High-throughput analysis in support of process chemistry and formulation research and development in the pharmaceutical industry

High-Throughput Analysis in the Pharmaceutical Industry

Volumn , Issue , 2008, Pages 247-277

  Li, Zhong ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85057466980     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (230)

1. Tufts Center for the Study of Drug Development, Impact Report, May/June 2003.
2. Tufts Center for the Study of Drug Development, Impact Report, September/October 2006.
3. Dong, M, Today’s Chem., 2000, 9, 46.
4. Majors, R.E, LCGC, 2006, 19, 352.
5. Wu, N. and Clausen, A.M, J. Sep. Sci., 2007, 30, 1167.
6. Snyder, L.R., Kirkland, J.J., and Glajch, J.L, Practical HPLC Method Development, 2nd ed., 1997, John Wiley & Sons: New York, Chap. 5.
7. Ahujia, S. and Scypinski, S, Handbook of Modern Pharmaceutical Analysis, 2001, Academic Press: New York, Chap. 4.
8. Gomis, D.B. et al, Anal. Chim. Acta, 2005, 531, 105.
9. Zhu, L. et al, Anal. Chim. Acta, 2007, 584, 370.
10. Kerns, E.H. et al, J. Chromatogr. B., 2003, 791, 381.
11. Wilson, D.M. et al, Combinator. Chem. High Throughput Screen., 2001, 4, 511.
12. Wyttenbath, N. et al, Pharm. Dev. Technol., 2005, 10, 499.
13. Alsenz, J. and Kansy, M, Adv. Drug Deliv. Rev. 2007, doi:10.1016/j.addr.2007.05.007.
14. Novakova, L. and Solich, P, J. Chromatogr. A., 2005, 1088, 24.
15. Nardi, C. and Bonelli, F, Rapid Commun. Mass Spectrum., 2006, 20, 2709.
16. Jerkovich, A.D., Mellors, J.S., and Jorgenson, J.W, LCGC, 2003, 21, 600.
17. Thompson, J.W. et al, LCGC 2003, April, 16-20.
18. Wu, N., Liu, Y., and Lee, M, J. Chromatogr. A., 2006, 1131, 142.
19. Ngugen, D.T.T. et al, J. Chromatogr. A., 2006, 1128, 105.
20. Villiers, A.D. et al, J. Chromatogr. A., 2006, 1127, 60.
21. Wren, S.A.C. and Tchelitcheff, P, J. Chromatogr. A., 2006, 1119, 140.
22. Novakova, L., Matysova, L., and Solich, P, Talanta, 2006, 68, 908.
23. Jones, M.D. and Plumb R.S, J. Sep. Sci., 2006, 29, 2409.
24. Antia, F.D. and Horvath, C, J. Chromatogr., 1988, 435, 1.
25. Yan, B. et al, Anal. Chem., 2000, 72, 1253.
26. Vanhoenacker, G. and Sandra, P, J. Sep. Sci., 2006, 29, 1822.
27. Thompson, J.D. and Carr, P.W, Anal. Chem., 2002, 74, 1017.
28. Yang, Y, LCGC April 2006, 53.
29. Thompson, J.D. and Carr, P.W, Anal. Chem, 2002, 74, 4150.
30. Thompson, J.D., Brown, J.S., and Carr, P.W, Anal. Chem. 2001, 73, 3340
31. Xiang, Y., Liu, Y., and Lee, M.L, J. Chromatogr. A. 2006, 198.
