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Lipid injectable emulsions: Pharmacopeial and safety issues
1Harvard Medical School, Boston, Massachusetts, USA. ddriscol@bidmc.harvard.edu
Pharmaceutical Research
|September 5, 2006
Summary
Lipid injectable emulsions, used for decades in parenteral nutrition, now have USP <729> standards for globule size. These standards enhance infusion safety by limiting large fat globules, preventing potential tissue damage.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Parenteral Nutrition
Background:
- Lipid injectable emulsions are essential for parenteral nutrition but lack pharmacopeial standards for optimal formulation.
- Previous attempts to establish standards failed due to technical challenges with globule size limits.
Purpose of the Study:
- To address the absence of pharmacopeial standards for lipid injectable emulsions.
- To introduce the United States Pharmacopeia (USP) Chapter <729> for assessing emulsion stability and safety.
Main Methods:
- The USP <729> Chapter employs two methods to measure globule size distribution.
- Method I measures mean droplet size, while Method II focuses on the large-diameter tail (> 5 µm).
Main Results:
- Method II's criteria for large globule limits are critical for ensuring infusion safety.
- Exceeding these limits in animal studies showed potential for oxidative stress and liver tissue damage.
Conclusions:
- The USP <729> provides essential criteria for evaluating lipid injectable emulsion stability and safety.
- Adoption of USP <729> is recommended to standardize pharmaceutical characteristics and improve patient safety.
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