Nanocapsule Shell Creation The capsules may be sized according to the specifics of capsulated molecules Colloidal particles are used for structural support. Shell is assembled using nanolayers of different components and functions. Adjusting shell thickness controls permeability, stability and degradation time, ultimately resulting in control of release time. Biodegradable shells may be assembled from polysaccharides and polypeptides (approved by FDA). Chitosan, alginate, dextran, and others polysaccharides. Gelatin, polylysine, polyglutamic acid, albumin, and other polypeptides.
Nearly 100% encapsulation efficiency using calcium carbonate microparticles.
The calcium carbonate – compound microparticles are then encapsulated by a biodegradable shell.
The encapsulation process is very mild and requires no chemical treatment.
CaCO3 particles may be dissolved in very mild conditions. The compound remains inside capsules with no change of conformation or loss of activity.
Encapsulation of Interferon Capture of Interferon using CaCO3 Shell material: Dextran sulfate sodium salt alternating with Poly-L-lysine hydrochloride. First and last layers are composed of dextran sulfate. Total number of layers is 7. Overall encapsulation efficiency is 90%-95%(weight to volume). Size of capsules is 4-5 microns(subject to clinical/delivery needs and can be adjusted accordingly). This is a preliminary trial. Shell material, thickness and capsule size may be altered to meet pharmacokinetic demands and requirements.
Safety of Nanoencapsulation Substances used for nanoencapsulation are biodegradable: Many are already FDA approved for human use in other applications. Subcutaneous injection: Results in degradation by macrophages. Local mild inflammation is noted on animal studies. No other significant reactions noted.
Safety of Nanoencapsulation Vero 1 cells after 60hours incubation: Synthetic capsule No degradation Dextran Sulfate and poly-Argininecapsule Degradation
Safety of Nanoencapsulation Mild tissue reaction. Good cellular uptake. Good capsule degradation.
Rationaleof Nanoencapsulation Main market-hepatitis C Potential for expansion to treatment of hepatitis B Renewed interest in interferon therapy for hepatitis B Limited treatment duration Potential for eAbseroconversion Potential for loss of sAg Large market internationally