Evaluation of a diltiazem cream preparation for estimation of degradation behavior

Bahar Köksel Özgen; Burcu Bulut; Nagehan Sarraçoğlu; Asuman Aybey Doğanay; Onur Pınarbaslı

doi:10.35333/jrp.2021.284

Evaluation of a diltiazem cream preparation for estimation of degradation behavior

Abstract

Diltiazem cream, which is used in chronic anal fissure (CAF) treatment, is known to be susceptible to hydrolysis and degradation in aqueous solutions. The major pathway of degradation is o-deacetylation which leads to formation of 'desacetyl diltiazem' and this study focuses on this degradation mechanism. In this study, degradation of diltiazem incorporated into an oil-in-water cream base was investigated. It was especially aimed to show the effect of the formulation preparation procedure on impurity formation during the diltiazem cream formulation. In this regard, preliminary studies were performed to optimize the formulation parameters for stability. The outcome of these studies was applied to the preparation procedure; the compositions of excipients were kept constant while the order of addition of excipients to the aqueous phase and the mixing time were varied. To our knowledge, there is no study published regarding the relation between this degradation and the formulation process. Formulations were characterized in terms of formation of the desacetyl diltiazem impurity with a validated stability indicating HPLC method. The cream formulation with the highest stability was obtained through mixing propylene glycol and water first and adding diltiazem active substance in the final step of formation of aqueous phase with a shortened stirring time. This preparation procedure exhibited reduced desacetyl diltiazem impurity formation.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmaceutical Delivery Technologies

Journal Section

Research Article

Authors

Bahar Köksel Özgen This is me
Türkiye

Burcu Bulut This is me
Türkiye

Nagehan Sarraçoğlu ^* This is me
Türkiye

Asuman Aybey Doğanay This is me
Türkiye

Onur Pınarbaslı
Türkiye

Publication Date

June 27, 2025

Submission Date

July 1, 2020

Acceptance Date

September 17, 2020

Published in Issue

Year 2021 Volume: 25 Number: 1

DOI

https://doi.org/10.35333/jrp.2021.284

IZ

https://izlik.org/JA85SK37HX

Cite

RIS / Bibtex

APA

Köksel Özgen, B., Bulut, B., Sarraçoğlu, N., Aybey Doğanay, A., & Pınarbaslı, O. (2025). Evaluation of a diltiazem cream preparation for estimation of degradation behavior. Journal of Research in Pharmacy, 25(1), 13-21. https://doi.org/10.35333/jrp.2021.284

AMA

1.Köksel Özgen B, Bulut B, Sarraçoğlu N, Aybey Doğanay A, Pınarbaslı O. Evaluation of a diltiazem cream preparation for estimation of degradation behavior. J. Res. Pharm. 2025;25(1):13-21. doi:10.35333/jrp.2021.284

Chicago

Köksel Özgen, Bahar, Burcu Bulut, Nagehan Sarraçoğlu, Asuman Aybey Doğanay, and Onur Pınarbaslı. 2025. “Evaluation of a Diltiazem Cream Preparation for Estimation of Degradation Behavior”. Journal of Research in Pharmacy 25 (1): 13-21. https://doi.org/10.35333/jrp.2021.284.

EndNote

Köksel Özgen B, Bulut B, Sarraçoğlu N, Aybey Doğanay A, Pınarbaslı O (June 1, 2025) Evaluation of a diltiazem cream preparation for estimation of degradation behavior. Journal of Research in Pharmacy 25 1 13–21.

IEEE

[1]B. Köksel Özgen, B. Bulut, N. Sarraçoğlu, A. Aybey Doğanay, and O. Pınarbaslı, “Evaluation of a diltiazem cream preparation for estimation of degradation behavior”, J. Res. Pharm., vol. 25, no. 1, pp. 13–21, June 2025, doi: 10.35333/jrp.2021.284.

ISNAD

Köksel Özgen, Bahar - Bulut, Burcu - Sarraçoğlu, Nagehan - Aybey Doğanay, Asuman - Pınarbaslı, Onur. “Evaluation of a Diltiazem Cream Preparation for Estimation of Degradation Behavior”. Journal of Research in Pharmacy 25/1 (June 1, 2025): 13-21. https://doi.org/10.35333/jrp.2021.284.

JAMA

1.Köksel Özgen B, Bulut B, Sarraçoğlu N, Aybey Doğanay A, Pınarbaslı O. Evaluation of a diltiazem cream preparation for estimation of degradation behavior. J. Res. Pharm. 2025;25:13–21.

MLA

Köksel Özgen, Bahar, et al. “Evaluation of a Diltiazem Cream Preparation for Estimation of Degradation Behavior”. Journal of Research in Pharmacy, vol. 25, no. 1, June 2025, pp. 13-21, doi:10.35333/jrp.2021.284.

Vancouver

1.Bahar Köksel Özgen, Burcu Bulut, Nagehan Sarraçoğlu, Asuman Aybey Doğanay, Onur Pınarbaslı. Evaluation of a diltiazem cream preparation for estimation of degradation behavior. J. Res. Pharm. 2025 Jun. 1;25(1):13-21. doi:10.35333/jrp.2021.284