Acta Scientific Pharmacology

Mini Review Volume 3 Issue 4

Principal Component Analysis in Drug-excipient Interactions

Farzad Khajavi*

Research and Development Section, Dr. Abidi Pharmaceutical Company, Tehran, Iran

*Corresponding Author: Farzad Khajavi, Research and Development Section, Dr. Abidi Pharmaceutical Company, Tehran, Iran.

Received: December 10, 2021; Published: March 30, 2022

Abstract

Studies about the interaction between active pharmaceutical ingredients (API) and excipients are so important in the pre-formulation stage of development of all dosage forms. Analytical techniques such as differential scanning calorimetry (DSC), Thermal gravimetry (TG), and Furrier transform infrared spectroscopy (FTIR) are commonly used tools for investigation regarding compatibility and incompatibility of APIs with excipients. Sometimes the interpretation of data obtained from these techniques is difficult because of severe overlapping of API spectrum with excipients in their mixtures. Principal component analysis (PCA) as a powerful factor analytical method is used in these situations to resolve data matrices acquired from these analytical techniques. Binary mixtures of API and interested excipients are considered and produced. Peaks of FTIR, DSC, or TG of pure API and excipient and their mixtures at different mole ratios will construct the rows of the data matrix. By applying PCA on the data matrix, the number of principal components (PCs) is determined so that it contains the total variance of the data matrix. By plotting PCs or factors obtained from the score of the matrix in two-dimensional spaces if the pure API and its mixture with the excipient at the high amount of API and the 1:1mixture form a separate cluster and the other cluster comprise of the pure excipient and its blend with the API at the high amount of excipient. This confirms the existence of compatibility between API and the interested excipient. Otherwise, the incompatibility will overcome a mixture of API and excipient.

Keywords: API; Compatibility; DSC; TG; Interactions

References

  1. AR Fassihi and PHR Persicaner. “Solid state interaction of bromazepam with polyvinylpyrrolidone in the presence of moisture”. International Journal of Pharmaceutics 37 (1987): 167.
  2. K Jackson., et al. “Drug-excipient interactions and their effect on absorption”. Pharmaceutical Science and Technology Today 3 (2000): 336.
  3. P Crowley and LG Martini. “Drug-Excipient Interactions”. Pharmaceutical Technology 13 (2001): 26.
  4. FM McDaid., et al. “Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drug-excipient interactions”. International Journal of Pharmaceutics 252 (2003): 235.
  5. Z Makai., et al. “Evaluation of the effects of lactose on the surface properties of alginate coated trandolapril particles prepared by a spray-drying method”. Carbohydrate Polymers 74 (2008): 712.
  6. B Tita., et al. “Compatibility study between ketoprofen and pharmaceutical excipients used in solid dosage forms”. Journal of Pharmaceutical and Biomedical Analysis 56 (2): (2011): 221.
  7. A Marini., et al. “Drug-excipient compatibility studies by physico-chemical techniques; The case of Indomethacin”. Journal of Thermal Analysis and Calorimetry 73 (2003): 529.
  8. R Chadha and S Bhandari. “Drug-excipient compatibility screening-Role of thermoanalytical and spectroscopic techniques”. Journal of Pharmaceutical and Biomedical Analysis 87 (2014): 82.
  9. ME Brown., et al. “DSC screening of potential prochloperazine-excipient interactions in preformulation studies”. Journal of Thermal Analysis and Calorimetry 56 (1999): 1317.
  10. G Pyramides., et al. “The combined use of DSC and TGA for the thermal analysis of atenolol tablets”. Journal of Pharmaceutical and Biomedical Analysis2 (1995): 103.
  11. MA Phipps., et al. “Excipient compatibility as assessed by isothermal microcalorimetry”. Journal of Pharmacy and Pharmacology 50 (1998): 9.
  12. EA Schmitt. “Excipient compatibility screening by isothermal calorimetry”. in: 53rd Calorimetry Conference, Midland, MI (1998).
  13. AW Newman and SR Byrn. “Solid-state analysis of the active pharmaceutical ingredient in drug products”. Dichlorodiphenyl Trichloroethane 8 (2003): 898-905.
  14. R Chadha., et al. “Thermomicroscopy and its pharmaceuticals applications”. in: A. Méndez-Vilas (Ed.): Current Microscopy Contributions to Advances in Science and Technology edition, Microscopy Book Series, Badajoz, Spain 13 (2012): 1013-1024
  15. L Qi., et al. “The development of microthermal analysis and photothermal microspectroscopy as novel approaches to drug-excipient compatibility studies”. International Journal of Pharmaceutics 354 (1-2): (2008): 149.
  16. Z Aigner., et al. “Compatibility studies of aceclofenac with retard tablet excipients by means of thermal and FT-IR spectroscopic methods”. Journal of Thermal Analysis and Calorimetry 104 (2011): 265.
  17. P Mura., et al. “Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy”. Journal of Pharmaceutical and Biomedical Analysis 18 (1998): 151.
  18. SA Botha and AP Lotter. “Compatibility Study Between Naproxen and Tablet Excipients Using Differential Scanning Calorimetry”. Drug Development and Industrial Pharmacy 16 (1990): 673.
  19. J Camacho., et al. “Data understanding with PCA: Structural and Variance Information plots”. Chemometrics and Intelligent Laboratory Systems 100 (2010): 48.
  20. J Jackson. “A User's Guide to Principal Components”. Wiley-Interscience, England (2003).
  21. K Kosanovich., et al. “Improved process understanding using multiway principal component analysis”. Engineering Chemical Research 35 (1996): 138.
  22. B Rojek and M Wesolowski. “DSC supported by factor analysis as a reliable tool for compatibility study in pharmaceutical mixtures”. Journal of Thermal Analysis and Calorimetry 138 (2019): 4531.
  23. B Rojek and M Wesolowski. “Compatibility studies of hydrocortisone with excipients using thermogravimetric analysis supported by multivariate statistical analysis”. Journal of Thermal Analysis and Calorimetry 127 (2017): 543.
  24.  

Citation

Citation: Farzad Khajavi. “Principal Component Analysis in Drug-excipient Interactions". Acta Scientific Pharmacology 3.4 (2022): 14-19.

Copyright

Copyright: © 2022 Farzad Khajavi. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




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