PharmPK Discussion - Oral Administration limits of hydroxypropyl beta cyclodextrin

• On 15 Jan 2013 at 11:29:26, Chris Marlor (cmarlor.aaa.achillion.com) sent the message
  

  
  I have a NCE that I would like to administer orally to rodents for 14
  consecutive days. The addition of hydroxypropyl beta cyclodextrin to the
  formulation increases the solubility of the NCE when diluted into
  simulated gastric fluid and simulated intestinal fluid. What is the NOEL
  (mg/kg/day) in rodents (rats) of hydroxypropyl beta cyclodextrin for
  repeat oral dosing (2-4 weeks)?
  
  Thank you,
  Chris Marlor
  
  

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• On 15 Jan 2013 at 18:24:11, Vaibhav Sihorkar (vaibhav_s.at.aurigene.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Chris,
  
  You can use up to 0.5 g/kg of hydroxypropyl beta cyclodextrin (i.e., 5%
  at a dose volume of 10 ml/Kg) roughly and up to 1 g/kg with some
  marginal hepatic issues. The literaure is abound with these limits and
  you can also request the supplier of cyclodextrin to furnish these
  informations.
  
  regards
  
  Vaibhav Sihorkar
  Head, Pharmaceutical Development
  Aurigene Discovery Technologies Ltd.,
  Bollaram Road, Miyapur,
  Hyderabad - 500049. A.P., India
  
  

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• On 15 Jan 2013 at 12:45:21, Ving Lee (VLee.at.adesisinc.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Chris,
  
  Please look at Food and Chemical Toxicology Vol. 43 (2005), pp.
  1451-1459.  Specifically, p. 1455.
  
  Good luck,
  
  Ving J. Lee
  CEO-CSO
  Adesis Inc.
  New Castle, DE 19720
  
  

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