Analytical challenges in the development of modified-release oral solid dosage forms: A review

Analyst

Volumn 121, Issue 10, 1996, Pages

  Bowker, Michael J ^a  

^a SANOFI   (France)

Author keywords

Dissolution testing; Modified, delayed, prolonged and extended release; Pellets and capsules; Review; Tablets

Indexed keywords

DRUG ANALYSIS; DRUG DEVELOPMENT; DRUG SOLUBILITY; MICROCAPSULE; PHARMACEUTICS; REVIEW; SUSTAINED RELEASE PREPARATION; TABLET;

EID: 0029959597     PISSN: 00032654     EISSN: None     Source Type: Journal    
DOI: 10.1039/an996210091r     Document Type: Review

References (106)

1. CPMP Working Party on Quality of Medicinal Products, Note for Guidance, Quality of Prolonged Release Oral Solid Dosage Forms, Commission of the European Communities 111/3172/91-EN.
2. United States Pharmacopoeial Convention, Pharmacopeial Forum, 1984, May-June, 4103.
3. United States Pharmacopoeial Convention, Pharmacopeial Forum, 1996, January-February, 1711.
4. Bongiovanni, G., Caramella, C., Carli, F., Gazzaniga, A., Iamartino, P., Maffione, G., and Ravelli, V., Pharm. Technol. Int., 1992, January-February, 24.
5. Leeson, L. J., and Carstensen, J. T., Dissolution Technology, Industrial Pharmaceutical Technology Section, Academy of Pharmaceutical Science, Washington, DC, 1974.
6. Hanson, W. A., Handbook of Dissolution Testing, Pharmaceutical Technology Publications, Springfield, OR, 1982.
7. Abdou, H. M., Dissolution, Bioavailability and Bioequivalence, Mack, Easton, PA, 1989.
8. Cabana, B. E., paper presented to the Proprietary Association's Research and Scientific Development Conference, New York, December 8, 1982.
9. Lee, T. Y., and Notari, R. E., Pharm. Res., 1987, 4, 311.
10. Lee, T. Y., and Notari, R. E., Pharm. Res., 1987, 4, 385.
11. Smolen, V. F., Acta Pharm. Technol., 1983, 29 (4), 313.
12. Gueurten, D., and Dubois, D. M., Pharm. Acta Helv., 1981, 56 (9-10), 296.
13. Cheung, W. K., Yacobi, A., and Silber, B. M., J. Controlled Release, 1988, 5, 263.
14. Giron, D., S.T.P. Pharma, 1988, 4, 330.
15. Moustafa, M. A., Ebian, A. R., Khalil, S. A., and Motawi, M. M., J. Pharm. Pharmacol., 1971, 23, 868.
16. Ebian, A. R., Khalil, S. A., Moustafa, M. A., and Gouda, M. W., Pharm. Acta Helv., 1979, 54, 111.
17. Ibrahim, H. G., Pisano, F., and Bruno, A., J. Pharm. Sci., 1977, 66, 669.
18. Matsunaga, J., Nambu, N., and Nagai, T., Chem. Pharm. Bull., 1976, 24, 1169.
19. Burger, A., Pharm. Ind., 1976, 38, 306.
20. Burger, A., Pharm. Ind., 1976, 38, 639.
21. Burger, A., Ramberger, R., and Schmidt, W., Pharmazie, 1981, 36, 41.
22. Conte, U., Columbo, P., Caramella, C., Bettinetti, G. P., Giordano, F., and LaManna, A., Farmaco, Ed. Pat., 1974, 30, 194.
23. Junginger, H., Pharm. Ind., 1976, 38, 388.
24. Junginger, H., Pharm. Ind., 1976, 38, 724.
25. Junginger, H., Pharm. Ind., 1977, 39, 68.
26. Pintye-Hodi, K., and Hollenbach, K., Pharmazie, 1979, 34, 807.
27. Summers, M., Enever, R., and Carless, J., J. Pharm. Pharmacol., 1976, 28, 89.
28. Kala, H., Traue, J., Haack, U., Moldenhauer, H., Kedvessy, G., and Selmeczi, B., Pharmazie, 1982, 37, 674.
29. Kala, H., Moldenhauer, H., Giese, R., Kedvessy, G., Selmeczi, B., and Pintye-Hodi, K., Pharmazie, 1981, 36, 833.
30. Chan, H. K., and Doelker, E., Drug Dev. Ind. Pharm., 1985, 11, 315.
31. Takahashi, Y., Nakashima, K., Ishihara, T., Nakagawa, H., and Sugimoto, I., Drug Dev. Ind. Pharm., 1985, 11, 1543.
