Polyelectrolyte nanoparticle constructs (NPs) comprising salmon calcitonin (sCT), chitosan (CS), and hyaluronic acid (HA) were previously established as having anti-inflammatory potential when injected via the intra-articular (i.a.) route to a mouse model. We attempted to translate the formulation to a large animal model, the lipopolysaccharide (LPS)-stimulated equine model of joint inflammation. The aim was to manufacture under aseptic conditions to produce sterile pyrogen-free NPs, to confirm physicochemical characteristics, and to test toxicity and efficacy in a pilot study. NP dispersions were successfully formulated using pharmaceutical-grade source materials and were aseptically manufactured under GMP-simulated conditions in a grade A modular aseptic processing workstation. The NP formulation had no detectable pathogen or endotoxin contamination. NPs were then tested versus a lactated Ringer's solution control following single i.a. injections to the radiocarpal joints of two groups of four horses pre-treated with LPS, followed by arthrocentesis at set intervals over 1 week. There was no evidence of treatment-related toxicity over the period. While there were no differences between clinical read-outs of the NP and the control, two synovial fluid-derived biomarkers associated with cartilage turnover revealed a beneficial effect of NPs. In conclusion, NPs comprising well-known materials were manufactured for an equine i.a.-injectable pilot study and yielded no NP-attributable toxicity. Evidence of NP-associated benefit at the level of secondary endpoints was detected as a result of decreases in synovial fluid inflammatory biomarkers.
Objectives To compare an intact immunoradiometric parathyroid hormone assay with (1) a non‐isotopic technique; and, (2) a whole parathyroid hormone immunoradiometric assay. Materials and Methods Intact parathyroid hormone concentrations were measured using immunoradiometric (Scantibodies) and chemiluminescent (Immulite 2000) assays. Whole parathyroid hormone concentration was measured using an immunoradiometric assay (Scantibodies). Results A total of 48 and 47 samples, respectively, were used to compare immunoradiometric and chemiluminescent intact parathyroid concentrations and intact and whole parathyroid hormone concentrations by immunoradiometric assays. Using chemiluminescence, 39 (81.3%) samples had intact parathyroid hormone concentrations at or below the reported limit of detection of the assay (0.3 pmol/L). Intact [6.3 (2.0 to 95.5) pmol/L] and whole [3.3 (0.8 to 125.2) pmol/L] immunoradiometric parathyroid hormone concentrations exhibited excellent correlation. Clinical Significance Not all parathyroid hormone assays perform similarly. The chemiluminescent assay in this study cannot be recommended for use in dogs. The immunoradiometric intact parathyroid hormone assay proved to be a more reliable method. Given the correlation between intact and whole parathyroid hormone concentrations, it remains unclear which one is superior for routine clinical decision‐making.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.