Development of Recombinant Human Growth Hormone (rhGH) sustained-release microspheres by a low temperature aqueous phase/aqueous phase emulsion method

European Journal of Pharmaceutical Sciences - Tập 62 - Trang 141-147 - 2014
Jian Kang1, Fei Wu1, Yunpeng Cai1, Mingxin Xu1, Mu He1, Weien Yuan1
1School of Pharmacy, Shanghai Jiao Tong University, 800 Dongchuan Road, Shanghai 200240, China

Tài liệu tham khảo

Bewley, 1972, Circular dichroism studies on human pituitary growth hormone and ovine pituitary lactogenic hormone, Biochemistry, 11, 884, 10.1021/bi00755a030 Cázares-Delgadillo, 2011, Human growth hormone: new delivery systems, alternative routes of administration, and their pharmacological relevance, Eur. J. Pharm. Biopharm., 78, 278, 10.1016/j.ejpb.2011.01.006 Chung, 2008, Thermo-sensitive and biodegradable hydrogels based on stereocomplexed Pluronic multi-block copolymers for controlled protein delivery, J. Control. Release, 127, 22, 10.1016/j.jconrel.2007.12.008 Cleland, 1996, Stable formulations of recombinant human growth hormone and interferon-gamma for microencapsulation in biodegradable microspheres, Pharm. Res., 13, 1464, 10.1023/A:1016063109373 Cleland, 1997, Recombinant human growth hormone poly(lactic-co-glycolic acid) (PLGA) microspheres provide a long lasting effect, J. Control. Release, 49, 193, 10.1016/S0168-3659(97)00075-8 Cleland, 1997, Recombinant human growth hormone poly(lactic-co-glycolic acid) microsphere formulation development, Adv. Drug Del. Rev., 28, 71, 10.1016/S0169-409X(97)00051-3 Elbert, 2001, Protein delivery from materials formed by self-selective conjugate addition reactions, J. Control. Release, 76, 11, 10.1016/S0168-3659(01)00398-4 Fu, 2000, Visual evidence of acidic environment within degrading poly(lactic-co-glycolic acid) (PLGA) microspheres, Pharm. Res., 17, 100, 10.1023/A:1007582911958 Geng, 2008, Formulating erythropoietin-loaded sustained-release PLGA microspheres without protein aggregation, J. Control. Release, 130, 259, 10.1016/j.jconrel.2008.06.011 Gertler, 1986, Human growth hormone-stimulated mitogenesis of Nb2 node lymphoma cells is not mediated by an immediate acceleration of phosphoinositide metabolism, Mol. Cell. Endocrinol., 48, 221, 10.1016/0303-7207(86)90045-6 Govardhan, 2005, Novel long-acting crystal formulation of human growth hormone, Pharm. Res., 22, 1461, 10.1007/s11095-005-6021-x Jin, 2008, Preparing polymer-based sustained-release systems without exposing proteins to water–oil or water–air interfaces and cross-linking reagents, J. Control. Release, 128, 50, 10.1016/j.jconrel.2008.02.010 Johnson, 1996, A month-long effect from a single injection of microencapsulated human growth hormone, Nat. Med., 2, 795, 10.1038/nm0796-795 Johnson, 1997, The stabilization and encapsulation of human growth hormone into biodegradable microspheres, Pharm. Res., 14, 730, 10.1023/A:1012142204132 Jordan, 2010, Sustained release hGH microsphere formulation produced by a novel supercritical fluid technology: in vivo studies, J. Control. Release, 141, 153, 10.1016/j.jconrel.2009.09.013 Kakizawa, 2010, Controlled release of protein drugs from newly developed amphiphilic polymer-based microparticles composed of nanoparticles, J. Control. Release, 142, 8, 10.1016/j.jconrel.2009.09.024 Kim, 1999, Microencapsulation of human growth hormone within biodegradable polyester microspheres: protein aggregation stability and incomplete release mechanism, Biotechnol. Bioeng., 65, 659, 10.1002/(SICI)1097-0290(19991220)65:6<659::AID-BIT6>3.0.CO;2-9 Kim, 2005, Development of a novel sustained release formulation of recombinant human growth hormone using sodium hyaluronate microparticles, J. Control. Release, 104, 323, 10.1016/j.jconrel.2005.02.012 Kim, 2006, Biodegradable polymeric microspheres