Volume 41 Number 2 April 2009

115

Novel Drug Delivery Systems:

Future Directions
Angelia Colwell Berkowitz, Diane M. Goddard

Intrapulmonary and Endotracheal Routes

of Administration
According to current guidelines recommended for the
management of cardiac arrest, the American Heart
Association has recommended that when intravenous
or intraosseous routes cannot be established, endotra-

Angelia Colwell Berkowitz, BSN RN CRNI, is a graduate student

at The University of Texas Health Science Center at San Antonio,
San Antonio, TX.
Questions or comments about this article may be directed to Diane
M. Goddard, BSN RN, at goddardd@uthscsa.edu. She is a graduate
student at The University of Texas Health Science Center at San
Antonio, San Antonio, TX.

Copyright 2009 American Association of Neuroscience Nurses

PHARMACOLOGY UPDATE

hen considering methods of medication

administration, one may initially consider
the traditional routes: oral, subcutaneous,
intramuscular, intravenous, and topical. These routes
use traditional medication delivery systems: needles,
syringes, fluted paper cups, IV bags, and catheters. It
must be noted that these medication delivery systems
may not always optimize rapid delivery of the appropriate concentration of medication to the appropriate
site, nor do they necessarily minimize local or systemic toxicity.
Medication delivery systems that concentrate medications only where needed and used could reduce the
destruction of surrounding tissues while minimizing
side effects. The benefits of such systems in the treatment of both acute and chronic conditions are clear.
Because research demonstrates that patient adherence
is improved when side effects are minimized, it is
imperative that drug delivery systems efficiently and
precisely deliver medications in a fashion that the
patient finds acceptable and tolerable. Patients themselves are demanding drug delivery systems that are
convenient, easy to use, and affordable.
Progress in the development of novel drug delivery
systems is bringing researchers and clinicians closer
to meeting the goals of maximum efficacy with minimal toxicity and inconvenience. This article reviews
several of these recent advances in medication delivery, some of which are already in use and some still
await clinical implementation.

cheal administration of some resuscitation drugs be

used. Medications that can be absorbed through the trachea include lidocaine, epinephrine, atropine, naloxone,
and vasopressin (American Heart Association [AHA],
2005). Although the optimal dose of these drugs has yet
to be established, two to two and one half times the recommended intravenous dose is used (AHA, 2005).
Recent studies investigated the intrapulmonary route
of drug administration. One study suggests that intrapulmonary vancomycin may have efficacy in acute
lung injuries, such as meconium aspiration syndrome
in neonates (Jeng, Lee, & Soong, 2007). Televancin is
also being studied for intrapulmonary use. Because the
antibacterial activity is not affected by pulmonary surfactant, further studies of intrapulmonary televancin for
use in treating gram-positive respiratory infections are
underway (Gotfried et al., 2008).

Implantable Technology for

Pain Management

Chronic pain affects as much as one half of the adult

population at some point during their lives, and 10%
of this population experiences pain that is considered
to be disabling. Management of chronic pain can be
difficult, and numerous treatment options have been
studied. Since Melzack and Wall first outlined their
Gate-Control Theory of Pain in 1962, understanding
the neuroscience of pain has improved significantly
(Chaudhari & Mackenzie, 2007). This has led to the
development of implantable neuromodulatory technologies for refractory pain. Neuromodulation seeks
to reduce afferent activity within pain pathways by
targeted drug delivery into cerebrospinal fluid, allowing drug delivery directly to the neural tissues
(Chaudhari & Mackenzie, 2007).
Implantable pumps can deliver analgesic drugs directly to the intrathecal or intracerebroventricular sites.
A programmable infusion pump can dispense medication at a preprogrammed rate that is then adjusted based
on symptoms. A wide variety of devices exist, spanning
the cost range. The intraventricular route has also been
used for patients with pain from head and neck cancer.
Morphine can be infused into the cerebral ventricles
after placement of an Ommaya reservoir or with a
continuous infusion pump (Bajwa & Warfield, 2008).
There has been relatively little experience with the

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116

Journal of Neuroscience Nursing

PHARMACOLOGY UPDATE

use of this procedure; however, it has been demonstrated that 50% to 90% of patients obtain excellent
initial relief (Bajwa & Warfield, 2008). The use of
implantable pumps is not without complications,
however, including infection, pharmacological side
effects, catheter dislodgment, and malfunction.

