Preparation, function, and safety evaluation of a novel degradable dermal filler, the cross-linked poly-γ-glutamic acid hydrogel particles

J Biomed Mater Res B Appl Biomater. 2023 Jul;111(7):1407-1418. doi: 10.1002/jbm.b.35245. Epub 2023 Mar 17.

Abstract

Poly-γ-glutamic acid (PGA) is a naturally degradable hydrophilic linear microbial polymer with moisturizing, immunogenic, cross-linking, and hydrogel water absorption properties similar to hyaluronic acid, a biomaterial that is commonly used as a dermal filler. To explore the development feasibility of cross-linked PGA as a novel dermal filler, we studied the local skin response to PGA fillers and the effect of various cross-linking preparations on the average longevity of dermal injection. Injection site inflammation and the formation of collagen and elastin were also determined. PGA hydrogel particles prepared using 28% PGA and 10% 1,4-butanediol diglycidyl ether showed optimal filler properties, resistance to moist heat sterilization, and an average filling longevity of 94.7 ± 61.6 days in the dermis of rabbit ears. Local redness and swelling due to filler injection recovered within 14.2 ± 3.6 days. Local tissue necrosis or systemic allergic reactions were not observed, and local collagen formation was promoted. Preliminary results suggested that dermal injection of cross-linked PGA particles appeared safe and effective, suggesting that cross-linked PGA particles could be developed as a new hydrogel dermal filler.

Keywords: collagen; cross-link; dermal filler; injectable; poly-γ-glutamic acid.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Biocompatible Materials
  • Butylene Glycols
  • Dermal Fillers*
  • Excipients
  • Glutamic Acid
  • Hyaluronic Acid
  • Hydrogels* / pharmacology
  • Rabbits

Substances

  • Biocompatible Materials
  • Butylene Glycols
  • Dermal Fillers
  • Excipients
  • Glutamic Acid
  • Hyaluronic Acid
  • Hydrogels