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Updated: Aug 2, 2026
10:28
An Injectable and Drug-loaded Supramolecular Hydrogel for Local Catheter Injection into the Pig Heart
Published on: June 7, 2015
[Pharmaceutic development of injectable Arduan]
1Richter Gedeon Vegyészeti Gyár Rt., Budapest.
Acta Pharmaceutica Hungarica
|May 1, 1992
Summary
Pipecuronium bromide, used in Arduan injections, degrades via hydrolysis and autoxidation. Lyophilized ampoules with mannitol and an inert gas atmosphere enhance its stability for medical use.
Area of Science:
- Pharmaceutical Chemistry
- Drug Stability
- Formulation Science
Context:
- Pipecuronium bromide, the active pharmaceutical ingredient in Arduan injections, is susceptible to degradation.
- Hydrolysis due to its two ester groups is the primary decomposition pathway.
- Autoxidation presents an additional degradation route, impacting drug efficacy and shelf-life.
Purpose:
- To develop a stable dosage form for pipecuronium bromide.
- To mitigate degradation pathways including hydrolysis and autoxidation.
- To ensure the integrity of pipecuronium bromide before and after administration.
Summary:
- Lyophilized ampoules containing mannitol were formulated to enhance the stability of pipecuronium bromide.
- Mannitol acts as a bulking agent and reduces the dielectric constant of water, increasing drug stability during lyophilization and upon reconstitution.
- An inert gas atmosphere was employed during manufacturing to prevent oxidative degradation of the drug substance.
- The final preparation demonstrated compatibility with common basic infusion solutions.
Impact:
- The developed formulation significantly improves the stability of pipecuronium bromide, extending its shelf-life.
- This enhanced stability ensures consistent drug delivery and therapeutic efficacy.
- The formulation's compatibility with infusion solutions facilitates its clinical application in various medical settings.
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