Inhalable antibiotics manufactured through use of near-critical or supercritical fluids

Aerosol Science and Technology

Volumn 46, Issue 4, 2012, Pages 403-410

  Manion, J'Aime R ^a   Cape, Stephen P ^a   McAdams, David H ^a   Rebits, Lia G ^b   Evans, Sarah ^b   Sievers, Robert E ^a,b  

^a UNIVERSITY OF COLORADO   (United States)

^b Aktiv Dry LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANDERSONS; ANTIBIOTIC TREATMENT; ASSISTED NEBULIZATION; COMBINED THERAPY; DELIVERY SYSTEMS; DRY POWDER INHALER; DRY POWDERS; DRYING PROCESS; GLOBAL HEALTH; GRAND CHALLENGE; KANAMYCINS; KARL FISCHER; L-LEUCINE; LOW COSTS; MICRO-PARTICLES; PARTICLE PROPERTIES; POWDER PRODUCTION; POWDER PROPERTIES; PROTOTYPE DEVICES; RESIDUAL MOISTURE; SCALE-UP EXPERIMENT; SIZE RANGES; UV EXPOSURE;

AMINO ACIDS; CARBON DIOXIDE; DRUG DOSAGE; EFFLUENT TREATMENT; MOISTURE; SCANNING ELECTRON MICROSCOPY; SUPERCRITICAL FLUIDS; X RAY DIFFRACTION;

ANTIBIOTICS;

CAPREOMYCIN; CARBON DIOXIDE; ISONIAZID; KANAMYCIN; LEUCINE; OXIDIZING AGENT;

ANTIBIOTIC THERAPY; ARTICLE; CRYSTALLIZATION; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SAFETY; DRUG STRUCTURE; MOISTURE; MULTIDRUG RESISTANT TUBERCULOSIS; NEBULIZATION; PARTICLE SIZE; POWDER INHALER; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; SUPERCRITICAL FLUID; X RAY DIFFRACTION;

EID: 84859783424     PISSN: 02786826     EISSN: 15217388     Source Type: Journal    
DOI: 10.1080/02786826.2011.634453     Document Type: Article

References (38)