with“open/closed” pores for sustained release of human growth hormone, J. Control. Release, 112, 167, 10.1016/j.jconrel.2006.02.004 Kwak, 2009, Development of a sustained-release recombinant human growth hormone formulation, J. Control. Release, 137, 160, 10.1016/j.jconrel.2009.03.014 Laursen, 1995, Continuous infusion versus daily injections of growth hormone (GH) for 4 weeks in GH deficient patients, J. Clin. Endocrinol. Metab., 80, 2410 Lee, 1997, In vivo characterization of sustained-release formulations of human growth hormone, J. Pharmacol. Exp. Ther., 281, 1431 Lee, 2005, Stabilizing peptide fusion for solving the stability and solubility problems of therapeutic proteins, Pharm. Res., 22, 1735, 10.1007/s11095-005-6489-4 Park, 2010, Sustained delivery of human growth hormone using a polyelectrolyte complex-loaded thermosensitive polyphosphazene hydrogel, J. Control. Release, 147, 359, 10.1016/j.jconrel.2010.07.126 Reiter, 2001, A multicenter study of the efficacy and safety of sustained release GH in the treatment of naive pediatric patients with GH deficiency, J. Clin. Endocrinol. Metab., 86, 4700, 10.1210/jcem.86.10.7932 Ren, 2011, Sustained-release polylactide-co-glycolide microspheres loaded with pre-formulated protein polysaccharide nanoparticles, Micro Nano Lett., 6, 70, 10.1049/mnl.2010.0107 Ricci, 2003, PH dependence of structural stability of interleukin-2 and granulocyte colony-stimulating factor, Protein Sci., 12, 1030, 10.1110/ps.0230103 Rong, 2011, Neuroprotective effect of erythropoietin-loaded composite microspheres on retinal ganglion cells in rats, Eur. J. Pharm. Sci., 43, 334, 10.1016/j.ejps.2011.05.011 Schwendeman, 2002, Recent advances in the stabilization of protein encapsulated in injectable PLGA delivery systems, Crit. Rev. Ther. Drug Carrier Syst., 19, 73, 10.1615/CritRevTherDrugCarrierSyst.v19.i1.20 Seo, 2011, The biological efficiency and bioavailability of human growth hormone delivered using injectable, ionic, thermosensitive poly(organophosphazene)-polyethylenimine conjugate hydrogels, Biomaterials, 32, 8271, 10.1016/j.biomaterials.2011.07.033 Tae, 2005, Sustained release of human growth hormone from in situ forming hydrogels using self-assembly of fluoroalkyl-ended poly(ethylene glycol), Biomaterials, 26, 5259, 10.1016/j.biomaterials.2005.01.042 Takada, 2003, A new animal model for evaluation of long-term growth rate over one month by rhGH/PLGA microcapsule formulations, J. Pharm. Pharmacol., 55, 951, 10.1211/0022357021323 Wolfson, 2006, Amber codon fashing ambrx augments proteins with unnatural amino acids, Chem. Biol., 3, 1011, 10.1016/j.chembiol.2006.10.003 Yang, 2009, Formulating protein therapeutics into particulate forms, Expert Opin. Drug Del., 6, 1123, 10.1517/17425240903156374 Yuan, 2011, Surgical wound healing using hemostatic gauze scaffold loaded with nanoparticles containing sustained-release granulocyte colony-stimulating factor, Int. J. Nanomed., 6, 3139, 10.2147/IJN.S26006 Yuan, 2012, Controlled-release and preserved bioactivity of proteins from (self-assembled) core-shell double-walled microspheres, Int. J. Nanomed., 7, 257, 10.2147/IJN.S27621 Yuan, 2007, Preparation of dextran glassy particles through freezing-induced phase separation, Int. J. Pharm., 339, 76, 10.1016/j.ijpharm.2007.02.018 Yuan, 2009, Preparation of polysaccharide glassy nanoparticles with stabilization of proteins, Int. J. Pharm., 366, 154, 10.1016/j.ijpharm.2008.09.007 Yuan, 2009, Development of protein delivery microsphere system by a novel s/o/o/w multi-emulsion, Eur. J. Pharm. Sci., 36, 212, 10.1016/j.ejps.2008.08.009 Yuan, 2010, Preparation of protein-loaded sustained-release microspheres via ‘solid-in-oil-in-hydrophilic oil-in-ethanol (S/O/hO/E)’ emulsification, Colloids Surf. B, 79, 326, 10.1016/j.colsurfb.2010.04.004