32. Lestremau, F. et al, J. Chromatogr. A., 2007, 1138, 120.
33. Ikegami, T. and Tanaka, N, Current Opinion in Chemical Biology, 2004, 8, 527.
34. Svec, F. and Geiser, L, LCGC, April 2006, 22.
35. Cabrera, K, J. Sep. Sci., 2004, 27, 843.
36. McCalley, D.V, J. Sep. Sci., 2003, 26, 187.
37. Kele, M. and Guiochon, G, J. Chromatogr. A., 2002, 960, 19.
38. Wu, N. et al, Anal. Chim. Acta, 2004, 523, 149.
39. Gerber, F. et al, J. Chromatogr. A., 2004, 1036, 127.
40. McCally, D.V, J. Chromatogr. A., 2002, 965, 51.
41. Liu, Y. et al, J. Liq. Chromatogr. Rel. Technol, 2005, 28, 341.
42. Higginson, P.D. and Sach, N.W, Org. Proc. Res. Dev, 2004, 8, 1009.
43. Tzanavaras, P.D. and Themelis, D.G, J. Pharm. Biomed. Anal, 2007, 43, 1483.
44. Tzanavaras, P.D. and Themelis, D.G, J. Pharm. Biomed. Anal, 2007, 43, 1526.
45. Aboul-Enein, H.Y. et al, J. Liq. Chromatogr. Rel. Technol, 2005, 28, 1357.
46. Kirkland, J.J, J. Chromatogr. Sci., 2000, 38, 535.
47. Novakova, L., Solichova, D., and Solich, P, J. Sep. Sci, 2006, 29, 2433.
48. Guillarme, D. et al, J. Chromatogr. A., 20007, 1149, 20.
49. Bones, J., Macka, M., and Paull, B, Analyst, 2007, 132, 208.
50. Kofman, J. et al, Am. Pharm. Rev, 2006, 9, 88.
51. Cunliffe, J.M., Adams-Hall, S.B., and Maloney, T.D, J. Sep. Sci. 2007, 30, DOI 10.1002/jssc.200600524.
52. Guillarme, D. et al, Eur. J. Pharm. Biopharm, 2007, 66, 475.
53. Yang, Y. and Hodeges, C.C, LCGC 2005, May, 3.
54. Ahujia, S. and Scypinski, S, Handbook of Modern Pharmaceutical Analysis, Academic Press: New York, 2001, Chap. 3.
55. Gomis, D.B. et al, J. Liq. Chromatogr. Rel. Technol, 2006, 29, 1861.
56. Yan, B, Analysis and Purification Methods in Combinatorial Chemistry, John Wiley & Sons: New York, 2004, Chap. 12.
57. www.sepmatic.com.
58. Lemmo, A.V., Hobbs, S., and Patel, P, Assay Drug Dev. Technol., 2004, 2, 389.
59. www.eksigent.com.
60. Sajonz, P. et al, Chirality, 2006, 18, 803.
61. Sajonz, P. et al, J. Chromatogr. A., 2007, 1145, 149.
62. Welch, C.J. et al, J. Liq. Chromatogr. Rel. Technol, 2006, 29, 2185.
63. Liu, Y. et al, J. Pharm. Biomed. Anal., 2007, 43, 1654.
64. Yaku, K. and Morishita, F, J. Biochem. Biophys. Meth., 2000, 43, 59.
65. Zhang, Y. et al, Drug Dis. Today, 2005, 10, 571.
66. Mukherjee, P.S, J. Pharm. Biomed. Anal., 2007, 43, 464.
67. Alexander, A.J. and Staab, A, Anal. Chem, 2006, 78, 3835.
68. Anton, K. and Berger, C, Supercritical Fluid Chromatography with Packed Columns, Vol. 75, 1998, Marcel Dekker: New York.
