The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment

Yagmur Pirincci Tok; Burcu Demiralp; Mazen Al-Mohaya; Yıldız Özsoy

doi:10.12991/jrespharm.1835939

The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment

Abstract

In this study, Dexketoprofen trometamol granulated with Kollicoat MAE 30DP to evaluate tableting properties was developed as an orally disintegrating formulation via using a quality by design approach. FMEA was used to identify the critical material properties and critical process parameters, as a result of which Prosolv® ODT G2, Emdex®, and Magnasweet® MM100 were determined as critical materials, and tablet compression pressure as a critical process parameter. Tablet properties of 54 prepared formulations were analyzed using the Box-Behnken design to evaluate the amount of polymer which can affect the tablet properties in the granulation process. In conclusion, it was observed that the low amount of Kollicoat MAE 30DP in the formulation had a low effect on the dissolution rate, especially at late-stage time points of the dissolution time horizon. However, the high amount of Kollicoat MAE 30DP had undesirable effects. Based on data, it can be concluded that it is critical to determine the content ratio of the Kollicoat MAE 30DP in the orally disintegrating tablet formulation of Dexketoprofen trometamol since it affects not only the bitter taste masking, but also tablet properties such as friability, breaking strength, disintegration time, and dissolution ratio.

Keywords

Project Number

None

References

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Details

Primary Language

English

Subjects

Pharmaceutical Delivery Technologies

Journal Section

Research Article

Authors

Yagmur Pirincci Tok
0000-0001-6915-0283
Türkiye

Burcu Demiralp ^*
0000-0003-2838-1688
Türkiye

Mazen Al-Mohaya
0000-0003-4176-0308
Türkiye

Yıldız Özsoy
0000-0002-9110-3704
Türkiye

Publication Date

May 11, 2026

Submission Date

December 4, 2025

Acceptance Date

May 7, 2026

Published in Issue

Year 2026 Volume: 30 Number: 3

DOI

https://doi.org/10.12991/jrespharm.1835939

IZ

https://izlik.org/JA54PF75JA

Cite

RIS / Bibtex

APA

Pirincci Tok, Y., Demiralp, B., Al-Mohaya, M., & Özsoy, Y. (2026). The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment. Journal of Research in Pharmacy, 30(3), 957-974. https://doi.org/10.12991/jrespharm.1835939

AMA

1.Pirincci Tok Y, Demiralp B, Al-Mohaya M, Özsoy Y. The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment. J. Res. Pharm. 2026;30(3):957-974. doi:10.12991/jrespharm.1835939

Chicago

Pirincci Tok, Yagmur, Burcu Demiralp, Mazen Al-Mohaya, and Yıldız Özsoy. 2026. “The Effect of Different Granulation Amounts of Kollicoat MAE 30DP® on ODT CQAs Using Risk Assessment”. Journal of Research in Pharmacy 30 (3): 957-74. https://doi.org/10.12991/jrespharm.1835939.

EndNote

Pirincci Tok Y, Demiralp B, Al-Mohaya M, Özsoy Y (May 1, 2026) The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment. Journal of Research in Pharmacy 30 3 957–974.

IEEE

[1]Y. Pirincci Tok, B. Demiralp, M. Al-Mohaya, and Y. Özsoy, “The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment”, J. Res. Pharm., vol. 30, no. 3, pp. 957–974, May 2026, doi: 10.12991/jrespharm.1835939.

ISNAD

Pirincci Tok, Yagmur - Demiralp, Burcu - Al-Mohaya, Mazen - Özsoy, Yıldız. “The Effect of Different Granulation Amounts of Kollicoat MAE 30DP® on ODT CQAs Using Risk Assessment”. Journal of Research in Pharmacy 30/3 (May 1, 2026): 957-974. https://doi.org/10.12991/jrespharm.1835939.

JAMA

1.Pirincci Tok Y, Demiralp B, Al-Mohaya M, Özsoy Y. The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment. J. Res. Pharm. 2026;30:957–974.

MLA

Pirincci Tok, Yagmur, et al. “The Effect of Different Granulation Amounts of Kollicoat MAE 30DP® on ODT CQAs Using Risk Assessment”. Journal of Research in Pharmacy, vol. 30, no. 3, May 2026, pp. 957-74, doi:10.12991/jrespharm.1835939.

Vancouver

1.Yagmur Pirincci Tok, Burcu Demiralp, Mazen Al-Mohaya, Yıldız Özsoy. The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment. J. Res. Pharm. 2026 May 1;30(3):957-74. doi:10.12991/jrespharm.1835939