Article Detail

Home > Article Detail
  • P-ISSN 1225-0163
  • E-ISSN 2288-8985

Process analytical technology (PAT): field applications and current status in pharmaceutical industries

Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2009, v.22 no.1, pp.35-43






  • Downloaded
  • Viewed

Abstract

The goal of PAT (Process Analytical Technology) is to build quality into products through better understanding and control of manufacturing processes, rather than merely testing the quality of the end product. Pharmaceutical manufacturers are trying to develop and implement new technologies in pharmaceutical production and quality control for real-time measurements of critical product and process parameters. Characterization of manufacturing process through experimental design, for evaluation of the effect of product and process variables, represents an integral part of the PAT framework. However, the publications regarding real PAT application to pharmaceutical process are very limited and the technologies are confidential as well. In this review, the case studies related to PAT are shown with real applications from a pharmaceutical company. Additionally, various applications of PAT on the developing stage are introduced with high analytical technologies for the improvement of quality control on manufacturing process.

keywords
process analytical technology (PAT), real-time measurements, PAT applications, quality control


Reference

1

1. US FDA, http://www.fda.gov/oc/guidance/gmp.html

2

2. US FDA, http://www.fda.gov/cder/guidance/6419fnl.pdf

3

3. J.-Y. Kim, Y.-J. Park, J.-W. Yeon, Y.-A. Woo, H.-J. Kim and K. Song, Anal. Sci. Tech., 21, 345-363(2008).

4

4. L. Abboud and S. Hensley, “New Prescription for Drug Makers: Update the Plant”, The Wall Street Journal, September 3(2003).

5

5. Y.-A. Woo and H.-J. Kim, Microchem. J., 78, 167- 173(2004).

6

6. Y.-A. Woo, H.-R. Lim, H.-J. Kim and H. Chung, J. Pharm. Biomed. Anal., 33, 1049-1057(2003).

7

7. Y.-A. Woo, J.-W. Ahn, I.-K. Chun and H.-J. Kim, Anal. Chem., 73, 4964-4971(2001).

8

8. M.-S. Hwang, S.-H. Cho, H. Chung and Y.-A. Woo, J. Pharm. Biomed. Anal., 38, 210-215(2005).

9

9. M. J. Kim, H. Chung, Y.-A. Woo and M. S. Kemper, Anal. Chim. Acta., 587, 190-197(2007).

10

10. J. Kim, J. Noh, H. Chung, Y.-A. Woo, M. S. Kemper and Y. Lee, Anal. Chim. Acta., 598, 280-285(2007).

11

11. M. J. Kim, H. Chung, Y.-A. Woo and M. S. Kemper, Anal. Chim. Acta., 579, 209-216(2006).

12

12. T. Norris, P. K. Aldridge and S. S. Sekulic, Analyst, 122, 549-552(1997).

13

13. S. H. Scafi and C. Pasquini, Analyst, 126, 2218- 2224(2001).

14

14. M. Blanco and M. A. Romero, Analyst, 126, 2212- 2217(2001).

15

15. Y.-A. Woo, H.-J. Kim and J. Cho, Microchem. J., 63, 61-70(1999).

16

16. A. Candolfi, R. De Maesschalck, D. L. Massart, P. A. Hailey and A. C. E. Harrington, J. Pharm. Biomed. Anal., 19, 923-935(1999).

17

17. P. R. Khan, R. D. Jee, R. A. Watt and A. C. Moffat, J. Pharm. Sci., 3, 447-453(1997).

18

18. V. W. Uhl and J. B. Gray, “Mixing: Theory and Practice Academic Press”, New York, 1967.

19

19. E. W. Ciurczak, Pharm. Tech., 15, 140-145(1991).

20

20. D. J. Wargo and J. K. Drennen, J. Pharm. Biomed. Anal., 14, 1415-1423(1996).

21

21. C. Van der Vlies, K. J. Kaffka and W. Plugge, Pharm. Technol. Eur., 7, 46-49(1995).

22

22. P. Gemperline, G. Puxty, M. Maeder, D. Walker, F. Tarczynski and M. Bosserman, Anal. Chem., 76, 2575-2582(2004).

23

23. P. A. Hailey, P. Doherty, P. Tapsell, T. Oliver and P. K. Aldridge, J. Pharm. Biome. Anal., 14, 551-559(1996).

24

24. S. S. Sekulic, H. W. Ward, D. R. Brannegan, E. D. Stanley, C. L. Evans, S. T. Sciavolino, P. A. Hailey and P. K. Aldridge, Anal. Chem., 68, 509-513(1996).

