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Original Article

Paediatric drug development of ramipril: reformulation, in vitro and in vivo evaluation

, , , , , , & show all
Pages 854-863 | Received 01 Sep 2014, Accepted 28 Mar 2015, Published online: 07 May 2015

References

  • Ravid M, Brosh D, Levi Z, et al. Use of enalapril to attenuate decline in renal function in normotensive, normoalbuminuric patients with type 2 diabetes mellitus: a randomized, controlled trial. Ann Intern Med 1998;128:982–8
  • Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001;345:851–60
  • Moltich ME, DeFonzo RA, Franz MJ, et al. Nephropathy in diabetes. Diabetes Care 2004;27:S79–83
  • AHFS. Drug information. Bethseda (MD): American Society of Health system Pharmacists, Inc.; 2004
  • Ilka K, Wollesky C, Kottra G, et al. Transport of angiotensin-converting enzyme inhibitors by H+/peptide transporters revisited. J Pharmacol Exp Ther 2008;327:432–41
  • Paediatric Formulary Committee. BNF for children 2011–2012 (British National Formulary for Children). London: Pharmaceutical Press; 2012
  • Nunn T, Williams J. Formulation of medicines for children. Br J Clin Pharmacol 2005;59:674–6
  • Development of Paediatric Medicines: Pharmaceutical Development. Points to Consider. World Health Organisation. Available from http://www.who.int/medicines/areas/quality_safety/quality_assurance/Rev3-PaediatricMedicinesDevelopment_QAS08-257Rev3_17082011.pdf
  • European Medicines Agency. Committee for medicinal products for human use (CHMP) Reflection Paper: Formulations of Choice for the Paediatric Population. Pre-authorisation Eval Med Hum Use. 2005;EMEA/CHMP/. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf
  • European Medicines Agency. Revised priority list for studies into off-patent paediatric medicinal products. 2010;EMA/480197(July 2010)
  • Committee for Medicinal Products for Human Use (CHMP). Assessment report Propylene glycol in medicinal products for children International non-proprietary name?: PROPYLENE GLYCOL. 2014;EMA/175205. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/03/WC500163989.pdf
  • Brewster ME, Loftsson T. Cyclodextrins as pharmaceutical solubilizers. Adv Drug Deliv Rev 2007;59:645–66
  • Zhao SH, Recknor J, Lunney JK, et al. Validation of a first-generation long-oligonucleotide microarray for transcriptional profiling in the pig. Genomics 2005;86:618–25
  • Cao X, Gibbs ST, Fang L, et al. Why is it challenging to predict intestinal drug absorption and oral bioavailability in human using rat model. Pharm Res 2006;23:1675–86
  • Eurpoean Medicines Agency. ICH guidelines Q2(R1) validation of analytical procedures: text and methodology. 1995
  • Higuchi T, Connors KA. Advances in analytical chemistry and instrumentation. New York (NY): Wiley-Interscience; 1965
  • Eurpoean Medicines Agency. ICH guidelines Q1A(R2) stability testing of new drug substances and products. 2003
  • Yang Y, Faustino PJ, Volpe DA, et al. Biopharmaceutics classification of selected β-blockers: solubility and permeability class membership. Mol Pharm 2007;4:608–14
  • Kanehisa M, Goto S. KEGG: Kyoto encyclopedia of genes and genomes. Nucleic Acid Res 2000;28:27–30
  • Kim Y, Oksanen DA, Massefski W, et al. Inclusion complexation of ziprasidone mesylate with beta-cyclodextrin sulfobutyl ether. J Pharm Sci 1998;87:1560–7
  • Zia V, Rajewski RA, Stella VJ. Effect of cyclodextrin charge on complexation of neutral and charged substrates: comparison of (SBE)7M-beta-CD to HP-beta-CD. Pharm Res 2001;18:667–73
  • Diego M De, Godoy G, Mennickent S, et al. Stress degradation studies of ramipril by a validated stability-indicating liquid chromatographic method. J Chil Chem Soc 2010;4:450–3
  • Stenberg P, Luthman K, Artursson P. Virtual screening of intestinal drug permeability. J Control Release 2000;65:231–43
  • Ramadan T, Camargo SMR, Herzog B, et al. Recycling of aromatic amino acids via TAT1 allows efflux of neutral amino acids via LAT2-4F2hc exchanger. Pflugers Arch 2007;454:507–16
  • Del Amo EM, Urtti A, Yliperttula M. Pharmacokinetic role of L-type amino acid transporters LAT1 and LAT2. Eur J Pharm Sci 2008;35:161–74
  • Daniel H. Molecular and integrative physiology of intestinal peptide transport. Annu Rev Physiol 2004;66:361–84
  • Buyse M, Berlioz F, Guilmeau S, et al. PepT1-mediated epithelial transport of dipeptides and cephalexin is enhanced by luminal leptin in the small intestine. J Clin Invest 2001;108:1483–94
  • Osman R, Al Jamal KT, Kan PL, et al. Inhalable DNase I microparticles engineered with biologically active excipients. Pulm Pharmacol Ther 2013;26:700–9
  • Kalinkova GN. Studies of beneficial interactions between active medicaments and excipients in pharmaceutical formulations. Int J Pharm 1999;187:1–15
  • Pestel S, Martin H-J, Maier G-M, Guth B. Effect of commonly used vehicles on gastrointestinal, renal, and liver function in rats. J Pharmacol Toxicol Methods 2006;54:200–14

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