AAPS PharmSciTech

, Volume 18, Issue 4, pp 1288–1292 | Cite as

Development and Optimization of an Ex Vivo Colloidal Stability Model for Nanoformulations

  • Muhammad Vaseem Shaikh
  • Manika Kala
  • Manish Nivsarkar
Rapid Communication


Nanotechnology is having a significant impact in the drug delivery systems and diagnostic devices. As most of the nanosystems are intended to be administered in vivo, there is a need for stability models, which could simulate the biological environment. Instability issues could lead to particle aggregation and in turn could affect the release of the drug from the nanosystems and even lead to clogging of the systemic blood circulation leading to life-threatening situation. We have developed an ex vivo colloidal stability model for testing the stability of nanosystems over a period of 48 h, which is the typical residence time of the nanoparticles in vivo. Tissue homogenates of rat spleen, brain, kidney, and liver were stabilized and optimized for the study; additionally, plasma and serum were used for the same. Poly (lactide-co-glycolic acid) nanoparticles were used as model nanosystem, and no significant change was found in the size and polydispersity index of the nanoparticles in the biological solutions. Moreover, no change in morphology was observed after 48 h as observed by TEM microscopy. Hence, the developed model could prevent the failure of the developed nanosystem during clinical and preclinical application by serving as an initial checkpoint to study their interaction with the complex milieu.


ex vivo colloidal stability PLGA nanoparticle nanosystem 



The authors would like to acknowledge B.V. Patel PERD Centre for providing facility required for the research undertaken, DST for providing financial assistance (IF120807), and NIRMA University.

Compliance of Ethical Standards

Conflict of Interest

The authors declare that they have no conflict of interest.

Supplementary material

12249_2016_597_MOESM1_ESM.docx (12 kb)
Supplementary Table 1 PDI of PLGA-NPs in different tissue homogenates. Data expressed as mean ± SD (n = 3) (DOCX 11 kb)
12249_2016_597_MOESM2_ESM.docx (11 kb)
Supplementary Table 2 Zeta potential of PLGA-NPs in different tissue homogenates. No significant difference was observed in zeta potential of NPs measured at different time points in tissue homogenates. Data expressed as mean ± SD (n = 3). (DOCX 11 kb)
12249_2016_597_Fig6_ESM.gif (9 kb)
Supplementary Fig. 1

Colloidal stability of PLGA-NPs in PBS at 37°C. (GIF 8 kb)

12249_2016_597_MOESM3_ESM.tif (358 kb)
High resolution image (TIF 357 kb)


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Copyright information

© American Association of Pharmaceutical Scientists 2016

Authors and Affiliations

  • Muhammad Vaseem Shaikh
    • 1
    • 2
  • Manika Kala
    • 1
    • 2
  • Manish Nivsarkar
    • 1
  1. 1.Department of Pharmacology and ToxicologyB. V. Patel Pharmaceutical Education and Research Development (PERD) CentreAhmedabadIndia
  2. 2.Faculty of PharmacyNIRMA UniversityAhmedabadIndia

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