Dr. Panchagnula and his research team are deeply grateful to the late Dr. Gordon A Ellard for his indispensable support and encouragement. The valuable assistance provided by Inderjit Singh, Kanwaljit Kaur and Shantaram Bhade during bioequivalence trials conducted at NIPER is acknowledged. The authors acknowledge with thanks the Global Drug Facility for providing an opportunity to compile this article.
1 WHO. The economic impacts of tuberculosis, Ministerial conference, Amsterdam 22-24 March 2000. Geneva: World Health Organization; 2000. WHO/CDS/STB/2000.5.
2 Raviglione MC, Sinder DE Jr, Kochi A. Global epidemiology of tuberculosis. Morbidity and mortality of a worldwide epidemic. JAMA, 1995;273 220-226.
3 WHO. WHO Report 2003, Global Tuberculosis Control. Surveillance, Planning, Financing. Geneva: World Health Organization; 2003a. WHO/CDS/TB/2003.316.
4 Espinal MA. The global situation of MDR-TB. Tuberculosis, 2003;48:44-51. 5 Fox W. Drug combinations and the bioavailability of rifampicin. Tubercle, 1990a;71:241-245.
6 Fox W. Tuberculosis in India, past, present and future. Ind J Tuberc, 1990b;37:175-213.
7 Fox W, Ellard GA, Mitchison DA. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council Tuberculosis Units, 1946-1986, with relevant subsequent publications. Int J Tuberc Lung Dis, 1999;3:S231-S279.
8 Blomberg B, Fourie B. Fixed-dose combination drugs for tuberculosis: application in standardized treatment regimens. Drugs, 2003;63:535-553.
9 Maher D, Chaulet P, Spinaci S, Harries AD. Treatment of tuberculosis guidelines - for national programmes. Geneva: World Heath Organization; 1997. WHO/TB/97/220.
10 Douglas JG, McLeod M. Pharmacokinetic factors in the modern drug treatment of tuberculosis. Clin Pharmacokinet, 1999;37:127-146.
11 WHO. Stop TB at the source - WHO report on the tuberculosis epidemic, 1995. Geneva: World Health Organization; 1995. WHO/TB/95.183.
12 WHO. Guidelines for establishing DOTS-Plus pilot projects for the management of multi-drug resistant tuberculosis (MDR-TB). Geneva: World Health Organization; 2000. WHO/CDS/TB/2000.279.
13 Iseman MD. MDR-TB and the developing world - a problem no longer to be ignored: the WHO announces ‘DOTS-Plus’ strategy. Int J Tuberc Lung Dis, 1998;2:867.
14 Panchagnula R, Agrawal S, Kaul CL. Fixed-dose combinations in the treatment of tuberculosis. Ind J Pharm Sci, 2001;63:1-9.
15 Agrawal S, Thomas NS, Dhanikula AB, Kaul CL, Panchagnula R. Antituberculosis drugs and new drug development. Curr Opin Pulm Med, 2001;7:142-147.
17 Cole ST, Brosch R, Parkhill J, Garnier T, Churcher C, Harris D, Gordon SV, Eiglmeier K, Gas S, Barry CE 3rd, Tekaia F, Badcock K, Basham D, Brown D, Chillingworth T, Connor R, Davies R, Devlin K, Feltwell T, Gentles S, Hamlin N, Holroyd S, Hornsby T, Jagels K, Barrell BG, et al. Deciphering the biology of Mycobacterium tuberculosis from the complete genome sequence. Nature, 1998;393:537-544.
18 Cohen, E., Goldschmid, A., and Garty, M. Fixed-dose combination therapy in the United States, Britain and Israel. IMAJ, 2001;3:572-574.
19 Laing R, Fourie B, Ellard G, Sesay M, Spinaci S, Blomberg B, Bryant D. Fixed-dose combination tablets for the treatment of tuberculosis. Report of an informal meeting held in Geneva 27 April 1999. Geneva: World Health Organization; 1999. WHO/CDS/CPC/TB/99.267.
20 Blomberg B, Spinaci S, Fourie B, Laing R. The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis. Bull WHO, 2001;79:61-79.
21 Blomberg B, Evans P, Phanouvong S, Nunn P. Informal consultation on 4-drug fixed-dose combinations (4FDCs) compliant with the WHO model list of essential drugs. 15-17 August 2001. Geneva: World Health Organization; 2002. WHO/CDS/TB/2002.299.
22 Zhang L, Kan G, Tu D, Wan L, Faruqi AR. Fixed-dose combination chemotherapy versus multiple, single-drug chemotherapy for tuberculosis. Curr Ther Res, 1996;57:849-856.
