical Sciences, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu, Rajasthan – 333001

Institute of Pharmaceutical Sciences, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu, Rajasthan – 333001

Rakesh Kumar Jat, Institute of Pharmaceutical Sciences, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu, Rajasthan – 333001

Institute of Pharmaceutical Sciences, Shri Jagdishprasad Jhabarmal Tibrewala University, Jhunjhunu, Rajasthan – 333001

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1.
Jena TK, Jat RK. Characterization of Sapropterin Dihydrochloride Tablet. JDDT [Internet]. 15Jun.2024 [cited 17Jul.2024];14(6):109-13. Available from: https://jddtonline.info/index.php/jddt/article/view/6599