Dr Mohammed Mahmoud Youssif

Whey protein isolate (WPI) has functional properties such as gelation and emulsification. Emulsion gels combine the benefits of both emulsions and hydrogels. In this study, WPI hydrogels and emulsion gels were developed with goji oil (GO) as the oil phase by the inclusion of blueberry extract (BE) in the protein matrix. Heat-denatured WPI (hWPI) particles and emulsions were characterized in terms of size distribution, ζ-potential, interfacial protein, and anthocyanin partition. The inclusion of anthocyanins-rich blueberry extract led to the aggregation of hWPI particles, but it also increased the interfacial protein of 10% goji oil emulsions to 20% and decreased their size distribution to 120 and 325 nm. WPI hydrogels and emulsion gels were analyzed in terms of their water-holding capacity, which decreased from 98% to 82% with the addition of blueberry extract and goji oil. Syneresis, rheological, and morphological characteristics were also analyzed. The gelation time of hWPI particles and emulsions was shortened from 24 h to 12 h when incorporating blueberry extract to form a dense network. The network was the most homogeneous and densest in the presence of 3% blueberry extract and 5% goji oil. The co-inclusion of blueberry extract and goji oil increased the syneresis during the freeze–thaw cycles, with the values rising from 13% to 36% for 5% BE hydrogel and BE-containing emulsion gels after the first cycle. All WPI hydrogels and emulsion gels exhibit predominantly elastic behavior. Moreover, anthocyanin release, antioxidant activity, and the fatty acid composition profile were also analyzed during in vitro digestion. Soluble and free anthocyanins in the digested medium were reduced with the goji oil content but increased with the blueberry extract content. The stability of polyunsaturated fatty acids in the digested medium was improved by the addition of blueberry extract. The antioxidant activity of the digested medium increased with the content of blueberry extract but decreased with the content of goji oil. The ABTS∙+ scavenging capacities decreased from 63% to 49% by increasing the content of GO from 0% to 10% and they increased from 48% to 57% for 5% BE and 10% GO emulsion gels as the BE content increased from 0% to 5% after 6 h of digestion. The data gathered should provide valuable insights for future efforts to co-encapsulate hydrophilic and hydrophobic agents, thereby enhancing their stability, bioavailability, and functional properties for potential applications in food industries.

PURPOSE: While imeglimin's, oral antidiabetic agent, efficacy and safety are established in Japanese and Western populations, pharmacokinetic data from Middle Eastern and African cohorts remain limited. This study aimed to evaluate the bioequivalence of test and reference imeglimin formulations under fasting conditions in healthy Egyptian adults.

METHODS: In a randomized, open-label, two-period, two-sequence crossover trial, healthy male and female adults received a single 500 mg oral dose of either formulation under fasting conditions, separated by a one-week washout. Adverse events (AEs) were assessed via direct questioning, participants' reporting, vital signs monitoring, and clinical laboratory evaluations. Plasma concentrations were measured up to 72 h post-dose, and pharmacokinetic parameters were derived using non-compartmental analysis. Bioequivalence was concluded if the geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for peak plasma concentration (C), area under the concentration-time curve to 72 h (AUC), and to infinity (AUC) were within 80-125%.

RESULTS: In 29 healthy participants, all pharmacokinetic endpoints met bioequivalence criteria. GMR (90% CI) for each pharmacokinetic endpoint were: C 101.75% (94.42-109.64); AUC 100.66% (94.28-107.46); AUC 100.13% (93.77-106.92). The intrasubject variability was low (14-17%). Both formulations were well tolerated, with only mild transient adverse events (headache, abdominal pain) and no serious events.

CONCLUSION: The test formulation of imeglimin was bioequivalent to the reference, with a favorable safety profile. This first pharmacokinetic and bioequivalence study in a Middle Eastern/African population supports regulatory approval and enhances opportunities for affordable access to imeglimin in type 2 diabetes management.

CLINICAL TRIAL NUMBER: The ClinicalTrials.gov registration number is NCT07127094, retrospectively registered on August 15, 2025.

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