Supercritical CO2 technology for one-pot foaming and sterilization of polymeric scaffolds for bone regeneration

  1. García-González, Carlos A.
  2. Santos-Rosales, Víctor
  3. Magariños, Beatriz
  4. Suárez-González, Javier 1
  5. Fariña, José B. 1
  6. Starbird, Ricardo
  7. Alvarez-Lorenzo, Carmen 2
  1. 1 Universidad de La Laguna
    info

    Universidad de La Laguna

    San Cristobal de La Laguna, España

    ROR https://ror.org/01r9z8p25

  2. 2 Universidade de Santiago de Compostela
    info

    Universidade de Santiago de Compostela

    Santiago de Compostela, España

    ROR https://ror.org/030eybx10

Journal:
International Journal of Pharmaceutics

ISSN: 0378-5173

Year of publication: 2021

Volume: 605

Pages: 120801

Type: Article

DOI: 10.1016/J.IJPHARM.2021.120801 GOOGLE SCHOLAR lock_openOpen access editor

More publications in: International Journal of Pharmaceutics

Abstract

Sterilization is a quite challenging step in the development of novel polymeric scaffolds for regenerative medicine since conventional sterilization techniques may significantly alter their morphological and physicochemical properties. Supercritical (sc) sterilization, i.e. the use of scCO2 as a sterilizing agent, emerges as a promising sterilization method due to the mild operational conditions and excellent penetration capability. In this work, a scCO2 protocol was implemented for the one-pot preparation and sterilization of poly(-caprolactone) (PCL)/poly(lactic-co-glycolic acid) (PLGA) scaffolds. The sterilization conditions were established after screening against both Gram-positive (Staphylococcus aureus) and Gram-negative (Escherichia coli, Pseudomonas aeruginosa) vegetative bacteria and spores of Bacillus stearothermophilus, Bacillus pumilus and Bacillus atrophaeus. The transition from the sterilization conditions (140 bar, 39 °C) to the compressed foaming (60 bar, 26 °C) was performed through controlled depressurization (3.2 bar/min) and CO2 liquid flow. Controlled depressurization/pressurization cycles were subsequently applied. Using this scCO2 technology toolbox, sterile scaffolds of well-controlled pore architecture were obtained. This sterilization procedure successfully achieved not only SAL-6 against well-known resistant bacteria endospores but also improved the scaffold morphologies compared to standard gamma radiation sterilization procedures.

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