Oil-in-Water Nanosized Emulsions for Drug Delivery and Targeting. Tamilvanan Shunmugaperumal

Чтение книги онлайн.

СКАЧАТЬ S.S. and Washington, C. (1988), Drug emulsion, European Patent 0,296, 845, A1.

      21 Dale, P.J., Kijlstra, J., and Vincent, B. (2006), The temperature stability of single and mixed emulsions stabilized by nonionic surfactants, Colloids Surf. A Physicochem. Eng. Aspects, 291, 85–92. doi:10.1016/j.colsurfa.2006.06.016

      22 Debevec, V., Srčič, S., and Horvat, M. (2018), Scientific, statistical, practical, and regulatory considerations in design space development, Drug Dev. Ind. Pharm., 44 (3), 349–364. doi:10.1080/03639045.2017.1409755

      23 EMA (2014), Questions and answers on level of detail in the regulatory submissions, EMA/59240/December 10, 2014.

      24 EMA (2017), Report from the EMA‐FDA QbD pilot program, EMA/213746/April 19, 2017.

      25 Eskandar, N.G., Simovic, S., and Clive, A. (2009), Nanoparticle coated submicron emulsions: sustained in‐vitro release and improved dermal delivery of all‐trans‐retinol, Pharm. Res., 26, 1764–1775. doi:10.1007/s11095‐009‐9888‐0

      26 Fahmy, R. Kona, R. Dandu, R. et al. (2012), Quality by design I: application of failure mode effect analysis (FMEA) and Plackett‐Burman design of experiments in the identification of “main factors” in the formulation and process design space for roller‐compacted ciprofloxacin hydrochloride immediate‐release tablets, AAPS PharmSciTech., 13 (4), 1243–1254. doi: 10.1208/s12249‐012‐9844‐x

      27 FDA Guidance for Industry (2004) PAT‐a framework for innovative pharmaceutical development, manufacturing, and quality assurance, (https://www.fda.gov/media/71012/download, Accessed on June 16, 2019).

      28 FDA Guidance for Industry (2006), Q8 pharmaceutical development, (https://www.fda.gov/media/71524/download, Accessed on June 16, 2019).

      29 Ghate, V.M., Kodoth, A.K., Raja, S. et al. (2019), Development of MART for the rapid production of nanostructured lipid carriers loaded with all‐trans retinoic acid for dermal delivery, AAPS PharmSciTech., 20, 162. doi:10.1208/s12249‐019‐1307‐1

      30 Goldstein, D., Gofrit, O., Nyska, A. et al. (2007a), Anti‐HER2 cationic immunoemulsion as a potential targeted drug delivery system for the treatment of prostate cancer, Cancer Res., 67, 269–275. doi:10.1158/0008‐5472.CAN‐06‐2731

      31 Goldstein, D., Nassar, T., Lambert, G. et al. (2005), The design and evaluation of a novel targeted drug delivery system using cationic emulsion‐antibody conjugates, J. Control. Release, 108, 418–432. doi:10.1016/j.jconrel.2005.08.021

      32 Goldstein, D., Sader, O., and Benita, S. (2007b), Influence of oil droplet surface charge on the performance of antibody‐emulsion conjugates, Biomed. Pharmacother., 61, 97–103. doi:10.1016/j.biopha.2006.08.005

      33 Grigoriev, D.O. and Miller, R. (2009), Mono‐ and multilayer covered drops as carriers, Curr. Opin. Colloid Interface Sci., 14, 48–59. doi:10.1016/j.cocis.2008.03.003

      34 Hagigit, T., Abdulrazik, M., Orucov, F. et al. (2010), Topical and intravitreous administration of cationic nanoemulsions to deliver antisense oligonucleotides directed towards VEGF KDR receptors to the eye, J. Control. Release, 145 (3), 297–305. doi:10.1016/j.jconrel.2010.04.013

      35 Hagigit, T., Nassar, T., Behar‐Cohen, F. et al. (2008), The influence of cationic lipid type on in vitro release kinetics of antisense oligonucleotide from cationic nanoemulsions, Eur. J. Pharm. Biopharm., 70 (1), 248–259. doi:10.1016/j.ejpb.2008.03.005