25

25. M. Blanco, R. Gonzalez and E. Bertran, Talanta, 56, 203-212(2002).

26

26. C.-K. Lai and C. C. Cooney, J. Pharm. Sci., 93, 60- 70(2004).

27

27. Z. Shi, R. P. Cogdill, S. M. Short and C. A. Anderson, J. Pharm. Biomed. Anal., 47, 738-745(2008).

28

28. A. J. O’Neil, R. D. Jee and A. C. Moffat, Analyst, 123, 2297-2302(1998).

29

29. A. J. O’Neil, R. D. Jee and A. C. Moffat, Analyst, 128, 1326-1330(2003).

30

30. J. P. Higgins, S. M. Arrivo, G. Thurau, R. L. Green, W. Bowen, A. Lange, A. C. Templeton, D. L. Thomas and R. A. Reed, Anal. Chem., 75, 1777-1785(2003).

31

31. J. J Schwegman, L. M. Hardwick and M. J. Akers, Pharm. Dev. Technol., 10, 151-173(2005).

32

32. X. Tang and M. J. Pikal, Pharm. Res., 21, 191-200(2004).

33

33. S. C. Tsinontides, P. Rajniak, D. Pham, W. A. Hunke, J. Placek and S. D. Reynolds, Int. J. Pharm.., 280, 1- 16(2004).

34

34. W. Y. Kuu, L. M. Hardwick and M. J. Akers, Int. J. Pharm., 302, 56-67(2005).

35

35. J. A. Searles, Am Pharm. Rev., 7, 58-68(2004).

36

36. M. Fransson and S. Folestad, Chemom. Intell. Lab. Syst., 84, 56-61(2006).

37

37. S. Kawai, Drying Tech., 11, 719-731(1993).

38

38. S. Watano, H. Takashima and K. Miyanami, J. Chem. Eng. Japan., 30, 223-229(1997).

39

39. A. Y. Gore, D. W. McFarland and N. H. Batuyios, Pharm. Tech., 9, 114-122(1985).

40

40. H. Gieseler, W. J. Kessler, M. Finson, S. J Davis, P. A. Mulhall, V. Bons, D. J. Debo and M. J. Pikal, J. Pharm. Sci., 96, 1776-1793(2007).

41

41. R. L. Green, G. Thurau, N. C. Pixley, A. Mateos, R. A. Reed and J. P. Higgins, Anal. Chem., 77, 4515-4522 (2005).

42

42. J. Burgbacher and J. Wiss, Org. Proc. Res. Dev., 12, 235-242(2008).

43

43. P. F. Taday, I. V. Bradley, D. D. Arnone and M. Pepper, J. Pharm. Sci., 92, 831-838(2003).

44

44. C. J. Strachan, T. Rades, D. A. Newnham, K. C. Godron,M. Pepper and P. F. Taday, Chem. Phys. Lett., 390, 20- 24(2004).

45

45. A. J. Fitzgerald, B. E. Cole and P. F. Taday., J. Pharm. Sci., 94, 177-183(2005).

46

46. C. J. Strachan, P. F. Taday, D. A. Newnham, K. C. Gordon, J. A. Zeitler, M. Pepper and T. Rades, J. Pharm. Sci., 94, 837-846(2005).

47

47. H. Wu, E. J. Heilweil, A. S. Hussain and M. A. Khan, J. Pharm. Sci., 97, 958-971(2008).

48

48. H. Wu, E. J. Heilweil, A. S. Hussain and M. A. Khan, J. Pharm. Sci., 97, 970-984(2008).

49

49. E. N. Lewis, J. W. Schoppelrei, E. Lee, L. H. Kidder, K. A. Bakeev (Eds.), “Process Analytical Technology”, Blackwell Publishing Ltd., Oxford, UK, 187-225, 2005.

50

50. E. Lee, W. X. Huang, P. Chen, E. N. Lewis and R. V. Vivilecchia, Spectroscopy, 21, 24-33(2006).

51

51. E. N. Lewis, J. Schoppelrei and E. Lee, Spectroscopy, 19, 26-36(2004).

상단으로 이동

Analytical Science and Technology