A Technical Overview of the IontoPatch

Principles of Operation: How IontoPatch Works

The IontoPatch™ is a drug delivery system intended for the administration of soluble salt medications into the body as a safe, pain-free alternative to hypodermic injection. This process, called iontophoresis, uses a mild electric field to propel drug molecules through the skin and into underlying tissue.

The Science of Iontophoresis

Iontophoresis utilizes bipolar electric fields to drive medication across the skin:

• Positive ions are transferred from the positive (+) chamber into the body.

• Negative ions are transferred from the negative (-) chamber into the body.

• The rate of ion transfer is directly proportional to the magnitude of the current flow.

Dosage Delivery: The total amount of drug transferred is related to the total electrical charge used. The conventional unit of delivery dosage is milliamp-minutes (mA-min), calculated as:

Iontophoresis is commonly used by healthcare providers to deliver water-soluble anti-inflammatory medications locally into subacute or acute inflammations. Studies have shown this method can penetrate medication to depths of at least 1 cm.

IontoPatch Design and Safety Features

The IontoPatch™ is a disposable, single-use device with a self-contained power source. Both the positive and negative medication chambers are integrated into the patch, allowing it to simultaneously deliver both negatively and positively charged compounds.

Continuous, Low-Level Current for Skin Safety

For optimal skin safety, IontoPatch™ is designed to use low levels of direct current and administers medication slowly and continuously over several hours.

• Integrated Power: The patch utilizes special coatings on its electrodes, which provide an initial potential of approximately one volt, plus an integrated 3V battery for a total potential of up to four volts.

• Electrode Consumption: The electrode coatings are gradually consumed during use. Current flow is automatically suspended when these coatings are depleted, ensuring a precisely controlled delivery amount (e.g., a labeled capacity of 80 mA-min).

Superior pH Management: Conventional iontophoresis systems can cause skin damage due to the electrolysis of water, which creates high and low pH levels at the electrodes. The IontoPatch™ electrodes are specifically designed not to electrolyze water. This prevents harmful pH changes, eliminates the need for buffers (which compete with medication delivery), and keeps current densities below levels associated with skin damage.

Delivery Rate and Time

The specific delivery time is dependent upon the individual patient's skin resistance (which can vary based on cleanliness, hydration, and delivery site).

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Warnings, Precautions, and Contraindications

Safe use of the IontoPatch™ requires adherence to specific guidelines.

Contraindications

Do not use the IontoPatch™:

• Overly damaged or denuded skin.

• For treatment around the orbital region of the head.

Patient Precautions and Warnings

• Drug Allergies: Patients should always be asked about their history of drug allergies or sensitivities before use.

• Systemic Effects: Medications delivered via the patch have the potential to reach the bloodstream and cause systemic effects. Patients and caregivers must carefully read all drug labeling to understand potential adverse effects and ensure correct dosing.

• Skin Reaction: Patients should be advised to report any undue burning or pain at once. If this occurs, treatment must be paused, the area inspected, and corrective action taken before resuming.

• Pressure: Do not wrap the patch tightly or apply excessive pressure for long periods of time.

• MRI: IontoPatch products should not be worn during MRI procedures.

• Removal: To minimize irritation, patients should remove the patch slowly using soap and water in the shower or bath.

Unsuitable Compounds

Acetic acid and iodine (non-ionic forms) are not recommended for use. Because they are non-ionic, they will not be delivered by iontophoresis and may cause skin irritation.