Methodology for the Evaluation of Chemical and Physical Interactions Between Drug Substances and Excipients

Preformulation in Solid Dosage Form Development

Volumn , Issue , 2008, Pages 437-476

  Brittain, Harry G ^a  

^a Center for Pharmaceutical Physics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84863727596     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9780849360862-18     Document Type: Chapter

References (155)

1. Cazes J. Ewing’s Analytical Instrumentation Handbook. 3rd ed. New York: Marcel Dekker, 2005.
2. Ahuja S, Scypinski S. Handbook of Modern Pharmaceutical Analysis. San Diego: Academic Press, 2001.
3. Ahuja S. Impurities Evaluation of Pharmaceuticals. New York: Marcel Dekker, 1998.
4. Ahuja S, Alsante KM. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. Amsterdam: Academic-Elsevier Press, 2003.
5. Karger BL, Snyder LR, Horvath C. An Introduction to Separation Science. New York: John Wiley & Sons, 1973.
6. Wilson I, Poole C, Cooke M. Encyclopedia of Separation Science. Vol. 1-10. Amsterdam: Elsevier Press, 2000.
7. Poole CF, Schuette SA. Contemporary Practice of Chromatography. Amsterdam: Elsevier Press, 1984.
8. Poole CF, Poole SK. Chromatography Today. Amsterdam: Elsevier Press, 1991.
9. Giddings JC. Unified Separation Science. New York: John Wiley & Sons, 1991.
10. Scott RPW. Techniques and Practice of Chromatography. New York: Marcel Dekker, 1995.
11. Heftmann E. Chromatography. 6th ed. Amsterdam: Elsevier Press, 2004.
12. Miller JM. Chromatography: Concepts and Contrasts. 2nd ed. New York: John Wiley & Sons, 2005.
13. Stahl E. Thin-Layer Chromatography-A Laboratory Handbook. Berlin: Springer-Verlag, 1965.
14. Kirchner JG. Thin-Layer Chromatography. New York: Wiley-Interscience, 1976.
15. Touchstone JC, Rodgers D. Thin-Layer Chromatography-Quantitative Environmental and Clinical Applications. New York: Wiley-Interscience, 1980.
16. Geiss F. Fundamentals of Thin Layer Chromatography. Heidelberg: Verlag, 1987.
17. Fried B, Sherma J. Thin-Layer Chromatography. 4th ed. New York: Marcel Dekker, 1999.
18. Hahn-Deinstrop E. Applied Thin-Layer Chromatography. Weinheim: Wiley-VCH, 2000.
19. Sherma J. Thin layer chromatography. In: Cazes J, ed. Ewing’s Analytical Instrumentation Handbook. 3rd ed. New York: Marcel Dekker, 2005: 995-1014.
20. Brittain HG. Nalmefene hydrochloride. In: Brittain HG, ed. Analytical Profiles of Drug Substances and Excipients. Vol. 24. San Diego: Academic Press, 1996:351-95.
21. Kalatzis E. J Pharm Sci 1970; 59:193-6.
22. McErland KM, Wood RJ, Matsui F, Lovering EG. J Pharm Sci 1978; 67: 958-61.
23. Vladimirov S, Fiser Z, Agbaba D, Zivanov-Stakic D. J Pharm Biomed Anal 1995; 13:675-8.
24. Patravale VB, Nair VB, Gore SP. J Pharm Biomed Anal 2000; 23:623-7.
25. Thoppil SO, Cardoza RM, Amin PD. J Pharm Biomed Anal 2001; 25:15-20.
26. Argekar AP, Powar SG. J Pharm Biomed Anal 2000; 21:1137-42.
27. Gorman PM, Jiang H. Isolation methods I: thin-layer chromatography. In: Ahuja S, Alsante KM, eds. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. Amsterdam: Academic-Elsevier Press, 2003: 203-30.
28. Scott RPW. Instrumentation for high-performance liquid chromatography. In: Cazes J, ed. Ewing’s Analytical Instrumentation Handbook. 3rd ed. New York: Marcel Dekker, 2005:687-726.
