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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

Design of Experiments for Critical Material Attributes Assessment of Linagliptin and Metformin Fixed-dose Combination Tablets

Kang Min Kim1★★ Corresponding author

  1. 1Department of Pharmaceutical Science and Technology, Kyungsung University, Busan, SOUTH KOREA.

CORRESPONDENCE

Kang Min Kim

Department of Pharmaceutical Science and Technology, Kyungsung University, Busan, SOUTH KOREA.

kimkmks@ks.ac.kr

Received: 02-11-2020; Revised: 17-02-2021; Accepted: 18-05-2021.

Volume 55, Issue 3 · pp. 701–708 · PUBLISHED 2021 · DOI: 10.5530/ijper.55.3.142

View on IJPER original site ↗

ABSTRACT

Aim of work: This study aimed to determine the amount of excipients in the critical material attributes of linagliptin and metformin sustained release (SR) fixed-dose combination (FDC) tablets using design of experiments (DoE). Methods: A 23 full factorial design with three center points was performed. For the screening of excipients, 3-factor responses (mannitol, sodium starch glycolate and pregelatinized starch for linagliptin; hydroxypropyl methylcellulose, sodium carboxymethyl cellulose (CMC) and hydroxypropyl cellulose for metformin), 2-levels and 1-center (n=3) point with three responses (friability, assay and dissolution) were applied to the DoE batch using Design-Expert. Results: Most excipients were an important factor in the friability, assay and dissolution results (P<0.05). In the screening of excipients, mannitol (40-60 mg) and pregelatinized starch (40-60 mg) with sodium starch glycolate (5 mg) for linagliptin and hydroxypropyl cellulose (15-23 mg) and CMC (40-55 mg) with hydroxypropyl methylcellulose (260 mg) for metformin were optimal. Conclusion: In summary, selection for the amount of excipients can be defined through levels of risk based on three responses. It can be concluded that the ranges of excipients leading to high quality (low friability and optimal ranges of assay and dissolution) for the screening of excipients were successfully observed by the DoE approach.

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    Kim, K. M. (2021). Design of Experiments for Critical Material Attributes Assessment of Linagliptin and Metformin Fixed-dose Combination Tablets. Indian Journal of Pharmaceutical Education and Research, 55(3), 701–708. https://doi.org/10.5530/ijper.55.3.142