Disposable Iontophoresis Pad

Disposable Iontophoresis Pad
Details:
Materials: The laminate structure includes a moisture-proof PET backing, a conductive silver/silver-chloride (Ag/AgCl) or carbon-ink electrode, a medication reservoir layer (rayon/polyester blend), and a pH-stabilizing buffer matrix.

ISO Standards: Manufactured under ISO 13485. Biocompatibility verified via ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation/Sensitization).

Conductivity Principle: The Ag/AgCl electrode minimizes half-cell potential and polarization. This ensures that the electrical energy is consumed by the movement of drug ions rather than the electrolysis of water, providing a linear and predictable drug delivery rate.

MOQ: 20,000+ for custom private label packaging.
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Description
Technical Parameters
 

Disposable Iontophoresis Pads | pH-Buffered Electrodes | TOP-RANK

 

 

Medical-grade disposable iontophoresis pads with integrated buffering technology. Maintains skin pH (5.5-7.0) during active medication transport. ISO 13485 and MDSAP compliant.

 

Product Overview

 

These disposable pads are the patient-interface for active transdermal drug delivery systems (Iontophoresis). They utilize a low-voltage electrical gradient to drive ionized medication across the stratum corneum. Unlike passive patches, the engineering focus here is on maintaining electrochemical stability to prevent skin irritation caused by the accumulation of hydrogen ($H^+$) or hydroxyl ($OH^-$) ions at the anode and cathode.

 

Key Features

 

  • Electrochemical pH Stabilization

    During active iontophoresis, water electrolysis at the electrodes can cause extreme pH shifts (acidic at the anode, alkaline at the cathode). Our pads integrate a chemical buffering system within the reservoir layer. This buffer neutralizes excess ions in real-time, keeping the skin-interface pH within the biocompatible range (5.5 - 7.0) for the duration of a 20-minute treatment.

     

  • Ag/AgCl Polarization Management

    Standard carbon electrodes can polarize quickly, leading to an increase in resistance and a decrease in drug delivery efficiency. By utilizing a screen-printed Silver/Silver-Chloride (Ag/AgCl) layer, we maintain a stable voltage-to-current ratio. This allows for precise milliampere-minute (mA-min) dosing, which is critical for clinical protocols involving dexamethasone or lidocaine.

     

  • High-Saturation Reservoir Integrity

    The absorption layer is engineered to hold 1.5cc to 3.0cc of solution without "leakage" or "wicking" at the edges. The high-density non-woven fiber matrix ensures that the drug solution is distributed evenly across the electrode surface, preventing current crowding and localized thermal hot spots.

 

Applications

 

Physical Therapy

Localized delivery of anti-inflammatory medications for tendonitis or bursitis.

 

Dermatology

Treatment of hyperhidrosis via water-based or anticholinergic iontophoresis.

 

Sports Medicine

Rapid recovery protocols requiring targeted corticosteroid transport.

OEM & Private Label

 

We provide manufacturing redundancy through our facilities in China and Vietnam to mitigate supply chain risks.

  • Packaging: Medical-grade aluminum foil pouches with validated MVTR (Moisture Vapor Transmission Rate) to prevent premature desiccation of the buffer.
  • Customization: Variable reservoir shapes (Circular, Rectangular, Butterfly) and custom lead wire lengths.
  • Traceability: Individual lot-coded pouches for compliance with MDSAP and MDR requirements.

 

Certifications

 

Regulatory: FDA 510(k), CE (MDR), UKCA.

Quality Systems: ISO 13485:2016 and MDSAP.

Testing: Batch-level validation of pH stability, reservoir absorbency, and electrical continuity.

 

FAQ

Q: Why do chemical burns occur if the buffer is exhausted?

A: If the current continues after the buffer capacity is depleted, the pH of the reservoir will shift rapidly (as low as 2.0 or as high as 12.0). These are chemical burns, not thermal ones. Our buffer is sized for a standard 40-80 mA-min treatment protocol to prevent this failure mode.

Q: How does the Ag/AgCl layer improve delivery accuracy?

A: Ag/AgCl is a non-polarizable electrode. It maintains a near-constant potential at the interface. Carbon-only electrodes require increasing voltage to maintain the same current as they polarize, which can lead to patient discomfort and inconsistent medication dosing.

CTA

 

B2B procurement teams can request technical data sheets and pH-stability bench test reports for engineering review.

👉 [Request Samples for Dose Validation]

 

 

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Specifications

 

Serial Number

Product Model

Product Appearance

Fill Volume

Maximum current

/maximum dose

Electrode types

01

ION-T01

image001

1.5 cc

4.0 mA / 80mA-min

Active drug delivery electrode

02

ION-T02

image002

2.5 cc

4.0 mA / 80mA-min

Active drug delivery electrode

03

ION-T03

image003

4.0 cc

4.0 mA / 80mA-min

Active drug delivery electrode

04

ION-T04

image004

2.0 cc

4.0 mA / 80mA-min

Active drug delivery electrode

05

ION-T05

image005

/

/

Return electrode

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