Optimization of formulation for enhanced intranasal delivery of insulin with translationally controlled tumor protein-derived protein transduction domain

References

• Arora P, Sharma S, Garg S. (2002). Permeability issues in nasal drug delivery. Drug Discov Today 7:967–75.
   PubMed Web of Science ®Google Scholar
• Avgerinos KI, Kalaitzidis G, Malli A, et al. (2018). Intranasal insulin in Alzheimer's dementia or mild cognitive impairment: a systematic review. J Neurol 265:1497–510.
   PubMed Web of Science ®Google Scholar
• Bae HD, Lee K. (2013). On employing a translationally controlled tumor protein-derived protein transduction domain analog for transmucosal delivery of drugs. J Control Release 170:358–64.
   PubMed Web of Science ®Google Scholar
• Bae H-D, Lee J, Jin X-H, et al. (2016). Potential of translationally controlled tumor protein-derived protein transduction domains as antigen carriers for nasal vaccine delivery. Mol Pharm 13:3196–205.
   PubMed Web of Science ®Google Scholar
• Bae H-D, Lee J, Jun K-Y, et al. (2018). Modification of translationally controlled tumor protein-derived protein transduction domain for improved intranasal delivery of insulin. Drug Deliv 25:1025–32.
   PubMed Web of Science ®Google Scholar
• Borzova VA, Markossian KA, Kleymenov SY, et al. (2017). A change in the aggregation pathway of bovine serum albumin in the presence of arginine and its derivatives. Sci Rep 7:3984.
   PubMed Web of Science ®Google Scholar
• Chandler SG, Thomas NW, Illum L. (1994). Nasal absorption in the rat. III. Effect of lysophospholipids on insulin absorption and nasal histology. Pharm Res 11:1623–30.
   PubMed Web of Science ®Google Scholar
• Choi J-M, Ahn M-H, Chae W-J, et al. (2006). Intranasal delivery of the cytoplasmic domain of CTLA-4 using a novel protein transduction domain prevents allergic inflammation. Nat Med 12:574–9.
   PubMed Web of Science ®Google Scholar
• D'Souza R, Mutalik S, Venkatesh M, et al. (2005). Insulin gel as an alternate to parenteral insulin: formulation, preclinical, and clinical studies. AAPS PharmSciTech 6:E184–9.
   PubMed Web of Science ®Google Scholar
• Dyer AM, Hinchcliffe M, Watts P, et al. (2002). Nasal delivery of insulin using novel chitosan based formulations: a comparative study in two animal models between simple chitosan formulations and chitosan nanoparticles. Pharm Res 19:998–1008.
   PubMed Web of Science ®Google Scholar
• el-Etr M, Slama G, Desplanque N. (1987). Preprandial intranasal insulin as adjuvant therapy in type II diabetics. Lancet 2:1085–6.
   PubMed Web of Science ®Google Scholar
• Fortuna A, Alves G, Serralheiro A, et al. (2014). Intranasal delivery of systemic-acting drugs: small-molecules and biomacromolecules. Eur J Pharm Biopharm 88:8–27.
   PubMed Web of Science ®Google Scholar
• Frauman AG, Jerums G, Louis WJ. (1987a). Effects of intranasal insulin in non-obese type II diabetics. Diabetes Res Clin Pract 3:197–202.
   PubMed Web of Science ®Google Scholar
• Frauman AG, Cooper ME, Parsons BJ, et al. (1987b). Long-term use of intranasal insulin in insulin-dependent diabetic patients. Diabetes Care 10:573–8.
   PubMed Web of Science ®Google Scholar
• Grassin-Delyle S, Buenestado A, Naline E, et al. (2012). Intranasal drug delivery: an efficient and non-invasive route for systemic administration: focus on opioids. Pharmacol Ther 134:366–79.
   PubMed Web of Science ®Google Scholar
• Guidotti G, Brambilla L, Rossi D. (2017). Cell-penetrating peptides: from basic research to clinics. Trends Pharmacol Sci 38:406–24.
   PubMed Web of Science ®Google Scholar
• Gupta B, Levchenko TS, Torchilin VP. (2005). Intracellular delivery of large molecules and small particles by cell-penetrating proteins and peptides. Adv Drug Deliv Rev 57:637–51.
