Novel Formulation Strategies for the Management of Surgical Site Infection

Abstract

The study focuses on the development of PLGA based nanoparticles of Gentamicin Sulphate. The nanoparticles were fabricated using two different techniques - double emulsion solvent removel technique and nanoprecipitation method. The nanoparticles prepared with double emulsion solvent removal technique were screened using Plackett Burman Design and optimized using Box-Behnken Design. The nanoparticles were spherical, smooth and possessed particle size of 280 ± 12.04 nm. The nanoparticles were casted into pullulan based film by solvent casting method. The nanoparticle loaded film was evaluated for tensile strength, % elongation and % drug entrapment efficiency. The antimicrobial effectiveness studies revealed that the property was retained in the film when compared to Gentamicin Sulphate. Further, In-vitro study using wound healing assay and In-vivo study using superficial incision model revealed that, film promotes migration of fibroblast cells in presence of microbial cultures of Staphylococcus aureus and Pseudomonas aeruginosa and faster healing of the incision. The nanoparticles prepared with nanoprecipitation method were optimized using Central Composite Design. The nanoparticles were spherical, possessed smooth surface and had 129.6 ± 4.79 nm particle size. The nanoparticles were loaded into pectin based film by solvent casting method. The nanoparticle loaded film was evaluated for tensile strength, % elongation and % drug entrapment efficiency. Antimicrobial studies of the film confirmed that the film retained the activity and in-vivo study using superficial incision model confirmed that film healed the incision faster compared to the available gentamicin sulphate cream as well as control. Both the films were subjected to sterilization using gaseous method (Ethylene Oxide gas) and results indicate the suitability of the method in terms of stability of the sterilized film. Stability studies were also performed at different condition 15 °C, 25 ± 2 °C/ 60 ± 5% RH and 40 ± 2 °C/ 75 ± 5% RH for a time period upto 6 months. The results of the stability studies indicate that 15 °C can be a proposed stability condition for the film.