ArticleEvidence-based complementary and alternative medicine : eCAM2021
Development of an Innovative Berberine Food-Grade Formulation with an Ameliorated Absorption: In Vitro Evidence Confirmed by Healthy Human Volunteers Pharmacokinetic Study.
Article in Evidence-based complementary and alternative medicine : eCAM, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 22 citations in OpenAlex.
- Review
- Berberine and its derivatives as candidate modulators of immunosenescence: a critical evaluation.Biogerontology · 2026Review
- Phytocompounds That Target White Adipose Tissue for Weight Loss: A Review Spanning From Ucp1 Induction in Rodents to Human Clinical Trials.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026Review
- Metabolic and Anti-Inflammatory Effects of Berberine-Rationale for Its Therapeutic Potential in Polycystic Ovary Syndrome.International journal of molecular sciences · 2026Review
- Article
- Article
- Melissa phospholipids improves sleep quality and mental well-being: concluding results from clinical study in adults with emotional distress.Food & nutrition research · 2026Article
- Article
- Berberine in oral diseases: molecular mechanisms and therapeutic implications.Frontiers in pharmacology · 2026Review
- Beneficial effects of berberine in the treatment of diabetes and its complications.Frontiers in pharmacology · 2025Review
- Ornamental Barberry Twigs as an Underexploited Source of Berberine-Rich Extracts-Preliminary Research.Current issues in molecular biology · 2024Article
- Bioactive Compounds Formulated in Phytosomes Administered as Complementary Therapy for Metabolic Disorders.International journal of molecular sciences · 2024Review
- Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers.Pharmaceutics · 2023Article
- Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial.Frontiers in pharmacology · 2023Article
- Gut Microbiota, Metabolic Disorders and Breast Cancer: Could Berberine Turn Out to Be a Transversal Nutraceutical Tool? A Narrative Analysis.International journal of molecular sciences · 2022Article
- In Vitro and In Vivo SucrosomialNutrients · 2022Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate in vitro solubility, bioaccessibility, and cytotoxic profile, together with a pharmacokinetic profile by oral administration to healthy volunteers of a novel food-grade berberine formulation (BBR-PP, i.e., berberine Phytosome®).
resultsAn in vitro increase of solubility in simulated gastric and intestinal fluids and an improved bioaccessibility at intestinal level along with a lower cytotoxicity with respect to berberine were observed with BBR-PP. The pharmacokinetic profile of the oral administration to healthy volunteers confirmed that berberine Phytosome® significantly ameliorated berberine absorption, in comparison to unformulated berberine, without any observed side effects. The berberine plasma concentrations observed with both doses of BBR-PP were significantly higher than those seen after unformulated berberine administration, starting from 45 min (free berberine) and 30 min (total berberine). Furthermore, BBR-PP improved berberine bioavailability (AUC) was significantly higher, around 10 times on molar basis and with observed dose linearity, compared to the unformulated berberine.
conclusionThese findings open new perspectives on the use of this healthy berberine formulation in metabolic discomforts.
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.