69. Villeneuve, M.S. and Anderegg, R.J, J. Chromatogr. A. 2007, 1998, 826, 217.
70. Phinney, K.W, Anal. Chem. 2000, 72, 204A.
71. Garzotti, M. and Hamdan, M, J. Chromatogr. B., 2002, 770, 53.
72. Matfouh, M. et al, J. Chromatogr. A., 2005, 1088, 67.
73. White, C, J. Chromatogr. A., 2005, 1074, 163.
74. Toribio, L. et al, J. Chromatogr. A., 2005, 1091, 118.
75. Gyllenhaal, O, J. Chromatogr. A., 2004, 1042, 173.
76. Toribio, L. et al, J. Chromatogr. A., 2001, 921, 305.
77. Biba, M. et al, Am. Pharm. Rev, 2005, 8, 68.
78. Welch, C.J., Biba, M., and Sajone, P, Chirality, 2007, 19, 34.
79. Welch, C.J. et al, Chirality 19, 184.
80. Gudat, A.E. and Firor, R.L, Agilent Application Note 2006, Publication 5989-5494EN.
81. Harvey, B.A. and Barra, J, Euro. J. Pharm. Biopharm, 2003, 55, 261.
82. Xu, H. et al, J. Pharm. Biomed. Anal., 2005, 38, 225.
83. Nevado, J.J. et al, J. Pharm. Biomed. Anal., 2005, 38, 52.
84. Mitrevski, B. and Zdravkovski, Z, Forensic Sci. Int., 2005, 152, 199.
85. Li, Z., Han, Y.H., and Martin, G.P, J. Pharm. Biomed. Anal., 2002, 28, 673.
86. Li, Z. et al, J. Chromatogr. A., 2006, 1104, 1.
87. Snow, N, J. Liq. Chromatogr. Rel. Technol, 2004, 27, 1317.
88. Matisova, E. and Domotorova, M, J. Chromatogr. A., 2003, 1000, 199.
89. Korytar, P. et al, Trends Anal. Chem, 2002, 21, 558.
90. Mastovska, K. and Lehotay, S.J, J. Chromatogr. A., 2003, 1000, 153.
91. Firor, R.L, Agilent Application Note 2007, Publication 5989-6078EN.
92. Wang, C, Agilent Application Note 2007, Publication 5989-6103EN.
93. Meng, C.K, Agilent Application Note 2006, Publication 5989-6026EN.
94. Chen, T.K., Phillips, J.G., and Durr, W, J. Chromatogr. A., 1998, 811, 145.
95. Raghani, A.R, J. Pharm. Biomed. Anal., 2002, 29, 507.
96. Rocheleau, M.J., Titley, M., and Bolduc, J, J. Chromatogr. B. 2004, 805, 77-86.
97. David, F. et al, J. Sep. Sci, 2006, 29, 695.
98. Pavon, J.J.P. et al, J. Chromatogr. A., 2007, 1141, 123.
99. Pavon, J.J.P. et al, Anal. Chem., 2006, 78, 4901.
100. Gudat, A.E., Firor, R.L., and Bober, U, Agilent Application Note 2007, Publication 5989-6079EN.
101. Camilleri, P, Capillary Electrophoresis: Theory and Practice, 2nd Ed., CRC Press: Boca Raton, FL, 1997.
102. Issaq, H.J, J. Liq. Chrom. Rel. Technol, 2002, 25, 1153.
103. Wan, H. and Thompson, R.A, Drug Dis. Today, 2005, 2, 171.
104. Natishan, T.K, J. Liq. Chrom. Rel. Technol, 2005, 28, 1115.
105. Ha, P.T.T., Hoogmartens, J., and Schepdael, A.V, J. Pharm. Biomed. Anal, 2006, 41, 1.
106. Macia, A. et al, Trends Anal. Chem, 2007, 26, 133.
107. Marin, A. and Barbas, C, Pharm. Biomed. Anal, 2004, 35, 769.
108. Sung, H.H. et al, Eur. J. Pharm. Biopharm, 2006, 64, 33.
109. Liu, S. et al, Talanta, 2006, 70, 644.
110. Pang, H.M., Kenseth, J., Coldiron, S, Drug Dis. Today, 2004, 9, 1072.
111. Henry, C.S, Microchip Capillary Electrophoresis: Methods and Protocols, Humana Press, Totowa, NJ, 2006.
112. Bakeev, K.A, Process Analytical Technology, Blackwell Publishing, 2005.
