Pharmacopeial compliance of fish oil-containing parenteral lipid emulsion mixtures: Globule size distribution (GSD) and fatty acid analyses
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- 作者：David F. Driscoll ; Pei-Ra Ling ; Bruce R. Bistrian
- 关键词：Fish oil-containing emulsions ; Globule size distribution ; n3-Fatty acids ; Pharmacopeial compliance
- 刊名：International Journal of Pharmaceutics
- 出版年：2009
- 出版时间：8 September 2009
- 年：2009
- 卷：379
- 期：1
- 页码：125-130
- 全文大小：161 K
文摘
Recently, the United States Pharmacopeia (USP) has established Chapter 729 with GSD limits for all lipid emulsions where the mean droplet size (MDS) must be <500 nm and the percent of fat larger than 5 μm (PFAT5) must be <0.05 % , irrespective of the final lipid concentration. As well, the European Pharmacopeia (EP) Monograph no. 1352 specifies n3-fatty acid (FA) limits (EPA + DHA ≥ 45 % ; total n3 or T-n3 ≥ 60 % ) for fish oil. We assessed compliance with USP physical and EP chemical limits of two fish oil-containing lipid emulsion mixtures. All lipid emulsions passed USP 729 limits. No samples tested had an MDS >302 nm or a PFAT5 value >0.011 % . Only one product met EP limits while the other failed. All emulsions tested were extremely fine dispersions and easily met USP 729 GSD limits. The n3-FAs profiles were lower in one, despite being labeled to contain 50 % more fish oil than the other product. This latter finding suggests the n3-FA content of the fish oil source and/or the applied manufacturing processes in these products is different.