Disposable Infusion Pumps

Another novel form of drug delivery is the disposable
infusion pump. These have been in clinical use for
more than 20 years, and their use has increased dramatically (Skryabina & Dunn, 2006). These devices are
predominantly used by ambulatory infusion centers and
by home healthcare organizations to deliver such therapies as chemotherapy, antimicrobials, analgesia, and
anesthesia. Disposable infusion pumps use the same
physical principle as other infusion pumps for delivery
of medications: mechanical restriction within the flow
path determines the speed of the pressurized fluid. The
pressure generated by these pumps is approximately
250 to 600 mm Hg. This can be compared with electric
pumps, which generate 5 to 1,200 mm Hg.
There are several types of disposable pumps. One
of these is the elastomeric pump. The drug in this
pump is contained in an elastomeric membrane that is
encased and protected by an outer shell. The force of
the stretched elastomer generates the pressure on the
fluid (Skryabina & Dunn, 2006). Baxter Healthcare
(Deerfield, IL) produces several of these pumps,
including the Intermate, the Singleday Infusor, the
Multirate Infuser, the PCA Infusor, and the Two Day
Infusor. Alaris (Dublin, OH) produces the ReadyMED
and Block Medical has the Eclipse.
Spring-powered disposable infusion pumps use
positive pressure and are powered by energy stored in
a compressed spring (Skryabina & Dunn, 2006). The
mechanical parts of this pump are reusable, and the bag
with the administration set is for single use. The Sidekick
and Paragon (I-Flow Corporation, Lake Forest, CA) are
reusable and the Springfusor (Go Medical Industries,
Pty, Ltd., Australia) and Beeline (McKinley Medical
LLC, Wheat Ridge, CO) are for single use only.
Disposable patient-controlled analgesia pumps are
also available. These pumps have an additional fixedvolume reservoir that is used for bolus dosing. The
user pushes a button, which forces a valve to open
and allows the reservoir to empty. The speed of filling
this reservoir is regulated by the pumps flow rate and
determines the lockout time. The reservoir is connected to the primary infusion line, which delivers the
basal rate (Skryabina & Dunn, 2006).
There are several factors that can affect the accuracy
and flow of disposable pumps, including ambient temperature, fluid viscosity, atmospheric pressure, back
pressure, partial filling, and storage. The advantages of

using disposable pumps include their small size, light

weight, simplicity of use, elimination of programming
errors, independence from an external power supply,
portability, and disposability. Disadvantages include the
possibility of inaccurate flow rates, fixed reservoir volume, inability to change flow rate, inability to trace the
history of analgesia demand, and the long-term cost
(Skryabina & Dunn, 2006).
Another method of pain management, the ON-Q
PainBuster Post-Op Pain Relief system by the I-Flow
Corporation (Lake Forest, CA), has been used after
gynecologic and orthopedic surgery. This device consists of a small balloon with a catheter extension.
When delivered with a local anesthetic agent, such as
bupivacaine, the device will deliver drug at a continuous rate directly to the surgical wound for as long as
5 days. A point-source catheter or a soaker catheter is
available based on the size of the wound. The clinician may choose from an OnDemand system, a Fixed
Flow Rate system, or a Select-A-Flow system that can
be used to titrate the medication dose externally. This
system requires little to no management or intervention by the caregiver or the patient and is completely
portable. It has been shown to reduce hospital stays,
narcotic use, and overall costs related to postoperative
pain (Medscape Medical News, 2002).

Surgically Implanted
Medication Delivery
Surgically implanted medication delivery systems are
noteworthy for their ease of use. They also improve adherence, a major concern in the pharmacological treatment of
individuals with serious psychiatric illnesses (Irani et al.,
2004). A subcutaneous surgically implanted medication
delivery system inserted under the skin eliminates the
need for oral medication, definitively addressing the
adherence issue. One system delivers psychoactive medication for as long as 14 months, significantly decreasing
the need for adherence checks in this historically difficult
population. The implant is biodegradable and does not
require a second surgical procedure.
One advantage of this system is that it allows the
patient to make decisions during periods of health
rather than after periods of exacerbation. An ongoing
study of haloperidol implants in schizophrenic
patients shows that lower doses, consistent steadystate serum levels, and fewer side effects make this
method of delivery more effective (Irani et al., 2004).
If the implanted medication needs to be reversed, the
implant can simply be removed.