113. Busaranon, K., Suntornsuk, W., and Suntornsuk, L, J. Pharm. Biomed. Anal, 2006, 41, 158.
114. Sarkar, M., Khandavilli, S., and Panchagnula, R, J. Chromtogr. B, 2006, 830, 349.
115. Gorog, S, Trends in Anal. Chem, 2007, 26, 12.
116. Amin, A.S. et al, Spectrochim. Acta A, in press.
117. El-Shabrawy, Y. et al, Il Farmaco, 2003, 58, 1033.
118. Sultan, M, Il Farmaco, 2002, 57, 865.
119. Abdine, H., Belal, F., and Zoman, N, Il Farmaco, 2002, 57, 267.
120. Al-Ghanam, S.M. and Belal, F, Il Farmaco, 2001, 56, 677.
121. Belal, F., Al-Zaagi, I.A., and Abounassif, M.A, Il Farmaco, 2000, 55, 425.
122. Erk, N, Il Farmaco, 2003, 58, 1209.
123. Bonsái, D. et al, J. Pharm. Biomed. Anal., 1997, 16, 431.
124. Ozaltin, N. and Kocer, A, J. Pharm. Biomed. Anal., 1997, 16, 337.
125. Fattah, A. and Walily, M.E, J. Pharm. Biomed. Anal., 1997, 16, 21.
126. Vignaduzzo, S. et al, Anal. Bioanal. Chem, 2006, 386, 2239.
127. Ni, Y., Qi, Z., and Kokot, S, Chemom. Intell. Lab. Syst, 2006, 82, 241.
128. Boeris, M.S., Luco, J.M., and Olsina, R.A, J. Pharm. Biomed. Anal., 2000, 24, 259.
129. Canafa, M.J. et al, Talanta, 1999, 49, 691.
130. Bernal, J.L. et al, J. Chromatgr. A., 1998, 823, 423.
131. Blanco, M. et al, J. Pharm. Biomed. Anal., 1996, 15, 329.
132. Salari, A., Young, R. E, Int. J. Pharm, 1998, 163, 157.
133. Helmy, R. et al, Anal. Chem, 2003, 75, 605.
134. Dohi, K., Kaneko, F., and Kawaguchi, T.J, Crystal Growth 2002, 237-239, 2227.
135. Bunaciu, A.A., Aboul-Enein, H.Y., and Fleschin, S, Il Farmaco, 2005, 60, 685.
136. Bunaciu, A.A., Aboul-Enein, H.Y., and Fleschin, S, Il Farmaco, 2005, 60, 33.
137. Boyer, C. et al, J. Pharm. Biomed. Anal., 2006, 40, 433.
138. Pan, L., LoBrutto, R., and Zhou, G, Talanta, 2006, 70, 661.
139. Friebe, A. and Siesler, H.W, Vibrational Spec., 2007, 43, 217.
140. Masmoudi, H. et al, Int. J. Pharm, 2005, 289, 117.
141. Perston, B.B. et al, Anal. Chem, 2007, 79, 1231.
142. Chan, K.L.A. et al, Vibrational Spec., 2007, 43, 221.
143. Chan, K.L.A. and Kazarian, S.G, Vibrational Spec., 2006, 42, 130.
144. Chan, K.L.A. and Kazarian, S.G, J. Comb. Chem, 2006, 8, 26.
145. Chan, K.L.A. and Kazarian, S.G, J. Comb. Chem, 2005, 7, 185.
146. Ciurczak, E.W. and Drennen, J.K. III, Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy, Marcel Dekker: New York, 2002.
147. Reich, G, Adv. Drug. Deliv. Rev, 2005, 57, 1109.
148. Luypaert, J., Massart, D.L., and Heyden, Y.V, Talanta, 2007, 72, 865.
149. Lee, E. et al, Spectroscopy, 2006, 21, 24.
150. Feng, Y.C. and Hu, C.Q, J. Pharm. Biomed. Anal., 2006, 41, 373.
151. John, C.T. and Pixley, N.C, Am. Pharm. Rev. 2007, January/February, 120.
152. Blanco, M. and Alcala, M, Anal. Chim. Acta, 2006, 557, 353.
153. Bodson, C. et al, J. Pharm. Biomed. Anal., 2006, 41, 783.
154. Zhao, L. et al, Spectrochim. Acta A, 2007, 66, 1327.
155. Chalmers, J. and Griffiths, P.R, Handbook of Vibrational Spectroscopy, Vols. 1-5, John Wiley & Sons: Chichester, 2001.