23 Su W-J, Perng R-P. Fixed-dose combination chemotherapy (Rifater/Rifinah) for active pulmonary tuberculosis in Taiwan: a two-year follow up. Int J Tuberc Lung Dis, 2002; 6: 1029-1032.
24 Gravendeel JMT, Asapa AS, Becx-Bleumink M, Vrakking HA. Preliminary results of an operational field study to compare side-effects, complaints and treatment results of a single-drug short-course regimen with a four-drug fixed-dose combination (4FDC) regimen in South Sulawesi, Republic of Indonesia. Tuberculosis, 2003;83:183-186.
25 Uplekar MW, Shepard DS. Treatment of tuberculosis by private general practitioners in India. Tubercle, 1991;72:284-290.
26 Uplekar M, Juvekar S, Morankar S, Rangan S, Nunn P. Tuberculosis patients and practitioners in private clinics in India. Int J Tuberc Lung Dis, 1998;2:324-329.
27 Moulding T, Dutt AK, Reichman LB. Fixed-dose combinations of antituberculosis medications to prevent drug resistance. Ann Intern Med, 1995;122:951-954.
28 Kuaban C, Bercion R, Noeske J, Cunin P, Nkamsse P, Ngo Niobe S. Anti-tuberculosis drug resistance in the West Province of Cameroon. Int J Tuberc Lung Dis, 2000;4:356-360.
29 Norval P, Blomberg B, Kitler M, Dye C, Spinaci S. Estimate of the global market for rifampicin-containing fixed-dose combination tablets. Int J Tuberc Lung Dis, 1999;3:S292-S300.
30 Sweetman SC. Martindale: the complete drug reference. 33rd edition. London: Pharmaceutical Press; 2002: 205-206, 215-217, 240-241.
31 Long MW, Snider DE Jr, Farer LS. US Public Health Service cooperative trial of three rifampicin-isoniazid regimens in treatment of pulmonary tuberculosis. Am Rev Resp Dis, 1979;119:879-894.
32 Sirgel FA, Botha FJ, Parkin DP, Van De Wal DW, Donald PR, Clark PK, Mitchison DA. The early bactericidal activity of rifabutin in patients with pulmonary tuberculosis by sputum viable counts: a new method of drug assessment. J Antimicrob Chemother, 1993;32:867-875.
33 Ritschel WA, Kearns GL. The LADMER system: liberation, absorption, distribution, metabolism, elimination and response. In: Handbook of basic pharmacokinetics including clinical applications. Eds. Ritschel WA, Kearns GL. Washington: American Pharmaceutical Association; 1999: 15-19.
34 Mitchison DA. Role of individual drugs in the chemotherapy of tuberculosis. Int J Tuberc Lung Dis, 2000;4:796-806.
35 Fourie B, Pillai G, McIlleron H, Smith P, Panchagnula R, Ellard G. 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). Geneva: World Health Organization; 1999. WHO/CDS/TB/99.274.
36 McIlleron H, Gabriels G, Smith PJ, Fourie PB, Ellard GA. The development of a standardized screening protocol for the in vivo assessment of rifampicin bioavailability. Int J Tuberc Lung Dis, 1999;3:S329-S335.
37 Panchagnula R, Agrawal S, Kaur KJ, Singh I, Kaul CL. Evaluation of rifampicin bioequivalence in fixed-dose combinations using the WHO/IUATLD recommended protocol. Int J Tuberc Lung Dis, 2000;4:1169-1172.
38 Laing R, McGoldrick KM. Tuberculosis drug issues: prices, fixed-dose combination products and second-line drugs. Int J Tuberc Lung Dis, 2000;4:S194-S207.
39 Shenfield GM. Fixed combination drug therapy. Drugs, 1982;23:462-480.
40 The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit. Committee for Proprietary Medicinal Products (CPMP): Note for guidance on fixed combination medicinal products. 1996. CPMP/EWP/240/95.
41 USP 24/NF 19 (Supplement 2). Rockville, MD: United States Pharmacopoeial convention 2000: 2854-2855.
42 USP 26/NF 21. Rockville, MD: United States Pharmacopoeial convention 2003a: 1640, 1643-1646.
43 WHO. Treatment of tuberculosis. Guidelines for national programmes. 3rd ed. Geneva: World Health Organization; 2003. WHO/CDS/TB/2003.313.
44 WHO. The use of essential drugs: thirteenth report of the WHO Expert Committee (including the revised Model List of Essential Drugs). Geneva: World Health Organization; 2003.
45 Panchagnula R, Agrawal S. Biopharmaceutics and pharmacokinetics in variable bioavailability of rifampicin. Int J Pharm, 2003; in press.