1. A. Schulman Inc. 2011. Additive: Antistatic Reduce Static Charging, A. Schulman Inc.
2. Borsje, P., de Jongste, J. C., Mouton, J. W., and, Tiddens, H. 2000. Aerosol Therapy in Cystic Fibrosis: A Survey of 54 cf Centers. Pediat. Pulmonology, 30: 368-376.
3. Bosquillon, C., Lombry, C., Preat, V., and, Vanbever, R. 2001. Influence of formulation excipients and physical characteristics of inhalation dry powders on their aerosolization performance. J. Control. Release, 70: 329-339. (Pubitemid 32155456)
4. Cape, S. P., Villa, J. A., Huang, E. T. S., Yang, T. H., Carpenter, J. F., and, Sievers, R. E. 2008. Preparation of Active Proteins, Vaccines and Pharmaceuticals as Fine Powders Using Supercritical or Near-Critical Fluids. Pharm. Res., 25: 1967-1990.
5. Chanwong, S., Maneekarn, N., Makonkawkeyoon, L., and, Makonkawkeyoon, S. 2007. Intracellular Growth and Drug Susceptibility of Mycobacterium tuberculosis in Macrophages. Tuberculosis, 87: 130-133. (Pubitemid 46217261)
6. Crowder, T. M., Rosati, J. A., Schroeter, J. D., Hickey, A. J., and, Martonen, T. B. 2002. Fundamental Effects of Particle Morphology on Lung Delivery: Predictions of Stokes Law And the Particular Relevance to dry Powder Inhaler Formulation and Development. Pharm. Res., 19: 239-245. (Pubitemid 34211838)
7. Girling, D. J. 1989. A Controlled Trial of 3-Month, 4-Month, and 6-Month Regimens of Chemotherapy for Sputum-Smear-Negative Pulmonsrt Tuberculosis-Results at 5 Years. Am. Rev. Respir. Dis., 139: 871-876. (Pubitemid 19094307)
8. Giudice, E. L., and, Campbell, J. D. 2006. Needle-Free Vaccine Delivery. Adv. Drug Deliver. Rev., 58: 68-89.
9. Heifets, L. 1988. Mic as a Quantitative Measurement of the Susceptability of Mycobacterium avium Strains to Seven Antituberculosis Drugs. Antimicrob. Agents Ch., 32: 1131-1136.
10. Heifets, L. B., Lindholmlevy, P. J., and, Flory, M. 1991. Comparison of Bacteriostatic and Bactericidal Activity of Isoniazid and Ethionamide Against Mycobacterium avium and Mycobacterium tuberculosis. Am. Rev. Respir. Dis., 143: 268-270.
11. Helms, R., Quan, D., Herfindal, E., and, Gourley, D. 2006. Textbook of Therapeutics: Drug and Disease Management-8th ed, Philadelphia: Lippincott Williams & Wilkins.
12. Hindle, M., and, Byron, P. R. 1995. Dose Emissions from Marketed Dry Powder Inhalers. Int. J. Pharm., 116: 169-177.
13. Hiyama, J., Marukawa, M., Shiota, Y., Ono, T., and, Mashiba, H. 2000. Factors Influencing Response to Treatment of Pulmonary Tuberculosis. Acta Med. Okayama, 54: 139-145.
14. Horsburgh, C. R., Feldman, S., and, Ridzon, R. 2000. Practice Guidelines for the Treatment of Tuberculosis. Clin. Infect. Dis., 31: 633-639. (Pubitemid 32295479)
15. Jovanovic, N., Bouchard, A., Hofland, G. W., Witkamp, G. J., Crommelin, D. J. A., and, Jiskoot, W. 2004. Stabilization of Proteins in dry Powder Formulations Using Supercritical Fluid Technology. Pharm. Res., 21: 1955-1969. (Pubitemid 40941214)
16. Kisich, K. O., Higgins, M. P., Park, I., Cape, S. P., Lindsay, L., Bennett, D. J. 2011. Dry Powder Measles Vaccine: Particle Deposition, Virus Replication, and Immune Response in Cotton Rats Following Inhalation. Vaccine, 29: 905-912.
17. Lin, W. H., Griffin, D. E., Rota, P. A., Papania, M., Cape, S. P., Bennett, D. 2011. Successful Respiratory Immunization with Dry Powder Live-Attenuated Measles Virus Vaccine in Rhesus Macaques. Proc. Nat. Acad. Sci. U S A, 108: 2987-2992.
18. May, J. C., Wheeler, R. M., and, Grim, E. 1986. The Determination of Residual Moisture in Several Freeze-Dried Vaccines and a Honey-Bee Venom Allergenic Extract by tg/ms. J. Therm. Anal., 31: 643-651.
19. Mitchell, J., Nagel, M., Doyle, C., Ali, R., Avvakoumova, V., Christopher, J. 2010. Relative Precision of Inhaler Aerodynamic Particle Size Distribution (apsd) Metrics by Full Resolution and Abbreviated Andersen Cascade Impactors (acis): Part 1. AAPS Pharm. Sci. Tech., 11: 843-851.
