Dissolution test as a surrogate for quality evaluation of rifampicin containing fixed dose combination formulations

International Journal of Pharmaceutics

Volumn 287, Issue 1-2, 2004, Pages 97-112

  Agrawal, Shrutidevi ^a   Panchagnula, Ramesh ^a  

^a Department of Pharmaceutics   (India)

Author keywords

Bioavailability; Bioequivalence; Dissolution; Fixed dose combination; Rifampicin; Tuberculosis

Indexed keywords

ETHAMBUTOL; ISONIAZID; PYRAZINAMIDE; RIFAMPICIN;

ARTICLE; BIOEQUIVALENCE; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; HYDRODYNAMICS; PRIORITY JOURNAL; QUALITY CONTROL; SIMULATION; STOMACH PH;

BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; HUMANS; HYDROGEN-ION CONCENTRATION; RIFAMPIN; SOLUBILITY; THERAPEUTIC EQUIVALENCY;

EID: 8444228877     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2004.09.005     Document Type: Article

References (47)

1. B. Abrahamsson, K. Roos, and J. Sjogren Investigation of prandial effects on hydrophilic matrix tablets Drug Dev. Ind. Pharm. 25 1999 765 771
2. Acocella, G., 1989. Human bioavailability studies. In: IUATLD Symposium on Quality Control of Anti-Tuberculosis Drugs, Dubrovnik, 6 October 1988, Bull. Int. Union Tuberc. Lung Dis. 64 (1989) 38-40.
3. B. Agoram, W.S. Woltosz, and M.B. Bolger Predicting the impact of physiological and biochemical processes on oral drug bioavailability Adv. Drug Deliv. Rev. 50 2001 S41 S67
4. S. Agrawal, K.J. Kaur, I. Singh, S.R. Bhade, C.L. Kaul, and R. Panchagnula Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose levels Int. J. Pharm. 233 2002 169 177
5. S. Agrawal, I. Singh, K.J. Kaur, S.R. Bhade, C.L. Kaul, and R. Panchagnula Bioequivalence assessment of rifampicin, isoniazid and pyrazinamide in a fixed dose combination of rifampicin, isoniazid, pyrazinamide and ethambutol vs. separate formulations at the same dose levels Int. J. Clin. Pharmacol. Ther. 40 2002 474 481
6. Agrawal, S., Panchagnula, R., 2004a. Implication of biopharmaceutic and pharmacokinetics of rifampicin in variable bioavailability from solid oral dosage forms. Biopharm. Drug Dispos., submitted for publication.
7. Agrawal, S., Panchagnula, R., 2004b. In vitro analysis of rifampicin and its effect on quality control tests of rifampicin containing dosage forms. Die Pharmazie, in press.
8. G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability Pharm. Res. 12 1995 413 420
9. Anonymous The promise and reality of fixed-dose combinations with rifampicin. A joint statement of the International Union Against Tuberculosis and Lung Disease and the Tuberculosis Program of World Health Organization Tuberc. Lung Dis. 75 1994 180 181
10. F. Aspesi Dissolution testing. In: IUATLD Symposium on Quality Control of Anti-Tuberculosis Drugs, Dubrovnik, 6 October 1988 Bull. Int. Union Tuberc. Lung Dis. 64 1989 37 38
11. U.V. Banakar, C.D. Lathia, and J.H. Wood Interpretation of dissolution rate data and techniques of in vivo dissolution U.V. Banakar Pharmaceutical Dissolution Testing 1992 Marcel Dekkar Inc. New York pp. 189-249
12. Blomberg, B., Evans, P., Phanouvong, S., Nunn, P., 2001. Informal consultation on 4-drug fixed dose combinations (4FDCs) compliant with the WHO model list of essential drugs. World Health Organization, Geneva, 15-17 August 2001. WHO/CDS/TB/2002.299, 2002.
13. B. Blomberg, and B. Fourie Fixed-dose combination drugs for tuberculosis: application in standardized treatment regimens Drugs 63 2003 535 553
14. BP (British Pharmacopoeia), 2002. British Pharmacopoeial Commission, London, 2431 pp.
15. J.B. Dressman, G.L. Amidon, Christos Reppas, and V.P. Shah Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms Pharm. Res. 15 1998 11 20
16. J.B. Dressman, R.R. Berardi, L.C. Dermentzoglou, T.L. Russell, S.P. Schmaltz, J.L. Barnett, and K. Jarvenpaa Upper gastrointestinal pH in young, healthy men and women Pharm. Res. 7 1990 756 761
17. FDA, 2000. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a biopharmaceutics classification system. United States Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August 2000.
18. Fourie, B., Pillai, G., McIlleron, H., Smith, P., Panchagnula, R., Ellard, G., 1999. Establishing the bioequivalence of rifampicin in fixed dose formulations containing isoniazid with or without pyrazinamide and/or ethambutol compared to single drug reference preparations administered in loose combination (Model Protocol). World Health Organization, WHO/CDS/TB/99.274.
