Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover study
Palmitoylethanolamide (PEA) is an endogenous lipid having the ability to suppress inflammatory responses, restore homeostasis, and modulate pain sensitivity. However, its concentration in the body is often limited, especially on aging, owing to low production and rapid metabolism. PEA supplementatio...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | CyTA - Journal of Food |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/19476337.2025.2516484 |
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| author | Maria Jose Louis Ashil Joseph Umesh Kannamangalam Vijayan Abhilash Balakrishnan Krishnakumar Illathu Madhavamenon |
| author_facet | Maria Jose Louis Ashil Joseph Umesh Kannamangalam Vijayan Abhilash Balakrishnan Krishnakumar Illathu Madhavamenon |
| author_sort | Maria Jose Louis |
| collection | DOAJ |
| description | Palmitoylethanolamide (PEA) is an endogenous lipid having the ability to suppress inflammatory responses, restore homeostasis, and modulate pain sensitivity. However, its concentration in the body is often limited, especially on aging, owing to low production and rapid metabolism. PEA supplementation suffers from poor oral bioavailability and half-life. This study was aimed to characterize a natural self-emulsifying hybrid-hydrogel formulation of PEA (P-fen), developed using fenugreek galactomannan seed mucilage (FenuMat®), and further investigate its pharmacokinetics in healthy human volunteers, in comparison with micronized PEA (m-PEA). P-fen was an amorphous powder with a high swelling index and improved solubility (56-fold). It was observed as microspheres of 250 μm size with a porous and smooth surface upon scanning electron microscopy (SEM) analysis. Dynamic light scattering (DLS) analysis indicated ~523 nm particles, with a zeta potential of −60 mV indicating its aqueous stability. In vitro gastrointestinal studies revealed sustained release with better bioaccessibility (>80%). Pharmacokinetics following a single dose of P-fen revealed 5-fold enhancement in bioavailability. |
| format | Article |
| id | doaj-art-e5a040c826bd4388a322ce88caf4b7d3 |
| institution | Kabale University |
| issn | 1947-6337 1947-6345 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | CyTA - Journal of Food |
| spelling | doaj-art-e5a040c826bd4388a322ce88caf4b7d32025-08-20T03:25:35ZengTaylor & Francis GroupCyTA - Journal of Food1947-63371947-63452025-12-0123110.1080/19476337.2025.2516484Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover studyMaria Jose Louis0Ashil Joseph1Umesh Kannamangalam Vijayan2Abhilash Balakrishnan3Krishnakumar Illathu Madhavamenon4R&D Centre, Akay Natural Ingredients, Kochi, IndiaR&D Centre, Akay Natural Ingredients, Kochi, IndiaR&D Centre, Akay Natural Ingredients, Kochi, IndiaR&D Centre, Akay Natural Ingredients, Kochi, IndiaR&D Centre, Akay Natural Ingredients, Kochi, IndiaPalmitoylethanolamide (PEA) is an endogenous lipid having the ability to suppress inflammatory responses, restore homeostasis, and modulate pain sensitivity. However, its concentration in the body is often limited, especially on aging, owing to low production and rapid metabolism. PEA supplementation suffers from poor oral bioavailability and half-life. This study was aimed to characterize a natural self-emulsifying hybrid-hydrogel formulation of PEA (P-fen), developed using fenugreek galactomannan seed mucilage (FenuMat®), and further investigate its pharmacokinetics in healthy human volunteers, in comparison with micronized PEA (m-PEA). P-fen was an amorphous powder with a high swelling index and improved solubility (56-fold). It was observed as microspheres of 250 μm size with a porous and smooth surface upon scanning electron microscopy (SEM) analysis. Dynamic light scattering (DLS) analysis indicated ~523 nm particles, with a zeta potential of −60 mV indicating its aqueous stability. In vitro gastrointestinal studies revealed sustained release with better bioaccessibility (>80%). Pharmacokinetics following a single dose of P-fen revealed 5-fold enhancement in bioavailability.https://www.tandfonline.com/doi/10.1080/19476337.2025.2516484PalmitoylethanolamideFenuMathybrid-hydrogelbioavailabilitypharmacokinetics |
| spellingShingle | Maria Jose Louis Ashil Joseph Umesh Kannamangalam Vijayan Abhilash Balakrishnan Krishnakumar Illathu Madhavamenon Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover study CyTA - Journal of Food Palmitoylethanolamide FenuMat hybrid-hydrogel bioavailability pharmacokinetics |
| title | Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover study |
| title_full | Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover study |
| title_fullStr | Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover study |
| title_full_unstemmed | Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover study |
| title_short | Pharmacokinetics of a natural hybrid-hydrogel formulation of palmitoylethanolamide (PEA): randomized, single-dose, double-blinded, 2-way crossover study |
| title_sort | pharmacokinetics of a natural hybrid hydrogel formulation of palmitoylethanolamide pea randomized single dose double blinded 2 way crossover study |
| topic | Palmitoylethanolamide FenuMat hybrid-hydrogel bioavailability pharmacokinetics |
| url | https://www.tandfonline.com/doi/10.1080/19476337.2025.2516484 |
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