E
LECTR O-OSMOTIC
DELIVERY
Proof of Electro-Osmotic Drug Delivery: A Prejudiced Clinical
Trial, Delivering From Mouth to Nose
By: Nicholas A. Sceusa, PharmD, and Paul M. Ehrlich, MD
ABSTRACT
INTRODUCTION
We aligned all vectors and
mucocilliary clearance contrary to
drug delivery, with the exception of
the single electrical vector induced by
the dosage form. The electrical vector
is considerably larger than the other
vectors, which made it possible to
perform a clinical trial prejudiced
against delivery. It would be strong
proof-of-concept if delivery were
detected in spite of all the opposing
vectors, gravity, and mucocilliary
clearance. A buffered lozenge
containing Zn++ was made to induce a
lowering of the pH of the mouth with
respect to the nose, and thereby a
relative reversal of charge between
mouth and nose. This reversal
established a favorable gradient
similar to a concentration cell, in
which Zn++ could then move over the
membrane of the palate into the nose.
The experiment was further
prejudiced by the fact that the probe
did not lie in apposition to the
delivering membrane, but was free in
the milieu. This form of delivery is
suitable for all dual-compartment and
mucous membrane anatomical
systems and disturbed membrane
systems, such as wounds and burns.
It can be combined with other novel
or classical delivery modalities. In
addition, very thin membranes can be
breached directly. Restriction of a
medication to a given volume, such
as an encapsulated tumor, is a unique
property of this system.
Previously, we have posed the
question of electro-osmotic delivery
and presented a mathematical model
from first principles in its favor.1, 2 We
now present the results of an IRB-approved, GCP-compliant, controlled
human clinical trial. This trial is
submitted as proof-of-concept that
electro-osmotic delivery exists and
can be induced by the dosage form.
Prejudicing the trial against
delivery was achieved by aligning all
the delivery vectors, except the
electrical vector, contrary to the
FIGURE 1
