Highly Concentrated Suspensions for Subcutaneous Delivery of an Active PolyPeptide Pharmaceutical

Life Sciences : Drug Delivery

Available for licensing

Inventors

  • Keith Johnston, Ph.D. , Chemical Engineering
  • Joshua Engstrom, Ph.D. , Chemical Engineering
  • Miguel Rodrigues, Ph.D. , University of Texas at Austin
  • Maria Andrea Miller (Mazuski), Ph.D. , University of Texas at Austin

Background/unmet need

Currently, therapeutic proteins and antibodies are delivered intravenously because of the poor stability and high viscosity of concentrated protein solutions. Subcutaneous delivery is more convenient and less painful; however, high dosage requirements greatly limits the utility of this method.

Previous attempts to increase the solubility of proteins have focused on addition of salts or suspension of the proteins in oil. Addition of salt can only reduce viscosity at protein concentrations that are not therapeutically useful. Thus far, oil suspensions have not been able to be used for the successful delivery of a protein or polypeptide due to high viscosity. This technology provides for a highly concentrated, syringable protein suspension.

Invention Description

UT Austin researchers have developed a formulation method for the stable suspension of protein and polypeptide at high concentrations that are suitable for subcutaneous delivery. The solvent system used to suspend the protein is pharmaceutically acceptable and may be adjusted to varying viscosities as needed. The suspensions are uniform after being lightly shaken for up to one year, and particle aggregation is not seen at micro- or macroscopic levels.

Benefits/Advantages

  • Can deliver a dose greater than 100 mg/mL
  • Uses pharmaceutically acceptable solvents
  • Utilizes particles that can be made by various techniques
  • Does not create aggregates at the protein or particle level
  • Can be redispersed after more than one year

Market potential/applications

Pharmaceutical companies requiring a delivery method for therapeutic agents that present problems such as aggregation and high viscosity at concentrations required for appropriate dosage.

Development Stage

Lab/bench prototype

IP Status

  • 3 foreign patents issued
  • 1 U.S. patent issued: 8,779,094