Congruence Medical Solutions LLC

Microliter Multi-Dosing Syringe

OVERVIEW
APPLICATIONS
CUSTOMIZE
DATA
SPECIFICATIONS
The Microliter Multi-Dosing Syringe (MMDS) platform enables injection of multiple, accurate microliter volume doses within a single procedure. Application areas include dermatology/cosmetics and intra-tumoral delivery (oncology) amongst others. It is proven to deliver accurate, precise doses1, and is easy to use, with no need to set the injection volume for each dose. This versatile platform incorporates standard pre-fillable syringes and has a wide array of customization options.
Configurations
  • Disposable, Single-Use, Multi-Dose (50μl – 500μl doses)
  • User controls injection speed
  • Dose setting options: Pre-set (factory-set) or User-set
  • Drug filling options: Pre-filled or User-filled (from a vial)
  • All options incorporate standard, third-party pre-fillable syringes
  • No user-assembly required

Key Benefits
  • High accuracy: +/-2.5μl
  • Easy to Use
    • User controlled priming in one simple step
    • No need to reset dose after first injection
    • Audible and visual indicators of dose start and dose stop
    • One-handed operation possible
    • Can deliver viscous drugs

Availability
  • IP Protected
  • Samples available for clinical/preclinical use
Applications

The MMDS platform is suitable for applications requiring multiple injections of 50μl – 500μl volume in the same procedure.

Currently with multiple dosing, the burden is on the clinician to manage the anatomical aspects of the injection and concurrently calculating the volume of each injection. The clinicians have to rely on standard syringe dose graduations to determine the injection volume. The clinician also is required to track cumulative injection volume.

This often leads to inaccurate dosing and/or is time-consuming. The MMDS addresses these needs while utilizing a standard pre-fillable syringe.

Application areas include injection of drugs in dermatology/cosmetics, neurology (brain delivery), intra-tumoral delivery (oncology), potent therapeutics, neurotoxins, and others.

Customize
The MMDS platform has 4 possible core configurations, enabling versatile use across the drug lifecycle (including various stages of drug development) and/or across multiple drugs in a portfolio.

Key configuration choices are:
  • Drug Filling: Pre-filled (syringe is primary drug container) or User-filled (Vial is primary drug container)
  • Dose Setting: Pre-set (fixed dose, factory-set) or User-Set (user selects volume)

Notes:
  • In order to ensure highest quality drug contact materials, the MMDS incorporates pre-fillable syringes even if the drug is not prefilled in the syringe
  • Variable injection volume can also be achieved by changing number of doses delivered

Other customization options include:
  • Choice of various ISO 11040 compliant standard syringes:
    • Siliconized, silicone-free or lubrication free
    • 0.5mL, 1mL long, 1mL short or 2.25mL; Type I Borosilicate glass or polymer (CoC or CoP)
    • Luer-lock or staked needle
  • Specific injection volume(s)
  • Accommodation for different drug viscosities
  • External look and feel
  • Other based on route of administration

If you are interested in other customization and configuration options to meet your specific needs, please contact us.
Data
The MMDS with a 1mL long prefillable syringe incorporated within it was shown to be able to consistently deliver accurate, precise 100 microliter dose volumes1…
… This is in stark contrast to data with 1mL long syringes with external dose marks, which shows inaccurate and imprecise dose volumes for a 100 microliter target dose1.

Additional data available upon request

Specifications

Instructions for use available upon request

1 Congruence study data