Development of a formulation platform for a spray-dried, inhalable tuberculosis vaccine candidate
Tài liệu tham khảo
Aguilo, 2016, Pulmonary but not subcutaneous delivery of BCG vaccine confers protection to tuberculosis-susceptible mice by an interleukin 17-dependent mechanism, J. Infect. Dis., 213, 813, 10.1093/infdis/jiv503
Andersen, 2005, The success and failure of BCG - implications for a novel tuberculosis vaccine, Nat. Rev. Microbiol., 3, 656, 10.1038/nrmicro1211
Argarkhedkar, 2014, Safety and immunogenicity of dry powder measles vaccine administered by inhalation: a randomized controlled Phase 1 clinical trial, Vaccine, 32, 6791, 10.1016/j.vaccine.2014.09.071
Arora, 2016, Highly respirable dry powder inhalable formulation of voriconazole with enhanced pulmonary bioavailability, Expert Opin. Drug Del., 13, 183, 10.1517/17425247.2016.1114603
Bahamondez-Canas, 2018, Intranasal immunization with dry powder vaccines, Eur. J. Pharm. Biopharm., 122, 167, 10.1016/j.ejpb.2017.11.001
Bakry, 2016, Stability of tuna oil and tuna oil/peppermint oil blend microencapsulated using whey protein isolate in combination with carboxymethyl cellulose or pullulan, Food Hydrocolloids, 60, 559, 10.1016/j.foodhyd.2016.04.026
Bertholet, 2010, A defined tuberculosis vaccine candidate boosts BCG and protects against multidrug-resistant Mycobaterium tuberculosis, Sci. Transl. Med., 2, 53, 10.1126/scitranslmed.3001094
Boraey, 2014, Diffusion controlled formation of microparticles, J. Aerosol Sci., 67, 131, 10.1016/j.jaerosci.2013.10.002
Carrigy, 2019, Amorphous pullulan trehalose microparticle platform for respiratory delivery, Int. J. Pharm., 563, 156, 10.1016/j.ijpharm.2019.04.004
Carrigy, 2019, Engineering stable spray-dried biologic powder for inhalation, 291
Borgström, 2000, Variability in lung deposition of inhaled drug, within and between asthmatic patients, with a pMDI and a dry powder inhaler, Turbuhaler®, Int. J. Pharm., 193, 227, 10.1016/S0378-5173(99)00341-5
Carrigy, 2019, Spray-dried anti-Campylobacter bacteriophage CP30A powder suitable for global distribution without cold chain infrastructure, Int. J. Pharm., 569, 1, 10.1016/j.ijpharm.2019.118601
Carrigy, 2019, Trileucine and pullulan improve anti-Campylobacter bacteriophage stability in engineered spray-dried microparticles, Ann. Biomed. Eng., 48, 1169, 10.1007/s10439-019-02435-6
Chan, 2017, Particle sizing of nanoparticle adjuvant formulations by dynamic light scattering (DLS) and nanoparticle tracking analysis (NTA), Methods Mol. Biol., 1494, 239, 10.1007/978-1-4939-6445-1_17
Chen, 2004, Single intranasal mucosal Mycobacterium bovis BCG vaccination confers improved protection compared to subcutaneous vaccination against pulmonary tuberculosis, Infect. Immun., 72, 238, 10.1128/IAI.72.1.238-246.2004
Chen, 2011, Destabilization of artificial biomembrane induced by the penetration of tryptophan, Appl. Surf. Sci., 257, 5070, 10.1016/j.apsusc.2011.01.023
de Boer, 2017, Dry powder inhalation: past, present and future, Expert Opin. Drug Del., 14, 499, 10.1080/17425247.2016.1224846
Derrick, 2014, Intranasal administration of Mycobacterium bovis BCG induces superior protection against aerosol infection with Mycobacterium tuberculosis in mice, Clin. Vaccine Immunol., 21, 1443, 10.1128/CVI.00394-14
Ekdawi-Sever, 2003, Diffusion of sucrose and α, α-trehalose in aqueous solutions, J. Phys. Chem. A, 107, 936, 10.1021/jp020187b
Erickson, 2009, Size and shape of protein molecules at the nanometer level determined by sedimentation, gel filtration, and electron microscopy, Biol. Proc. Online, 11, 32, 10.1007/s12575-009-9008-x
Feng, 2011, Mechanistic models facilitate efficient development of leucine containing microparticles for pulmonary drug delivery, Int. J. Pharm., 409, 156, 10.1016/j.ijpharm.2011.02.049
Finlay, 2019
Flynn, 2011, Macrophages and control of granulomatous inflammation in tuberculosis, Mucosal Immunol., 4, 271, 10.1038/mi.2011.14
Fox, 2013, Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania, Vaccine, 31, 1633, 10.1016/j.vaccine.2012.10.048
Gomez, M., Archer, M., Barona, D., Wang, H., Ordoubadi, M., Bin Karim, S., Carrigy, N.B., Wang, Z., McCollum, J., Press, C., Gerhardt, A., Fox, C.B., Kramer, R.M., Vehring, R., 2020. Microparticle encapsulation of subunit tuberculosis vaccine candidate containing nanoemulsion adjuvants via spray drying. Manuscript submitted for publication.
