Safety and efficacy of a new micronized formulation of the ALIAmide palmitoylglucosamine in preclinical models of inflammation and osteoarthritis pain

Marika Cordaro, Rosalba Siracusa, Daniela Impellizzeri, Ramona D' Amico, Alessio Filippo Peritore, Rosalia Crupi, Enrico Gugliandolo, Roberta Fusco, Rosanna Di Paola, Carlo Schievano, Salvatore Cuzzocrea. Arthritis Res Ther. 2019 Nov 28;21(1):254.

Laboratory studyOther animalsWith N-palmitoyl-D-glucosamine (a related ALIAmide, not PEA, tested alone in plain and micronised forms)

This study tested palmitoylethanolamide together with N-palmitoyl-D-glucosamine (a related ALIAmide, not PEA, tested alone in plain and micronised forms). Its results cannot be assigned to palmitoylethanolamide alone. More combination studies.

Design

Laboratory study

Subjects

Rats: an acute toxicity test, a carrageenan paw inflammation model and a monoiodoacetate knee osteoarthritis model; numbers not stated in the abstract

Dose used in the study

Palmitoylglucosamine or micronised palmitoylglucosamine 30 or 100 mg/kg by mouth (inflammation model); 30 mg/kg three times a week (osteoarthritis model); dexamethasone 0.1 mg/kg as reference

Duration

Up to 6 hours in the inflammation model; 21 days in the osteoarthritis model

What was measured

Acute oral toxicity; paw oedema, thermal hyperalgesia, myeloperoxidase and histology; mechanical allodynia, motor function, joint histology and X-ray damage, mast cell counts, macrophages and serum TNF-alpha, IL-1beta, NGF and MMPs.

What the authors reported

The study found:

• The LD50 of micronised palmitoylglucosamine was above 2000 mg/kg.
• A single oral dose of either form reduced carrageenan oedema, infiltrate and hyperalgesia; the micronised form also lowered the histology score.
• In the osteoarthritis model the micronised form outperformed the plain form on allodynia, locomotor disability and joint damage.
• Both forms reduced mast cell counts and serum markers, the micronised form to a greater extent.

Limits of this study

Rat models using palmitoylglucosamine, not palmitoylethanolamide; it cannot show effect in people or animals treated in practice. Cuzzocrea is co-inventor on Epitech Group patents; the other authors declare no competing interests.

Source

PubMed 31779692 · doi:10.1186/s13075-019-2048-y

Entry checked against the abstract on PubMed on 2026-09-22. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.