Abstract
The study focuses on the in vitro and in vivo evaluation of the developed gentamicin sulphate (GS)-loaded poly lactic-co-glycolic acid (PLGA) nanoparticle (PNP)-based pullulan film (PNP-F). Sterilization being an essential pre-requisite for the dosage form was carried out using ethylene oxide. Post-sterilization, PNP-F was evaluated for mechanical properties, percentage drug loading, antimicrobial effectiveness study, test for sterility and in vitro dissolution study using Strat-M® membrane. In vitro dissolution study revealed that GS gradually released from PNP-F and the highest cumulative percentage drug release was found to be 86.76 ± 0.03% at 192 h. Wound healing assay was performed to study the effect of PNP-F over migratory potential of dermal fibroblast cells (NIH-3T3) in the presence of micro-organisms, Pseudomonas aeruginosa (PA) and Staphylococcus aureus (SA). PNP-F inhibited the growth of PA and SA, allowing the growth of fibroblast cells indicating its suitability for application. In vivo study of surgical site was performed by superficial incision model in Wistar rats. Measurement of in vivo incision healing confirmed faster wound healing in the incision which received PNP-F compared to marketed cream containing GS.
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Acknowledgements
The authors would like to acknowledge Institute of Pharmacy, Nirma University, Ahmedabad, India, for providing the facility to Mr. Chetan Dhal for performing the study as a part of PhD research work to be submitted to Nirma University. The authors are highly thankful to Council for Scientific and Industrial Research (CSIR), India, for providing financial assistance and senior research fellowship to Mr. Chetan Dhal (Fellowship ID: 09/1048(008)/2018 EMR-I) during the PhD. The authors acknowledge Dr. Snehal Patel and Mr. Vishal Chavda, Institute of Pharmacy, Nirma University, Ahemdabad, for their support during in vivo studies. The authors would like to acknowledge Dr. Manish Nivsarkar, Director, PERD Centre, Ahmedabad, for providing cell line facility and Dr. Neeta Shrivastava and Ms. Sonam Sinha, PERD Centre, Ahmedabad, for supporting cell line study. The authors are thankful to Mr. Sumer Singh, Director, Oasis Test House, Ahmedabad, for supporting test for sterility. The authors also thank Evonik, Germany, and Jawa Pharmaceuticals, Gurgaon, India, for providing gift samples of PLGA and GS, respectively.
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Dhal, C., Mishra, R. In vitro and in vivo evaluation of gentamicin sulphate-loaded PLGA nanoparticle-based film for the treatment of surgical site infection. Drug Deliv. and Transl. Res. 10, 1032–1043 (2020). https://doi.org/10.1007/s13346-020-00730-7
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DOI: https://doi.org/10.1007/s13346-020-00730-7