29. Simpson CF. Practical High Performance Liquid Chromatography. London: Heyden & Son Ltd., 1976.
30. Kucera P. Microcolumn High Performance Liquid Chromatography. Amsterdam: Elsevier Press, 1984.
31. Poppe H. Instrumentation for High Performance Liquid Chromatography. Amsterdam: Elsevier Press, 1978.
32. Kirkland JJ. Modern Practice of Chromatography. New York: John Wiley & Sons, 1971.
33. Browen PR, Hartwick RA. High Performance Liquid Chromatography. New York: John Wiley & Sons, 1989.
34. Meyer VR. Practical High Performance Liquid Chromatography. 3rd ed. Chichester: John Wiley & Sons, 2000.
35. Snyder LR, Kirkland JJ. Introduction to Modern Liquid Chromatography. New York: John Wiley & Sons, 2000.
36. Berridge JC. Techniques for the Automated Optimization of HPLC Separations. New York: John Wiley & Sons, 1985.
37. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC Method Development. 2nd ed. New York: John Wiley & Sons, 1997.
38. Scott RPW. Small Bore Liquid Chromatography Columns. New York: John Wiley & Sons, 1984.
39. Scott RPW. Silica Gel and Bonded Phases. New York: John Wiley & Sons, 1993.
40. Neue UD. HPLC Columns: Theory, Technology, and Practice. New York: Wiley-VCH, 1997.
41. Sadek PC. The HPLC Solvent Guide. New York: John Wiley & Sons, 1996.
42. Smallwood IM. Handbook of Organic Solvent Properties. New York: Halsted Press, 1996.
43. Brown AC, Wallace DL, Burce GL, Mathes S. Liquid Chromatography Detectors. New York: Basel-Kong, 1983.
44. Parriott D. A Practical Guide to HPLC Detection. San Diego: Academic Press, 1993.
45. Xu QA, Trissel LA. Stability-Indicating HPLC Methods for Drug Analysis. London: Pharmaceutical Press, 2003.
46. Lunn G. HPLC Methods for Recently Approved Pharmaceuticals. New York: Wiley-Interscience, 2005.
47. Bergna HE. J Chromatogr 1991; 549:1.
48. Shoenmakers PJ, Billiet HAH, de Galan L. J Chromatogr 1979; 185:179; 1981; 218:259.
49. King B, Grahm GS. Handbook of Derivatives for Chromatography. Philadelphia: Heyden Press, 1979.
50. Wirth DD, Baertschi SW, Johnson RA, et al. J Pharm Sci 1998; 87:31-9.
51. Lessen T, Zhao DC. J Pharm Sci 1996; 85:326-9.
52. Serrajuddin ATM, Thakur AB, Ghoshal RN, et al. J Pharm Sci 1999; 88: 696-704.
53. Tambwekar KR, Kakariya RB, Garg S. J Pharm Biomed Anal 2003; 32: 441-50.
54. Verma RK, Garg S. J Pharm Biomed Anal 2002; 30:583-91.
55. Shao Y, Alluri R, Mummert M, Koetter U, Lech S. J Pharm Biomed Anal 2004; 35:625-31.
56. Malan CEP, de Villiers MM, Ltter AP. J Pharm Biomed Anal 1997; 15: 549-57.
57. Malan CEP, de Villiers MM, Ltter AP. Drug Dev Indust Pharm 1997; 23: 533-7.
58. Ceshel GC, Badiello R, Ronchi C, Maffei P. J Pharm Biomed Anal 2003; 32: 1067-72.
59. Verma RK, Garg S. J Pharm Biomed Anal 2005; 38:633-44.
60. Kibbey CE, Poole SK, Robinson B, Jackson JD, Durham D. J Pharm Sci 2001; 90:1164-75.
61. Brinkman UATh. Hyphenation: Hype and Fascination. Amsterdam: Elsevier, 1999.
62. Burninsky DJ, Wang F. Mass spectral characterization. In: Ahuja S, Alsante KM, eds. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. Amsterdam: Academic-Elsevier Press, 2003:249-99.
63. Armentrout PB. The Encyclopedia of Mass Spectrometry. Vol. 1. Theory and Ion Chemistry. Amsterdam: Elsevier, 2003.
64. Gross ML. The Encyclopedia of Mass Spectrometry. Vol. 2. Biological Applications Part A. Amsterdam: Elsevier, 2004.
65. Caprioli RM. The Encyclopedia of Mass Spectrometry. Vol. 3. Biological Applications Part B. Amsterdam: Elsevier, 2004.
