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Pharmaceutics 2018, 10(1), 5; doi:10.3390/pharmaceutics10010005

Development of a Parenteral Formulation of NTS-Polyplex Nanoparticles for Clinical Purpose

1
Nanosciences and Nanotechnology Department, Center for Research and Advanced Studies of the National Polytechnical Institute, Mexico City 07360, Mexico
2
Chemistry Department, Center for Research and Advanced Studies of the National Polytechnical Institute, Mexico City 07360, Mexico
3
Pharmacology Department, Center for Research and Advanced Studies of the National Polytechnical Institute, Mexico City 07360, Mexico
4
Physics Department, Center for Research and Advanced Studies of the National Polytechnical Institute, Mexico City 07360, Mexico
5
Physiology, Biophysics and Neurosciences Department, Center for Research and Advanced Studies of the National Polytechnical Institute, Mexico City 07360, Mexico
6
Pharmaceutical Nanotechnology Department, Psicofarma, S.A. de C.V., Mexico City 14050, Mexico
These authors contributed equally to this work.
*
Author to whom correspondence should be addressed.
Received: 9 December 2017 / Revised: 23 December 2017 / Accepted: 2 January 2018 / Published: 3 January 2018
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Abstract

Neurotensin (NTS)-polyplex is a nanoparticle system for targeted gene delivery that holds great promise for treatment of Parkinson’s disease and various types of cancer. However, the high instability in aqueous suspension of NTS-polyplex nanoparticles is a major limitation for their widespread clinical use. To overcome this obstacle, we developed a clinical formulation and a lyophilization process for NTS-polyplex nanoparticles. The reconstituted samples were compared with fresh preparations by using transmission electron microscopy, dynamic light scattering, electrophoretic mobility, circular dichroism and transfection assays in vitro and in vivo. Our formulation was able to confer lyoprotection and stability to these nanoparticles. In addition, transmission electron microscopy (TEM) and size exclusion-high performance liquid chromatography (SEC-HPLC) using a radioactive tag revealed that the interaction of reconstituted nanoparticles with fetal bovine or human serum did not alter their biophysical features. Furthermore, the formulation and the lyophilization procedure guaranteed functional NTS-polyplex nanoparticles for at least six months of storage at 25 °C and 60% relative humidity. Our results offer a pharmaceutical guide for formulation and long-term storage of NTS-polyplex nanoparticles that could be applied to other polyplexes. View Full-Text
Keywords: nanoparticles; gene therapy; formulation; lyophilization; transfection; stability nanoparticles; gene therapy; formulation; lyophilization; transfection; stability
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Aranda-Barradas, M.E.; Márquez, M.; Quintanar, L.; Santoyo-Salazar, J.; Espadas-Álvarez, A.J.; Martínez-Fong, D.; García-García, E. Development of a Parenteral Formulation of NTS-Polyplex Nanoparticles for Clinical Purpose. Pharmaceutics 2018, 10, 5.

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