Original Research


DOI :10.26650/IstanbulJPharm.2020.0003   IUP :10.26650/IstanbulJPharm.2020.0003    Full Text (PDF)

Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation

Gökay Günİbrahim KarabacakMüge GüleliŞevki KızılokSercan SemizMahmut ÖzbekSüleyman Özakın

Background and Aims: The aim of the research work was to compare excipient effects and develop a stable pharmaceutical product in the form of lyophilized powder. Mannitol, lactose monohydrate, EDTA and glycine are widely used in pharmaceutical formulations and food products.

Methods: The production method consists of mainly four parts: raw material weighing process, preparation of bulk solutions, lyophilization and analytical determination. A total of five formulations were prepared and lyophilized to the stability study. To improve the stability of hydroxocobalamin formulations (F1-F5), they were evaluated with different excipients (mannitol, lactose monohydrate, EDTA and glycine) during the stability period. Stability studies were performed to check impurity and assay of hydroxocobalamin.

Results: The rate of impurity and assay results were compared to F1-F5 formulations. As a result of impurity and assay analysis for F3 and F4, the formulations were found to be within limit. Both of them were determined to the best formulations for impurity of hydroxocobalamin.

Conclusion: The research proposes a new stable formulation and proper storage conditions for lyophilized hydroxocobalamin parenteral solutions. The impurity problem of lyophilized hydroxocobalamin formulation was optimized with lactose monohydrate and lactose monohydrate + EDTA combination.


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APA

Gün, G., Karabacak, İ., Güleli, M., Kızılok, Ş., Semiz, S., Özbek, M., & Özakın, S. (2020). Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation. İstanbul Journal of Pharmacy, 50(2), 89-94. https://doi.org/10.26650/IstanbulJPharm.2020.0003


AMA

Gün G, Karabacak İ, Güleli M, Kızılok Ş, Semiz S, Özbek M, Özakın S. Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation. İstanbul Journal of Pharmacy. 2020;50(2):89-94. https://doi.org/10.26650/IstanbulJPharm.2020.0003


ABNT

Gün, G.; Karabacak, İ.; Güleli, M.; Kızılok, Ş.; Semiz, S.; Özbek, M.; Özakın, S. Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation. İstanbul Journal of Pharmacy, [Publisher Location], v. 50, n. 2, p. 89-94, 2020.


Chicago: Author-Date Style

Gün, Gökay, and İbrahim Karabacak and Müge Güleli and Şevki Kızılok and Sercan Semiz and Mahmut Özbek and Süleyman Özakın. 2020. “Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation.” İstanbul Journal of Pharmacy 50, no. 2: 89-94. https://doi.org/10.26650/IstanbulJPharm.2020.0003


Chicago: Humanities Style

Gün, Gökay, and İbrahim Karabacak and Müge Güleli and Şevki Kızılok and Sercan Semiz and Mahmut Özbek and Süleyman Özakın. Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation.” İstanbul Journal of Pharmacy 50, no. 2 (May. 2024): 89-94. https://doi.org/10.26650/IstanbulJPharm.2020.0003


Harvard: Australian Style

Gün, G & Karabacak, İ & Güleli, M & Kızılok, Ş & Semiz, S & Özbek, M & Özakın, S 2020, 'Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation', İstanbul Journal of Pharmacy, vol. 50, no. 2, pp. 89-94, viewed 20 May. 2024, https://doi.org/10.26650/IstanbulJPharm.2020.0003


Harvard: Author-Date Style

Gün, G. and Karabacak, İ. and Güleli, M. and Kızılok, Ş. and Semiz, S. and Özbek, M. and Özakın, S. (2020) ‘Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation’, İstanbul Journal of Pharmacy, 50(2), pp. 89-94. https://doi.org/10.26650/IstanbulJPharm.2020.0003 (20 May. 2024).


MLA

Gün, Gökay, and İbrahim Karabacak and Müge Güleli and Şevki Kızılok and Sercan Semiz and Mahmut Özbek and Süleyman Özakın. Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation.” İstanbul Journal of Pharmacy, vol. 50, no. 2, 2020, pp. 89-94. [Database Container], https://doi.org/10.26650/IstanbulJPharm.2020.0003


Vancouver

Gün G, Karabacak İ, Güleli M, Kızılok Ş, Semiz S, Özbek M, Özakın S. Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation. İstanbul Journal of Pharmacy [Internet]. 20 May. 2024 [cited 20 May. 2024];50(2):89-94. Available from: https://doi.org/10.26650/IstanbulJPharm.2020.0003 doi: 10.26650/IstanbulJPharm.2020.0003


ISNAD

Gün, Gökay - Karabacak, İbrahim - Güleli, Müge - Kızılok, Şevki - Semiz, Sercan - Özbek, Mahmut - Özakın, Süleyman. Evaluation of excipients effects on the impurity profile of lyophilized hydroxocobalamin formulation”. İstanbul Journal of Pharmacy 50/2 (May. 2024): 89-94. https://doi.org/10.26650/IstanbulJPharm.2020.0003



TIMELINE


Submitted16.01.2020
Accepted03.06.2020
Published Online27.08.2020

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