Iontophoresis-A Review
By - 02/08/2006
.jpg "Dr. (Mrs). Swarnlata Saraf")
Dr. Swarnlata Saraf
The objective of delivery system is to achieve optimum therapeutic management.
But, it still remains a challenge in the field of pharmaceuticals for delivery
of ionic species such as proteins and peptides.
Development of iontophoretic system is a breakthrough in this field designed
to improve the delivery rate of ionic compounds. This technique generates an
electrical potential gradient that facilitates the movement of solute ions across
the membrane. Moreover with the advent of more sophisticated techniques available
for the production of recombinant proteins and peptides, there is an ever-increasing
demand of novel delivery systems that could effectively deliver these ionic
species at the specific site.
Iontophoresis seems to be an ideal candidate to sort out the limitations associated
with the delivery of ionic drugs. In this review, efforts have been made to
summarize all the aspects of iontophoretic delivery including history, types
and various factors affecting the drug delivery.
Introduction
There has been a growing awareness in recent years of potential therapeutic
importance of achieving true controlled drug delivery where the rate of drug
output may be modulated in a precisely controlled manner1. Transdermal
drug delivery has usefulness in achieving the controlled delivery of pharmaceuticals,
which are relatively small in molecular size and rather lipophilic in nature,
however, these systems are rather limited in their capability of achieving the
transdermal systemic delivery of peptides, proteins and drugs which is often
charged and highly hydrophilic in nature2. In order to deliver an
ionic drug, peptide/protein molecule through transdermal delivery to attain
a systemic effect, chemical and/or physical methods are required to enhance
the rate of penetration of therapeutic agent through the main diffusion barrier3,
4. The intophoratic technique is highly desirable to improve the transdermal
delivery of peptide and proteins using a lower current intensity with a short
time period4. The idea of applying electric current to increase the
penetration of electrically charged drugs into surface tissues was probably
organized by Veratti in 19475,6. Leduc did the first well-documented
experiments at the beginning of the 20th century7,8. Leduc demonstrated
the introduction of strychnine and cyanide ions into the rabbits when the correct
polarities were applied.
Inchley also carried out similar experiments in 19219. The application of iontophoresis to the treatment of hyperhydrosis could be reduced by ion transfer of certain applied solutions by electro-phoretic technique. Today, the treatment of hyperhydrosis is the most successful and popular applications of iontophoresis in dermatological medication10. The transdermal delivery of many ionized drugs at therapeutic levels is precluded by their slow rate of diffusion under a concentration gradient alone are now application with the help of iontophoretic technique and devices11.
Iontophoresis can be defined as the process in which the flux or rate of absorption
of ionic solutes into or through skin is enhanced by applying a voltage drop/electric
field across the skin12, 13. Transdermal iontophoretic technique
is capable of administering drugs in a pulsatile pattern by alternately applying
and terminating the current input at programmed rate14. In addition,
delivery rate can be controlled by the intensity of applied electric current
or Electro-chemical potential gradient15. It can also be define as
a means of enhancing the flux of ionic drugs across skin by the application
of an electrochemical potential gradient16.
Types
Voltage drop across a membrane driving force for the flux of ions through it opens up new type of approaches to mode transport of ionic drugs across skin. Iontophoresis is usually defined as either anodal (+) in which the positive anode is placed in the solution applied to the epidermis and negative cathode is placed in the solution applied to the epidermis and negative cathode is placed in the dermal receptor solution, or cathodal (-), in which the electrode location are reserved. Anodal (+) introphoresis is facilitated by the movement of a caution from the donor to the receptor, whereas cathodal iontophoresis implies the movement of an anion from the donor to receptor17. Gangaross et.al.18 reported that the penetration of antiviral compound 5-iodo-2-deoxyuridine can be increased by both anodal (+) and cathodal (-) iontophoresis. It was hypothetized that anodal (+) iontophoresis of iodourine may be due to hydrokinesis. It is known that, under the driving force of a potential gradient, manovalent cations cross the skin more easily than manovalent anions19.
