PharmPK Discussion - DMA and NMP in formulations

• On 30 Sep 2010 at 07:44:58, "Tahraoui, Ahmed" (Ahmed.Tahraoui.-a-.crl.com) sent the message
  

  
  Hi,
   Has anybody used DMA or NMP in formulation? If yes what the upper  concentration (mg/kg/day) used for each species either IV, IM or oral?  Is there any public reference ?
   Thanks
   Ahmed
  
  

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• On 30 Sep 2010 at 15:28:10, "Beaupre,AJ" (AJ.Beaupre.aaa.colostate.edu) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dimethylacetamide is used in pharmaceutical preparations as a solvent in
  parenteral formulations and is generally regarded as a nontoxic material
  when used as an excipient. Animal toxicity studies indicate that
  dimethylacetamide is readily absorbed into the bloodstream following
  inhalation or topical application. Repeated exposure to dimethylacetamide
  may be harmful and can result in liver damage.
  High intravenous doses (>400 mg/kg/day for 3 days) may be hallucinogenic.
  
  LD50 (rabbit, SC): 9.6 g/kg11
  LD50 (rat, IP): 2.75 g/kg
  LD50 (rat, IV): 2.64 g/kg
  LD50 (rat, oral): 4.93 g/kg
  LD50 (mouse, inhalation): 7.2 g/kg
  LD50 (mouse, IP): 2.8 g/kg
  LD50 (mouse, IV): 3.02 g/kg
  LD50 (mouse, SC): 9.6 g/kg
  
  N-methylpyrrolidone is considered a poison by the intravenous route. It is
  moderately toxic by ingestion, skin contact, and intraperitoneal routes. It
  is an experimental teratogen; mutagenicity data have been reported.
  
  LD50 (mouse, IP): 3.05 g/kg12
  LD50 (mouse, IV): 0.155 g/kg
  LD50 (mouse, oral): 5.13 g/kg
  LD50 (rabbit, SC): 8.0 g/kg
  LD50 (rat, IP): 2.472 g/kg
  LD50 (rat, IV): 0.0805 g/kg
  LD50 (rat, oral): 3.914 g/kg
  
  Hope this helps.  All of the above information was obtained from the
  Handbook of Pharmaceutical Excipients.
  
  Cheers,
  AJ
  
  

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