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Abstract: We examined the effect of 0–20% back pressure, which functions as a resistance to emulsification in a high-pressure homogenizer, on emulsification of lipid nanodispersions (emulsion and liposomes) less than 100nm in diameter. Back pressure in the range of 0.9–3.8% of the emulsification pressure enhanced the emulsification, and the particle diameter of lipid nanodispersion was the smallest at 2% back pressure. The back pressure effect was independent of the actual pressure, which was regarded as the difference between the emulsification and the back pressures. The mechanism of the back pressure effect was considered to be enhancement of emulsification by suppression of collapse cavitation in the high-pressure emulsification module. This back pressure effect appeared in emulsification of emulsion and liposomes, and was seen predominantly in the early emulsification phase (within 10 passages). The particles of lipid nanodispersions prepared at 2% back pressure with adequate re-circulation achieved physicochemically optimal diameter with a narrow size distribution, and were more stable at 60°C for 7 days than particles prepared with 20% back pressure. Our results indicate that emulsification with a low level of back pressure is effective for production of stable lipid nanodispersions with narrow size distribution. [Copyright &y& Elsevier]

Abstract: 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 <500nm and the percent of fat larger than 5μm (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 >302nm 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. [Copyright &y& Elsevier]

Abstract: The droplet size distribution of 50 batches of multi-chamber bags containing the parenteral nutrition emulsions Intralipid (Kabiven and Kabiven Peripheral) or Structolipid (StructoKabiven and StructoKabiven Peripheral), respectively, has been investigated. The results show that the non-compounded lipid emulsions analysed are in compliance with the United States Pharmacopeia (USP) chapter 729, Method II limit for the droplet size distribution, PFAT5 <0.05%. [Copyright &y& Elsevier]