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Intellipharmaceutics Updates Developments On Its Rexista(TM) Oxycodone Technology

Stocks in this article: I IPCI

TORONTO, July 15, 2013 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced an update on the following events in its Rexista™ oxycodone development program:

1) The results of the current stage of development and physico-chemical tests to assess abuse-deterrent properties of its Rexista™ oxycodone

2) Stability studies

3) Successful Phase I clinical trial of its Rexista™ abuse-deterrent oxycodone, designed around its proprietary drug delivery system.

The physico-chemical tests were conducted on either an intact, pulverized or microwaved Rexista™ oxycodone and included:

  • Crush resistance studies conducted to evaluate the potential for abuse by chewing and licking of Rexista™ oxycodone;
  • Alcohol challenge studies conducted to evaluate the potential for "dose dumping" related to inadvertent or deliberate co-administration of Rexista™ oxycodone with alcohol;
  • Extraction studies in beverages, aqueous and non-aqueous media conducted to evaluate the potential for abuse related to oral administration of oxycodone obtained from dissolved Rexista™ oxycodone;
  • Vaporization studies conducted to evaluate the potential for abuse related to insufflation of oxycodone obtained from heating of Rexista™ oxycodone; and
  • Syringeability and injectability studies conducted to evaluate the potential for abuse related to intravenous administration of oxycodone obtained from dissolved, pulverized or microwaved Rexista™ oxycodone. 

Results from such physico-chemical studies suggest that:

  • Rexista™ oxycodone should be difficult to abuse through crushing, chewing or licking;
  • Release of oxycodone from Rexista™ oxycodone is likely to be slower or not instantaneous in a range of beverages and solvents;
  • Rexista™ oxycodone should not "dose dump", or instantaneously release the entire dose of oxycodone, in the presence of ethanol over a range of concentrations;
  • Rexista™ oxycodone when pulverized and reduced to particles should be difficult and time consuming to syringe or inject in the form and volume suitable for intravenous administration;
  • Release of oxycodone should be insignificant or inefficient via heating and vaporization;
  • Extraction of oxycodone from Rexista™ oxycodone which has been microwaved should be difficult or inefficient; and
  • Rexista™ oxycodone when pulverized or reduced to particles should be difficult or inefficient to snort or inhale.

Results from accelerated stability studies indicate that Rexista™ oxycodone formulation is stable even at a high temperature (40°C) and relative humidity (70%) of storage.

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