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Drug Delivery: Enteral Route01:18

Drug Delivery: Enteral Route

The enteral drug administration involves three primary routes: oral, sublingual, and buccal. Oral ingestion is the most prevalent, safe, economical, and convenient method for drug administration. However, it has certain drawbacks, including limited absorption due to the drug's low water solubility or poor membrane permeability, possible emesis from GI mucosa irritation, destruction of drugs by digestive enzymes or low gastric pH, and irregular absorption along with food or other drugs.
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Development of a nalmefene formulation suitable for a community-use auto-injector.

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A new nalmefene formulation using magnesium chloride enhances absorption for faster opioid overdose reversal. This rapid intramuscular injection offers a critical advantage when life support is unavailable.

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Area of Science:

  • Pharmacology
  • Drug Delivery
  • Emergency Medicine

Background:

  • Opioid-induced respiratory depression (OIRD) requires rapid reversal.
  • Nalmefene is an opioid antagonist used to treat OIRD.
  • Intramuscular administration aims for faster absorption compared to other routes.

Purpose of the Study:

  • To develop an improved nalmefene formulation for faster intramuscular absorption.
  • To reduce the time to onset of reversal for OIRD.
  • To evaluate the efficacy of the new formulation compared to existing treatments.

Main Methods:

  • Screening of absorption enhancers in rats and dogs.
  • Clinical studies in healthy participants evaluating nalmefene formulations with varying MgCl2 concentrations.
  • Assessment of pharmacokinetics and pharmacodynamics in participants experiencing fentanyl-induced OIRD, comparing MgCl2-nalmefene, intranasal naloxone, and placebo.

Main Results:

  • Preclinical studies confirmed MgCl2 enhances nalmefene absorption rate.
  • Clinical trials showed a nalmefene formulation with 0.94% MgCl2 achieved faster absorption than a NaCl formulation.
  • The MgCl2-nalmefene formulation demonstrated quicker and more effective reversal of OIRD than intranasal naloxone.

Conclusions:

  • A nalmefene formulation with magnesium chloride significantly enhances absorption via intramuscular injection.
  • This improved formulation offers a faster onset of action for treating OIRD.
  • The rapid absorption makes this formulation particularly valuable for emergency treatment of opioid overdose where immediate life support is not accessible.