Poloxamer 188 (Pluronic F-68)
Excipient Role & Function
Poloxamer 188 (also known by trade names Kolliphor® P188 or Pluronic® F68) is a non-ionic surfactant used as a stabilizing agent in parenteral biologic formulations. Its primary function is to protect the active drug substance (e.g., AAV particles or proteins) from physical stress at interfaces (air-liquid, solid-liquid), preventing aggregation and adsorption to container surfaces.
Excipient Specifications
- Identity: The material must be confirmed as Poloxamer 188.
- Concentration (Quantity): The excipient must be present at the correct concentration in the final drug product. The target concentration in AAV and monoclonal antibody formulations is typically very low, often in the range of 0.001% to 0.1% w/v (e.g., a target of 0.005% is common). A usual specification is then set at 90.0% - 110.0% of this target concentration.
Primary Analytical Method
Characterization / Orthogonal Methods
Regulatory & Compendial Status
Poloxamer 188 is a widely used excipient with its own official monograph in the United States Pharmacopeia-National Formulary (USP-NF). The raw material must meet the tests and criteria defined in this monograph to be considered compendial grade for pharmaceutical use. Its inclusion and concentration in a final drug product must be justified based on data gathered during formulation development, in line with the principles of Quality by Design (QbD).