Short answer

Designers should consider the impact of excipients on solution viscosity and interparticle forces when developing injectable formulations, aiming for formulations that balance stability with ease of administration.

Field: Human Factors
Source: mAbs (2025)
Method: Experimental analysis
Evidence: Strong effect

Strategic selection and concentration of excipients like polysorbate 20 and sucrose can significantly modulate the viscosity of monoclonal antibody solutions, impacting their manufacturability and injectability. This human factors research insight is drawn from a 2025 study published in mAbs. Using Experimental analysis, researchers explored how this design variable affects real-world outcomes. The key design takeaway: Designers should consider the impact of excipients on solution viscosity and interparticle forces when developing injectable formulations, aiming for formulations that balance stability with ease of administration.

Study

Human FactorsNew This WeekStrong effect

Optimizing Injectable Drug Viscosity Through Excipient Formulation

mAbs · 2025

Key Findings

01Elevated protein concentrations and lower temperatures increased interparticle interactions, leading to higher viscosity.
02Polysorbate 20 reduced interactions by adsorbing to the protein surface.
03Sucrose influenced viscosity through a concentration-dependent mechanism involving exclusion and crowding.
04A combination of NaCl and polysorbate 20 was most effective in reducing viscosity.
05Protein structure remained stable under tested thermal and shear conditions.

Application

Design takeaway

How to apply

When developing a new injectable drug formulation, systematically screen different combinations and concentrations of known viscosity-modulating excipients (e.g., surfactants, sugars, salts) and measure the resulting solution viscosity and interparticle interactions.

Project actions

01When designing a product that needs to be injected or flow through a narrow tube, consider how the liquid's thickness (viscosity) will affect its performance.
02Investigate how different additives (excipients) can change the flow properties of your product.

Method & Evidence

AimHow do excipients like polysorbate 20 and sucrose, in combination with varying salt concentrations and temperatures, influence the rheological properties of monoclonal antibody solutions?

MethodExperimental analysis

ProcedureThe study employed rheology, Raman spectroscopy, and a measure of interaction strength (k D) to analyze monoclonal antibody solutions under various conditions. Different concentrations of NaCl and polysorbate 20, along with varying temperatures and protein concentrations, were tested. Raman spectroscopy was used to assess protein structural integrity, while rheology measured viscosity and k D quantified interparticle interactions.

ContextBiopharmaceutical formulation development for injectable drugs

Variables

IV["Concentration of excipients (Polysorbate 20, Sucrose, NaCl)","Temperature","Protein concentration"]

DV["Solution viscosity","Interparticle interaction strength (k D)"]

CV["Protein type (monoclonal antibody)","Raman spectral analysis (Amide I/III regions)"]

Strengths & Limitations

Strengths

+Utilized multiple analytical techniques (rheology, spectroscopy) for a comprehensive understanding.
+Investigated synergistic effects of different formulation components.

Limitations

The specific chemical interactions studied are complex and may not directly apply to all liquid formulations. Real-world manufacturing processes can introduce additional variables not accounted for in controlled experiments.

Reliability & validity

The use of multiple measurement techniques (rheology, k D, Raman spectroscopy) enhances the validity of the findings. Repeating experiments under identical conditions would be crucial for assessing reliability.

Think critically

While excipients can control viscosity, what are the potential trade-offs in terms of long-term stability, biocompatibility, or cost?

Design Principles

"Colloidal interaction landscapes can be engineered through strategic excipient selection to optimize the rheological properties of protein-based formulations for improved manufacturability and injectability."

For designers and engineers developing injectable drug delivery systems, understanding how formulation components affect fluid properties is crucial. This knowledge allows for the creation of formulations that are not only stable and effective but also easy to administer, improving patient experience and compliance.

What This Means for Your Design

By carefully choosing ingredients like special sugars and cleaning agents, you can make thick liquid medicines flow more easily, making them easier to produce and inject.

How to use in your project

1.This research can inform the selection of materials and their concentrations in a design project aimed at creating a fluid product with specific flow characteristics.

Add to My Project

Quick Cite

Paragraph starter

The study by Eskens et al. (2025) highlights the critical role of excipients in modulating the rheological properties of protein solutions. By strategically employing agents like polysorbate 20 and sucrose, designers can engineer formulations with optimized viscosity, impacting both manufacturability and the user experience of injectable products. This research provides a framework for understanding how colloidal interactions can be manipulated to achieve desired fluid dynamics in complex formulations.

Source

mAbs

Temperature and excipient mediated modulation of monoclonal antibody interactions revealed by <i>k</i> D, rheology, and Raman spectroscopy

journal · 2025

View source

Questions About This Research

What does the research say about optimizing injectable drug viscosity through excipient formulation?: Designers should consider the impact of excipients on solution viscosity and interparticle forces when developing injectable formulations, aiming for formulations that balance stability with ease of administration. Evidence: mAbs (2025).
Why does "Optimizing Injectable Drug Viscosity Through Excipient Formulation" matter for design?: For designers and engineers developing injectable drug delivery systems, understanding how formulation components affect fluid properties is crucial. This knowledge allows for the creation of formulations that are not only stable and effective but also easy to administer, improving patient experience and compliance.
How can designers apply this research?: Designers should consider the impact of excipients on solution viscosity and interparticle forces when developing injectable formulations, aiming for formulations that balance stability with ease of administration.
What were the main findings?: Elevated protein concentrations and lower temperatures increased interparticle interactions, leading to higher viscosity.. Polysorbate 20 reduced interactions by adsorbing to the protein surface.. Sucrose influenced viscosity through a concentration-dependent mechanism involving exclusion and crowding.. A combination of NaCl and polysorbate 20 was most effective in reducing viscosity.
What research method was used?: Experimental analysis.
How strong is the evidence?: Evidence strength is rated Strong effect, based on a 2025 journal from mAbs.
What should I do differently in my next project?: When developing a new injectable drug formulation, systematically screen different combinations and concentrations of known viscosity-modulating excipients (e.g., surfactants, sugars, salts) and measure the resulting solution viscosity and interparticle interactions.
What are the limitations?: The study focused on specific monoclonal antibodies and excipients; results may vary for different biologics or formulation components. The direct translation of rheological properties to clinical injectability requires further in vivo validation.