Multi-kinetic release of benznidazole-loaded multiparticulate drug delivery systems based on polymethacrylate interpolyelectrolyte complexes

Eur J Pharm Sci. 2018 Jul 30:120:107-122. doi: 10.1016/j.ejps.2018.04.034. Epub 2018 Apr 27.

Abstract

Interpolyelectrolyte complexes (IPEC) formulated as multiparticulate drug delivery systems (MDDS) are interesting carriers to improve drug' performance. Benznidazole (BZ) is the first-line drug for Chagas treatment; however, it presents side effects and toxicity, conditioning its efficacy and safety. The goal of this work was to obtain novel MDDS composed by IPEC based on different polymethacrylate carriers loaded with BZ and to investigate in vitro drug delivery performance for oral administration. Physicochemical characterizations were studied and preclinical studies in a murine model of acute Chagas disease were also performed. The MDDS composed by BZ-loaded IPEC based on polymethacrylates were obtained by casting solvent followed by wet granulation methods with yields >83%. FT-IR demonstrated ionic interaction between the polyelectrolytes. Confocal microscopy, DSC and PXRD revealed a fraction uniformly distributed of free BZ on the multiparticles. The rheological evaluation of the MDDS showed adequate flow features for their formulation in hard gelatin-capsules. The type and composition of IPEC conditioned the modulation of BZ release and fluid uptake results. MDDS based on more hydrophylic Eudragit® showed very fast dissolution (Q15min > 85%), while an extended release (Q120min ≤ 40%) for the hydrophobic ones was observed. Capsules containing a combination of two MDDS with different release profile of BZ showed promising properties to improve Chagas disease pharmacotherapy in the preliminary in vivo assay performed, in which the BZ-loaded MDDS exhibited efficacy to reduce parasitemia, while decreasing the levels of liver injury markers in comparison to BZ conventional treatment. Multi-kinetic BZ delivery systems developed are interesting pharmaceutical alternatives to improve the treatment of Chagas disease.

Keywords: Benznidazole; Chagas disease; Eudragit®; Multiparticulate drug delivery systems; Polyelectrolyte complexes.

Publication types

  • Comparative Study

MeSH terms

  • Adhesiveness
  • Administration, Oral
  • Animals
  • Capsules
  • Chagas Disease / drug therapy
  • Chagas Disease / parasitology
  • Disease Models, Animal
  • Drug Carriers*
  • Drug Compounding
  • Drug Delivery Systems / methods*
  • Drug Liberation
  • Gelatin / chemistry
  • Hydrophobic and Hydrophilic Interactions
  • Kinetics
  • Male
  • Mice, Inbred BALB C
  • Nitroimidazoles / administration & dosage*
  • Nitroimidazoles / chemistry
  • Particle Size
  • Polyelectrolytes / chemistry*
  • Polymethacrylic Acids / chemistry*
  • Rheology
  • Solubility
  • Spectroscopy, Fourier Transform Infrared
  • Technology, Pharmaceutical / methods
  • Trypanocidal Agents / administration & dosage*
  • Trypanocidal Agents / chemistry

Substances

  • Capsules
  • Drug Carriers
  • Nitroimidazoles
  • Polyelectrolytes
  • Polymethacrylic Acids
  • Trypanocidal Agents
  • methylmethacrylate-methacrylic acid copolymer
  • polymethacrylic acid
  • Gelatin
  • benzonidazole