Composite films for vaginal delivery of tenofovir disoproxil fumarate and emtricitabine
Tài liệu tham khảo
World Health Organization, Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV, Geneva, Switzerland, 2015.
PrEPWatch, Country Updates. Available from URL: <http://www.prepwatch.org/advocacy/country-updates/> (accessed Dec 9, 2017).
Baeten, 2012, Antiretroviral prophylaxis for HIV prevention in heterosexual men and women, N. Engl. J. Med., 367, 399, 10.1056/NEJMoa1108524
Thigpen, 2012, Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana, N. Engl. J. Med., 367, 423, 10.1056/NEJMoa1110711
McCormack, 2016, Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial, Lancet, 387, 53, 10.1016/S0140-6736(15)00056-2
Marrazzo, 2015, VOICE Study Team, Tenofovir-based preexposure prophylaxis for HIV infection among African women, N. Engl. J. Med., 372, 509, 10.1056/NEJMoa1402269
Van Damme, 2012, Preexposure prophylaxis for HIV infection among African women, N. Engl. J. Med., 367, 411, 10.1056/NEJMoa1202614
Murnane, 2013, Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial, AIDS, 27, 2155, 10.1097/QAD.0b013e3283629037
Sheth, 2016, HIV pre-exposure prophylaxis for women, J. Virus Erad., 2, 149, 10.1016/S2055-6640(20)30458-1
Cottrell, 2016, A translational pharmacology approach to predicting outcomes of preexposure prophylaxis against HIV in men and women using tenofovir disoproxil fumarate with or without emtricitabine, J. Infect. Dis., 214, 55, 10.1093/infdis/jiw077
Donnell, 2014, HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention, J. Acquir. Immune Defic. Syndr., 66, 340, 10.1097/QAI.0000000000000172
Molina, 2015, On-demand preexposure prophylaxis in men at high risk for HIV-1 infection, N. Engl. J. Med., 373, 2237, 10.1056/NEJMoa1506273
Baeten, 2013, Systemic and topical drugs for the prevention of HIV infection: antiretroviral pre-exposure prophylaxis, Annu. Rev. Med., 64, 219, 10.1146/annurev-med-050911-163701
Cottrell, 2014, Topical microbicides and HIV prevention in the female genital tract, J. Clin. Pharmacol., 54, 603, 10.1002/jcph.292
Abdool Karim, 2010, Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women, Science, 329, 1168, 10.1126/science.1193748
Baeten, 2016, MTN-Aspire Study Team, Use of a vaginal ring containing dapivirine for HIV-1 prevention in women, N. Engl. J. Med., 375, 2121, 10.1056/NEJMoa1506110
Nel, 2016, Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women, N. Engl. J. Med., 375, 2133, 10.1056/NEJMoa1602046
Srinivasan, 2016, Topical delivery of tenofovir disoproxil fumarate and emtricitabine from pod-intravaginal rings protects macaques from multiple SHIV exposures, PLoS One, 11, e0157061, 10.1371/journal.pone.0157061
Moss, 2014, Pharmacokinetics and preliminary safety study of pod-intravaginal rings delivering antiretroviral combinations for HIV prophylaxis in a macaque model, Antimicrob. Agents Chemother., 58, 5125, 10.1128/AAC.02871-14
Clark, 2014, Evaluation of rapidly disintegrating vaginal tablets of tenofovir, emtricitabine and their combination for HIV-1 prevention, Pharmaceutics, 6, 616, 10.3390/pharmaceutics6040616
Nel, 2011, Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women, J. Womens Health (Larchmt.), 20, 1207, 10.1089/jwh.2010.2476
Rohan, 2014, Vaginal microbicide films, 291
Caramella, 2015, Mucoadhesive and thermogelling systems for vaginal drug delivery, Adv. Drug Deliv. Rev., 92, 39, 10.1016/j.addr.2015.02.001
das Neves, 2017, Antiretroviral drug-loaded nanoparticles-in-films: a new option for developing vaginal microbicides?, Expert Opin. Drug Deliv., 14, 449, 10.1080/17425247.2017.1270938
Sosnik, 2015, Advantages and challenges of the spray-drying technology for the production of pure drug particles and drug-loaded polymeric carriers, Adv. Colloid Interface Sci., 223, 40, 10.1016/j.cis.2015.05.003
Destache, 2016, Topical tenofovir disoproxil fumarate nanoparticles prevent HIV-1 vaginal transmission in a humanized mouse model, Antimicrob. Agents Chemother., 60, 3633, 10.1128/AAC.00450-16
Cunha-Reis, 2016, Nanoparticles-in-film for the combined vaginal delivery of anti-HIV microbicide drugs, J. Control. Release, 243, 43, 10.1016/j.jconrel.2016.09.020
Smith, 2013, Intravaginal ring eluting tenofovir disoproxil fumarate completely protects macaques from multiple vaginal simian-HIV challenges, Proc. Natl. Acad. Sci. U.S.A., 110, 16145, 10.1073/pnas.1311355110
Machado, 2016, Development and in vivo safety assessment of tenofovir-loaded nanoparticles-in-film as a novel vaginal microbicide delivery system, Acta Biomater., 44, 332, 10.1016/j.actbio.2016.08.018
Owen, 1999, A vaginal fluid simulant, Contraception, 59, 91, 10.1016/S0010-7824(99)00010-4
Moore, 1996, Mathematical comparison of dissolution profiles, Pharm. Tech., 20, 64
International Organization for Standardization, ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity, Geneva, Switzerland.