Intranasal Delivery
Intranasal formulation is a remarkable and easy mode
of drug delivery. It is a needle-free, patient-friendly

Copyright @ 2009 American Association of Neuroscience Nurses. Unauthorized reproduction of this article is prohibited.

Medication Adherence
Medication adherence can be problematic with older
adults. One of the most basic forms of medication
delivery, the pillbox, is continually being updated. An
interactive pillbox can be a useful tool in reminding
this population about their medication times. Pillboxes
are available that can hold as much as a 1-month supply of medications, with separate compartments for as
many as four drugs. After programming, the box will
beep at the time a medication is due to be taken, indicate the appropriate compartment, and display the
number of pills to take. When the compartment lid is
lifted, an audio message instructs the patient on the
number of pills to take, along with specific information about how that medication should be taken. The
data are gathered and can be transmitted via phone
lines to the caregiver to confirm the time at which the
medication was taken. Even patients thought to be
compliant accidentally skip doses of medication, a
silent problem improved by these devices. Pillboxes
with multiple compartments are particularly helpful

117

for older patients when dealing with multiple pill

regimens.

PHARMACOLOGY UPDATE

route that does not contribute to biohazardous waste

(Wermeling, Miller, & Rudy, n.d.). Pharmacokinetically, the absorption rate is so rapid that it results in a
faster onset of action compared with oral and intramuscular administration. In addition, hepatic firstpass metabolism is avoided (Wermeling et al., n.d.).
(The metabolism of an administered dose of a drug by
the liver before it reaches systemic circulation is
referred to as the first-pass metabolism.) For many
oral drugs, a clinically significant portion of the drug
taken is destroyed during first-pass metabolism,
requiring a higher oral dose for a given effect (Wynne,
Woo, & Olyaei, 2007).
Intranasal drugs can be delivered in a variety of
formulations that include powders, drops, topical gels,
and sprays. Consideration must be given to normal
physiologic processes when using the intranasal route,
as the nose is an important defense system for environmental hazards. Any disruption of its normal physiology may leave the patient vulnerable to a variety of
complications (Wermeling et al., n.d.). The delivery
devices for intranasal medications can be costly, as illustrated by intranasal insulin, and can be a deterrent to
patient use. Initially thought to be a desired route compared with subcutaneous insulin, patients found intranasal insulin to be burdensome and costly (R. Talbert,
personal communication, February 21, 2008).
Until recently, vitamin B12 has been available only
by intramuscular injection. Calomist (cyanocobalamin) Nasal Spray is now available in a 25-mg/spray
form that is used daily in lieu of the monthly injections. This can now be included in the daily routine
with less impact of a missed dose.

Volume 41 Number 2 April 2009

Future Trends
As technological innovation spreads throughout medicine
so does the cutting edge come to drug delivery systems.

Mucoadhesive Drug Delivery

The BioErodible MucoAdhesive (BEMA) delivery
system is designed to deliver either local or systemic
levels of drugs across mucosal tissues. This delivery
system offers rapid onset of action and improved drug
bioavailability compared with the oral route. As an
added benefit, drug inactivation by first-pass metabolism in the liver is avoided. The BEMA delivery system consists of a dime-sized disk with bioerodible
layers that delivers drugs rapidly over specified time
intervals. The erosion rate is controllable, and there is
no residue to remove and so far has shown promise for
the administration of pain medications, antiemetics,
and antimigraine drugs ( Clinical Trials, 2008 ,
February).
One example of this technology is the BEMA Fentanyl mouth patch from BioDelivery Sciences International (Raleigh, NC), which is currently in phase
III trials. It is designed to assist with breakthrough
cancer pain for opioid-tolerant patients. Dr. James
North, MD, principal investigator for the phase III
efficacy study reports, Breakthrough cancer pain
can be devastating to patients with cancer and their
families. Patients suffering from breakthrough cancer
pain need treatment options that provide effective
pain relief and are easy to administer" (Triangle Business Journal, 2009, May). In August 2008, the U.S.
Food and Drug Administration reviewed their filing;
a final decision regarding regulatory approval for
this system was unknown when this article went to
press.

