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Towards a Maraviroc long-acting injectable nanoformulation.

Lee M Tatham1, Alison C Savage2, Andrew Dwyer2

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European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|April 24, 2018
PubMed
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A novel long-acting injectable (LAI) formulation of maraviroc (MVC) shows promise for HIV prevention. This nanodispersion demonstrated sustained drug release and improved pharmacokinetic profiles in preclinical studies.

Keywords:
IntramuscularLong-Acting Injectable (LAI)Long-Acting Parenteral (LAP)MaravirocNanodispersionNanomedicinePharmacokineticsPre-exposure Prophylaxis (PrEP)

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Area of Science:

  • Pharmacology
  • Nanotechnology
  • Virology

Background:

  • Suboptimal adherence to antiretroviral (ARV) therapy is a major challenge in HIV management, leading to viral rebound and drug resistance.
  • Long-acting injectable (LAI) formulations offer a potential solution to improve adherence and therapeutic outcomes.
  • Maraviroc (MVC), a CCR5 antagonist, has a unique resistance profile and tissue distribution, making it an attractive candidate for LAI development, particularly for HIV Pre-Exposure Prophylaxis (PrEP).

Purpose of the Study:

  • To develop and characterize a long-acting injectable (LAI) nanodispersion formulation of maraviroc (MVC).
  • To evaluate the in vitro drug release and in vivo pharmacokinetic properties of the MVC LAI nanodispersion in a preclinical model.

Main Methods:

  • A 70 wt% MVC-loaded nanodispersion was prepared using emulsion-templated freeze-drying, stabilized with polyvinyl alcohol (PVA) and sodium 1,4-bis(2-ethylhexoxy)-1,4-dioxobutane-2-sulfonate (AOT).
  • In vitro release rate studies were conducted using a size-selective membrane.
  • Pharmacokinetic studies were performed in rats following intramuscular injection of the nanodispersion or an aqueous MVC solution.

Main Results:

  • The MVC LAI nanodispersion exhibited a significantly reduced in vitro release rate constant compared to an aqueous MVC solution.
  • In rats, the MVC LAI formulation resulted in a 3.4-fold increase in AUC0-∞ and a 2.6-fold increase in terminal half-life (t½) compared to the aqueous preparation.
  • Sustained MVC concentrations were observed for up to 10 days post-injection.

Conclusions:

  • The developed MVC LAI nanodispersion formulation demonstrates favorable in vitro and in vivo characteristics for sustained drug delivery.
  • These findings support the potential of a MVC LAI formulation for enhancing HIV therapy adherence and efficacy, as well as for HIV prevention strategies like PrEP.