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A new alternative for intravenous lipid emulsion 20% w/w from superolein oil and its effect on lipid and liver profiles in an animal model

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Abstract

Purpose

Intravenous lipid emulsion (IVLE) was first used to prevent essential fatty acids deficiency. IVLE with α-tocopherol was reported to provide protection against parenteral nutrition-associated liver disease. This study aims to determine the optimal parameters and conditions in developing a physically stable IVLE from superolein palm oil (SoLE 20%) and its effect on lipid and liver profiles in an animal model.

Methods

SoLE 20% was prepared using superolein oil and MCT oil (1:1), stabilized with egg lecithin and homogenized using a high pressure homogenizer. Mean droplet size was used as the response variable and was measured using laser diffraction and dynamic light scattering method. Physical stability at 4 °C, 25 °C and 40 °C storage temperatures were determined based on particle size and distribution, polydispersity index, zeta potential, viscosity, vitamin E contents and pH. Sterility and pyrogenicity were also investigated. Rabbits were administered with 1.0 g/kg SoLE 20% for 5 h and repeated daily for 3 days to investigate its effect on blood lipid and liver enzymes profile.

Results

SoLE 20% was succesfully prepared using the optimized parameters of 800 psi, 7 cycles and 1.2 g lecithin. The IVLE prepared had a particle size of 252.60 ± 4.88 nm and was physically stable for 4 weeks at different storage temperatures. SoLE 20% had a high content of natural vitamin E, remained sterile and pyrogen free. It was also safe for intravenous administration and did not alter the blood lipid (p > 0.05) and liver enzymes profiles (p > 0.05) of the rabbits.

Conclusion

The optimal parameters to develop a stable superolein based IVLE are 800 psi homogenization pressure, 7 homogenization cycles and using 1.2 g lecithin as the emulsifier. SoLE 20% is safe for intravenous administration and does not significantly alter lipid and liver enzymes profiles of the rabbits.

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Acknowledgements

This work has been supported by Universiti Kebangsaan Malaysia and the superolein oil has been supplied by FELDA IFFCO Sdn. Bhd. (Klang, Malaysia).

Funding

This study was funded by Universiti Kebangsaan Malaysia (Grant No. ETP-2013-073).

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Authors and Affiliations

  1. Centre for Drug Delivery Research, Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia

    Mohd. Haz Hairul Amran, Mohd. Hanif Zulfakar, Mohd. Fairuz Danik & Ahmad Fuad Shamsuddin

  2. Parenteral Nutrition Unit, Department of Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia

    Mohd. Haz Hairul Amran

  3. Department of Pharmacy, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia

    Mohd. Shakrie Palan Abdullah

  4. Pharmacy Service Division - Enforcement Pharmacy, Kelantan State Health Department, Kota Bharu, Kelantan, Malaysia

    Mohd. Shakrie Palan Abdullah

  5. Faculty of Pharmacy and Health Sciences, Universiti Kuala Lumpur Royal College of Medicine, No. 3, Jalan Greentown, 30450, Ipoh, Perak, Malaysia

    Ahmad Fuad Shamsuddin

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  1. Mohd. Haz Hairul Amran
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  2. Mohd. Hanif Zulfakar
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  5. Ahmad Fuad Shamsuddin
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Corresponding author

Correspondence to Ahmad Fuad Shamsuddin.

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The authors declare that they have no conflict of interest.

Ethical approval

Animal study was approved by Universiti Kebangsaan Malaysia Animal Ethic Committee with approval number of FF/2017/AHMAD FUAD/24-MAY/847-JULY-2017-FEB.-2018.

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Amran, M.H.H., Zulfakar, M.H., Danik, M.F. et al. A new alternative for intravenous lipid emulsion 20% w/w from superolein oil and its effect on lipid and liver profiles in an animal model. DARU J Pharm Sci 27, 191–201 (2019). https://doi.org/10.1007/s40199-019-00262-7

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