Contact Lens Sustained Release

Contact lens sustained-release drug delivery systems
are currently under investigation. Ocular drug bioavailability is known to be very poor. It is estimated
that 95% of medication delivered by eyedrops is lost
as the medication mixes with tears and drains into the
nasal canal ( in-Pharma Technologist.com, 2005 ,
January). This medication delivery method is wasteful
and can lead to unwanted local and systemic side
effects. New drug delivery systems are being developed using polymers in contact lenses, which hold
therapeutic agents within their matrices to increase
drug bioavailability to the eye. As the contact lens
comes in contact with the eye, channels open that permit sustained drug delivery (Young, 2004). Researchers
in Singapore have developed a new contact lens

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Journal of Neuroscience Nursing

PHARMACOLOGY UPDATE

ophthalmic drug delivery system that has the ability

to control the flow of drug by varying the width of the
channels. In this manner, the drug delivery rate can be
controlled and the drug remains effective for longer
periods. Because the lenses are made in a one-step
process, cost of manufacture is kept low. Potential
applications include medication delivery for a range
of eye diseases, including glaucoma, a leading cause
of blindness that is currently difficult to treat, and
loading wound-healing drugs in the lenses to treat
corneal wounds. The lens material can also be modified to produce self-lubricating contact lenses to relieve
the discomfort of contact lens wearers suffering from
dry eyes (Alvarez-Lozano, Hiratani, & Concheiro,
2006; in-Pharma Technologist, 2005).

Depot Technology
Depot technology offers potential improvement over
daily dosing by maintaining constant blood levels for
medications that are more typically delivered by daily
injection. The technique is applicable for local and systemic drug administration. The medication is first mixed
with polymers, which are engineered to biodegrade at a
desired rate. The solution is then injected in the patient
either subcutaneously or intramuscularly with a finegauge needle. Once injected, the solution solidifies and
becomes an implant that acts as a depot system, releasing medication over days or months (Cox, n.d.).

Automated Anesthesia
Possibly on the market in the next 5 years will be
McSleepy, the first automated general anesthesia
delivery system. The software system continuously
titrates and delivers appropriate doses of standard
drugs based on its monitoring of brainwave patterns,
muscle contractions, heart rate, and blood pressure
readings without manual intervention. According to
researchers, The system can calculate the appropriate
drug doses for any given moment of anesthesia faster
and more precisely than a human. It has been designed
to analyze biological information and constantly adapt
to changes, even recognizing monitoring malfunction ( Canadian Press, 2008 ). The system is not
expected to replace the operating room anesthesiologist but to serve as an aid during long procedures.

Nanotechnology
A new generation of drug delivery systems is being
created as a result of the ability to design nanoparticles and their matrixes. Nanoparticles are very small
molecules with a diameter of 1 to 100 nm. Drugs can
be coupled to or encapsulated within these specialized
molecules. Advantages of using nanoparticles as drug
delivery systems include increased drug bioavailability and precise delivery of therapeutic agents to target

organs, tissues, and cells (Leary, Liu, & Apuzzo, 2006).

Presently only 1 of 100,000 molecules of therapeutic
intravenous drug reaches its desired destination. As a
result of this, clinicians are faced with deciding whether
to increase the drug dosage, which can lead to side
effects, or reduce the dosage, which can limit the therapeutic effect (Bulletin Board, 2008). Valuable clinical
breakthroughs in using nanotechnology have already
occurred in the areas of oncology, cardiovascular medicine, neurology, and orthopedics.
On the horizon are nanoparticles made of biodegradable and biocompatible mesoporous silicon particles designed to efficiently carry therapeutic agents to
their intended site by successfully penetrating the
bodys immune system. These multistage nanoparticle
systems deliver therapeutic agents in a manner similar
to a space rocket launching from Earth through our
atmosphere, in that the multilayered nanoparticle disposes of its outer layer as it moves through the body.
Each layer of the nanoparticle is designed to efficiently
meet and overcome each physiologic barrier that it
encounters as it moves through the body. As a result,
the multistage nanoparticle drug delivery system is
able to successfully carry therapeutic agents to the
intended site with greater efficiency and reduce the
need for a higher drug dose. As an added advantage,
by successfully limiting drug side effects, it is hoped
that greater patient drug adherence will result (Tasciotti,
Liu, & Bhavane, 2008).
Nanoshells are another exciting development in
drug delivery. These molecules are hollow silica
spheres covered with silver, gold, or other metals that
can be chemically equipped to carry antibodies. This
technology allows the nanoshell to successfully attach
to specific cells within the body and deliver their payload. By precisely delivering medication to the intended
site, systemic side effects can be minimized (Leary
et al., 2006). Drugs may also be encapsulated within
the metal nanoshells. The healthcare provider of the
future will have the ability to trigger the nanoshell
with an external force to release its therapeutic agent
at the precise time that it reaches its intended target
within the body. Infrared light and magnetic fields are
currently being explored as possible triggers. This
drug delivery system is expected to be especially useful in the area of oncology for the treatment of tumors
because high concentrations of therapeutic agents can
be delivered to the tumor, and the toxic effects to surrounding tissues can be minimized (Yih & Al-Fandi,
2006; Hafeli, 2004).
Drug-loaded erythrocytes are another nanotechnology drug delivery system under development..
Erythrocytes are split open and loaded with the desired
therapeutic agent. Using nanotechnology, the surface
of the erythrocyte is enhanced with glutaraldehyde,