156. Schrader, B, Infrared and Raman Spectroscopy: Methods and Applications, VCH: Weinheim, 1995.
157. Waterwig, S. and Neubert, R.H.H, Adv. Drug Delivery Rev, 2005, 57, 1144.
158. Baeyens, W., Verpoort, F., and Vergote, G, Trends Anal. Chem, 2002, 21, 8697.
159. Kim, M. et al, Anal. Chim. Acta, 2007, 587, 200.
160. Mazurek, S. and Szostak, R, J. Pharm. Biomed. Anal., 2006, 40, 1235.
161. DeBeer, T.R.M. et al, Anal. Chim. Acta 2007, 192.
162. DeBeer, T.R.M. et al, Eur. J. Pharm. Sci, 2004, 23, 355.
163. DeBeer, T.R.M. et al, Eur. J. Pharm. Sci, 2007, 30, 229.
164. Dennis, A.C. et al, Int. J. Pharm., 2004, 279, 43.
165. Cantu, R. et al, Am. Pharm. Rev. 2007, 96.
166. Karabas, I., Orkoula, M.G., and Kontoyannis, C.G, Talanta, 2007, 71, 1382.
167. Kauffman, J.F., Dellibovi, M., and Cunningham, C.R, J. Pharm. Biomed. Anal., 2007, 43, 39.
168. Kim, M. et al, Anal. Chim. Acta, 2006, 579, 209.
169. Mazurek, S. and Szostak, R, J. Pharm. Biomed. Anal., 2006, 40, 1225.
170. Johansson, J., Pettersson, S., and Folestad, S, J. Pharm. Biomed. Anal., 2005, 39, 510.
171. Szostak, R. and Mazurek, S, J. Mol. Struct., 2004, 704, 229.
172. Lowry, S. et al, JALA 2006, April, 75.
173. Kojima, T. et al, Pharm. Res., 2006, 23, 806.
174. Gamberini, M.C. et al, J. Mol. Struct., 2006, 785, 216.
175. Morlock, G. and Ueda, Y, J. Chromatogr. A, 2007, 1143, 243.
176. Ricci, C. et al, Anal. Bioanal. Chem, 2007, 387, 551.
177. Williams, J.P. et al, Rapid Commun. Mass Spectrom, 2006, 20, 1447.
178. Leuthod, L.A. et al, Rapid Commun. Mass Spectrom, 2006, 20, 103.
179. Chen, H. et al, Anal. Chem, 2005, 77, 6915.
180. Shamsipur, M. et al, J. Pharm. Biomed. Anal., 2007, 43, 1116.
181. Salem, A.A., Mossa, H.A., and Barsoum, B.N, J. Pharm. Biomed. Anal., 2006, 41, 654.
182. Wawer, I., Pisklak, M., and Chilmonczyk, Z, J. Pharm. Biomed. Anal., 2005, 38, 865.
183. Zoppi, A., Linares, M., and Longhi, M, J. Pharm. Biomed. Anal., 2005, 37, 627.
184. Fardella, G. et al, Int. J. Pharm, 1995, 121, 123.
185. Hanna, G.M. and Lau-Cam, C.A, J. Pharm. Biomed. Anal., 1993, 11, 855.
186. Kwakye, J.K, Talanta, 1985, 32, 1069.
187. Berendt, R.T. et al, Trends Anal. Chem, 2006, 25, 977.
188. Nelson, B.N., Schieber, L.J., and Munson, E.J, Solid State Nuclear Magnetic Resonance, 2006, 29, 204.
189. Rao, R.N. and Talluri, M, J. Pharm. Biomed. Anal., 2007, 43, 1.
190. Huang, J. et al, J. Pharm. Biomed. Anal., 2006, 40, 227.
191. Zachariadis, G.A. and Michos, C.E, J. Pharm. Biomed. Anal., 2007, 43, 951.
192. Wang, L., Marley, M., and Bahnck, C, J. Pharm. Biomed. Anal., 2003, 33, 955.
193. Lam, R. and Salin, E, J. Anal. At. Spectrom, 2004, 19, 938.