19. W. Fox Drug combinations and the bioavailability of rifampicin Tubercle 71 1990 241 245
20. A.M. Healy, L.G. McCarthy, K.M. Gallagher, and O.I. Corrigan Sensitivity of dissolution rate to location in the paddle dissolution apparatus J. Pharm. Pharmacol. 54 2002 441 444
21. N. Katori, N. Aoyagi, and T. Terao Estimation of agitation intensity in the GI tract in humans and dogs based on in vitro/in vivo correlation Pharm. Res. 12 1995 237 243
22. H. Keberle Physicochemical factors of drugs affecting absorption, distribution and excretion Acta Pharmacol. 1970 30 47
23. M.T. Kenny, and B. Strates Metabolism and pharmacokinetics of the antibiotic rifampicin Drug Metab. Rev. 12 1981 159 218
24. S.A.H. Khalil, L.K. El-Khordagui, and Z.A. El-Gholmy Effect of antacids on oral absorption of rifampicin Int. J. Pharm. 20 1984 99 106
25. J. Kukura, P.E. Arratia, E.S. Szalai, and F.J. Muzzio Engineering tools for understanding the hydrodynamics of dissolution tests Drug Dev. Ind. Pharm. 29 2003 231 239
26. Laing, R., Fourie, B., Ellard, G., Sesay, M., Spinaci, S., Blomberg, B., Bryant, D., 1999. Fixed-dose combination tablets for the treatment of tuberculosis. Report of an informal meeting held in Geneva, 27 April 1999. World Health Organization, Geneva, WHO/CDS/CPC/TB/99.267.
27. R. Lobenberg, and G.L. Amidon Modern bioavailability and biopharmaceutics classification system. New scientific approaches to international regulatory standards Eur. J. Pharm. Biopharm. 50 2000 3 12
28. Maher, D., Chaulet, P., Spinaci, S., Harries, A.D., 1997. Treatment of tuberculosis - guidelines for national programmes. World Heath Organization, Geneva, WHO/TB/97/220.
29. P. Mannisto Absorption of rifampicin from various preparations and pharmaceutic forms Clin. Pharmacol. Ther. 21 1976 370 374
30. M.N. Martinez, and G.L. Amidon A mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals J. Clin. Pharmacol. 42 2002 620 643
31. K.M. O'connor, and O.I. Corrigan Effect of a basic organic excipient on the dissolution of diclofenac salts J. Pharm. Sci. 91 2002 2271 2281
32. R. Panchagnula, K.J. Kaur, I. Singh, and C.L. Kaul The WHO simplified study protocol in practice: investigation of combined formulations supplied by the WHO Int. J. Tuberc. Lung Dis. 3 1999 S336 S342
33. R. Panchagnula, I. Singh, K.J. Kaur, and C.L. Kaul Bioequivalence of rifampicin from two drugs fixed-dose combined formulation compared to separate formulations Methods Find. Exp. Clin. Pharmacol. 21 1999 625 628
34. R. Panchagnula, K.J. Kaur, I. Singh, and C.L. Kaul Bioequivalence of rifampicin when administered as a fixed-dose combined formulation of four drugs versus separate formulations Methods Find. Exp. Clin. Pharmacol. 22 2000 689 694
35. R. Panchagnula, and S. Agrawal Biopharmaceutic and pharmacokinetic aspects of variable bioavailability of rifampicin Int. J. Pharm. 271 2004 1 4
36. Pharmacopoeia of India (The Indian Pharmacopoeia), 1996. Indian Pharamcopoeia Committee, New Delhi, pp. 666-667.
37. B.R. Rohrs Dissolution method development for poorly soluble compounds Dissolut. Tech. 8 2001 1 5
38. A. Scholz, Abrahamsson, S.M. Diebold, E. Kostewicz, B.I. Polentarutti, A. Ungell, and J.B. Dressman Influence of hydrodynamics and particle size on the absorption of felodipine on labradors Pharm. Res. 19 2002 42 46
39. Sen, H., Jindal, K.C., Deo, K.D., Gandhi, K.T., 2002. An improved process for preparation of four-drug anti-tubercular fixed dose combination. International patent no. WO 02/087547 A1.
40. V.P. Shah, Gurbarg m, A. Noory, S. Dighe, and J.P. Skelly Influence of higher rates of agitation on release patterns of immediate release drug products J. Pharm. Sci. 81 1992 500 503
41. Supplement 1 to USP 24/NF 19, 2000. United States Pharmacopeial Convention, Rockville, MD, pp. 2655-2656.
42. Supplement 2 to USP 24/NF 19, 2000. United States Pharmacopeial Convention, Rockville, MD, pp. 2854-2855.
43. C. Tuleu, C. Andreiux, P. Boy, and J.C. Chaumeil Gastrointestinal transit of pellets in rats: effect of size and density Int. J. Pharm. 180 1999 123 131
44. USP 24/NF 18, 2000. United States Pharmacopeial Convention, Rockville, MD, pp. 1485-1487.
45. USP 25/NF 19, 2002. United States Pharmacopeial Convention, Rockville, MD, pp. 1531-1535.
46. USP 26/NF 21, 2003. United States Pharmacopeial Convention, Rockville, MD, pp. 1640, 1643-1646.
47. K.C. Waterman, and S.C. Sutton A computational model for particle size influence on drug absorption during controlled release colonic delivery J. Control Release 86 2003 293 304