Iontophoresis Defined

Self-contained iontophoresis patches deliver a calibrated charge over a predetermined treatment period. The dosage of drug ions driven into the skin is directly proportional to the charge delivered. The charge dosage is calculated as mAmp*min. The result of a high accuracy iontophoresis system is improved pain relief, and higher quality of life.

Dosage Accuracy Testing

Two recent studies were conducted by Dr. Michael Johnson M.D. and his research group, titled Iontophoresis Patch Comparison: Short and Long Treatment Duration 80 mAmp*mn Devices, and Treatment Duration Variability in 80 mAmp*min Devices. The studies were specifically performed for product evaluation. The testing method applied is industry-standard – FDA approved; In each study, 38 patches of each brand were tested head-to-head for dosage accuracy, and duration variability.

The study tests provided factual numbers that show ActivaPatch® IontoGo™ 4.0, IontoGo™ 12.0, and IntelliDose™ 2.5 significantly outperform IontoPatchSTAT®, and IontoPatch® 80 in dosage accuracy. Dr. Michael Johnson’s reports documented the following results:

Study #1: Dosage Accuracy Results

ActivaPatch® IontoGo™ 4.0 vs. IontoPatch® STAT

ActivaPatch® IontoGo™ 4.0
4 hour treatment time with a dosage spec. of 80 mAmp*min.
Sampled devices delivered 79% of the specified dosage.

IontoPatchSTAT®
4 hour treatment time with a dosage spec. of 80 mAmp*min.
Sampled devices delivered 72% of the dosage specification.

ActivaPatch® IontoGo™ 12.0 vs. IontoPatch® 80

ActivaPatch® IontoGo™ 12.0
12 hour treatment time with a dosage spec. of 80 mAmp*min.
Sampled devices delivered 81% of the specified dosage.

IontoPatch® 80
14 hour treatment time with a dosage spec. of 80 mAmp*min. IontoPatch® 80 demonstrated increased variability with the outlier underperformance appearing to be due to battery failures.
Sampled devices delivered only 42% of the specified dosage.

View test result graphical data

Importance of Dosage Accuracy

ActivaPatch® products successfully operate at 80% of specified dosage to compensate for varying skin impedances. This compensation provides a safety factor for patients with low skin impedance. The higher dosage accuracy performed by ActivaPatch® products means that the dosage delivered is true to what has been prescribed by your physician. The potential benefit of this has improved patient outcomes through reduced risk of under dosing which results in more pain for the patient, lowering their quality of life.

Variability of Skin Impedence

“Iontophoresis patches are used on human skin which is known to have a highly variable impedance, both between subjects and over time. Subjects with very low skin impedance will receive a higher dose. The IontoGo (4.0 and 12.0) electrodes present a balanced approach to the variability of skin impedance. Both IontoGo electrodes undershoot the nominal dosage by approximately 20%. This provides a safety factor for patients with low skin impedance. Conversely, the Travanti IontoPatch (80 and STAT) electrodes are heavily biased to under-deliver the dosage. They under-deliver by 30 to 60%.”
       – Dr. Michael Johnson M.D.

Study #2: Treatment Duration Variability Results

ActivaPatch® IntelliDose 2.5 vs. IontoPatch®

ActivaPatch® IntelliDose™ 2.5
2.5 hour treatment time with a dosage spec. of 80 mAmp*min.
Sampled devices delivered the most precise and repeatable treatments, with a standard deviation of only 2 min.

IontoPatchSTAT®
4 hour treatment time with a dosage spec. of 80 mAmp*min. Sampled devices were noted for a wide dispersion of treatment times, with a standard deviation of 46 min.

IontoPatch® 80
14 hour treatment time with a dosage spec. of 80 mAmp*min. Sampled devices had a very wide dispersion of treatment times, with a standard deviation of 358 min.

View test result data table

Importance of Duration Variability

The microprocessor controlled ActivaPatch® IntelliDose™ 2.5 calculated treatment durations were by a large margin the most precise and repeatable. The range of IntelliDose™ 2.5 durations was very narrow with just 9 minutes of difference between all samples. The IntelliDose™ 2.5 microprocessor allows for increased timing accuracy, and allows for increased communication with the patient.

The timing variability of the battery depletion devices impacts the accuracy of the total dose delivery. The battery depletion devices (IontoPatchSTAT®, IontoPatch® 80) were notable for wide dispersion of the treatment durations. A patient might wear an IontoPatch STAT for three extra hours after the battery had depleted. The patient might wear an IontoPatch 80 for twelve extra hours after the battery had depleted. This extra wear time represents patient inconvenience and potential for skin irritation.

Test Conclusions: Dosage Accuracy, and Duration Variability

Dosage Accuracy Summary

Treatment Duration Accuracy Summary

Treatment Duration Variability Summary

If you are using IontoPatch®, the products you are using are underperforming.

Demand the best from your supplier! Demand the Best-In-Class:

Download the white paper report, and Dr. Michael Johnson M.D. Profile:
Iontophoresis Patch Comparison: Short and Long Treatment
Treatment Duration Variability in 80 mAmp*min Devices
Dr. Michael Johnson M.D. Profile

Testing Method
The test system has been used for FDA dosage evaluation, and is the basis for 510k performance for the last two decades. Two silver plates (2” x 2”, 99.9% pure) were connected by a 10 kOhm resistor. Iontophoresis patches were placed so that positive and negative electrodes were separated on hydrated Delstar hydropolymer, adherent to each of the silver plates. The iontophoresis patches were hydrated with a 0.9% saline solution according to supplied instructions. The delivery electrode was filled with the prescribed amount of Dexamethasone Sodium Phosphate (4mg/ml). A digital data logger (Agilent 34970A) was used to measure voltage and current every minute.

IontoPatch is a trademark of Travanti Pharma Inc.