194. Wang, T., Wu, J., and Egan, R.S, J. Pharm. Biomed. Anal., 2000, 23, 867.
195. Lewen, N. et al, J. Pharm. Biomed. Anal., 2004, 35, 739.
196. Wang, T., Jia, X., and We, J, J. Pharm. Biomed. Anal., 2003, 33, 639.
197. Zachariadis, G.A. and Kapsimali, D.C, J. Pharm. Biomed. Anal., 2006, 41, 1212.
198. Vukovic, J., Matsuoka, S., and Zupanic, O, Talanta, 2007, 71, 2085.
199. St-Onge, L. et al, J. Pharm. Biomed. Anal., 2004, 36, 277.
200. St-Onge, L. et al, Spectrochim. Acta B, 2002, 57, 1131.
201. Moreira, A.B. et al, Anal. Chim. Acta, 2005, 539, 257.
202. Moreira, A.B., Dias, I.L.T., and Kubota, L.T, Anal. Chim.Acta, 2004, 523, 49.
203. Pulgarin, J.A.M., Bermejo, L.F.G., and Lara, J.L.G, Anal. Chim. Acta, 2003, 495, 249.
204. Gotardo, M.A. et al, Talanta, 2004, 64, 361.
205. Dehring, K.A. et al, J. Pharm. Biomed. Anal., 2004, 36, 447.
206. Sugano, K., Kato, T., and Mano, T, J. Pharm. Sci, 2006, 95, 2115.
207. Tinke, A.P., Vanhoutte, K., and Winter, H.D, Int. J. Pharm, 2005, 297, 80.
208. Hansen, E.H. and Wang, J, Anal. Lett, 2004, 37, 345.
209. Hansen, E.H. and Miro, M, Trends in Anal. Chem, 2007, 26, 18.
210. Economou, A, Trends in Anal. Chem, 2005, 24, 416.
211. Wang, J. and Hansen, E.H, Trends Anal. Chem, 2003, 22, 225.
212. Chocholous, P., Solich, P., and Satinsky, D, Anal. Chim. Acta 2007, doi:10.1016/j.aca.2007.02.018.
213. Tzanavaras, P.D. and Themelis, D.G, Anal. Chim. Acta, 2007, 588, 1.
214. Calatayud, J.M. In Automation in the Laboratory, Taylor & Francis: London, 1996.
215. Evgenev, M.I., Garmonov, S.Y., and Shakirova, L.S, J. Anal. Chem, 2001, 56, 313.
216. Pimenta, A.M. et al, J. Pharm. Biomed. Anal., 2006, 40, 16.
217. Solich, P. et al, Trends Anal. Chem, 2003, 22, 116.
218. Valcarcel, M., de Castro, M.D.L., and Tena, M.T, Anal. Proc, 1993, 30, 276.
219. Fligge, T.A. and Schuler, A, J. Pharm. Biomed. Anal., 2006, 42, 449.
220. Tan, H. et al, JALA, 2005, 10, 364.
221. Dai, W.G., Dong, L.C., and Eichenbaum, G, Int. J. Pharm. 2006, doi:10.1016/j.ijpharm.2006.11.034.
222. Carlson, E. et al, JALA, 2005, 10, 374.
223. Banakar, U.V, Pharmaceutical Dissolution Testing, 1991, Taylor & Francis: London, Chap. 4.
224. Dressman, J. and Kramer, J, Pharmaceutical Dissolution Testing, 2005, Taylor & Francis: London, Chap. 13.
225. Rolli, R, J. Automated Meth. Mgt. Chem., 2003, 25, 7.
226. Lu, X., Lozano, R., and Shah, P, Dis. Technol., 2003, 11, 6.
227. Bohets, H., Vanhoutte, K., and Nagels, L.J, Anal. Chim. Acta, 2007, 581, 181.
228. Wu, J., Yang, M., and Chen, J, Spectros. Spec. Anal., 2006, 26, 1761.
229. Wiberg, K.H. and Hultin, U.K, Anal. Chem., 2006, 78, 5076.
230. Fortunato, D, Pharm. Tech., 2006, 30, 116.