Hydration and Dispersion: Two Key Steps in Six AestheFill Reconstitution Methods.

Abstract

AestheFill, a biostimulator containing poly-D,L-lactic acid (PDLLA) microspheres and carboxymethyl cellulose (CMC), is supplied as lyophilized powders in vials. It must be reconstituted with sterile water for injection into homogeneous suspensions before administration. In AestheFill, PDLLA microspheres do not dissolve in water, while CMC acts as a suspender for the PDLLA microspheres. However, CMC tends to form lumps when introduced to water. Agglomeration technology is utilized to prevent the formation of CMC lumps during reconstitution. This is why the lyophilized powders of AestheFill are agglomerated into granules. Reconstituting these granules involves several steps: wetting, sinking, disintegration, and dissolution. In this article, we summarize six different reconstitution methods for AestheFill. Additionally, our analysis identifies two key, time-consuming processes: the hydration of lyophilized granules and the dispersion of CMC and PDLLA microparticles.Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .