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Biomedicines
By Wojciech Gruszczyński, Monika Filipowska and Paweł Kubik.
Background/Objectives: This descriptive pilot documented preparation-related, microscopic, and aqueous-exposure appearances of nine injectable biostimulator products spanning poly-L-lactic acid (PLLA), poly-D,L-lactic acid (PDLLA), polycaprolactone (PCL), and calcium hydroxyapatite (CaHA).
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Nine products were examined (one unit per product). Five reconstitution-required products underwent manufacturer-specified dilution and mixing, a study-defined 120-min observation period, and re-agitation; this interval is not clinical preparation guidance. Four products were assessed as supplied. Following baseline sampling, the remaining material underwent product-specific introduction into dishes initially containing 15 mL of sterile 0.9% NaCl and incubation for 72 h at 37 °C. Three random fields were photographed and assessed per product, stage, and magnification. Fields were unpaired; no statistical analysis was performed.
Four reconstituted samples had a single-phase appearance and one a liquid–foam appearance; both PDLLA samples appeared visually thick/cohesive. Immediate bulk patterns comprised homogeneous dispersion (two samples), non-homogeneous dispersion (four), and retained rod-like extrusion (three). Microscopy showed spherical, ovoid, and irregular particles and spindle-like microstructures. After 72 h, dominant morphology categories corresponded to baseline, while additional appearances and aggregation categories differed between unpaired fields for some samples.
The examined samples showed features not uniformly aligned with material platform. The images provide a preliminary reference for further physicochemical and in vivo histopathological studies. This single-unit study does not establish reproducibility, chemical stability, or clinical performance.
Published in Biomedicines. The abstract is shown as published and remains the work of its authors; read the full article at the source.
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