Tuberculosis chemotherapy: current drug delivery approaches

Frieden TR, Sterling TR, Munsiff SS, Watt CJ, Dye C: Tuberculosis (Seminar). The Lancet 2003,362(9387):887–899. Singh S: Tuberculosis. Current Anaesthesia & Critical Care (Focus on: Tropical Diseases) 2004,15(3):165–171. World Health Organization – Geneva 2003: Treatment of TB: Guidelines for National Programmes. Katzung BG: Basic & Clinical Pharmacology. 8th edition. San Francisco, USA: McGraw-Hill; 2001. Williams DA, Lemke TL: Foye's Principles of Medicinal Chemistry. 5th edition. Philadelphia, USA: Lippincott, Williams and Wilkins; 2002. Comstock GW, Livesay VT, Woolpert SF: The prognosis of a positive tuberculin reaction in childhood and adolescence. Am J Epidemiol 1974, 99:131–138. Sutherland I: Recent studies in the epidemiology of tuberculosis, based on the risk of being infected with tubercle bacilli. Adv Tuberc Res 1976, 19:1–63. 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. Iseman MD: Treatment of multidrug-resistant tuberculosis. N Engl J Med 1993, 329:784–791. World Health Organization. Communicable Diseases Cluster: Fixed-dose combination tablets for the treatment of tuberculosis. 1999. Gibbon C, Editor: South African Medicines Formulary. 6th edition. Medical Association of South Africa in co-operation with the Pharmaceutical Society of South Africa; 2004. Heifets LB, Lindholm-Levy P: Comparison of bactericidal activities of streptomycin, amikacin, kanamycin, and capreomycin against Mycobacterium avium and M tuberculosis . Antimicrob Agents Chemother 1989, 33:1298–1301. Garg RK: Classic diseases revisited: Tuberculosis of the central nervous system (Review). Postgrad Med J 1999, 75:133–140. Mitchison DA: Mechanism of drug action in short-course chemotherapy. Bulletin International Union Against Tuberculosis 1985, 65:30–7. Iseman MD, Madsen LA: Drug-resistant tuberculosis. Clin Chest Med 1989, 10:341–53. Rattan A, Kalia A, Ahmad N: Multidrug-Resistant Mycobacterium tuberculosis : Molecular Perspectives. [http://www.cdc.gov/ncidod/eid/vol4no2/rattang.htm] All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India; Parsons LM, Salfinger M, Clobridge A, Dormandy J, Mirabello L, Polletta VL, Sanic A, Sinyavskiy O, Larsen SC, Driscoll J, Zickas G, Taber HW: Phenotypic and molecular characterization of Mycobacterium tuberculosis isolates resistant to both isoniazid and ethambutol. Antimicrob Agents Chemother 2005, 49:2218–2225. Somoskovi A, Parsons LM, Salfinger M: The molecular basis of resistance to isoniazid, rifampin, and pyrazinamide in Mycobacterium tuberculosis . Respiratory Research 2001, 2:164–168. Lund W, Editor: The Pharmaceutical Codex: Principles and Practice of Pharmaceutics. 12th edition. London, UK: The Pharmaceutical Press; 1994. Jindani A, Aber VR, Edwards EA, Mitchison DA: The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis 1980, 12:939–949. Sanders WE Jr, Hartwig C, Schneider N, Cacciatore R, Valdez H: Activity of amikacin against mycobacteria in vitro and in murine tuberculosis. Tubercle 1982, 63:201–208. Peloquin CA: Pharmacology of the antimycobacterial drugs. Med Clin North Am 1993, 77:1253–1262. Blaser J, Konig C, Fatio R, Follath F, Cometta A, Glauser M: Multicenter quality control study of amikacin assay for monitoring once-daily dosing regimens. Ther Drug Monit 1995, 17:133–136. Kohno S, Koga H, Kaku M, Maesaki S, Hara K: Prospective comparative study of ofloxacin or ethambutol for the treatment of pulmonary tuberculosis. Chest 1992, 102:1815–1818. Kennedy