Application of a four-fluid nozzle spray drier to prepare inhalable rifampicin-containing mannitol microparticles

AAPS PharmSciTech

Volumn 9, Issue 3, 2008, Pages 755-761

  Mizoe, Takuto ^a   Ozeki, Tetsuya ^a   Okada, Hiroaki ^a  

^a TOKYO UNIVERSITY OF PHARMACY AND LIFE SCIENCES   (Japan)

Author keywords

Four fluid nozzle; Inhalation; Microparticles; Spray dry; Tuberculosis

Indexed keywords

ACETONE; CHOLESTEROL; MANNITOL; METHANOL; NANOPARTICLE; PHOSPHATIDYLCHOLINE; RIFAMPICIN;

AEROSOL; ANIMAL EXPERIMENT; AQUEOUS SOLUTION; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG ELIMINATION; DRUG RETENTION; DRUG TARGETING; IN VITRO STUDY; IN VIVO STUDY; LUNG ALVEOLUS MACROPHAGE; MALE; NONHUMAN; PARTICLE SIZE; RAT; SPRAY DRYING; X RAY DIFFRACTION;

ADMINISTRATION, INHALATION; AEROSOLS; ANIMALS; CHEMISTRY, PHARMACEUTICAL; DESICCATION; DRUG DELIVERY SYSTEMS; LUNG; MALE; MANNITOL; PARTICLE SIZE; RATS; RATS, SPRAGUE-DAWLEY; RIFAMPIN;

EID: 57149143764     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-008-9109-x     Document Type: Article

References (38)