      36 Han, J. and Washington, C. (2005), Partition of antimicrobial additives in an intravenous emulsion and their effect on emulsion physical stability, Int. J. Pharm., 288 (2), 263–271. doi:10.1016/j.ijpharm.2004.10.002

      37 Hu, Z., Deng, Y., and Sun, Q. (2004), Synthesis of precipitated calcium carbonate nanoparticles using a two‐membrane system, Colloid J., 66 (6), 745–750. doi:10.1007/s10595‐005‐0017‐4

      38 ICH (2005), Q9 quality risk management, (Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf.) Accessed on August 1, 2019.

      39 ICH (2008), Q10 pharmaceutical quality system, (Availabe at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf.) Accessed on August 1, 2019.

      40 ICH (2009), Q8(R2) pharmaceutical development. Part I: pharmaceutical development, and Part II: annex to pharmaceutical development, (Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf.) Accessed on August 1, 2019.

      41 Ishii, F. and Nii, T. (2005), Properties of various phospholipid mixtures as emulsifiers or dispersing agents in nanoparticle drug carrier preparation, Colloids Surf. B Biointerfaces, 41 (4), 257–262. doi:10.1016/j.colsurfb.2004.12.018

      42 Joglekar, A.T. (1987), Product excellence through design of experiments, Cereal Foods World, 32, 857–868.

      43 Jumaa, M., Furkert, F.H., and Müller, B.W. (2002), A new lipid emulsion formulation with high antimicrobial efficacy using chitosan, Eur. J. Pharm. Biopharm., 53 (1), 115–123. doi:10.1016/s0939‐6411(01)00191‐6

      44 Jumaa, M. and Müller, B.W. (1998), The effect of oil components and homogenization condition on the physicochemical properties and stability of parenteral fat emulsions, Int. J. Pharm., 163 (s1–s2), 81–89. doi:10.1016/S0378‐5173(97)00369‐4

      45 Jumaa, M. and Müller, B.W. (1999), Physicochemical properties of chitosan‐lipid emulsions and their stability during the autoclaving process, Int. J. Pharm., 183 (2), 175–184. doi:10.1016/s0378‐5173(99)00086‐1

      46 Jumaa, M. and Müller, B.W. (2002), Parenteral emulsions stabilized with a mixture of phospholipids and PEG‐660‐12‐hydroxy‐stearate: evaluation of accelerated and long‐term stability, Eur. J. Pharm. Biopharm., 54 (2), 207–212. doi:10.1016/s0939‐6411(02)00057‐7

      47 Kador, P.F. and Kinoshita, J.H. (1978), Phospholipid effects on the rat lens transport systems, Exp. Eye Res., 26 (6), 657–665. doi:10.1016/0014‐4835(78)90100‐8

      48 Kim, T.W., Chung, H., Kwon, I.C. et al. (2005), Airway gene transfer using cationic emulsion as a mucosal gene carrier, J. Gen. Med., 7 (6), 749–758. doi:10.1002/jgm.711

      49 Kim, Y.J., Kim, T.W., Chung, H. et al. (2003), The effects of serum on the stability and the transfection activity of the cationic lipid emulsion with various oils, Int. J. Pharm., 252 (1–2), 241–252. doi:10.1016/s0378‐5173(02)00676‐2

      50 Lan, Q., Yang, F., Zhang, S. et al. (2007), Synergistic effect of silica nanoparticle and cetyltrimethyl ammonium bromide on the stabilization of O/W emulsions, Colloids Surf. A Physicochem. Eng. Aspects, 302 (1–3), 126–135. doi:10.1016/j.colsurfa.2007.02.010

      51 Lance, M.R., Washington, C., and Davis, S.S. (1995), Structure and toxicity of amphotericin B/triglyceride emulsion formulations, J. Antimicrob. Chemother., 36 (1), 119–128. doi:10.1093/jac/36.1.119

      52 Landfester, K. (2006), Synthesis of colloidal particles in miniemulsions, Annu. Rev. Mater. СКАЧАТЬ