Grasmeijer, 2016, Model to predict inhomogeneous protein-sugar distribution in powders prepared by spray drying, J. Aerosol Sci., 101, 22, 10.1016/j.jaerosci.2016.07.012
Grasmeijer, 2019, Identifying critical process steps to protein stability during spray drying using a vibrating mesh or a two-fluid nozzle, Eur. J. Pharm. Sci., 128, 152, 10.1016/j.ejps.2018.11.027
Grgic, 2004, Regional aerosol deposition and flow measurements in an idealized mouth and throat, J. Aerosol Sci., 35, 21, 10.1016/S0021-8502(03)00387-2
Hesseling, 2009, Disseminated bacille Calmette-Guerin disease in HIV-infected South African infants, Bull. World Health Organ., 87, 505, 10.2471/BLT.08.055657
Hickey, 2016, Inhaled drug treatment for tuberculosis: past progress and future prospects, J. Control. Release, 240, 127, 10.1016/j.jconrel.2015.11.018
Hoe, 2014, Use of a fundamental approach to spray-drying formulation design to facilitate the development of multi-component dry powder aerosols for respiratory drug delivery, Pharm. Res., 32, 449, 10.1007/s11095-013-1174-5
Infectious Disease Research Institute, 2019. Identifier: NCT03722472, Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults. Available: https://clinicaltrials.gov/ct2/show/NCT03722472?term=id93&draw=2&rank=1. [Accessed 23 April 2020].
Ivey, J., Bhambri, P., Lewis, D., Church, T., Finlay, W., Vehring, R., 2016. Dried corticosteroid particle formation from evaporating monodisperse propellant solution droplets. In: AAPS Annual Meeting and Exposition, Denver.
Ivey, 2010, The use of modeling in spray drying of emulsions and suspensions accelerates formulation and process development, Comput. Chem. Eng., 34, 1036, 10.1016/j.compchemeng.2010.02.031
Jones, 2017, Stability and pre-formulation development of a plant-produced anthrax vaccine candidate, Vaccine, 35, 5463, 10.1016/j.vaccine.2016.12.009
Jones, 2013, Effect of processing variables and bulk composition on the surface composition of spray dried powders of a model food system, J. Food Eng., 118, 19, 10.1016/j.jfoodeng.2013.03.027
Kanojia, 2016, A design of experiment approach to predict product and process parameters for a spray dried influenza vaccine, Int. J. Pharm., 511, 198, 10.1016/j.ijpharm.2016.08.022
Kanojia, 2017, Developments in forumulation and delivery of spray dried vaccines, Human Vaccines Immunother., 13, 2364, 10.1080/21645515.2017.1356952
Kramer, 2018, Development of a thermostable nanoemulsion adjuvanted vaccine against tuberculosis using a design-of-experiments approach, Int. J. Nanomed., 13, 3689, 10.2147/IJN.S159839
Kunda, 2015, Pulmonary dry powder vaccine of pneumococcal antigen loaded nanoparticles, Int. J. Pharm., 495, 903, 10.1016/j.ijpharm.2015.09.034
Langford, 2018, Drying technologies for biopharmaceutical applications: recent developments and future direction, Drying Technol., 36, 677, 10.1080/07373937.2017.1355318
Leathers, 2003, Biotechnical production and applications of pullulan, Appl. Microbiol. Biotechnol., 62, 468, 10.1007/s00253-003-1386-4
Lechuga-Ballesteros, 2008, Trileucine improves aerosol performance and stability of spray-dried powders for inhalation, J. Pharm. Sci., 97, 287, 10.1002/jps.21078
LeClair, 2019, Stabilization of HSV-2 viral candidate by spray drying, Int. J. Pharm., 569, 1, 10.1016/j.ijpharm.2019.118615
Leung, 2019, Thermal stabilization of viral vaccines in low-cost sugar films, Sci. Rep., 9
Leung, 2018, Effect of storage temperature on the stability of spray dried bacteriophage powders, Eur. J. Pharm. Biopharm., 127, 213, 10.1016/j.ejpb.2018.02.033
Li, 2006, London-van der Waals adhesiveness of rough particles, Powder Technol., 161, 248, 10.1016/j.powtec.2005.10.012
Li, 2016, L-Leucine as an excipient against moisture on in vitro aerosolization performances of highly hygroscopic spray-dried powders, Eur. J. Pharm. Biopharm., 102, 132, 10.1016/j.ejpb.2016.02.010
Marple, 2003, Next generation pharmaceutical impactor (a new impactor for pharmaceutical inhaler testing) Part 1: Design, J. Aerosol Med., 16, 283, 10.1089/089426803769017659
McAdams, 2012, Spray drying and vaccine stabilization, Exp. Rev. Vaccines, 11, 1211, 10.1586/erv.12.101
Nakagaki, 1982, Penetration of leucine and norleucine into lecithin monolayers from underlying aqueous solutions, Bull. Chem. Soc. Jpn., 55, 3381, 10.1246/bcsj.55.3381
Orr, 2013, Adjuvant formulation structure and composition are critical for the development of an effective vaccine against tuberculosis, J. Control. Release, 172, 190, 10.1016/j.jconrel.2013.07.030
Orr, 2014, Elimination of the cold-chain dependance of a nanoemulsion adjuvant vaccine against tuberculois by lyophilization, J. Control. Release, 10, 20, 10.1016/j.jconrel.2013.12.025
Pavkov, 2010, Characteristics of a capsule based dry powder inhaler for the delivery of indacterol, Curr. Med. Res. Opin., 26, 2527, 10.1185/03007995.2010.518916
Price, 2020, Design and optimization of a temperature-stable dry powder BCG vaccine, Pharm. Res., 37, 1
Raula, 2010, Investigations on particle surface characteristics vs. dispersion behaviour of L-leucine coated carrier-free inhalable powders, Int. J. Pharm., 385, 79, 10.1016/j.ijpharm.2009.10.036
Ruzycki, 2018, An in vitro examination of the effects of altitude on dry powder inhaler performance, J. Aerosol Med. Pulmonary Drug Del., 31, 221, 10.1089/jamp.2017.1417
Sangon Biotech, 2018. Safety Data Sheets: Pullulan. Available: https://www.sangon.com/productImage/SDS/A506209/A506209_EN_S.pdf. [Accessed 5 April 2020].