1. E. Merisko-Liversidge, G. G. Liversidge, and E. R. Cooper. Nanosizing: A formulation approach for poorly water-soluble compounds. Eur. J. Pharm. Sci. 18: 113-120 (2003).
2. N. Rasenack, N. H. Hartenhauer, and B. W. Muller. Microcrystals for dissolution rate enhancement of poorly water-soluble drugs. Int. J. Pharm. 254: 137-145 (2003).
3. N. Rasenack, and B. W. Muller. Dissolution rate enhancement by in situ micronization of poorly water-soluble drugs. Pharm. Res. 19: 1894-1900 (2002).
4. T. L. Rogers, K. A. Overhoff, P. Shah, M. J. Santiago Yacaman, K. P. Johnston, and R. O. William 3rd. Micronized powders of a poorly water soluble drug produced by a spray-freezing into liquid-emulsion process. Eur. J. Pharm. Biopharm. 55: 161-172 (2003).
5. T. L. Rogers, A. C. Nelsen, J. Hu, J. N. Brown, M. Sarkari, T. J. Young, K. P. Johnston, and R. O. William Jr. A novel particle engineering technology to enhance dissolution of poorly water soluble drugs: spray-freezing into liquid. Eur. J. Pharm. Biopharm. 54: 271-280 (2002).
6. A. Billon, B. Bataille, G. Cassanas, and M. Jacob. Development of spray-dried acetaminophen microparticles using experimental designs. Int. J. Pharm. 203: 159-168 (2000).
7. C. R. Muller, V. L. Bassani, A. R. Pohlmann, C. B. Michalowski, P. R. Petrovick, and S. S. Guterres. Preparation and characterization of spray-dried polymeric nanocapsules. Drug. Dev. Ind. Pharm. 26: 343-347 (2000).
8. M. D. L. Moretti, E. Gavini, C. Juliano, and G. P. Pirisino Giunchedi. Spray-dried microspheres containing ketoprofen formulated into capsules and tablets. J. Microencapsul. 18: 111-121 (2001).
9. P. D. Martino, M. Scoppa, E. EJoiris, G. F. Palmieri, C. Andres, Y. Pourcelot, and S. Martelli. The spray drying of acetazolamide as method to modify crystal properties and to improve compression behavior. Int. J. Pharm. 213: 209-221 (2001).
10. O. C. Chidavaenzi, G. Buckton, and F. Koosha. The effect of co-spray drying with polyethylene glycol 4000 on the crystallinity and physical form of lactose. Int. J. Pharm. 216: 43-49 (2001).
11. L. Mu, and S. S. Feng. Fabrication, characterization and in vitro release of paclitaxel (Taxol) loaded poly(lactic-co-glycolic acid) microspheres prepared by spray drying technique with lipid/cholesterol emulsifiers. J. Control. Release. 76: 39-254 (2001).
12. M. Asada, H. Takahashi, H. Okamoto, H. Tanino, and K. Danjo. Theophylline particle design using chitosan by the spray drying. Int. J. Pharm. 270: 167-174 (2004).
13. G. Dollo, P. Le Corre, A. Guerin, F. Chevanne, J. L. Burgot, and R. Leverge. Spray-dried redispersible oil-in-water emulsion to improve oral bioavailability of poorly soluble drugs. Eur. J. Pharm. Biopharm. 19: 273-280 (2004).
14. T. Ozeki, S. Beppu, T. Mizoe, Y. Takashima, Y. Yuasa, and H. Okada. Preparation of two-drug composite microparticles to improve the dissolution of insoluble drug in water for use with the 4-fluid nozzle spray drier. J. Control. Release. 107: 387-394 (2005).
15. T. Ozeki, S. Beppu, T. Mizoe, Y. Takashima, Y. Yuasa, and H. Okada. Preparation of polymeric submicron particle-containing microparticles using a 4-fluid nozzle spray drier. Pharm. Res. 23: 177-183 (2005).
16. T. Mizoe, S. Beppu, T. Ozeki, and H. Okada. One-step preparation of drug-containing microparticles to enhance the dissolution and absorption of poorly water-soluble drug using a 4-fluid spray drier. J. Control. Release. 120: 205-210 (2007a).
17. T. Mizoe, S. Beppu, T. Ozeki, and H. Okada. Preparation of drug nanoparticle-containing microparticles using a 4-fluid spray drier for oral, pulmonary, and injection dosage forms. J. Control. Release. 122: 10-15 (2007b).
18. World Health Organization. Tuberculosis facts, 2007, WHO, Geneva, 2007.
19. P. O'Hara, and A. J. Hickey. Respirable PLGA micro-spheres containing rifampicin for the treatment of tuberculosis: Manufacture and characterization. Pharm. Res. 8: 955-961 (2000).
20. R. Sharma, D. Saxena, A. K. Dwivedi, and A. Misra. Inhalable microparticles containing drug combinations to target alveolar microphages for treatment of pulmonary tuberculosis. Pharm. Res. 18: 1405-1410 (2001).
