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Formulation and optimization for DPP-4 inhibitor nanomicelles using response surface methodology.

Deepika Sharma1, Samir Bhargava1, Bhavna Kumar1

  • 1Faculty of Pharmacy, DIT University, Uttarakhand, India.

Drug Development and Industrial Pharmacy
|December 5, 2019
PubMed
Summary
This summary is machine-generated.

Researchers developed optimized polymeric nanomicellar (PNM) formulations for sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The optimized PNM formulation demonstrates high stability and potential for minimizing drug side effects.

Keywords:
DPP-4 inhibitorscentral composite designpolymeric nanomicellesresponse surface methodologysitagliptin

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Area of Science:

  • Pharmaceutical Nanotechnology
  • Drug Delivery Systems
  • Polymer Science

Background:

  • Dipeptidyl peptidase-4 (DPP-4) inhibitors are oral antidiabetics targeting the DPP-4 enzyme.
  • Developing stable and effective delivery systems is crucial for improving therapeutic outcomes and reducing side effects of antidiabetic drugs like sitagliptin.

Purpose of the Study:

  • To formulate, statistically optimize, and characterize polymeric nanomicellar (PNM) formulations of the DPP-4 inhibitor sitagliptin.
  • To utilize a natural polymer and nonionic surfactant for creating stable nanomicelles.
  • To evaluate the potential of PNM formulations for enhanced drug delivery and reduced side effects.

Main Methods:

  • Response Surface Methodology (RSM) with a full central composite design was employed for optimization.
  • Sitagliptin-loaded polymeric nanomicelles were prepared using a direct dissolution method.
  • Characterization included particle size, polydispersity index, zeta potential, drug loading, entrapment efficiency, and in vitro drug release.

Main Results:

  • The optimized formulation (PNM 10) exhibited a low polydispersity index (0.564) and a particle size of 368.2 nm.
  • PNM 10 achieved a drug loading of 38.67% ± 0.23% and an entrapment efficiency of 79.67% ± 0.54%.
  • An in vitro drug release of 82.34% ± 0.78% was observed for PNM 10.

Conclusions:

  • Statistically optimized polymeric nanomicelles (PNM 10) provide a stable and effective formulation for sitagliptin.
  • This nanomicellar approach shows promise for developing futuristic drug delivery systems that can minimize potential drug side effects.
  • The optimized formulation is deemed safe for application and suitable for prolonged use.