Shang, 2015, Comparative numerical modeling of inhaled micron-sized particle deposition in human and rate nasal cavities, Inhalation Toxicol., 27, 694, 10.3109/08958378.2015.1088600
Sibum, 2020, Dispersity and storage stability optimization of high dose ioniazid dry powder inhalation formulations with L-leucine or trileucine, Pharmaceutics, 12, 1
Sigma-Aldrich, 2020. Safety Data Sheet: L-Leucine. Available: https://www.sigmaaldrich.com/catalog/product/sigma/l8000?lang=en®ion=US. [Accessed 5 April 2020].
Sou, 2015, Spray-dried influenza antigen with trehalose and leucine produces an aerosolizable powder vaccine formulation that induces strong systemic and mucosal immunity after pulmonary administration, J. Aerosol Med. Pulmonary Drug Del., 28, 361, 10.1089/jamp.2014.1176
Toniolo, 2019, Excipient selection for thermally stable enveloped and non-enveloped viral vaccine platforms in dry powders, Int. J. Pharm., 561, 66, 10.1016/j.ijpharm.2019.02.035
United States Pharmacopeia, 2017. <601> Aerosols, nasal sprays, metered-dose inhalers, and dry powder inhalers.
Usmani, 2005, Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size, Am. J. Respir. Crit. Care Med., 172, 1497, 10.1164/rccm.200410-1414OC
Vandenheuvel, 2014, Instability of bacteriophages in spray-dried trehalose powders is caused by crystallization of the matrix, Int. J. Pharm., 472, 202, 10.1016/j.ijpharm.2014.06.026
Vehring, 2005, Red-excitation dispersive Raman spectroscopy is a suitable technique for solid-state analysis of respirable pharmaceutical powders, Appl. Spectrosc., 59, 286, 10.1366/0003702053585318
Vehring, 2008, Pharmaceutical particle engineering via spray drying, Pharm. Res., 25, 999, 10.1007/s11095-007-9475-1
Vehring, 2007, Particle formation in spray drying, Aerosol Sci., 38, 728, 10.1016/j.jaerosci.2007.04.005
Verreck, 2017, Variable BCG efficacy in rhesus populations: pulmonary BCG provides protection where standard intradermal vaccination fails, Tuberculosis, 104, 46, 10.1016/j.tube.2017.02.003
Wang, 2017, Macro-Raman spectroscopy for bulk composition and homogeneity analysis of multi-component pharmaceutical powders, J. Pharm. Biomed. Anal., 141, 180, 10.1016/j.jpba.2017.04.003
Wang, 2016, Micro-encapsulation and stabilization of DHA containing fishoil in protein-based emulsion through mono-disperse droplet spray dryer, J. Food Eng., 175, 74, 10.1016/j.jfoodeng.2015.12.007
Wang, 2019, Particle surface roughness improves colloidal stability of pressured pharmaceutical suspensions, Pharm. Res., 36
World Health Organization (WHO), 2006. Temperature sensitivity of vaccines. Available: https://apps.who.int/iris/handle/10665/69387. [Accessed 17 April 2020].
World Health Organization, 2018
World Health Organization, 2019
Zhang, 2007, In vivo-in vitro comparison of deposition in three mouth-throat models with Qvar® and Turbuhaler® inhalers, J. Aerosol Med., 20, 227, 10.1089/jam.2007.0584
Zhou, 2011, Comparison of deposition in the USP and physical mouth-throat models with solid and liquid particles, J. Aerosol Med. Pulmonary Drug Del., 24, 277, 10.1089/jamp.2011.0882