N, Berger L, Curram J: Randomized controlled trial of a drug regimen that includes ciprofloxacin for the treatment of pulmonary tuberculosis. Clin Infect Dis 1996, 22:827–833. Rastogi N, Goh KS: In vitro activity of the new difluorinated quinolone sparfloxacin (AT-4140) against Mycobacterium tuberculosis compared with activities of ofloxacin and ciprofloxacin. Antimicrob Agents Chemother 1991, 35:1993–1996. Ji B, Lounis N, Maslo C, Truffot-Pernot C, Bonnafous P, Grosset J: In vitro and in vivo activities of moxifloxacin and clinafloxacin against Mycobacterium tuberculosis . Antimicrob Agents Chemother 1998, 42:2066–2069. Bastian I, Portaels F: Multidrug resistant tuberculosis. London, UK: Kluwer Academic Publishers; 2000:165. Jagannath C, Reddy VM, Kailasam S, O'Sullivan JF, Gangadharam PR: Chemotherapeutic activity of clofazimine and its analogues against Mycobacterium tuberculosis : in vitro intracellular and in vivo studies. Am J Respir Crit Care Med 1995, 151:1083–1086. Reddy VM, Nadadhur G, Daneluzzi D, O'Sullivan JF, Gangadharam PR: Anti tuberculosis activities of clofazimine and its new analogs B4154 and B4157. Antimicrob Agents Chemother 1996, 40:633–636. Cynamon MN, Palmer GS: In vitro activity of amoxicillin in combination with clavulanic acid against Mycobacterium tuberculosis . Antimicrob Agents Chemother 1983, 24:429–431. Chambers HF, Kocagoz T, Sipit T, Turner J, Hopewell PC: Activity of amoxicillin/clavulanate in patients with tuberculosis. Clin Infect Dis 1998, 26:874–877. Donald PR, Sirgel FA, Venter A: Early bactericidal activity of amoxicillin in combination with clavulanic acid in patients with sputum smear-positive pulmonary tuberculosis. Scand J Infect Dis 2001, 33:466–469. Cavalieri SJ, Biehle JR, Sanders WE: Synergistic activities of clarithromycin and antituberculous drugs against multidrug-resistant Mycobacterium tuberculosis . Antimicrob Agents Chemother 1995, 39:1542–1545. Hoffner SE, Gezelius L, Olsson-Liljequist B: In-vitro activity of fluorinated quinolones and macrolides against drug-resistant Mycobacterium tuberculosis . J Antimicrob Chemother 1997, 40:885–888. Luna-Herrera , Reddy VM, Daneluzzi D, Gangadharam PRJ: Antituberculosis activity of clarithromycin. Antimicrob Agents Chemother 1995, 39:2692–2695. Mor N, Esfandiari A: Synergistic activities of clarithromycin and pyrazinamide against Mycobacterium tuberculosis in human macrophages. Antimicrob Agents Chemother 1997, 41:2035–2036. Mukherjee JS, Rich ML, Socci AR: Programmes and principles in treatment of multidrug-resistant tuberculosis. The Lancet 2004,363(9407):474–481. Heifets LB, Lindholm-Levy PJ, Flory M: Thiacetazone: in vitro activity against Mycobacterium avium and M tuberculosis . Tubercle 1990, 71:287–291. Okwera A, Whalen C, Byekwaso F: Randomised trial of thiacetazone and rifampicin-containing regimens for pulmonary tuberculosis in HIV-infected Ugandans: the Makerere University-Case Western University Research Collaboration. The Lancet 1994, 344:1323–1328. Prabakaran D, Singh P, Jaganathan KS, Vyas SP: Osmotically regulated asymmetric capsular systems for simultaneous sustained delivery of anti-tubercular drugs. J Contr Rel 2004,95(2):239–248. Chen Y-J: The solubility enhancement and the stability assessment of rifampicin, isoniazid and pyrazinamide in aqueous media. In Master of Science Thesis. Rhodes University, South Africa; 2000. Kochi A, Vareldzis B, Styblo K: Multi-drug resistant TB and its control. Res Microbiol 1993, 144:104–110. Agrawal S, Kaur