Pharmacokinetics, subject satisfaction, and tolerability of a novel oral iron formulation based on naturally occurring microalgae Spirulina platensis
- 1Zambon SpA
Abstract
IntroductionStudy to evaluate the pharmacokinetics (PK), subject satisfaction, and gastrointestinal (GI) tolerability of single and multiple doses of a novel oral iron formulation based on iron enriched microalgae Spirulina platensis supplemented with inactivated yeast.
MethodsTwelve healthy women with baseline serum iron 4-12 {micro}mol/L (22.3-67.0 {micro}g/dL) were admitted to the study site for 3 days in this single centre, multiple-dose, open-label study. Subjects received an oral dose of Monurelle(R) Ferro Naturale (MFN) on Days 1, 2, and 3. Blood for PK analysis was collected pre-dose (0) and at 1, 2, 3, 4, 5, 8 hours after dosing on Days 1 and 3, with assessment of subject satisfaction and GI tolerability performed 3 hours after each dose.
ResultsBoth single and multiple dosing with MFN led to a defined peak level (Cmax) and increased systemic exposure (AUC0-t), with serum iron rising to almost double the circulating amount at 5 h post-dose (tmax). Mean ({+/-}SD) percent change from baseline at 5 h post-dose was 94.7% ({+/-}56.1) on Day 1 and 72.0% ({+/-}70.7) on Day 3.
The majority of subjects reported being satisfied with the product and would use it again in the future. MFN was very well tolerated, with only one adverse event (AE) reported (episode of vomiting after the first dose, that lasted for one minute and did not recur after the two further doses of MFN). No other subject experienced any GI side effects.
DiscussionThis first report of oral Monurelle(R) Ferro Naturale in humans shows this novel formulation to provide a favourable PK profile with respect to serum iron concentrations, with excellent tolerability and high subject satisfaction.
Related
- Safety, Tolerability, and Pharmacokinetics of EGT710, a Novel Coronavirus Mpro Inhibitor, in Healthy Adults: A Randomized, Single- and Multiple-Dose Study.
- Pharmacokinetics, safety, and tolerability of ceftibuten-ledaborbactam etzadroxil in participants with renal impairment
- A Poly‐L‐Lactic Acid Formulation for Nasolabial Fold Correction: Handling, Tolerability and Effectiveness in a Prospective Observational Study
- Formononetin as a Natural Product-Derived Candidate for Diabetic Microvascular Complications: Mechanistic Evidence, Pharmacokinetics, Formulation Strategies, and Translational Barriers
- Selection of the optimal long-acting injectable formulation of ivermectin for use in humans to target malaria vectors in Western Africa: evaluation of pharmacokinetics and mosquitocidal efficacy in cattle under laboratory conditions
BibTeX
@misc{radicioni2026pharmacokinetics,
title = {{Pharmacokinetics, subject satisfaction, and tolerability of a novel oral iron formulation based on naturally occurring microalgae Spirulina platensis}},
author = {M. Radicioni and R. Assandri and A. Bastianello and E. Gentile and E. P. Tiberio and F. Sala and P. Magrone},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.15.26363044},
url = {https://www.medrxiv.org/content/10.64898/2026.09.15.26363044v1},
note = {CC BY-ND},
}
RIS
TY - UNPB
TI - Pharmacokinetics, subject satisfaction, and tolerability of a novel oral iron formulation based on naturally occurring microalgae Spirulina platensis
AU - M. Radicioni
AU - R. Assandri
AU - A. Bastianello
AU - E. Gentile
AU - E. P. Tiberio
AU - F. Sala
AU - P. Magrone
PY - 2026
DA - 2026/09/15
PB - medRxiv
DO - 10.64898/2026.09.15.26363044
UR - https://www.medrxiv.org/content/10.64898/2026.09.15.26363044v1
AB - IntroductionStudy to evaluate the pharmacokinetics (PK), subject satisfaction, and gastrointestinal (GI) tolerability of single and multiple doses of a novel oral iron formulation based on iron enriched microalgae Spirulina platensis supplemented with inactivated yeast. MethodsTwelve healthy women with baseline serum iron 4-12 {micro}mol/L (22.3-67.0 {micro}g/dL) were admitted to the study site for 3 days in this single centre, multiple-dose, open-label study. Subjects received an oral dose of Monurelle(R) Ferro Naturale (MFN) on Days 1, 2, and 3. Blood for PK analysis was collected pre-dose (0) and at 1, 2, 3, 4, 5, 8 hours after dosing on Days 1 and 3, with assessment of subject satisfaction and GI tolerability performed 3 hours after each dose. ResultsBoth single and multiple dosing with MFN led to a defined peak level (Cmax) and increased systemic exposure (AUC0-t), with serum iron rising to almost double the circulating amount at 5 h post-dose (tmax). Mean ({+/-}SD) percent change from baseline at 5 h post-dose was 94.7% ({+/-}56.1) on Day 1 and 72.0% ({+/-}70.7) on Day 3. The majority of subjects reported being satisfied with the product and would use it again in the future. MFN was very well tolerated, with only one adverse event (AE) reported (episode of vomiting after the first dose, that lasted for one minute and did not recur after the two further doses of MFN). No other subject experienced any GI side effects. DiscussionThis first report of oral Monurelle(R) Ferro Naturale in humans shows this novel formulation to provide a favourable PK profile with respect to serum iron concentrations, with excellent tolerability and high subject satisfaction.
ER -