Merits
01. It is a non-invasive technique could serve as a substitute for chemical enhancers20.
02. It eliminates problems like toxicity problem, adverse reaction formulation
problems associated with presence of chemical enhancers in pharmaceuticals21.
03. It may permit lower quantities of drug compared to use in TDDS, this may
lead to fewer side effects.
04. TDDS of many ionized drug at therapeutic levels was precluded by their
slow rate of diffusion under a concentration graduation, but iontophoresis enhanced
flux of ionic drugs across skin under electrical potential gradient20.
05. Iontophoresis prevent variation in the absorption of TDDS.
06. Eliminate the chance of over or under dosing by continuous delivery of
drug programmed at the required therapeutic rate.
07. Provide simplified therapeutic regimen, leading to better compliance.
08. Permit a rapid termination of the modification, if needed, by simply by
stopping drug input from the iontophoretic delivery system22.
09. It is important in systemic delivery of peptide/protein based pharmaceuticals,
which are very potent, extremely short acting and often require delivery in
a circadian pattern to simulate physiological rhythm, eg. Thyrotropin releasing
hormone, somatotropine, tissue plasminogen activates, inter ferons, enkaphaline,
etc23.
10. Provide predictable and extended duration of action.
11. Reduce frequency of dosage.
12. Self-administration is possible.
13. A constant current iontophoretic system automatically adjust the magnitude
of the electric potential across skin which is directly proportional to rate
of drug delivery and therefore, intra and inter-subject variability in drug
delivery rate is substantially reduced. Thus, minimize inter and intra-patient
variation24.
14. An iontophoretic system also consists of a electronic control module which
would allow for time varying of free-back controlled drug delivery24.
15. Iontophoresis turned over control of local anesthesia delivery in reducing
the pain of needle insertion for local anesthesia25.
16. By minimizing the side effects, lowering the complexity of treatment and
removing the need for a care to action, iontophoretic delivery improve adherence
to therapy for the control of hypertension26.
17. Iontophoretic delivery prevents contamination of drugs reservoir for extended
period of time27.
Demerits
01. Iontophoretic delivery is limited clinically to those applications for
which a brief drug delivery period is adequate28.
02. An excessive current density usually results in pain.
03. Burns are caused by electrolyte changes within the tissues.
04. The safe current density varies with the size of electrodes29.
05. The high current density and time of application would generate extreme
pH, resulting in a chemical burn17.
06. This change in pH may cause the sweat duct plugging perhaps precipitate
protein in the ducts, themselves or cosmetically hyperhydrate the tissue surrounding
the ducts28.
07. Electric shocks may cause by high current density at the skin surface.
08. Possibility of cardiac arrest due to excessive current passing through
heart.
09. Ionic form of drug in sufficient concentration is necessary for iontophoretic
delivery.
10. High molecular weight 8000-12000 results in a very uncertain rate of delivery.
Physico-chemical parameters
The movement of drug ions across the skin is dependent not only the magnitude
of apparent electric field, but also upon the concentration of solution, the
molecular size of drug to be passed, as well as charge and valence of ion.
(i) pH:
The iontophoretic drug delivery rate is dependent on the ionic form of drug
delivery, which is extremely effected by the pH of the system, when the skin
is maintained at a negative charge by exposing the solution with pH 4 or higher,
it facilitate the transdermal delivery of cationic drugs30,31. Sanderson
et. al.,23 suggested that the control of pH offers advantage of polarization
effects on skin and enhance the perm selectivity of skin for catecholemine drug
during iontophoretic delivery. Several authors reported the pH dependent penetration
enhancement of lidocaine32, thyrotropin releasing hormone33
enalaprilate34 insulin4, acetate ions35.