KJ, Singh I, Bhade SR, Kaul CL, Panchagnula R: Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose level. Int J Pharm 2002,233(1–2):169–177. Edlin BR, Tokars JI, Grico MH, Crawford JT, Williams J, Sordillo EM, Ong KR, Kilburn JO, Dooley SW, Castro KG: An outbreak of MDR TB among hospitalized patients with the acquired immunodeficiency syndrome. New Engl J Med 1992, 326:1514–1521. Fischl MA, Uttamchandani RB, Daikos GL, Poblete RB, Moreno JN, Reyes RR, Boota AM, Thompson LM, Cleary TJ, Lai S: An outbreak of TB caused by multiple-drug-resistant tubercle bacilli among patients with HIV infection. Ann Intern Med 1992, 117:177–183. Falk R, Randolph TW, Meyer JD, Kelly RM, Manning MC: Controlled release of ionic compounds from poly (L-lactide) microspheres produced by precipitation with a compressed antisolvent. J Contr Rel 1997,44(1):77–85. Pandey R, Sharma A, Zahoor A, Sharma S, Khuller GK, Prasad B: Poly (DL-lactide-co-glycolide) nanoparticle-based inhalable sustained drug delivery system for experimental tuberculosis. J Antimicrob Chemother 2003, 52:981–986. Kailasam S, Daneluzzi D, Gangadharam PRJ: Maintenance of therapeutically active levels of isoniazid for prolonged periods in rabbits after a single implant of biodegradable polymer. Tuber Lung Dis 1994,75(5):361–365. Dutt M, Khuller GK: Sustained release of isoniazid from a single injectable dose of poly (DL-lactide-co-glycolide) microparticles as a therapeutic approach towards tuberculosis. Int J Antimicrob Agents 2001, 17:115–122. Dutt M, Khuller GK: Chemotherapy of Mycobacterium tuberculosis infections in mice with a combination of isoniazid and rifampicin entrapped in Poly (DL-lactide-co-glycolide) microparticles. J Antimicrob Chemother 2001,47(6):829–35. Ain Q, Sharma S, Garg SK, Khuller GK: Role of poly [DL-lactide-co-glycolide] in development of a sustained oral delivery system for antitubercular drug(s). Int J Pharm 2002,239(1–2):37–46. Mathur IS, Gupta HP, Srivastava SK, Singh S, Madhu K, Khanna NM: Evaluation of subdermal biodegradable implants incorporating rifampicin as a method of drug delivery in experimental tuberculosis of guinea pigs. J Med Microbiol 1985,20(3):387–392. Barik BB, Gupta BK, Pal M: Preparation and evaluation of rifampicin microspheres. The Eastern Pharmacist 1993, 36:173–175. Denkbas EB, Kaitian X, Tuncel A, Piskin E: Rifampicin carrying poly (-lactide) microspheres: loading and release. J Biomater Sci Polym Ed 1995,6(9):815–825. Nakhare S, Vyas SP: Prolonged release of rifampicin from internal phase of multiple w/o/w emulsion systems. Indian J Pharm Sci 1995,57(2):71–77. Khopade AJ, Mahadik KR, Jain NK: Enhanced brain uptake of rifampicin from w/o/w multiple emulsions via nasal route. Indian J Pharm Sci 1996,58(2):83–85. Amar HO, Khalil RM: Preparation and evaluation of sustained release solid dispersions of drugs with Eudragit polymers. Drug Dev Ind Pharm 1997,23(11):1043–1054. Deol P, Khuller KG: Lung specific stealth liposomes: stability, biodistribution and toxicity of liposomal antitubercular drugs in mice. Biochem Biophys Acta 1997,1334(2–3):161–172. Schierholz JM: Physico-chemical properties of a rifampicin releasing polydimethylsiloxane shunt. Biomaterials 1997,18(8):635–641. Uppadhyay AK, Omray LK, Khopade AJ, Jam NK: Studies on a reverse micellelamellar phase transition based depot preparation of rifampicin. Pharmazie 1997,52(2):961–962. Sreenivasa Rao B, Ramana Murthy KV: Studies on rifampicin release from ethylcellulose coated nonpareil beads. Int J Pharm 2002,231(1):97–106. Makino K, Nakajima T, Shikamura M, Ito F, Ando S, Kochi C, Inagawa H, Soma G, Terada H: Efficient intracellular delivery of rifampicin to alveolar macrophages using rifampicin-loaded PLGA microspheres: effects of molecular weight and composition of PLGA on release of rifampicin. Colloids Surf, B: Biointerfaces 2004, 36:35–42. Barrow EL, Winchester GA, Staas JK, Quenelle DC, Barrow WW: Use of microsphere technology for targeted delivery of rifampin to Mycobacterium tuberculosis -infected macrophages. Antimicrob Agents Chemother 1998, 42:2682–2689. Anisimova YV, Gelperina SI, Peloquin CA, Heifets LB: Nanoparticles as antituberculosis drugs carriers: effect on activity against mycobacterium tuberculosis in human monocyte-derived macrophages. J Nanopart Res 2000, 2:165–171. Sharma R, Saxena D, Dwivedi AK, Misra A: Inhalable microparticles containing drug combinations to target alveolar macrophages for treatment of pulmonary tuberculosis. Pharm Res 2001, 18:1405–1410. Ahsan F, Rivas IP, Khan MA, Torres Suarez AI: Targeting to macrophages: role of physicochemical properties of particulate carriers-liposomes and microspheres-on the phagocytosis by macrophages. J Contemp Relig 2002, 79:29–40. Zhou H, Zhang Y, Biggs DL, Manning MC, Randolph TW, Christians U, Hybertson BM, Ng K: Microparticle-based lung delivery of INH decreases INH metabolism and targets alveolar macrophages. J Contr Rel 2005,107(2):288–299. Suarez S, O'Hara P, Kazantseva M, Newcomer CE, Hopfer R, McMurray DN, Hickey AJ: Airways delivery of rifampicin microparticles for the treatment of tuberculosis. J Antimicrob Chemother 2001, 48:431–434. O'Hara P, Hickey AJ: Respirable PLGA microspheres containing rifampicin for the treatment of tuberculosis: manufacture and characterization. Pharm Res 2000, 17:955–961. Zahoor A, Sharma S, Khuller GK: Inhalable alginate nanoparticles as antitubercular drug carriers against experimental tuberculosis. Int J Antimicrob Agents 2005,26(4):298–303. Zahoor A, Pandey R, Sharma S, Khuller GK: Pharmacokinetic and pharmacodynamic behaviour of antitubercular drugs encapsulated in alginate nanoparticles at two doses. Int J Antimicrob Agents 2006,27(5):409–416. Pandey R, Khuller GK: Solid lipid particle-based inhalable sustained drug delivery system against experimental tuberculosis. Tuberculosis 2005,85(4):227–234. Vyas SP, Kannan ME, Sanyog Jain, Mishra V, Singh P: Design of liposomal aerosols for improved delivery of rifampicin to alveolar macrophages. Int J Pharm 2004,269(1):37–49. Gangadharam PR, Geeta N, Hsu YY, Wise DL: Chemotherapy of tuberculosis in mice using single implants of isoniazid and pyrazinamide. Int J Tuberc Lung Dis 1999, 3:515–520. 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. Pillai G, Fourie PB, Padayatchi N, Onyebujoh PC, Mcllleron H, Smith PJ, Gabriels GR: Recent bioequivalence studies on fixed dose combination antituberculosis drug formulations available on the global market. Int J Tuberc Lung Dis 1999, 3:S309-S316. Panchagnula R, Agrawal S: Biopharmaceutic and pharmacokinetic aspects of variable bioavailability of rifampicin. Int J Pharm 2004,271(1–2):1–4. Coupe AJ, Davis SS, Wilding IR: Variation in gastrointestinal transit of pharmaceutical dosage forms in healthy subjects. Pharm Res 1991,8(3):360–364. Shishoo CJ, Shah SA, Rathod IS, Savale SS, Vora MJ: Impaired bioavailability of rifampicin in presence of isoniazid from fixed dose combination (FDC) formulation. Int J Pharm 2001, 228:53–67. Digenis GA: The in vivo behavior