Stabilization of therapeutic protein on a polymer surface
When it comes to administration of recombinant human growth hormone (r-hGh), short half-life, instability in gastrointestinal tract, and low circulation time requiring frequent parenteral administration can lead to patient noncompliance. Researchers are investigating several polymer nanoparticle and micro particle based long acting delivery systems. However, comprehension of structural stability and polymer grade is fundamental for developing sustained delivery of protein like r-hGH. Evaluation of the conformational changes in secondary and tertiary structure and quantitative analysis of adsorbed r-hGH or any therapeutic protein at an interface with the polymer of different hydrophobicity as a function of pH is required enable selection of a polymer grade suitable for long acting dosage form development. This invention fulfills these needs.