Transdermal delivery is not a new concept to
the US. For many years,
technologies such as DC Current, Iontophoresis, Electroporation, and
Ultrasounds have been providing the benefits of transdermal delivery,
however, they all had their own limitations. So that you have a better
understanding of how we developed our newest technology,
Dermoelectroporation, we thought we would provide you with the limits
of the existing technologies first.
Limitations of Existing
Technologies
Iontophoresis
Iontophoresis is an active
(electrically driven) method of delivery drugs into the body. It is
based on the fact that compounds are composed of both positive and
negative charged ions. When these compounds are placed in an
appropriate solution, they dissociate into their polar components and
assume a positive or negative charge. While in a charged state, each
ion can be influenced by an electrical field within the solution.
Positive charged ions are attracted to the negative pole and repelled
from the positive pole, and vice versa. This electro-repulsion of like
charges is the driving force for Iontophoresis.
Limits of Iontophoresis
- Electrolysis reaction at the electrodes
- Change in the pH of the ionic drug solution
- Ineffective for delivering high weight
molecules (only drug molecules less than 10,000 Dalton are
deliverable)
Electroporation
Electroporation is a non-invasive method of
delivery drugs into the body. When a high level electrical current is
applied to a drug solution, Electroporation drives the drug ions
through the skin breaking the stratum corneum.
Limits of
Electroporation
- This high level electrical current causes
severe skin damage.
- Burnings
- Discomfort
- Pain
Ultrasound
We all have natural water-based channels.
Ultrasounds have a vibration feature that creates distance between
these channels allowing the ionic drug solution to penetrate and pass
through.
Limits of Ultrasounds
- No electrical current is applied
- Effects limited to the skins surface
- Ineffective for delivering high weight
molecules
Mattioli
Engineering's Solution
Mattioli Engineering
removed the limits by combining the advantages of the existing
technologies to create the Transderm Ionto System.
The Transderm Ionto
System, using Mattioli Engineering's newest technology -
Dermoelectroporation, is the only transdermal delivery device FDA
cleared as an alternative to injections.
Technology
Description
Dermoelectroporation is a patented,
proprietary technology from Mattioli Engineering. It utilizes the skins
water based "channels" to allow ionic drug solutions to penetrate due
to controlled "electroporation-like" continuous reversed polarity
electrical pulses. Because of this, Dermoelectroporation is able to
control the average pulse value and vary the pulse shape according to
the skins specific electrical impedance.
Dermoelectroporation
promotes the transdermal delivery of both micro- and macro molecules
(more than 800,000Dalton) safely into the body without the need of
modifying the ionic drug solution pH, as with traditional
iontophoresis. Dermoelectroporation does not require a pH compensation
patch, driving gels, or pre-charged ions.
Unlike
traditional iontophoresis, Dermoelectroporation does not have an
electrolysis reaction at the site of the electrodes. There is no
degradation of the molecule being delivered.This means that both
positive and negative ions of the drug are delivered into the body -
the drug is delivered as a whole.
Benefits of
Dermoelectroporation
- Non-invasive
- No trauma or
bruising from an injection
- Capability to
transdermally deliver both micro- and macro molecules
- No electrolysis reaction at the site of the
electrodes
- No variation or
change in the ionic drug solution pH, ensuring that the patient
experiences no discomfort or irritation
- Both positive and negative ions are
transdermally delivered