32. Randall, C. S., DiNenno, B. K., Schultz, R. K., Dayter, L., Konieczny, M., and Wunder, S. L., Int. J. Pharm., 1995, 120, 235.
33. Workshop Session on Preformulation Testing, Pharmaceutical Analytical Sciences Group Meeting, Autumn 1993.
34. Wells, J. I., Pharmaceutical Preformulation, Ellis Horwood, Chichester, 2nd edn., 1993.
35. Ford, J. L., and Timmins, P., Pharmaceutical Thermal Analysis - Techniques and Applications, Ellis Horwood, Chichester, 1989, ch. 8-10.
36. Levy, G., and Procknal, J., J. Pharm. Sci., 1964, 53, 656.
37. Okkerse, E., DeLeenheer, A., and Heyndrickx, A., J. Assoc. Off. Anal. Chem., 1971, 54, 1406.
38. Nakamachi, H., Yamaoka, T., Wada, Y., and Miyaka, F., Chem. Pharm. Bull., 1982, 30, 3685.
39. ICH Topic Q2B, Validation of Analytical Methods: Methodology (Step 2, Draft 29/11/95). Note for Guidance on Validation of Analytical Methods: Methodology (CPMP/ICH/281/95), European Union, 1995.
40. Winkel, D. R., and Hendrick, S. A., J. Pharm. Sci., 1984, 73, 115.
41. Cyr, T. D., Lawrence, R. C., and Lovering, E. G., Pharm. Res., 1992, 9, 1224.
42. Thoma, K., and Heckenmueller, H., Pharmazie, 1986, 41, 328.
43. Luce, G. T., Manuf. Chem. Aerosol News, 1978, 49, 50.
44. Warren, J. W., Jr., and Rowe, E.J., Can. J. Pharm. Sci., 1975, 10, 40.
45. Fessi, H., Duchene, D., Marty, J. P., and Puisieux, F., S.T.P. Pharm. Prat., 1986, 2, 202.
46. Thoma, K., and Oschmann, R., Pharmazie, 1991, 46, 331.
47. Cordes, G., Pharm. Ind., 1969, 31, 566.
48. Thoma, K., and Heckenmueller, H., Pharmazie, 1987, 42, 837.
49. Sheen, P. C., Sabol, P. J., Alcorn, G. J., and Feld, K. M., Drug Dev. Ind. Pharm., 1992, 18, 851.
50. Everett, M. R., Medical Biochemistry, Hamish Hamilton Medical Books, New York, 1946.
51. Geigy Scientific Tables, ed. Lentner, G., Ciba-Geigy, Basle, 8th edn., 1981.
52. Wilkinson, R., Chemical Methods in Clinical Medicine, London, 1974, p. 454.
53. Wagner, J. G., Drug Intell., 1968, 2, 30.
54. Rein, H., Einf. in die Physiologie des Menschen, Berlin, 1964.
55. Hofmann, A. F., Pressman, J. H., and Code, C. F., Drug Dev. Ind. Pharm., 1983, 9, 1077.
56. Wilson, C. J., Parr, G. D., Kennerley, J. W., Taylor, M. J., Davis, S. S., Hardy, J. G., and Rees, J. A., Int. J. Pharm., 1984, 18, 1.
57. Wilson, C. G., and Washington, N., Manuf. Chem., 1985, February, 37.
58. Ashby, L. J., Beezer, A. E., and Buckton, G., Int. J. Pharm., 1989, 51, 245.
59. Buckton, G., Beezer, A. E., Chatham, S. M., and Patel, K. K., Int. J. Pharm., 1989, 56, 151.
60. El-Arini, S. K., Shiu, G. K., and Skelly, J. P., Int. J. Pharm., 1989, 55, 25.
61. Macheras, P., Koupparis, M., and Apostolelli, E., Int. J. Pharm., 1987, 36, 73.
62. Hunter, E., Fell, J. T., and Sharma, H., Drug Dev. Ind. Pharm.,1982, 8, 751.
63. Davis, S. S., Hardy, J. G., Taylor, M. J., Whalley, D. R., and Wilson, C. G., Int. J. Pharm., 1984, 21, 167.
64. Davis, S. S., Hardy, J. G., Taylor, M. J., Whalley, D. R., and Wilson, C. G., Int. J. Pharm., 1984, 21, 331.
65. May, H. A., Wilson, C. G., and Hardy, J. G., Int. J. Pharm., 1984, 19, 169.
66. Davis, S. S., Khosla, R., Wilson, C. G., Washington, N., and Malkowska, S., Int. J. Pharm., 1990, 60, 191.
67. Davis, S. S., S.T.P. Pharma, 1987, 3, 412.
68. Shah, V., Yamamoto, L. A., Schuirman, D., Elkins, J., and Skelly, J. P., Pharm. Res., 1987, 4, 416.