Gallay, 2017, Prevention of vaginal and rectal HIV transmission by antiretroviral combinations in humanized mice, PLoS One, 12, e0184303, 10.1371/journal.pone.0184303
Laborde, 2017, Impact of the dapivirine vaginal ring on sexual experiences and intimate partnerships of women in an HIV prevention clinical trial: managing ring detection and hot sex, AIDS Behav.
Ramazani, 2016, Strategies for encapsulation of small hydrophilic and amphiphilic drugs in PLGA microspheres: state-of-the-art and challenges, Int. J. Pharm., 499, 358, 10.1016/j.ijpharm.2016.01.020
Thakral, 2013, Eudragit: a technology evaluation, Expert Opin. Drug Deliv., 10, 131, 10.1517/17425247.2013.736962
Larsson, 2012, Suspension stability; why particle size, zeta potential and rheology are important, Ann. Trans. Nord. Rheol. Soc., 20, 209
Bootz, 2004, Comparison of scanning electron microscopy, dynamic light scattering and analytical ultracentrifugation for the sizing of poly(butyl cyanoacrylate) nanoparticles, Eur. J. Pharm. Biopharm., 57, 369, 10.1016/S0939-6411(03)00193-0
Pokharkar, 2015, Engineering of a hybrid polymer-lipid nanocarrier for the nasal delivery of tenofovir disoproxil fumarate: physicochemical, molecular, microstructural, and stability evaluation, Eur. J. Pharm. Sci., 71, 99, 10.1016/j.ejps.2015.02.009
Mandal, 2017, An enhanced emtricitabine-loaded long-acting nanoformulation for prevention or treatment of HIV infection, Antimicrob. Agents Chemother., 61, e01475-16, 10.1128/AAC.01475-16
Schafroth, 2012, Nano and microparticle engineering of water insoluble drugs using a novel spray-drying process, Colloids Surf. B Biointerfaces, 90, 8, 10.1016/j.colsurfb.2011.09.038
Seremeta, 2014, Spray-dried didanosine-loaded polymeric particles for enhanced oral bioavailability, Colloids Surf. B Biointerfaces, 123, 515, 10.1016/j.colsurfb.2014.09.055
Akil, 2015, Formulation and characterization of polymeric films containing combinations of antiretrovirals (ARVs) for HIV prevention, Pharm. Res., 32, 458, 10.1007/s11095-014-1474-4
Cunha, 2014, Characterization of commercially available vaginal lubricants: a safety perspective, Pharmaceutics, 6, 530, 10.3390/pharmaceutics6030530
Preis, 2014, Mechanical strength test for orodispersible and buccal films, Int. J. Pharm., 461, 22, 10.1016/j.ijpharm.2013.11.033
Fan, 2016, Preferred physical characteristics of vaginal film microbicides for HIV prevention in Pittsburgh women, Arch. Sex. Behav., 46, 1111, 10.1007/s10508-016-0816-1
Dezzutti, 2012, Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity, PLoS One, 7, e48328, 10.1371/journal.pone.0048328
Levin, 2003, A journey through two lumens!, Int. J. Impot. Res., 15, 2, 10.1038/sj.ijir.3900977
Fernández-Romero, 2015, Preclinical assessments of vaginal microbicide candidate safety and efficacy, Adv. Drug Deliv. Rev., 92, 27, 10.1016/j.addr.2014.12.005
das Neves, 2015, Precise engineering of dapivirine-loaded nanoparticles for the development of anti-HIV vaginal microbicides, Acta Biomater., 18, 77, 10.1016/j.actbio.2015.02.007
Catalone, 2005, Comparative safety evaluation of the candidate vaginal microbicide C31G, Antimicrob. Agents Chemother., 49, 1509, 10.1128/AAC.49.4.1509-1520.2005
Gali, 2010, In vitro evaluation of viability, integrity and inflammation in genital epithelia upon exposure to pharmaceutical excipients and candidate microbicides, Antimicrob. Agents Chemother., 54, 5105, 10.1128/AAC.00456-10
Hillier, 2005, In vitro and in vivo: the story of nonoxynol 9, J. Acquir. Immune Defic. Syndr., 39, 1, 10.1097/01.qai.0000159671.25950.74