Abstract
Objective: The study was designed to prepare Nano-sponge formulation loaded with nifedipine. Studying parameters which affecting the formulas in addition to pharmacokinetics and toxicity tests.
 Methods: Nine Nano-sponge formulations were prepared by the solvent evaporation technique. Different ratios of polymer ethylcellulose, CO-polymers β-cyclodextrin and hydroxypropyl β-cyclodextrin in addition to solubilizing agent polyvinyl alcohol were used. Thermal analysis, X-ray powder diffraction (XRPD), shape and surface morphology, particle size, %production yield, %porosity, % swelling, and % drug entrapment efficiency of Nano-sponge were examined. Release kinetic also studied beside comparison of pharmacokinetic parameters of the optimum choice formula and marketed one in addition to Toxicological consideration.
 Results: Particle size in the range of 119.1 nm to 529 nm which were increased due to the increase in the concentration of polymer to the drug. Nano-sponge revealed porous, spherical nature. Increased in the drug/polymer molar ratios (1:1 to 1:3) may increase their % production yield ranged from 62.1% to 92.4%. The drug content of different formulations was in the range of 77.9% to 94.7%, and entrapment efficiency was in the range of 82.72 % to 96.63%. Drug released in controlled sustained pattern and followed Higuchi, s diffusion mechanism. Pharmacokinetic parameters of optimized formula showed significant higher maximum plasma drug concentration, area under plasma concentration-time curve, volume of distribution and mean residence time. Nano-sponge loaded drug proved biological safety at low concentrations.
 Conclusion: Nano-sponge drug delivery system has showed small Nano size, porous with controlled drug release and significant-high plasma drug concentration that improved solubility, drug bioavailability and proved safety.
Highlights
Nano-sponge is novel class of hyper-cross linked polymer-based colloidal structures consisting of solid nanoparticles with colloidal sizes and Nanosized cavities
Emulsion of high surface area and small droplets size were formed with high stirring rate and Nano-sponge with smaller size were formulated
Low potential values were observed for formulas prepared with Polyvinyl alcohol (PVA) indicating steric hindrance stabilization, while high values were observed for formulas prepared with β-cyclodextrin and HP β-cyclodextrin pointed to electrostatic repulsive stabilization and prevention of particles aggregation [29]
Summary
Nano-sponge is novel class of hyper-cross linked polymer-based colloidal structures consisting of solid nanoparticles with colloidal sizes and Nanosized cavities They enhance stability, reduce side effects and modify drug release. Calcium channels antagonists are still favored as primary treatment for older black patients and sub-lingual nifedipine has previously been used in hypertensive emergencies, it has a very low bioavailability, and it is photosensitive and thermally unstable. This compound, when exposed to daylight and certain wavelengths of artificial light readily converts to a nitrophenyl pyridine derivative (NFPD) In the present study nifedipine was formulated as a Nano-sponge system helps to retain the drug for longer period and to increase the solubility and bioavailability with decrease side effects
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