66. Nibbering N. The Encyclopedia of Mass Spectrometry. Vol. 4. Fundamentals of and Applications to Organic (and Organometallic) Compounds. Amsterdam: Elsevier, 2005.
67. Shalliker RA, Gray MJ. HPLC-hyphenated techniques. In: Cazes J, ed. Ewing’s Analytical Instrumentation Handbook. 3rd ed. New York: Marcel Dekker, 2005:945-94.
68. Yu LR, Conrads TP, Veenstra TD. Mass spectrometry instrumentation. In: Cazes J, ed. Ewing’s Analytical Instrumentation Handbook. 3rd ed. New York: Marcel Dekker, 2005:429-43.
69. Niessen WMA, van der Greef J. Liquid Chromatography-Mass Spectrometry. New York: Marcel Dekker, 1992.
70. Chowdhury S. Identification and Quantification of Drugs, Metabolites, and Metabolizing Enzymes by LC-MS. Amsterdam: Elsevier, 2005.
71. Niessen WMA. Liquid Chromatography-Mass Spectrometry. 3rd ed. New York: Taylor & Francis, 2006.
72. Cappiello A. Advances in LC-MS Instrumentation. Amsterdam: Elsevier, 2007.
73. Yu Y, Hwang TL, Algayer K, et al. J Pharm Biomed Anal 2003; 33: 999-1015.
74. Lovdahl MJ, Hurley TR, Tobias B, Priebe SR. J Pharm Biomed Anal 2002; 28:917-24.
75. Brittain HG, Bogdanowich SJ, Bugay DE, DeVincentis J, Lewen G, Newman AW. Pharm Res 1991; 8:963-73.
76. Brittain HG. Physical Characterization of Pharmaceutical Solids. New York: Marcel Dekker, 1995.
77. Robertson JM. Organic Crystals and Molecules. Ithaca: Cornell University Press, 1953.
78. Kitaigorodskii AI. Organic Chemical Crystallography. New York: Consultants Bureau, 1957.
79. Stout GH, Jensen LH. X-Ray Structure Determination: A Practical Guide. New York: Macmillan Co., 1968.
80. Woolfson MM. X-Ray Crystallography. Cambridge: Cambridge University Press, 1970.
81. Rousseau JJ. Basic Crystallography. Chichester: John-Wiley & Sons, 1998.
82. Krawitz AD. Introduction to Diffraction in Materials Science and Engineering. New York: John Wiley & Sons, 2001.
83. Cullity BD, Stock SR. Elements of X-ray Diffraction. 3rd ed. New York: Prentice-Hall, 2001.
84. Suryanarayanan R. X-ray powder diffractometry. In: Brittain HG, ed. Physical Characterization of Pharmaceutical Solids. New York: Marcel Dekker, 1995:187-221.
85. Brittain HG. X-ray diffraction of pharmaceutical materials. In: Brittain HG, ed. Profiles of Drug Substances, Excipients, and Related Methodology. Amsterdam: Elsevier Academic Press, 2003:273-319.
86. Klug HP, Alexander LE. X-Ray Diffraction Procedures for Polycrystalline and Amorphous Materials. 2nd ed. New York: Wiley-Interscience, 1974.
87. Chung FH, Smith DK. Basic Industrial Applications of X-Ray Diffraction. New York: Marcel Dekker, 2000.
88. Roy S, Alexander KS, Riga AT, Chatterjee K. J Pharm Sci 2003; 92:747-59.
89. Yamada T, Saito N, Anraku M, Imai T, Otagiri M. Pharm Dev Tech 2000; 5:443-54.
90. Airaksinen S, Luukkonen P, Jørgensen A, Karjalainen M, Rantanen J, Yliruusi J. J Pharm Sci 2003; 92:516-28.
91. Martinez-Oharriz MC, Martin C, Goni MM, Rodrigues-Espinosa C, Tros-Ilarduya MC, Zornoza A. Eur J Pharm Sci 1999; 8:127-32.
92. Mirza S, Deinamaki J, Miroshnyk I, et al. J Pharm Sci 2006; 95:1723-32.
93. Ford JL, Timmins P. Pharmaceutical Thermal Analysis. Chichester: Ellis Horwood, 1989.
94. McCauley JA, Brittain HG. Thermal methods of analysis. In: Brittain HG, ed. Physical Characterization of Pharmaceutical Solids. New York: Marcel Dekker, 1995:223-51.
