The role of sonication in preparing injectable poly-l-lactic acid.

Abstract

Injectable poly-l-lactic acid (PLLA) carries the risk of nodule or microlump formation. Various methods including sonication have been tried to minimize these adverse effects of PLLA. This study investigated the change in size, distribution, and properties of PLLA particles after sonication, and the duration of sonication needed to reach the ideal particle size. Two indicators, the average size of PLLA particles and diameter at 90%, were measured at each timepoint: at 0, 10, 60, 120, and 240 minutes of sonication. The characteristics and particle shape were assessed at 0 and 240 minutes. The average particle size and the diameter at 90% decreased drastically until 10minutes of sonication and then increased slightly at 60minutes. After 60 minutes, the average size and the diameter at 90% gradually decreased over time and reached 42.2μm and 75.7μm, respectively, at 120 minutes. After 240 minutes of sonication, the average particle size was 35.9μm, much smaller than the smallest proper size required (40μm). Standard deviation decreased gradually over time, which means that a more even distribution was obtained. Crystalline remnants were significantly less left with 120 minutes sonication compared to those with 120 minutes hydration only. PLLA particles were more cracked at the center, and microcrystals were more loosely distributed at the periphery after 120 minutes sonication. Sonication help reduce the average size of PLLA particles and achieve more even distribution. Therefore, we believe sonication may attribute to the safer use of PLLA.