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Objective <p>Polycystic Ovary Syndrome (PCOS) is a multifactorial endocrine disorder characterized by hormonal imbalance, ovarian cyst formation, and metabolic dysfunction. This study aimed to develop a self-nanoemulsifying drug delivery system (SNEDDS) incorporating sea buckthorn (SBT) pulp oil to improve its stability, oral bioavailability, and therapeutic performance.</p> Methods <p>SBT oil, rich in bioactive fatty acids (myristic, palmitic, linolenic, and linoleic acids), was formulated into SNEDDS using a pseudoternary phase diagram approach. The optimized formulation exhibited a globule size below 200&#xa0;nm, a zeta potential of − 20.2 mV, and a polydispersity index (PDI) of 0.254. In vitro release of total UV-detectable constituents was evaluated and fitted to the Korsmeyer–Peppas kinetic model. In vivo efficacy was assessed using a letrozole-induced PCOS rat model and compared with pure SBT oil and metformin.</p> Results <p>SBT-SNEDDS demonstrated a 2.49-fold higher In vitro release (86.56%) compared to pure SBT oil (34.32%), indicating sustained, non-Fickian diffusion. In vivo studies showed improved ovarian histoarchitecture and partial restoration of hormonal balance, with a 1.12-fold increase in follicle-stimulating hormone (FSH) and a 1.15-fold decrease in luteinizing hormone (LH). Improvements in lipid and liver function profiles suggested metabolic recovery and systemic safety. The overall therapeutic performance of SBT-SNEDDS was comparable to that of metformin in this experimental model.</p> Conclusion <p>SBT oil-loaded SNEDDS represents a promising lipid-based delivery system for enhancing the therapeutic potential of SBT oil in the management of PCOS. However, the absence of a blank SNEDDS control is acknowledged as a limitation, as formulation excipients may independently influence permeability and biological responses. Additionally, In vitro release assessment was based on total UV-detectable constituents rather than individual chemical markers. Further studies incorporating appropriate formulation controls, marker-based analytical techniques, and clinical evaluation are warranted to confirm long-term efficacy and safety in humans.</p> Graphical Abstract <p></p>

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Development and Evaluation of Sea Buckthorn Oil-Loaded SNEDDS for Hormonal and Lipid Regulation in PCOS

  • 期刊论文

  • 发表日期：

    2026年2月12日

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  • Sourabh Patil S P,
  • Kanika Thakur K T,
  • Rohit Sharma R S,
  • Ankit Awasthi A A,
  • Lalit Sharma L S,
  • Bigul Yogeshwar Bhardwaj B Y B,
  • Thakur Gurjeet Singh T G S,
  • Poonam Negi P N

摘要

Objective

Polycystic Ovary Syndrome (PCOS) is a multifactorial endocrine disorder characterized by hormonal imbalance, ovarian cyst formation, and metabolic dysfunction. This study aimed to develop a self-nanoemulsifying drug delivery system (SNEDDS) incorporating sea buckthorn (SBT) pulp oil to improve its stability, oral bioavailability, and therapeutic performance.

Methods

SBT oil, rich in bioactive fatty acids (myristic, palmitic, linolenic, and linoleic acids), was formulated into SNEDDS using a pseudoternary phase diagram approach. The optimized formulation exhibited a globule size below 200 nm, a zeta potential of − 20.2 mV, and a polydispersity index (PDI) of 0.254. In vitro release of total UV-detectable constituents was evaluated and fitted to the Korsmeyer–Peppas kinetic model. In vivo efficacy was assessed using a letrozole-induced PCOS rat model and compared with pure SBT oil and metformin.

Results

SBT-SNEDDS demonstrated a 2.49-fold higher In vitro release (86.56%) compared to pure SBT oil (34.32%), indicating sustained, non-Fickian diffusion. In vivo studies showed improved ovarian histoarchitecture and partial restoration of hormonal balance, with a 1.12-fold increase in follicle-stimulating hormone (FSH) and a 1.15-fold decrease in luteinizing hormone (LH). Improvements in lipid and liver function profiles suggested metabolic recovery and systemic safety. The overall therapeutic performance of SBT-SNEDDS was comparable to that of metformin in this experimental model.

Conclusion

SBT oil-loaded SNEDDS represents a promising lipid-based delivery system for enhancing the therapeutic potential of SBT oil in the management of PCOS. However, the absence of a blank SNEDDS control is acknowledged as a limitation, as formulation excipients may independently influence permeability and biological responses. Additionally, In vitro release assessment was based on total UV-detectable constituents rather than individual chemical markers. Further studies incorporating appropriate formulation controls, marker-based analytical techniques, and clinical evaluation are warranted to confirm long-term efficacy and safety in humans.

Graphical Abstract