BCS class II drug loaded protein nanoparticles with enhanced oral bioavailability: in vitro evaluation and in vivo pharmacokinetic study in rats

Abstract

The aim of the study was to improve the bioavailability of atorvastatin calcium (ATC) by formulating polymeric nanoparticles (NPs) with an easy and cost-effective approach. ATC entrapped gelatin nanoparticles (AEGNPs) were prepared by using a simple one-step desolvation method. The formed NPs were characterized by scanning electron microscopy, Fourier transform infrared spectroscopy, and differential scanning calorimetry. Morphological study exhibited a homogenous spherical shape of formulated NPs. FTIR studies revealed the chemical compatibility of the drug with gelatin. The improvement in drug delivery kinetics of AEGNPs could be attributed to amorphization along with the reduction in particle size of ATC. The pharmacokinetic study in Sprague-Dawley rats revealed that the C_max and AUC_0–24 of AEGNPs in rats were ∼4-fold and ∼11-fold higher than that of pure ATC suspension. The research presented successfully shows that AEGNPs preparation by one-step desolvation, using minimum excipients is a quick, easy and reproducible method. These results suggest that the ATC encapsulated gelatin NP is a promising approach for the oral delivery of ATC, improving the bioavailability of the drug.

Keywords:

• Atorvastatin calcium
• one-step desolvation
• AEGNPs
• pharmacokinetics
• bioavailability

Acknowledgements

The authors thank Amoli Organics Pvt. Ltd. and Nitta Gelatin India Ltd., for providing gift samples of drug and polymer. Authors would also like to acknowledge the management of Bharati Vidyapeeth’s College of Pharmacy, CBD, Navi Mumbai, India for providing necessary support for conduction of this work.

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.