(ii) Species variation:
The vide differences in physical characteristics such as appendages per unit
area, thickness and structural changes between human and laboratory rodent display
a variation in penetration of drugs36,37. The average penetration
of drugs is in order of rabbit > rat > guineas pig > human. Human skin
is very much less permeable than other rodents but iontophoretic delivery of
drug is 7-fold greater in human skin consists of greater negative charge/or
greater area fraction of negative pores38. Siddique et. al.,4
observed that idiosyncrasy in hairless rats during the iontophoretic delivery
of insulin.
(iii) Characteristics of Penetrants:
The rate of penetration of substances through the intact skin depends on the
size, charge, and configuration of molecules and relative solubility of the
compound in lipid, water, in the Horney layer and on the vehicle in which the
compound is presented to the skin39. The iontophoresis gives uncertain
drug delivery rate for an ionic solute of molecular weight 8000 to 12,00040.For
a negatively charged species, the size dependent flux enhancement neutralizes
the influence of electric field. Conversely, positive charged species becomes
increasingly important to effect the electric field as the size of permeant
increases. Pickal37 reported that the flux enhancement ration for
cations and neutral species in negative pores increases as the size of Penetrants
increases.
(iv)Concentration:
The concentration dependent iontophoretic delivery has not been fully investigated,
some of the authors reported that as the concentration of drugs viz. hydromorphones41
and acetate ions36 increase in reservoir system then permeation of
drug also increases. The iontopheric delivery of insulin does not effected by
the reservoir concentration at the current range of 0.2 – 0.8 MA42.
O’malley and Oester43 showed the flux of solute was non-linearly
proportional to its concentration.
(v) Buffer Systems:
Buffer systems also affect the permeation of drugs by iontophoresis. It is
important to optimize the concentration of buffer species in the system and
should be sufficiently high to maintain good buffer capacity but should not
reach an extent such that the current is mostly carried by the buffer species
instead of drug special which may result the low efficiency of iontophoretic
permeation20.
(vi) Ionic Strength:
The ionic strength of a drug delivery system is directly related to the iontophoretic
permeation of drugs. Some authors reported that increasingly the ionic strength
of the system decreases the permeation rate of drug20,44, and has
no significant effect on penetration up to the 0.5 V45.
(vii) Electrodes:
The electrode materials used for iontophoretic delivery are to be harmless
to the body and sufficiently flexible to apply closely to the body surface.
The most common electrodes are aluminum foil, platinum and silver/silver chloride
electrodes used for iontophoretic drug delivery. A better choice of electrode
is silver/silver chloride because it minimizes electrolysis of water during
drug delivery.
The positioning of electrodes in reservoir depends on the charge of the active
drug. The distribution of drug within the skin depends on the size and position
of electrodes. They are usually selected according to individuals needs. Larger
electrode areas introduce the greater amounts of drug but lesser current density
is tolerated to the skin in a non-linear manner. Metal electrodes touching to
the skin produce burns with much lower current in composition to padded electrodes.
A loose contact between the padded electrode and skin also produce burn due
to uneven distribution of current. The safe current density varies with the
size of electrodes46,47.
(viii) Temperature:
The penetration of drug through skin is affected by dual effect of both humidity
and temperature1. The iontophoretic delivery follows the Arhenious
equation and enhances drug permeation with temperature48.
Electrical parameters
(I) Current:
The extent of charged molecules, which may penetrate through the skin, are
theoretically proportional to the intensity of current and the duration of treatment
for a transdermal iontophoretic delivery3,49. The relationship between
the drug delivery rate (D) and current (I) follows the given question:
D = It M/Zf
Where, t is the fraction of current carried by drug ions or transference number,
M is the molecular weight of drug ion, Z is the molecular charge per drug ion
and F is Faraday’s constant.
Srinivasan et. al.20 suggested that increase in permeability of
drug through skin may be more gradual than the increase in the current. Lelawogs
et. al.15 reported the permeability rate of arginine-vassopressin
was dependent not only upon the current density applied but also on the delivery
mode of applied current.
