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Bio-evaluation of Poly-Lactate co-Glycolic Acid (PLGA) nanoparticles loaded with radio-labeled rifampicin.
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  • Imran Ibni Rather,
  • Nusrat Shafiq,
  • Jaya Shukla,
  • Gurvinder Kaur,
  • Somit Pandey,
  • Ritika Kondel,
  • Avaneesh Pandey,
  • B.R Mittal,
  • Navneet Sharma,
  • G.K Khuller,
  • Samir Malhotra
Imran Ibni Rather
PGIMER
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Nusrat Shafiq
Post Graduate Institute of Medical Education and Research
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Jaya Shukla
PGIMER
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Gurvinder Kaur
PGIMER
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Somit Pandey
PGIMER
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Ritika Kondel
PGIMER
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Avaneesh Pandey
PGIMER
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B.R Mittal
PGIMER
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Navneet Sharma
PGIMER
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G.K Khuller
PGIMER
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Samir Malhotra
Post Graduate Institute of Medical Education and Research

Corresponding Author:[email protected]

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Abstract

The poly lactate co-glycolic acid (PLGA) nanoparticles of tubercular drugs have been demonstrated to have sustained release profile over seven days. There is no information on the location or mode of release of these nanoparticles in living system. Therefore, we have planned the study to explore the pharmacokinetics and biodistribution of PLGA rifampicin nanoparticles in healthy human volunteers. Rifampicin was labeled with 99mTc by indirect method and nanoparticles were prepared by a single emulsion evaporation method. To investigate the pharmacokinetics and biodistribution of nanoparticles, a single dose of 450 mg of rifampicin was administered orally to healthy human volunteers divided into two different groups. Following a single oral dosage of the rifampicin nanoformulation, the PK parameters were significantly different between the nanoparticle and conventional groups AUC (113.8 vs 58.6), MRT (16.2 vs 5.8) and Ke (0.04 vs 0.10). Also SPECT/CT images revealed bio-distrubution of nanoparticles in the distal portions of the intestine, which is consistent with our dosimetry analysis Significant difference in PK parameters and bio-distribution of nanoparticles in spleen and lymph nodes with maximum deposition were observed in large intestine. Nanoparticle distribution pattern may be advantageous for the treatment of intestinal or lymph node TB and has the potential to result in a lower dose of rifampicin nanoformulation for the treatment of pulmonary TB.
10 Nov 2022Submitted to British Journal of Clinical Pharmacology
27 Jan 2023Submission Checks Completed
27 Jan 2023Assigned to Editor
27 Jan 2023Review(s) Completed, Editorial Evaluation Pending
02 Feb 2023Reviewer(s) Assigned
15 Mar 2023Editorial Decision: Revise Major
05 Apr 20231st Revision Received
05 Apr 2023Submission Checks Completed
05 Apr 2023Assigned to Editor
05 Apr 2023Review(s) Completed, Editorial Evaluation Pending
06 Apr 2023Reviewer(s) Assigned
28 Apr 2023Editorial Decision: Revise Major
23 Jun 20232nd Revision Received
24 Jun 2023Submission Checks Completed
24 Jun 2023Assigned to Editor
24 Jun 2023Review(s) Completed, Editorial Evaluation Pending
25 Jun 2023Reviewer(s) Assigned
20 Jul 2023Editorial Decision: Accept