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International Journal of Science, Strategic Management and Technology

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SELF-EMULSIFYING DRUG DELIVERY SYSTEM (SEDDS) FOR ENHANCING BIOAVAILABILITY OF BCS CLASS II DRUGS

AUTHORS:
Rohit K. Sharma
Anjali P. Mehta
Mentor
Prof. Saurabh N. Verma
Affiliation
Department of Pharmaceutics & Pharmaceutical Chemistry,
Apex College of Pharmaceutical Sciences, India
CC BY 4.0 License:
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract

The Self-Emulsifying Drug Delivery System (SEDDS) represents an advanced lipid-based formulation platform designed to enhance the oral bioavailability of poorly water-soluble drugs, especially those categorized under Biopharmaceutics Classification System (BCS) Class II. BCS Class II drugs exhibit high permeability but low aqueous solubility, resulting in limited dissolution and inconsistent absorption. SEDDS enhance solubility and absorption through spontaneous formation of fine oil-in-water emulsions in the gastrointestinal tract, facilitated by surfactants and co-solvents. This comprehensive review discusses mechanisms of self-emulsification, formulation considerations, key excipients, in vitro characterization techniques, and in vivo performance. Challenges such as drug precipitation, scale-up, and regulatory considerations are evaluated. Case studies of drugs like curcumin, simvastatin, and paclitaxel are presented to illustrate successful bioavailability enhancements. The article also highlights recent developments such as solid SEDDS (S-SEDDS), supersaturated SEDDS (Su-SEDDS), and polymer-assisted SEDDS. Future directions emphasize targeted delivery, patient compliance, and integration with nanomedicine approaches. This review aims to provide pharmaceutical scientists with a comprehensive resource on designing and deploying SEDDS to overcome solubility barriers in drug development. Formulation strategies focus on optimizing the ratio of oils, surfactants, and co-solvents to achieve stable emulsification and maximize drug loading. In vitro characterization typically involves assessing droplet size, zeta potential, and drug release profiles to predict in vivo performance. Additionally, in vivo studies evaluate pharmacokinetic parameters to confirm enhanced bioavailability and therapeutic efficacy.

Keywords
Self-Emulsifying Drug Delivery System SEDDS BCS Class II lipid-based formulations bioavailability enhancement solubility oral drug delivery
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Sharma, R. K. & Mehta, A. P. (2025). Self-Emulsifying Drug Delivery System (SEDDS) for Enhancing Bioavailability of BCS Class II Drugs. International Journal of Science, Strategic Management and Technology, Volume 01(03), 1-9. https://doi.org/10.55041/ijsmt.v1i3.004

Sharma, Rohit, and Anjali Mehta. "Self-Emulsifying Drug Delivery System (SEDDS) for Enhancing Bioavailability of BCS Class II Drugs." International Journal of Science, Strategic Management and Technology, vol. Volume 01, no. 03, 2025, pp. 1-9. doi:https://doi.org/10.55041/ijsmt.v1i3.004.

Sharma, Rohit, and Anjali Mehta. "Self-Emulsifying Drug Delivery System (SEDDS) for Enhancing Bioavailability of BCS Class II Drugs." International Journal of Science, Strategic Management and Technology Volume 01, no. 03 (2025): 1-9. https://doi.org/https://doi.org/10.55041/ijsmt.v1i3.004.

References

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2.       Porter CJH, Trevaskis NL, Charman WN. Lipid-based formulations for oral administration: Physiological considerations and biopharmaceutical strategies. Adv Drug Deliv Rev. 2007.


3.       Date AA, et al. Self-emulsifying drug delivery systems: formulation insights, characterization, and applications. Crit Rev Ther Drug Carrier Syst. 2010.


4.       Laffleur, F., Millotti, G., & Lagast, J. (2025). An overview of oral bioavailability enhancement through self-emulsifying drug delivery systems. Expert Opinion on Drug Delivery, 22(5), 659–671. https://doi.org/10.1080/17425247.2025.2479759


5.       Kale, A. A., & Patravale, V. B. (2008). Design and Evaluation of Self-Emulsifying Drug Delivery Systems (SEDDS) of Nimodipine. AAPS PharmSciTech, 9(1), 191–196. https://doi.org/10.1208/s12249-008-9037-9


6.       Subramaniam, S., Elz, A., Wignall, A., Kamath, S., Ariaee, A., Hunter, A., Newblack, T., Wardill, H. R., Prestidge, C. A., & Joyce, P. (2023). Self-emulsifying drug delivery systems (SEDDS) disrupt the gut microbiota and trigger an intestinal inflammatory response in rats. International Journal of Pharmaceutics, 648, 123614. https://doi.org/10.1016/j.ijpharm.2023.123614


7.       Almeida, S. R. D., & Tippavajhala, V. K. (2019). A Rundown Through Various Methods Used in the Formulation of Solid Self-Emulsifying Drug Delivery Systems (S-SEDDS). AAPS PharmSciTech, 20(8). https://doi.org/10.1208/s12249-019-1550-5


8.       Kamble, R. N., Mehta, P. P., & Kumar, A. (2015). Efavirenz Self-Nano-Emulsifying Drug Delivery System: In Vitro and In Vivo Evaluation. AAPS PharmSciTech, 17(5), 1240–1247. https://doi.org/10.1208/s12249-015-0446-2


9.       Yadav, K. S., Arora, S., Yasaswi, P. S., Nirale, P., Solanki, A., & Bhat, J. (2024). Self-nano-emulsifying Drug Delivery Systems of Atorvastatin Calcium Liquid Filled in Hard Shell Capsules for Improved Oral Bioavailability in Rabbits. Current Nanoscience, 20(4), 554–563. https://doi.org/10.2174/1573413719666230417085132


10.    Zakkula, A., Gabani, B. B., Jairam, R. K., Kiran, V., Todmal, U., & Mullangi, R. (2020). Preparation and optimization of nilotinib self-micro-emulsifying drug delivery systems to enhance oral bioavailability. Drug Development and Industrial Pharmacy, 46(3), 498–504. https://doi.org/10.1080/03639045.2020.1730398

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This article has undergone plagiarism screening and double-blind peer review. Editorial policies have been followed. Authors retain copyright under CC BY-NC 4.0 license. The research complies with ethical standards and institutional guidelines.
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