Nanonization of Recombinant Human Growth Hormone Using Supercritical Fluid Process

摘要

Small nano-size particles with narrow particle size distribution are needed for applications in pulmonary delivery and controlled release systems. In the case of drug administration to the lung through inhalation, the small particle size is especially important because large particles tend to fall out of the gas stream and deposit in the mucosa of the upper airways before reaching the alveoli of the lungs. Pulmonary and parenteral delivery can avoid the hepatic for first-pass effect and the digestive process typical for oral administration of drugs. Recombinant human growth hormone (hGH) is often prone to denaturation or degradation in the solution. Therefore, the process of preparation of hGH solid nanoparticles is indispensable for the pulmonary delivery for hGH. Solution enhanced dispersion (SEDS) process by supercritical fluid was successfully applied to produce ultra-fine particles of recombinant human growth hormone (hGH). We used aqueous ethanol solution for hGH. SEDS experiments were carried out by varying pressure, temperature, concentration of protein solution. Nano-Size spherical particles for hGH were successfully obtained by SEDS and particle sizes were 40 - 150 nm for hGH. Especially, we did not use any additive to enhance the activity of hGH during SEDS Process.