(ii)Voltage:
The ionic flux due to an applied voltage drop across a membrane is based on
the fundamental thermodynamic properties of the system. The diffusion of drug
during iontophoresis follows Nerst-Plank equation. It states that the flux of
the ionic drug due to applied electric filed is directly proportional to the
voltage drop and charge of the ion50. Masada et. al.,12
demonstrated ionic flux of Tetraethyl ammonium bromide (TEAB) with varying voltage
drop (0.125, 0.250, 0.250, 1.000). The enhancement factor for hairless mouse
skin showed good agreement up to 0.5 volts and significantly higher at 1.0 volt
due to skin damage but it is up to 0.25 V.
(iii)Resistance:
The electrical resistance of the skin varies widely with iontophoretic drug
delivery. The resistance of the skin during iontophoretic application was much
lower on sweat pores, especially when they discharge sweat51. A slight
fall in resistance occurs when electrode was interested in to the epidermis.
(iv) Frequency/Impedance:
The frequency of the applied current charges especially in man5,
variability of frequency dependent impedance of human skin ranges from 10 KHzs
to 100 Khzs. The impedance of the skin decreases at higher frequencies less
time is available to accumulate the charge on the skin surface during an applied
pulse7.The iontophoretic delivery of insulin decreases with increasing
the frequency in the range of 50-2000 Hzs3 but Bagniefski and Burnett
observed decrease in sodium ion flux with increase in frequency (10 Khzs)52.
The theoretical relationship between impedance of skin and frequency follows
this equation:
1/ZT = 1/ZR + 1/ZC
(v) On/Off Ratio3:
The on/off ratio of electricity effects the relative proportion of polarization
and depolarization of skin, which results the efficiency of transdermal iontophoretic
drug delivery. The number of on/off cycles in each second is shown as frequency.
For example the on/off ration 1 : 1 at frequency 2000 Hzs (0.5 ms/cycle) provides
0.25 ms depolarization period and same time for the polarization.Liu et. al.,3
suggested that the on /off ration of 1 : 1 at 2000 Hzs yields better glucose
control for iontophoretic insulin delivery than 4:1, 8:1 on/off ration. Apparently,
1:4 and 8:1 rations, results a residue polarization the skin from the previous
cycle which reduce the efficiency of insulin delivery.
(vi)Wave Form:
The waveform also affects the iontophoretic delivery of drug. The insulin delivery
was highest at sinusoidal waveform than square and triangular waveform3.
Operational parameters
(i)Duration of Application:
The transport of drug delivery depends on the duration of current applied53 in iontophoretic drug delivery. The iontophoretic penetration of drug linearly increased with increasing application time15. The skin permeation of arginine vasopressin54 achieves higher plateau rate and in case of insulin delivery, 2-3 fold reduced the blood glucose levels with increase in duration of iontophoretic application.
(ii)Mode of Current:
Direct current (DC) iontophoretic dosing of drug inevitably develops a skin
polarization potential, which reduce the efficiency of iontophoretic delivery
and cause skin irritation, burning and redness.But pulsed DC dosing pattern
is effective for drug transport, the same time average voltage because it faces
lower skin resistance in comparison to simple DC application in flux enhancement.
Lelawong et. al.15 reported that the skin permeation rate of arginine
vaspressine revealed no difference in the flux enhancement by simple DC and
pulsed DC technique. But, blood glucose level was markedly reduced by pulsed
DC in comparison to simple Dc in insulin3 delivery at the same current
density. It also maintained at much lower levels for a longer period of time.
Efficiency of drug delivery
The efficiency of iontophoretic drug delivery can be defined as that fraction
of all ions which cross the skin are drug ions which cross the skin for each
mole of electrons flowing through the external circuit. This can be calculated
from the slope of the plot of drug delivery rate ® versus current (I), which
flows the given equation:
R = Ro + Fi. I
Where, Ro is the positive drug delivery using iontophoresis and Fi is the iontophoretic
constant defined as the amount of drug (on a weight basis) delivered per uni-time
per unit current.