69. Bachiller, M., Goni Leza, M., and DeNo Lengaran, C., Farm. Clin., 1986, 3, 144.
70. Eskilson, C., Manuf. Chem., 1985, March, 33.
71. Chan, R. K., and Rudnic, E. M., Int. J. Pharm., 1991, 70, 261.
72. Sakr, A., and Oyola, J. R., Pharm. Ind., 1986, 48, 92.
73. Akbuga, J., Pharmazie, 1992, 47, 128.
74. Dahlstrom, H., and Eriksson, S., Acta Pharm. Suec., 1971, 8, 505.
75. Takenaka, U., Kawashima, Y., and Lin, S. Y., J. Pharm. Sci., 1980, 69, 1388.
76. Nixon, J. R., Jalsenjak, I., Nicolaidou, C. F., and Harris, M., Drug Dev. Ind. Pharm., 1978, 4, 117.
77. Gurny, R., Buri, P., Sucker, H., Guitard, P., and Leuenberger, H., Pharm. Acta Helv., 1977, 52, 247.
78. Juslin, M. Turakka, L., and Puumalainen, P., Pharm. Ind., 1980, 42, 829.
79. Bechgaard, H., Acta Pharm. Technol., 1982, 28, 149.
80. Bechgaard, H., and Nielsen, G. H., Drug Dev. Ind. Pharm., 1978, 4, 53.
81. Clarke, G., Newton, J. M., and Short, M. D., Int. J. Pharm., 1993, 100, 81.
82. Husson, I., Leclerc, B., Spenlehauer, G., Veillard, M., and Couarraze, G., Int. J. Pharm., 1992, 86, 113.
83. Friedman, M., Donbrow, M., and Samuelov, Y., J. Pharm. Pharmacol., 1979, 31, 396.
84. Giunchedi, P., Maggi, L., Conte, U., and Caramella, C., Int. J. Pharm., 1991, 77, 177.
85. ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products. Step 4 Document, issued October 27th, 1995; ICH Draft Harmonised Tripartite Guideline: Stability Testing: Requirements for New Dosage Forms. Step 2 Document, signed off November 29th, 1995. ICH Draft Harmonised Tripartite Guideline: Stability Testing: Photostability Testing. Step 2 Document, signed off November 29th, 1995.
86. Hoblitzell, J. R., Thakker, K. D., and Rhodes, C.T., Pharm. Acta Helv., 1985, 60, 28.
87. Thoma, K., and Oschmann, R., Pharmazie, 1992, 47, 595.
88. Dahl, T. C., and Sue, I. T., Drug Dev. Ind. Pharm., 1990, 16, 2097.
89. Murthy, K. S., and Ghebre-Sellassie, I., J. Pharm. Sci., 1993, 82, 113.
90. Dahl, T. C., Sue, I., Lan, T., and Yum, A., Pharm. Res., 1991, 8, 412.
91. Munday, D. L., and Fassihi, A. R., Drug Dev. Ind. Pharm., 1991, 17, 2135.
92. Raggi, M. A., Cavrini, V., and Di Petra, A. M., Boll. Chim. Farm., 1980, 119, 663.
93. Schwartz, J. B., and Alvino, T. P., J. Pharm. Sci., 1976, 65, 572.
94. Chowhan, Z. T., Amaro, A. A., and Chi, L. H., Drug Dev. Ind. Pharm., 1982, 8, 713.
95. Goracinova, K., and Simov, A., Pharmazie, 1992, 47, 801.
96. Canafe, K., and Duman, G., Pharmazie, 1993, 48, 935.
97. Chafetz, L., Hong, W., Tsilifonis, D. C., Taylor, A. K., and Philip, J., J. Pharm. Sci., 1984, 73, 1186.
98. Murthy, K. S., Enders, N. A., and Fawzi, M. B., Pharm. Technol., 1989, 72.
99. Cooper, J. W., Ansel, H. C., and Cadwallader, D. E., J. Pharm. Sci., 1973, 62, 1156.
100. Swarin, S. J., and Lipari, F., J. Liq. Chromatog., 1983, 6, 425.
101. Pina, E., Sousa, A. T., and Brojo, A. P., J. Liq. Chromatogr., 1995, 18, 2683.
102. Belman, S., Anal. Chim. Acta, 1963, 29, 120.
103. Hollander, V. P., Dimowro, S., and Pearson, O. H., Endocrinology, 1951, 49, 617.
104. Dempster, M. A., MacDonald, B. F., Gemperline, P. J., and Boyer, N. R., Anal. Chim. Acta, 1995, 310, 43.
105. Skelly, J. P., Yamamoto, L. A., Shah, V. P., Yau, M. K., and Barr, W. H., Drug Dev. Ind. Pharm., 1986, 12, 1159.
106. Skelly, J. P., Yau, M. K., Elkins, J. S., Yamamoto, L. A., Shah, V. P., and Barr, W. H., Drug Dev. Ind. Pharm., 1986, 12, 1117.