   PubMed Web of Science ®Google Scholar
• Hinchcliffe M, Illum L. (1999). Intranasal insulin delivery and therapy. Adv Drug Deliv Rev 35:199–234.
   PubMed Web of Science ®Google Scholar
• Hussain AA. (1998). Intranasal drug delivery. Adv Drug Deliv Rev 29:39–49.
   PubMed Web of Science ®Google Scholar
• Jarver P, Langel U. (2004). The use of cell-penetrating peptides as a tool for gene regulation. Drug Discov Today 9:395–402.
   PubMed Web of Science ®Google Scholar
• Khafagy E-S, Morishita M, Isowa K, et al. (2009). Effect of cell-penetrating peptides on the nasal absorption of insulin. J Control Release 133:103–8.
   PubMed Web of Science ®Google Scholar
• Khafagy E-S, Kamei N, Nielsen EJB, et al. (2013). One-month subchronic toxicity study of cell-penetrating peptides for insulin nasal delivery in rats. Eur J Pharm Biopharm 85:736–43.
   PubMed Web of Science ®Google Scholar
• Kim M, Maeng J, Jung J, et al. (2011a). Design and evaluation of variants of the protein transduction domain originated from translationally controlled tumor protein. Eur J Pharm Sci 43:25–31.
   PubMed Web of Science ®Google Scholar
• Kim M, Kim M, Kim HY, et al. (2011b). A protein transduction domain located at the NH2-terminus of human translationally controlled tumor protein for delivery of active molecules to cells. Biomaterials 32:222–30.
   PubMed Web of Science ®Google Scholar
• Kim NA, Thapa R, Jeong SH, et al. (2019). Enhanced intranasal insulin delivery by formulations and tumor protein-derived protein transduction domain as an absorption enhancer. J Control Release 294:226–36.
   PubMed Web of Science ®Google Scholar
• Mathias NR, Hussain MA. (2010). Non-invasive systemic drug delivery: developability considerations for alternate routes of administration. J Pharm Sci 99:1–20.
   PubMed Web of Science ®Google Scholar
• Meade BR, Dowdy SF. (2007). Exogenous siRNA delivery using peptide transduction domains/cell penetrating peptides. Adv Drug Deliv Rev 59:134–40.
   PubMed Web of Science ®Google Scholar
• Morris MC, Depollier J, Mery J, et al. (2001). A peptide carrier for the delivery of biologically active proteins into mammalian cells. Nat Biotechnol 19:1173–6.
   PubMed Web of Science ®Google Scholar
• Owens DR, Zinman B, Bolli G. (2003). Alternative routes of insulin delivery. Diabet Med 20:886–98.
   PubMed Web of Science ®Google Scholar
• Pires A, Fortuna A, Alves G, et al. (2009). Intranasal drug delivery: how, why and what for? J Pharm Pharm Sci 12:288–311.
   PubMed Web of Science ®Google Scholar
• Sakuma S, Suita M, Masaoka Y, et al. (2010). Oligoarginine-linked polymers as a new class of penetration enhancers. J Control Release 148:187–96.
   PubMed Web of Science ®Google Scholar
• Schwarze SR, Hruska KA, Dowdy SF. (2000). Protein transduction: unrestricted delivery into all cells? Trends Cell Biol 10:290–5.
   PubMed Web of Science ®Google Scholar
• Shao Z, Krishnamoorthy R, Mitra AK. (1992). Cyclodextrins as nasal absorption promoters of insulin: mechanistic evaluations. Pharm Res, 9 09:1157–63.
   Web of Science ®Google Scholar
• Smirnova E, Safenkova I, Stein-Margolina V, et al. (2015). pH-responsive modulation of insulin aggregation and structural transformation of the aggregates. Biochimie 109:49–59.
   PubMed Web of Science ®Google Scholar
• Vives E, Brodin P, Lebleu B. (1997). A truncated HIV-1 Tat protein basic domain rapidly translocates through the plasma membrane and accumulates in the cell nucleus. J Biol Chem 272:16010–7.
   PubMed Web of Science ®Google Scholar