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Research Articles

Long-term stability of insulin glulisine loaded nanoparticles formulated using an amphiphilic cyclodextrin and designed for intestinal delivery

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Pages 1073-1079 | Received 13 Jan 2020, Accepted 22 May 2020, Published online: 09 Jun 2020

References

  • Chi EY, Krishnan S, Randolph TW, et al. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm Res. 2003;20(9):1325–1336.
  • Wang W. Instability, stabilization, and formulation of liquid protein pharmaceuticals. Int J Pharm. 1999;185(2):129–188.
  • Nettleton EJ, Tito P, Sunde M, et al. Characterization of the oligomeric states of insulin in self-assembly and amyloid fibril formation by mass spectrometry. Biophys J. 2000;79(2):1053–1065.
  • Sluzky V, Tamada JA, Klibanov AM, et al. Kinetics of insulin aggregation in aqueous solutions upon agitation in the presence of hydrophobic surfaces. Proc Natl Acad Sci U S A. 1991;88(21):9377–9381.
  • Costantino HR, Langer R, Klibanov AM. Moisture-induced aggregation of lyophilized insulin. Pharm Res. 1994;11(1):21–29.
  • Valo H, Kovalainen M, Laaksonen P, et al. Immobilization of protein-coated drug nanoparticles in nanofibrillar cellulose matrices-enhanced stability and release. J Control Release. 2011;156(3):390–397.
  • O’Mahony AM, Ogier J, Desgranges S, et al. A click chemistry route to 2-functionalised PEGylated and cationic [small beta]-cyclodextrins: co-formulation opportunities for siRNA delivery. Org Biomol Chem. 2012;10(25):4954–4960.
  • Bilensoy E, Hincal AA. Recent advances and future directions in amphiphilic cyclodextrin nanoparticles. Expert Opin Drug Deliv. 2009;6(11):1161–1173.
  • Presas E, McCartney F, Sultan E, et al. Physicochemical, pharmacokinetic and pharmacodynamic analyses of amphiphilic cyclodextrin-based nanoparticles designed to enhance intestinal delivery of insulin. J Control Release. 2018;286:402–414.
  • Ameri M, Maa Y-F. Spray drying of biopharmaceuticals: stability and process considerations. Dry Technol. 2006;24(6):763–768.
  • Maa YF, Nguyen PA, Sweeney T, et al. Protein inhalation powders: spray drying vs spray freeze drying. Pharm Res. 1999;16(2):249–254.
  • Abdul-Fattah AM, Truong-Le V, Yee L, et al. Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on stability (I): stability of a monoclonal antibody. J Pharm Sci. 2007;96(8):1983–2008.
  • Abdul-Fattah AM, Kalonia DS, Pikal MJ. The challenge of drying method selection for protein pharmaceuticals: product quality implications. J Pharm Sci. 2007;96(8):1886–1916.
  • Tang X, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm Res. 2004;21(2):191–200.
  • Stärtzel P, Gieseler H, Gieseler M, et al. Freeze-drying of l-arginine/sucrose-based protein formulations, part 2: optimization of formulation design and freeze-drying process conditions for an l-arginine chloride-based protein formulation system. J Pharm Sci. 2015;104(12):4241–4256.
  • Greenfield NJ. Using circular dichroism spectra to estimate protein secondary structure. Nat Protoc. 2006;1(6):2876–2890.
  • O'Mahony AM, Cronin MF, McMahon A, et al. Biophysical and structural characterisation of nucleic acid complexes with modified cyclodextrins using circular dichroism. J Pharm Sci. 2014;103(5):1346–1355.
  • Aguirre TAS, Rosa M, Coulter IS, et al. In vitro and in vivo preclinical evaluation of a minisphere emulsion-based formulation (SmPill®) of salmon calcitonin. Eur J Pharm Sci. 2015;79:102–111.
  • Depaz RA, Pansare S, Patel SM. Freeze-drying above the glass transition temperature in amorphous protein formulations while maintaining product quality and improving process efficiency. J Pharm Sci. 2016;105(1):40–49.
  • Schwegman JJ, Hardwick LM, Akers MJ. Practical formulation and process development of freeze-dried products. Pharm Dev Technol. 2005;10(2):151–173.
  • Abdelwahed W, Degobert G, Stainmesse S, et al. Freeze-drying of nanoparticles: formulation, process and storage considerations. Adv Drug Deliv Rev. 2006;58(15):1688–1713.
  • Fonte P, Soares S, Costa A, et al. Effect of cryoprotectants on the porosity and stability of insulin-loaded PLGA nanoparticles after freeze-drying. Biomatter. 2012;2(4):329–339.

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