95. Craig DQM, Reading M. Thermal Analysis of Pharmaceuticals. Boca Raton: CRC Press, 2007.
96. Giron D. J Pharm Biomed Anal 1986; 4:755-70.
97. Wendlandt WW. Thermal Analysis. 3rd ed. New York: John Wiley & Sons, 1986.
98. Wells JI. Pharmaceutical Preformulation: The Physicochemical Properties of Drug Substances. New York: Halsted Press, 1988.
99. Pope MI, Judd MD. Introduction to Differential Thermal Analysis. London: Heyden, 1977.
100. Brown ME. Introduction to Thermal Analysis: Techniques and Applications. New York: Chapman and Hall, 1998.
101. Alexander KS, Riga AT, Haines PJ. Thermoanalytical instrumentation and applications. In: Cazes J, ed. Ewing’s Analytical Instrumentation Handbook. 3rd ed. New York: Marcel Dekker, 2005:445-507.
102. Keattch CJ, Dollimore D. Introduction to Thermogravimetry. 2nd ed. London: Heyden, 1975.
103. Ford JL, Francomb MM. Drug Dev Indust Pharm 1985; 11:1111-22.
104. Durig T, Fassihi AR. Int J Pharm 1993; 97:161-70.
105. Tomassetti M, Catalani A, Rossi V, Vecchio S. J Pharm Biomed Anal 2005; 37:949-55.
106. Mura P, Manderioli A, Bramanti G, Furlanetto S, Pinzauti S. Int J Pharm 1995; 119:71-9.
107. Mura P, Bettinetti GP, Faucci MT, Manderioli A, Parrini PL. Thermochim Acta 1998; 321:59-65.
108. Mura P, Faucci MT, Manderioli A, Furlanetto S, Pinzauti S. Drug Dev Indust Pharm 1998; 24:747-56.
109. Mura P, Faucci MT, Manderioli A, Bramanti G, Ceccarelli L. J Pharm Biomed Anal 1998; 18:151-63.
110. Brittain HG. Molecular motion and vibrational spectroscopy. In: Brittain HG, ed. Spectroscopy of Pharmaceutical Solids. New York: Taylor and Francis, 2006:205-33.
111. Herzberg G. Infrared and Raman Spectra of Polyatomic Molecules. New York, NY: Van Nostrand Reinhold Co., 1945.
112. Herzberg G. Spectra of Diatomic Molecules. 2nd ed. New York, NY: Van Nostrand Reinhold Co., 1950.
113. Pauling L, Wilson EB. Introduction to Quantum Mechanics. New York: McGraw-Hill, 1935.
114. Eyring H, Walter J, Kimball GE. Quantum Chemistry. New York: John Wiley & Sons, 1944.
115. Kauzmann W. Quantum Chemistry. New York: Academic Press, 1957.
116. Davis JC. Advanced Physical Chemistry. New York: Ronald Press, 1965.
117. Levine IN. Quantum Chemistry. Boston: Allyn and Bacon, 1970.
118. Hanna MW. Quantum Mechanics in Chemistry. Menlo Park: Benjamin/Cummings, 1981.
119. Barrow GM. Molecular Spectroscopy. New York: McGraw-Hill, 1962.
120. King GW. Spectroscopy and Molecular Structure. New York: Holt, Rinehart and Winston, 1964.
121. Brittain EFH, George WO, Wells CHJ. Introduction to Molecular Spectroscopy. London: Academic Press, 1970.
122. Guillory WA. Introduction to Molecular Structure and Spectroscopy. Boston: Allyn and Bacon, 1977.
123. McHale JL. Molecular Spectroscopy. Upper Saddle River, NJ: Prentice Hall, 1999.
124. Rao CNR. Chemical Applications of Infrared Spectroscopy. New York: Academic Press, 1963.
125. Kendall DN. Applied Infrared Spectroscopy. New York: Reinhold Pub, 1966.
126. Conley RT. Infrared Spectroscopy. Boston, MA: Allyn and Bacon, 1966.
127. Colthup NB, Daly LH, Wiberley SE. Introduction to Infrared and Raman Spectroscopy. 2nd ed. London: Academic Press, 1975.
