Stabilized composition of 26 mg/mL of high molecular weight HA for subcutaneous injection to improve skin quality

Abstract

Aim: Skin firmness is one of the key parameters to define skin quality and facial aging. Among the minimally invasive anti-aging strategies, hyaluronic acid (HA) injection is widely accepted to improve skin quality. While most of the available HA injectables are designed and intended for intradermal injection, a novel HA/sorbitol composition containing 2.6% high molecular weight hyaluronic acid stabilized by sorbitol was recently developed to be specifically injected into the adipose tissue to improve the quality of all skin layers, especially the skin firmness. Methods: The HA/sorbitol composition was investigated versus product comparators in terms of biophysical properties, tolerance in subcutaneous tissue with in vivo implantation study, and skin firmness assessment on human skin explants. Results: The HA/sorbitol composition was characterized by unique and differentiated biophysical properties, proper distribution and high tolerance of the gel composition into the adipose tissue, and the ability to efficiently improve skin firmness. Conclusion: The HA/sorbitol composition represents a new attractive solution to treat facial skin aging with an injection strategy specifically targeting the adipose tissue instead of the dermis, to improve the quality of the skin.

Comprehensive Evaluation of Injectability Attributes in OxiFree™ Dermal Fillers: MaiLi® Product Variants and Clinical Case Reports

“…Of note, all of the considered MaiLi ® dermal filler variants are industrially manufactured using a specifically designed hydrogel production process (Table 1). Namely, enhanced hydrogel system resilience and distinctive projection capacities were previously reported for OxiFree™-based products compared to alternative commercial dermal fillers [19,20]. Specifically, such attributes are derived through an optimized manufacturing process, which may be broken down into four main phases, as follows [23]: In addition, noteworthy clinical advantages were previously set forth around this dermal filler technology, comprising the sparing use of hydrogel for patient treatment, based on the enhanced functional parameters conferred by specific viscoelasticity attributes [18][19][20][21].…”

“…Namely, enhanced hydrogel system resilience and distinctive projection capacities were previously reported for OxiFree™-based products compared to alternative commercial dermal fillers [19,20]. Specifically, such attributes are derived through an optimized manufacturing process, which may be broken down into four main phases, as follows [23]: In addition, noteworthy clinical advantages were previously set forth around this dermal filler technology, comprising the sparing use of hydrogel for patient treatment, based on the enhanced functional parameters conferred by specific viscoelasticity attributes [18][19][20][21]. From a formulation viewpoint, it should be noted that manufacturers are legally required to declare the concentration of HA in their dermal filler products (Table 1).…”

“…Contrasting with such findings, preliminary in-use clinical feedback by the practicing co-authors reported no tangible discrepancies or differences in the in vivo injection characteristics of several MaiLi ® product variants (i.e., MaiLi ® Precise, Define, Volume, Extreme; Oxi-Free™ manufacturing technology) [17]. Based on such subjective reports of qualitatively and quantitatively enhanced injectability attributes and building on previous scientific works, prospective investigations of MaiLi ® dermal fillers in terms of in-use behaviour were warranted [1,[18][19][20][21]. Specifically, a key design interest of the new study was to compare in vitro and in vivo MaiLi ® product injectability (i.e., during clinical facial dermal filling) to maximize the translational and clinical relevance of the obtained datasets.…”