of multiparticulate versus single unit dosage formulations. In Multipaticulate Oral Drug Delivery. Edited by: Ghebre-Sellassie I. New York, USA: Marcel Dekker, Inc; 1994:333–355. Laing R, Fourie B, Ellard G, Sesay M, Spinaci S, Blomberg B, Bryant D: Fixed-dose combination tablets for the treatment of tuberculosis. In Report of an informal meeting held in Geneva, Tuesday, 27 April 1999. World Health Organization, Geneva, WHO/CDS/CPC/TB/99.267; World Health Organization: Stop TB: Stop TB: Frequently asked questions about the 4-drug fixed-dose combination tablet recommended by the World Health Organization for treating tuberculosis. Geneva: WHO, September WHO/CDS/STB/2002.18; 2002. Singh S, Mariappan TT, Sharda N, Chakraborti AK: The reason for an increase in decomposition of rifampicin in the presence of isoniazid under acid conditions. Pharm Pharmacol Comm 2000,6(11):405–410. Singh S, Mariappan TT, Sharda N, Singh B: Degradation of rifampicin, isoniazid and pyrazinamide from prepared mixtures and marketed single and combination products under acid conditions. Pharm Pharmacol Comm 2000,6(11):491–494. Mohan B, Sharda N, Singh S: Evaluation of the recently reported USP gradient HPLC method for analysis of anti-tuberculosis drugs for its ability to resolve degradation products of rifampicin. J Pharm Biomed Anal 2003,31(3):607–612. Mariappan TT, Jindal KC, Singh S: Overestimation of rifampicin during colorimetric analysis of anti-tuberculosis products containing isoniazid due to formation of isonicotinyl hydrazone. J Pharmaceut Biomed Anal 2004,36(4):905–908. Sankar R, Sharda N, Singh S: Behaviour of decomposition of rifampicin in the presence of isoniazid on the pH range 1–3. Drug Dev Ind Pharm 2003,29(7):733–738. McMurry J: Organic Chemistry. 4th edition. Pacific Groove, CA, USA: Brooks/Cole; 1996. Mariappan TT, Singh S: Regional gastrointestinal permeability of rifampicin and isoniazid (alone and their combination) in the rat. Int J Tuberc Lung Dis 2003,7(8):797–803. Flynn GL: Considerations in controlled release drug delivery system. Pharm Tech 1982, 6:33–39. Ranade VV, Hollinger MA: Drug Delivery Systems. 2nd edition. CRC Press; 2003. Sensi P: History of the development of rifampin. Rev Infect Dis 1983,5(Suppl 3):S402–406. Agrawal S, Ashokraj Y, Bharatam PV, Pillai O, Panchagnula R: Solid-state characterization of rifampicin samples and its biopharmaceutic relevance. Eur J Pharm Sci 2004,22(2–3):127–144. Majeed M, Badmaev V, Rajendran R: Use of piperine to increase the bioavailability of nutritional compounds. United States Patent 5536506 1996. Giannola LI, Giammona G, Alotta R: Pro-drugs of isoniazid: synthesis and diffusion characteristics of acyl derivatives. Pharmazie 1992,47(6):423–5. Crooks PA, Cynkowski T, Cynkowska G, Guo H, Ashton P: Permeable, water soluble, non-irritating prodrugs of chemotherapeutic agents with oxaalkanoic acids. United States Patent 6765019 2004. Lippold BC: Oral Controlled Products: Therapeutic and Biopharmacceutic Assessment. Edited by: Gundert-Remy U, Moller H. Wissenschaftlice Verlagsgesellschaft, Stuggart; 1990:39–57. Pillay V, Fassihi R: In vitro release modulation from crosslinked pellets for site-specific drug delivery to the gastrointestinal tract: I. Comparison of pH-responsive drug release and associated kinetics. J Contr Rel 1999,59(2):229–242. Schmidt C, Bodmeier R: A multiparticulate drug-delivery system based on pellets incorporated into congealable polyethylene glycol carrier materials. Int J Pharm 2001,216(1–2):9–16.