Characterization of Sapropterin Dihydrochloride Tablet

Authors

  • 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

DOI

https://doi.org/10.22270/jddt.v14i6.6599

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

References

Rodwell, Victor W., and Robert K. Murray. "Biochemistry & Medicine." Harper's Illustrated Biochemistry, 31e Rodwell VW, Bender DA, Botham KM, Kennelly PJ, Weil P. Rodwell V.W., & Bender D.A., & Botham K.M., & Kennelly P.J., & Weil P(Eds.), Ed 26, 2003, 255.

https://pubchem.ncbi.nlm.nih.gov/compound/Phenylalanine

Tripathi, K.D. (2013) Essentials of Medical Pharmacology. 7th Edition, Jaypee Brothers Medical Publishers (P) Ltd., New Delhi, 816-835. https://doi.org/10.5005/jp/books/12256

Angela T. S. Wyse, Tiago M. dos Santos, Bianca Seminotti & Guilhian Leipnitz, Insights from Animal Models on the Pathophysiology of Hyperphenylalaninemia: Role of Mitochondrial Dysfunction, Oxidative Stress and Inflammation, Molecular Neurobiology 2021;58:2897-2909. https://doi.org/10.1007/s12035-021-02304-1 PMid:33550493

Ekenna IC, Abali SO, Comparison of the use of kinetic model plots and DD solver software to evaluate the drug release from griseofulvin tablets, Journal of Drug Delivery and Therapeutics. 2022;12(2-S):5-13 https://doi.org/10.22270/jddt.v12i2-S.5402

Daniel A. Hussar et al; New Drugs: Nebivolol hydrochloride, nilotinib, and sapropterin dihydrochloride; 2008; Journal of the American Pharmacist Association; https://doi.org/10.1331/JAPhA.2008.08509 PMid:18359737

Dennis J. Cada; 2008; Sapropterin Dihydrochloride Tablets Hospital Pharmacy, Volume 43, Number 4, pp 307-314. https://doi.org/10.1310/hpj4304-307

Nenad Blau; Sapropterin dihydrochloride for phenylketonuria and tetrahydrobiopterin deficiency, Expert Review of Endocrinology & Metabolism; 2010;5(4):483-494, https://doi.org/10.1586/eem.10.39 PMid:30780801

Deniz Kor, Berna Şeker Yılmaz, Fatma Derya Bulut, Serdar Ceylaner and Neslihan Önenli Mungan; Improved metabolic control in tetrahydrobiopterin (BH4), responsive phenylketonuria with sapropterin administered in two divided doses vs. a single daily dose; J Pediatr Endocrinol Metab; aop; 2017 DOI https://doi.org/10.1515/jpem-2016-0461 .

Lunan Pharmaceutical Group Co.; 2019; Preparation and in vitro/in vivo Evaluation of Sapropterin Dihydrochloride Immediate Release Tablets; CJPH; 50(08): 883-889; DOI: https://doi.org/10.16522/j.cnki.cjph.2019.08.010 .

Emanuela Scudellaro, Luciana Tartaglione, Fabio Varriale, Carmela Dell' Aversano and Orazio Taglialatela-Scafati, HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets, Pharmaceutics 2020;12:323; https://doi.org/10.3390/pharmaceutics12040323 PMid:32260076 PMCid:PMC7237990

https://www.trc-canada.com/product-detail/?T795613 (accessed on 23.08.2022).

Published

15-06-2024
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How to Cite

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

How to Cite

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