Prediction of saxagliptin stability using a new approach based on Partial Least Squares and Design of Experiments

References

• Bajaj S, Singla D, Sakhuja N. 2012. Stability testing of pharmaceutical products. J Appl Pharm Sci. 2:129–138.
   Google Scholar
• Carstensen JT, Rhodes CT. 2000. Drug stability, principles and practices. 3 ed. Vol. 107. New York: Marcel Dekker.
   Google Scholar
• Colgan ST, Timpano RJ, Roberts M, Weaver R, Ryan K, Fields KW, Scrivens G. 2014. Opportunities for lean stability strategies. J Pharm Innov. 9:259–271.
   Web of Science ®Google Scholar
• Cook J, Cruanes MT, Gupta M, Riley S, Crison J. 2014. Quality-by-design: are we there yet? AAPS PharmSciTech. 15:140–148.
   PubMed Web of Science ®Google Scholar
• Darrington RT, Jiao J. 2004. Rapid and accurate prediction of degradant formation rates in pharmaceutical formulations using high-performance liquid chromatography-mass spectrometry. J Pharm Sci. 93:838–846.
   PubMed Web of Science ®Google Scholar
• Eriksson L, Johansson E, Kettaneh-Wold N, Wikstrom C, Wold S. 2008. Design of experiments – principles and applications. 3rd ed. Umea (Sweden): Umetrics AB.
   Google Scholar
• Fan Z, Zhang L. 2015. One- and two-stage Arrhenius models for pharmaceutical shelf life prediction. J Biopharm Stat. 25:307–316.
   PubMed Web of Science ®Google Scholar
• Ferreira AP, Tobyn M. 2015. Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era. Pharm Dev Technol. 20:513–527.
   PubMed Web of Science ®Google Scholar
• Gabrielsson J, Lindberg N, Lundstedt T. 2002. Multivariate methods in pharmaceutical application. J Chemometrics. 16:141–160.
   Web of Science ®Google Scholar
• Gabrielsson J, Lindberg N-O, Pålsson M, Nicklasson F, Sjöström M, Lundstedt T. 2003. Multivariate methods in the development of a new tablet formulation. Drug Dev Ind Pharm. 29:1053–1075.
   PubMed Web of Science ®Google Scholar
• Jordan N, Zakrajsek J, Bohanec S, Roskar R, Grabnar I. 2018. Applying the methodology of design of experiments to stability studies: a partial least squares approach for evaluation of drug stability. Drug Dev Ind Pharm. 44:778–786.
   PubMed Web of Science ®Google Scholar
• Lin TYD, Chen CW. 2003. Overview of stability study designs. J Biopharm Stat. 13:337–354.
   PubMedGoogle Scholar
• ICH Q1A(R2). 2003. ICH Q1A(R2), Stability testing of new drug substances and products. ICo Harmonization. CPMP/ICH/2736/99.
   Google Scholar
• ICH Q1E. 2003. ICH Q1E, Evaluation of stabiliy data. CPMP/ICH/420/02.
   Google Scholar
• ICH Q8(R2). 2009. ICH Q8(R2), Pharmaceutical development. CHMP/ICH/167068/04.
   Google Scholar
• Mishra V, Thakur S, Patil A, Shukla A. 2018. Quality by design (QbD) approaches in current pharmaceutical set-up. Expert Opin Drug Deliv. 15:737–758.
   PubMed Web of Science ®Google Scholar
• Naversnik K, Bohanec S. 2008. Predicting drug hydrolysis based on moisture uptake in various packaging designs. Eur J Pharm Sci. 35:447–456.
   PubMed Web of Science ®Google Scholar
• Naversnik K, Jurecic R. 2016. Humidity-corrected Arrhenius equation: the reference condition approach. Int J Pharm. 500:360–365.
   PubMed Web of Science ®Google Scholar
• Peraman R, Bhadraya K, Reddy YP. 2015. Analytical quality by design: a tool for regulatory flexibility and robust analytics. Int J Anal Chem. 2015:868727.
   PubMed Web of Science ®Google Scholar
• Peters JU. 2007. 11 Years of cyanopyrrolidines as DPP-IV inhibitors. Curr Top Med Chem. 7:579–595.
   PubMed Web of Science ®Google Scholar
• Politis SN, Colombo P, Colombo G, Rekkas DM. 2017. Design of experiments (DoE) in pharmaceutical development. Drug Dev Ind Pharm. 43:889–901.
   PubMed Web of Science ®Google Scholar
• Robnik B, Likozar B, Wang B, Stanic Ljubin T, Casar Z. 2019. Understanding and kinetic modeling of complex degradation pathways in the solid dosage form: the case of saxagliptin. Pharmaceutics. 11:452.
   Web of Science ®Google Scholar
• Sheiner LB, Beal SL. 1981. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 9:503–512.
   PubMedGoogle Scholar
• Singh DK, Singh S, Bajaj S. 2018. Regulatory guidelines on stability testing and trending of requirements. In: Bajaj S, Singh S, editors. Methods for stability testing of pharmaceuticals. New York (NY): Springer New York; p. 1–30.
   Google Scholar
• Waterman KC, Adami RC. 2005. Accelerated aging: prediction of chemical stability of pharmaceuticals. Int J Pharm. 293:101–125.
   PubMed Web of Science ®Google Scholar
• Waterman KC, MacDonald BC. 2010. Package selection for moisture protection for solid, oral drug products. J Pharm Sci. 99:4437–4452.
   PubMed Web of Science ®Google Scholar
• Waterman KC. 2011. The application of the Accelerated Stability Assessment Program (ASAP) to quality by design (QbD) for drug product stability. AAPS PharmSciTech. 12:932–937.
   PubMed Web of Science ®Google Scholar
• Wu Y, Levons J, Narang AS, Raghavan K, Rao VM. 2011. Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility. AAPS PharmSciTech. 12:1248–1263.
   PubMed Web of Science ®Google Scholar
• Yekpe K, Abatzoglou N, Bataille B, Gosselin R, Sharkawi T, Simard JS, Cournoyer A. 2018. Developing a quality by design approach to model tablet dissolution testing: an industrial case study. Pharm Dev Technol. 23:646–654.
   PubMed Web of Science ®Google Scholar
• Yu LX. 2008. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 25:781–791.
   PubMed Web of Science ®Google Scholar
• Zakrajsek J, Stojic V, Bohanec S, Urleb U. 2015. Quality by design based optimization of a high performance liquid chromatography method for assay determination of low concentration preservatives in complex nasal formulations. Acta Chim Slov. 62:72–82.
   PubMed Web of Science ®Google Scholar