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Injectability of high concentrated suspensions using model microparticles.

Kavin Kowsari¹, Lynn Lu¹, Steven C Persak¹

¹Device Development and Technology, Merck Research Laboratories, Merck & Co. Inc., Rahway, NJ 07065, USA.

Journal of Pharmaceutical Sciences

|October 6, 2024

Summary

High-concentration particle suspensions can clog needles during injection. This study developed a method to visualize and measure clogging, finding that larger needle diameters and particle density reduce clogging, while viscosity and particle size increase it.

Keywords:

Experimental characterization Fluorescent imaging Microparticle suspensions Needle clogging Particle jamming Suspension delivery Syringeability

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Area of Science:

Pharmaceutical Sciences
Biomaterials Engineering
Drug Delivery Systems

Background:

High-concentration particle suspensions are challenging for injection due to needle occlusion.
Particle bridging and filtering in syringe-needle systems risk dose accuracy and injectability.
Limited understanding exists on the initiation of clogging in these delivery systems.

Purpose of the Study:

To experimentally characterize the transient injection behavior of suspensions.
To investigate factors influencing suspension particle jamming and needle clogging.
To provide a framework for quantifying clogging risk in drug-loaded particle suspensions.

Main Methods:

Developed a custom fluorescence tagging and imaging technique with an integrated force sensor.
Visually observed local particle concentrations and monitored plunger force during injection.
Systematically studied effects of particle properties, vehicle viscosity, injection rate, device dimensions, and tissue backpressure.

Main Results:

Increased needle inner diameter (ID) and particle density significantly reduced clogging risk.
Increased vehicle viscosity, particle size, and tissue backpressure significantly increased clogging.
Identified key parameters influencing suspension injectability and dose delivery.

Conclusions:

The developed experimental framework effectively quantifies clogging risk in particle suspensions.
Findings offer guidelines for balancing particle design for pharmaceutical impact with injection feasibility.
Informed decisions can be made regarding formulation and device parameters to optimize drug delivery.