21. S. Suarez, P. O'Hara, M. Kazantseva, C. E. Newcomer, R. Hopfer, D. N. McMurray, and A. J. Hickey. Respirable microspheres containing rifampicin for the treatment of tuberculosis: Screening in an infections disease model. Pharm. Re s. 18: 1315-1319 (2001).
22. S. P. Vyas, M. E. Kannan, S. Jain, V. Mishra, and P. Singh. Design of liposomal aerosols for improved delivery of rifampicin to alveolar microphages. Int. J. Pharm. 269: 37-49 (2004).
23. K. Makino, T. Nakajima, M. Shikamura, F. Ito, S. Ando, C. Kochi, H. Inagawa, G. Soma, and H. Terada. Efficient intracellular delivery of rifampicin to alveolar macrophages using rifampicin-loaded PLGA microspheres: Effect pf molecular weight and composition of PLGA on release of rifampicin. Colloids Surf. B Biointerface s. 36: 35-42 (2004).
24. A. Yoshida, M. Matsumoto, H. Hshizume, Y. Oda, T. Tomishige, H. Inagawa, C. Kohchi, M. Hino, F. Ito, K. Tomoda, T. Nakajima, K. Makino, H. Terada, H. Hori, and G. Soma. Selective delivery of rifampicin incorporated into poly(dl -lacyic-co-glycolic) acid microspheres after phagocytotic uptake by alveolar macrophages, and the killing effect against intracellular Mycobacterium bovis Calmette-Guérin. Microbes Infect. 8: 2484-2491 (2006).
25. K. Hirota, T. Hasegawa, H. Hinata, F. Ito, H. Inagawa, C. Kochi, G. Soma, K. Makino, and H. Terada. Optimum condition for efficient phagocytosis of rifampicin-loaded PLGA microspheres by alveolar macrophages. J. Control. Release. 119: 69-76 (2007).
26. A. Sharma, S. Sharma, and G. K. Khuller. Lectin-functionalized poly(lactide-co-glycolide) nanoparticles as oral/aerosolized antitubercular drug carriers for treatment of tuberculosis. J. Antimicrob. Chemother. 54: 761-766 (2004).
27. R. Pandey, S. Sharma, and G. K. Khuller. Nebulization of liposome encapsulated antitubercular drugs in guinea pigs. Int. J. Antimicrob. Agents. 24: 93-94 (2004).
28. G. K. Khuller, M. Kapur, and S. Sharma. Liposome technology for drug delivery against mycobacterial infections. Curr. Pharm. Des. 10: 3263-3274 (2004).
29. R. Pandey, and G. K. Khuller. Antitubecular inhaled therapy: opportunities, progress and challenges. J. Antimicrob. Chemother. 55: 430-435 (2005).
30. R. Pandey, and G. K. Khuller. Solid lipid particle-based inhalable sustained drug delivery system against experimental tuberculosis. Tuberculosis. 85: 227-234 (2005).
31. H. Zhou, Y. Zhang, D. L. Biggs, M. C. Manning, T. W. Randolph, U. Christians, B. M. Hybertson, and K. Ng. Microparticle-based lung delivery of INH decreases INH metabolism and targets alveolar macrophages. J. Control. Release. 107: 288-299 (2005).
32. Y. S. Schwartz, M. I. Dushikin, V. A. Vavilin, E. V. Melnikova, O. M. Khoschenko, V. A. Kozlov, A. P. Agafonov, A. V. Alekseev, Y. Rassadkin, A. M. Shetapalov, M. S. Azaev, D. V. Saraev, P. N. Filimonov, Y. Kurunov, A. V. Svistelnik, V. A. Krasnov, A. Pathak, S. C. Derrick, R. C. Reynolds, S. Morris, and V. M. Blinov. Novel conjugate of moxifloxacin and carboxymethylated glucan with enhanced activity against Mycobacterium tuberculosis. Antimicrob. Agents Chemother. 50: 1982-1988 (2006).
33. P. Muttil, J. Kaur, K. Kumar, A. B. Yadav, R. Sharma, and A. Misra. Inhalable microparticles containing large payload of anti-tuberculosis drugs. Eur. J. Pharm. Sci. 32: 140-150 (2007).
34. P. Podczrck. Optimization of the operation conditions of an Andersen-Cascade impactor and the relationship to centrifugal adhesion measurements to aid the development of dry powder inhalations. Int. J. Pharm. 149: 51-61 (1997).
35. European Pharmacopoeia 3rd Ed, Section 2.9. 18-prepartions for inhalation: Aerodynamic assessment of fine particles. Council of Europe, Strasbourg, France, pp 113-124, 2001.
36. United States Pharmacopoeia, Chapter 601-physical tests and determinations: Aerosols. Rockville, MD, USA, pp 2105-2123, 2003.
37. H. Murakoshi, T. Saotome, Y. Fujii, T. Ozeki, Y. Takashima, H. Yuasa, and H. Okada. Effect of physical properties of carrier particles on drug emission from a dry powder inhaler device. J. Drug Del. Sci. Tech. 15: 223-226 (2005).
38. M. Watanabe, T. Ozeki, T. Shibata, H. Murakoshi, Y. Takashima, H. Yuasa, and H. Okada. Effect of shape of sodium salicylate particles on physical property and in vitro aerosol performance of granules prepared by pressure swing granulation method. AAPS Pharm. Sci Tech. 4: Article 64 (2003).