Synergistic manner of drug delivery
The penetration of drug through transdermal route can be achieved via the
application of a combination of penetration enhancement technique.Several authors28,55
demonstrated the penetration of drugs (e.g. debutamine hydrochloride, azidothi-amidine)
with the use of chemical enhancer (e.g. sod. Lauryl sulfate, decylmethyl
sulfoxide) in combination of iontophoresis. The enhancement of drug through
skin is greater with a combination technique, when the single technique is used.
Srinivasan et. al.56 explored the feasibility of synergism between
the ethanol treated iontophoretic delivery of leuprolide and cholystokinin
analogue. The penetration of tetracycline into tissue subject by the use of
both Electro and phonophoresis were high than those obtained by the use of either
Electro or phonophoresis57.
Conclusion
From the literature cited and the personal experiences gained during developing
iontophoretic system, this system seems to be a potential alternative delivery
system for charged species. Iontophoretic drug delivery has developed a new
application system for dermal and transdermal delivery of drugs that is electro-phoretically
self-regulated device with electronic indicator58. The controlled
or feed back iontophoretic drug delivery may include the use of polymeric system
responsive to an oscillation magnetic field, temperature sensitive polymers59,60,
polymers responsive to externally applied ultrasound and chemically sensitive
polymers. The iontophoretic delivery of macromolecules will open the doors to
non-invasive transdermal delivery of peptide-based pharmaceuticals, following
the advances in recombinant DNA technology, which are the wonder drugs of tomorrow.
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About Authors
Swarnlata Saraf*, Deependra Singh and S. Saraf
Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur, 492 010 C.G.
INDIA
Dr. (Mrs). Swarnlata Saraf has nearly 14 years of research
and teaching experience. She is a leading scientist and well-known in the field
of herbal cosmatics . Dr. Saraf did her doctoral research at the Dept. of Pharmacy,
Dr. H. S. Gour University, SAGAR. She has over 40 publications to her credit
published in international and national journals. She is an active member of
ipa ,apti and iste. Her research interest extends from Herbal Cosmetics to transdermal
drug delivery (specially Iontiphoresis), New Drug Delivery Systems for biological
therapeutic agents. She has Co-authored 1 books, in press. Presently, she is
working as a Reader at Institute of pharmacy Pt. Ravishankar Shukla University,
Raipur, (C.G.)
*Author for correspondence (e-mail: shailendrasaraf@rediffmail.com)
Mr. Deependra Singh has nearly 6 years of research and teaching
experience. He is a hard working researcher . Mr . Singh did his masters degree
at Dept. of Pharmacy, Dr. H. S. Gour University, SAGAR. he has over 16 publications
to his credit published in international and national journals. he is an founder
secretary of ipa local branch Chhattisgarh. His research interest extends from
Noble topical delivery systems, Delivery Systems for biologicals to Plant tissue
culture . Presently, he is working as a Lecturer at Institute of pharmacy Pt.
Ravishankar Shukla University, Raipur, (C.G.)
Prof. S. Saraf has nearly 17 years of research and teaching
experience at both U.G. and P.G. levels. He is a leading scientist and well-known
academician . Prof. Saraf did his doctoral research at the Dept. of Pharmacy,
Dr. H. S. Gour University, SAGAR. under the supervision of Prof. V. K. Dixit,
a renowned Pharmacognosist. He has over 50 research publications to his credit
published in international and national journals. He has delivered invited lectures
and chaired many sessions in several National Conferences and Symposia in India.
His research interest extends from Herbal Cosmetics to Herbal drug standardization
Modern analytical techniques, New Drug Delivery Systems with biotechnology bias.
He has authored 1 books, in press. Presently, he is Professor and Director Institute
of pharmacy and Dean, Faculty of Technology, Pt. Ravishankar Shukla University
, Raipur , (C.G.)