20. Mitragotri, S. 2005. Immunization Without Needles. Nat. Rev. Immunol., 5: 905-916. (Pubitemid 41746760)
21. Muttil, P., Wang, C. C., and, Hickey, A. J. 2009. Inhaled Drug Delivery for Tuberculosis Therapy. Pharm. Res., 26: 2401-2416.
22. Namgyal, P. 2006. Introduction of New Vaccines in the Asia Pacific Region: Challenges and Opportunities. World Health Organization,. Geneva
23. Nuermberger, E. L., Yoshimatsu, T., Tyagi, S., OBrien, R. J., Vernon, A. N., Chaisson, R. E. 2004. Moxifloxacin-Containing Regimen Greatly Reduces Time to Culture Conversion in Murine Tuberculosis. Am. J. Resp. Crit. Care, 169: 421-426. (Pubitemid 38134824)
24. Pandey, R., and, Khuller, G. K. 2005. Antitubercular Inhaled Therapy: Opportunities, Progress and Challenges. J. Antimicrob. Chemoth., 55: 430-435. (Pubitemid 40542580)
25. Rebits, L. G., Bennett, D. J., Bhagwat, P. A., Morin, A., and, Sievers, R. E. 2007. Method for Quantifying the Sample Collected by an Andersen Cascade Impactor Using Total Organic Carbon Analysis. J. Aerosol Sci., 38: 1197-1206. (Pubitemid 350116085)
26. Shakoor, O., Taylor, R. B., and, Behrens, R. H. 1997. Assessment of the Incidence of Substandard Drugs in Developing Countries. Trop. Med. Int. Health, 2: 839-845. (Pubitemid 27396011)
27. Shin, S. Y., Furin, J., Alcantara, F., Hyson, A., Joseph, K., Sanchez, E. 2004. Hypokalemia Among Patients Receiving Treatment for Multidrug-Resistant Tuberculosis. Chest, 125: 974-980. (Pubitemid 38367288)
28. Sievers, R. E., Cape, S. P., Quinn, B. P., Searles, J. A., Best, J. A., Burger, J. L. 2006. Stabilization, Nebulization, and Near-Ambient Temperature Drying of Measles Vaccine, Igg Antibody, tb Antibiotics, and Zanamivir. Resp. Drug Deliv. X, 2: 401-404.
29. Sievers, R. E., Huang, E. T. S., Villa, J. A., Kawamoto, J. K., Evans, M. M., and, Brauer, P. R. 2001. Low-Temperature Manufacturing of Fine Pharmaceutical Powders with Supercritical Fluid Aerosolization in a Bubble Dryer (r). Pure Appl. Chem., 73: 1299-1303.
30. Sievers, R. E., Quinn, B. P., Cape, S. P., Searles, J. A., Braun, C. S., Bhagwat, P. 2007. Near-Critical Fluid Micronization of Stabilized Vaccines, Antibiotics and Anti-Virals. J. Supercrit. Fluid, 42: 385-391. (Pubitemid 47039202)
31. Stelmach, R., Bussamra, M. H., Rodrigues, J. C., and, Cukier, A. 2009. A Randomized, Comparative Study of Formoterol and Terbutaline Dry Powder Inhalers in the Treatment of Mild to Moderate Asthma Exacerbations in the Pediatric Acute Care Setting. Ann. Allerg. Asthma, Im., 103: 248-253.
32. Taylor, R. B., Shakoor, O., and, Behrens, R. H. 1995. Drug Quality, a Contributor to Drug-Resistance. Lancet, 346: 122-122.
33. Traini, D., Adi, H., Young, P. M., Chan, H. K., and, Agus, H. 2010. Co-Spray-Dried Mannitol-Ciprofloxacin Dry Powder Inhaler Formulation for Cystic Fibrosis and Chronic Obstructive Pulmonary Disease. Eur. J. Pharm. Sci., 40: 239-247.
34. Tyagi, S., Nuermberger, E., Yoshimatsu, T., Williams, K., Rosenthal, I., Lounis, N. 2005. Bactericidal Activity of the Nitroimidazopyran pa-824 in a Murine Model of Tuberculosis. Antimicrob. Agents Ch., 49: 2289-2293. (Pubitemid 40734456)
35. Varmus, H., Klausner, R., Zerhouni, E., Acharya, T., Daar, A. S., and, Singer, P. A. 2003. Grand Challenges in Global Health. Science, 302: 398-399. (Pubitemid 37296252)
36. Vianna, E. O., Souza, M. L. D., Meneghini, A. C., Ferraz, E., and, Borges, M. C. 2009. Knowledge of and Technique for Using Inhalation Devices Among Asthma Patients and Copd Patients. J. Bras. Pneumol., 35: 824-831.
37. 2011. Frequently Asked Questions About tb and hiv. World Health Organization, Geneva,. http://www.who.int/tb/hiv/faq/en/ World Health Organization
38. Wolf, A. J., Linas, B., Trevejo-Nunez, G. J., Kincaid, E., Tamura, T., Takatsu, K., and, Ernst, J. D. 2007. Mycobacterium tuberculosis Infects Dendritic Cells with high Frequency and Impairs Their Function in Vivo. J. Immunol., 179: 2509-2519.