Polymeric hGH Prodrug Formulation for High-Concentration Injection

The patent changes the concentration parameter of hGH in the formulation by using polymeric carriers that enable higher hGH loading. This allows more hGH to be administered per injection volume, treating patients with higher dose requirements without increasing injection volume, thus avoiding injection site pain.

The patent uses composite formulations combining hGH with polymeric carriers (such as polylactic acid, polyglycolic acid, or their copolymers). These composite materials enable sustained release of hGH at higher concentrations, allowing adequate dosing for conditions like Turner syndrome and chronic kidney disease without requiring large injection volumes.

The patent optimizes the concentration parameter by selecting specific polymeric carriers and their molecular weights to achieve high hGH loading while maintaining injectability. The formulation allows adequate hGH concentration for conditions like ISS and Turner syndrome without requiring multiple injections or excessive volumes.

The patent creates localized high-concentration hGH depots at the injection site through polymeric carriers that release hGH sustainably. This local concentration strategy provides adequate dosing for high-requirement patients while maintaining convenient single-injection administration.

The patent carefully controls the viscosity parameter by selecting appropriate polymeric carriers and their concentrations. The formulation achieves sufficient stability for storage and handling while maintaining low enough viscosity to be administered through fine gauge needles, ensuring proper dosing for pediatric and adult patients.

The patent creates a formulation that exhibits appropriate rheological properties, maintaining stability during storage but flowing easily during injection. The polymeric carrier system provides dynamic behavior that ensures both formulation integrity and injectability through fine gauge needles.