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Ready-to-use parenteral amiodarone: a feasibility study towards a long-term stable product formulation
Maartje S Jacobs1, Marianne Luinstra1,2, Jan Reindert Moes1
1Department of Clinical Pharmacy, Martini Hospital, Groningen, The Netherlands.
Summary
A stable, ready-to-use parenteral amiodarone formulation was successfully prepared using sulfobutylether-beta-cyclodextrin (SBE-BCD). This development enhances medication safety for acute intravenous amiodarone administration.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Parenteral amiodarone requires enhanced solubility for intravenous administration.
- Cyclodextrins are effective excipients for improving the solubility of poorly soluble drugs.
- Developing stable, ready-to-use formulations is crucial for acute clinical settings.
Purpose of the Study:
- To assess the feasibility of creating a stable, ready-to-use parenteral amiodarone formulation.
- To utilize cyclodextrins, specifically hydroxypropyl-beta-cyclodextrin (HP-BCD) and sulfobutylether-beta-cyclodextrin (SBE-BCD), as dissolution enhancers.
- To evaluate the long-term stability of the optimized formulation.
Main Methods:
- Preformulation studies were conducted with varying molar ratios of HP-BCD and SBE-BCD to amiodarone.
- The influence of pH and temperature on dissolution rates was investigated.
- Shelf-life stability of a ready-to-use iso-osmotic amiodarone preparation (1.8 mg/mL with SBE-BCD, 1:3 molar ratio) was assessed over 12 months.
- A validated high-performance liquid chromatography (HPLC) ultraviolet method was used for amiodarone content analysis.
Main Results:
- The amiodarone-SBE-BCD complex at a 1:3 molar ratio and pH 4.0-5.0 demonstrated optimal solubility and dissolution characteristics (90 minutes).
- SBE-BCD required a lower molar ratio compared to HP-BCD for effective solubilization.
- The amiodarone content remained stable in the final formulation after 12 months of storage at 21°C under ambient light conditions.
Conclusions:
- A ready-to-use parenteral amiodarone formulation is chemically, physically, and microbiologically feasible for hospital pharmacy preparation.
- This ready-to-administer product offers significant potential to improve medication safety in acute care settings.
- Production and availability of this formulation should be strongly considered for clinical practice.
Keywords:
cyclodextrinsintravenous amiodaronepharmaceutical formulationready-to-usesulfobutylether-beta-cyclodextrinMore Related Videos
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