128. Nakanishi K, Solomon PH. Infrared Absorption Spectroscopy. San Francisco, CA: Holden-Day, 1977.
129. Bhagavantam S. Scattering of Light and the Raman Effect. New York: Chemical Publishing Co., 1942.
130. Grasselli JG, Snavely MK, Bulkin BJ. Chemical Applications of Raman Spectroscopy. New York: Wiley-Interscience, 1981.
131. Grasselli JG, Bulkin BJ. Analytical Raman Spectroscopy. New York: John Wiley & Sons, 1991.
132. Ferraro JR, Nakamoto K. Introductory Raman Spectroscopy. New York: Academic Press, 1994.
133. Lewis IR, Edwards HGM. Handbook of Raman Spectroscopy. New York: Marcel Dekker, 2001.
134. Wilson EB, Decius JC, Cross PC. Molecular Vibrations: The Theory of Infrared and Raman Vibrational Spectra. New York: McGraw-Hill Book Co., 1955.
135. Fredericks P, Rintoul L, Coates J. Vibrational spectroscopy: instrumentation for infrared and Raman spectroscopy. In: Cazes J, ed. Ewing’s Analytical Instrumentation Handbook. 3rd ed. New York: Marcel Dekker, 2005: 163-238.
136. Markovich RJ, Pidgeon C. Pharm Res 1991; 8:663-75.
137. Bugay DE, Williams AC. Vibrational spectroscopy. In: Brittain HG, ed. Physical Characterization of Pharmaceutical Solids. New York: Marcel Dekker, 1995:59-91.
138. Brittain HG. J Pharm Sci 1997; 86:405-12.
139. Bugay DE, Brittain HG. Infrared absorption spectroscopy. In: Brittain HG, ed. Spectroscopy of Pharmaceutical Solids. New York: Taylor and Francis, 2006:235-69.
140. Pivonka DE, Chalmers JM, Griffiths PR. Applications of Vibrational Spectroscopy in Pharmaceutical Research and Development. New York: Wiley, 2007.
141. Bugay DE, Brittain HG. Raman spectroscopy. In: Brittain HG, ed. Spectroscopy of Pharmaceutical Solids. New York: Taylor and Francis, 2006:271-312.
142. Bugay DE, Findlay WP. Pharmaceutical Excipients: Characterization by IR, Raman, and NMR Spectroscopy. New York: Marcel Dekker, 1999.
143. Taylor LS, Langkilde FW. J Pharm Sci 2000; 89:1342-53.
144. Sarisuta N, Kumpugdee M, Müller BW, Puttipipatkhachorn S. Int J Pharm 1999; 186:109-18.
145. Hartauer KJ, Guillory JK. Drug Dev Indust Pharm 1991; 17:617-30.
146. Sekizake H, Danjo K, Eguchi H, Yonezawa Y, Sumada H, Otsuka A. Chem Pharm Bull 1995; 43:988-93.
147. Taylor LS, Zografi G. Pharm Res 1997; 14:1691-8.
148. Martinez-Oharriz MC, Rodriguez-Espinosa C, Martin C, Goni MM, Tros-Ilarduya MC, Sanchez M. Drug Dev Indust Pharm 2002; 28:717-25.
149. Joshi DV, Patil VB, Pokharkar VB. Drug Dev Indust Pharm 2002; 28: 687-94.
150. Riley CM, Rosanske TW. Development and Validation of Analytical Methods. Oxford: Pergamon-Elsevier, 1996.
151. Swartz M, Krull IS. Analytical Method Development and Validation. New York: Taylor & Francis, 1997.
152. Miller JM, Crowther JB. Analytical Chemistry in a GMP Environment. New York: John Wiley & Sons, 2000.
153. Chan CC, Lam H, Lee YC, Zhang XM. Analytical Method Validation and Instrument Performance Verification. New York: John Wiley & Sons, 2004.
154. Bliesner DM. Validating Chromatographic Methods. New York: John Wiley & Sons, 2006.
155. United States Pharmacopoeia: General Test < 1225 >, Validation of Compendial Procedures. United States Pharmacopoeia. 30th ed. Vol. 1. United States Pharmacopoeial Convention, Rockville, MD, 2007:680-3.