Copyright @ 2009 American Association of Neuroscience Nurses. Unauthorized reproduction of this article is prohibited.

119

formation of amyloid- protein found in Alzheimers

disease. Nanomachines that could move through the
body troubleshooting and repairing tiny brain or cardiovascular lesions lie in the future (Morrow et al, 2007).

PHARMACOLOGY UPDATE

antibodies, or specific carbohydrates, which increase

the erythrocytes circulation half-life, allowing for
body barrier penetration and precise drug delivery.
Once delivered into the patients body, the erythrocytes
circulate in the blood and reticuloendothelial systems
and slowly release the intended agent (Hirlekar, Patel,
& Dand, 2008).
A vaccine carrier system using nanoemulsions is currently being researched. This medication delivery system
uses nanotechnology to vaccinate against HIV. There is
recent evidence that HIV can infect the mucosal immune
system. Therefore, developing mucosal immunity
through the use of nanoemulsions may become very
important in the future fight against HIV (Bielinska,
Janxzak, & Landers, 2008). The oil-based emulsion is
administered in the nose, as opposed to traditional vaccine routes. Research is demonstrating that genital
mucosa immunity may be attained with vaccines that
are administered into the nasal mucosa.
Engineered nanotechnology molecules have demonstrated superior performance over present-day monovalent drug delivery systems that have only one site of
attachment. A special architectural class of nanoparticles called dendrimers consists of a central core
with many branches that allow molecules to attach to
its surface (Morrow, Bawa, & Wei, 2007). Dendrimers
in research have been fashioned into sophisticated
anticancer machines carrying five chemical tools: one
to bind to cancer cells, a second that will fluoresce
upon locating genetic mutations, a third that assists in
imaging the tumor shape with x-rays, another that carries drugs to be released on demand, and one that sends
a signal when cancerous cells are dead (Nova Science
Now, n.d.). Additionally, in the future, dendrimers may
be used to place genes in cells. It is also hypothesized
that nanotechnology could be used to design specially
engineered cardiomyocytes to repair damaged hearts
and erythrocytes capable of delivering much higher
levels of oxygen to tissues (Morrow et al., 2007).
Precise therapy parameters in the future may be
maintained with implantable drug delivery and biosensing microchips. These intelligent systems will
provide real-time therapeutic monitoring and control
the time, amount, rate, and location of drug delivery.
The microchip devices will contain an array of individually sealed and actuated reservoirs. The passage
of a threshold level of electric current through the
device will cause it to disintegrate, exposing the drugs
in the reservoir to the surrounding environment
(Maloney, Uhland, & Polito, 2005).
In the area of neuroscience, biosensor technology
is already being used to monitor glutamate levels at
the surface of living cells to provide information on
the neurological damage occurring in stroke and neurodegenerative disorders and to detect the early

Volume 41 Number 2 April 2009

Conclusion
This review of recent literature revealed a number of
interesting and unique drug delivery systems. Just as yesterdays nurse would be amazed by current drug delivery
systems, todays nurse is administering drugs via delivery
systems that tomorrows nurse may find archaic.
Todays nurse should remain aware of new developments in drug delivery systems. Although nanotechnology is not yet here for daily use, other new methods
of drug delivery continue to come to market, such as
intranasal medications, pain balls, and disposable
pumps. It is hoped that the reader is now more familiar
with some of these options that are currently available.

Acknowledgment
We thank Cheryl Lehman, PhD, RN, CRRN-A, BC,
Associate Professor at the University of Texas Health
Science Center at San Antonio, for her guidance and
support with this article.

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