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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 ?
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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.
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