3. INTRODUCTION TO IMPLANTS
• In the past, drugs were frequently administered orally, as
liquids or in powder forms.
• To avoid problems incurred through the utilization of the
oral route of drug administration, new dosage forms
containing the drug(s) were introduced.
• As time progressed, there was a need for delivery
systems that could maintain a steady release of drug to
the specific site of action.
• Therefore, drug delivery systems were developed to
optimize the therapeutic properties of drug products and
render them more safe, effective, and reliable.
• Implantable drug delivery systems (IDDS) are an
example of such systems available for therapeutic use.
4. IMPLANT (DEFINITION)
• An implant is a medical device manufactured to replace a
missing biological structure, support a damaged biological
structure, or enhance an existing biological structure.
• Medical implants are man-made devices, in contrast to
a transplant, which is a transplanted biomedical tissue.
• The surface of implants that contact the body might be made
of a biomedical material such as titanium, silicone,
or apatite depending on what is the most functional.
• In some cases implants contain electronics e.g. artificial
pacemaker and cochlear implants.
• Some implants are bioactive, such as subcutaneous drug
delivery devices in the form of implantable pills or drug-
eluting stents
6. The Advantages of implantation
therapy include.
•
Convenience:
Effective concentration of drug in the blood can
be maintained for longer period of time by
techniques such as continuous intravenous
infusion or repeated injections.
• Improved drug delivery:
The drug is distributed locally or in systemic
circulation with least interference by metabolic or
biological barriers.
7. • Compliance:
By allowing a reduction, or complete elimination, of
patient-involved dosing compliance is increased
hugely.
• Potential for controlled release:
Implants are available which deliver drugs by zeroorder
controlled release kinetics. The advantages of
zero order controlled release are:
• (a) Peaks (toxicity) and troughs (ineffectiveness) of
• conventional therapy is avoided,
• (b) Dosing frequency is reduced,
• (c)Patient compliance is increased.
8. • Potential for bio-responsive release:
Bio-responsive release from implantables is an
area of on-going research.
• Potential for intermittent release:
Intermittent release can be facilitated by
externally programmable pumps.
• Flexibility:
In the choice of materials, methods of
manufacture, degree of drug loading, drug
release rate etc. considerable flexibility is
possible.
9. The Disadvantages of implantables include:
• Invasive:
To initiate therapy either a minor or a major surgical
procedure is required to initiate therapy.
Appropriate surgical personnel is required for this,
and may be time-consuming,traumatic.
• Danger of device failure:
There is no associated danger with this treatment that
the device may for some reason fail to work. This
again requires surgical involvement to correct.
10. • Termination:
Osmotic pumps and non-biodegradable polymeric
implants also are surgically recovered at the end of
therapy. Although surgical recovery is not required
in biodegradable polymeric implants. Its on-going
biodegradation makes it difficult to end drug
delivery, or to maintain the accurate dose at the end
of its lifetime.
• Limited to potent drugs:
In order to minimize patient’s discomfort the size of
an implant is usually kept small. Therefore most
implants have a limited loading capacity so that
frequently only somewhat potent medicines such as
hormones may be appropriate for delivery by
implantable devices.
• Biocompatibility issues:
Concerns over body reactions to a foreign substance
often increase the issues of biocompatibility and
safety of an implant.
11. • Possibility of adverse reactions:
A high concentration of the drug delivered by an
implantable device at the implantation site may
produce adverse reactions.
• Commercial disadvantages:
An enormous amount of R&D investment,effort
and time is required in the development on an
IDDS.
13. Background
A Transdermal Patch is a medicated adhesive patch
that is placed on the skin to deliver a specific dose of
medication through the skin and into the bloodstream.
Often, this promotes healing to an injured area of the
body. An advantage of a transdermal drug delivery route
over other types of medication delivery such as oral,
topical, intravenous, intramuscular, etc. is that the patch
provides a controlled release of the medication into the
patient, usually through either a porous membrane
covering a reservoir of medication or through body heat
melting thin layers of medication embedded in the
adhesive.
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14. Medicines
in
pill form
have a long,
tortuous journey
to get to
destination
must go
through the
digestive
system
they are
absorbed
into the
blood
they pass
through the
liver, before
circulating to
the rest of the
body
the liver must
eventually
eliminate them
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15. 3
Transdermal Patch
Much more than a Surgical Tape
Transdermal
patches
are simple to use
deliver drugs
straight
into the
bloodstream
through the
skin.
16. The main
Componen ts
The main components to a transdermal patch are:
Liner - Protects the patch during storage. The liner is
removed prior to use.
Drug solution in direct contact with release linerDrug -
Adhesive - the patch
patch to the
Serves to adhere the components of
together along with adhering the
skin
Membrane -
Backing -
Controls the release of the drug from the
reservoir and multi-layer patches
Protects the patch from the outer environment
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17. There are five main types
of transdermal patches.
Single-layer Drug-in-Adhesive
Multi-layer Drug-in-Adhesive
Reservoir
Matrix
Vapour Patch
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18. Single-layer Drug-in-Adhesive
The adhesive layer of this system also contains the drug. In this
type of patch the adhesive layer not only serves to adhere the
various layers together, along with the entire system to the skin,
but is also responsible for the releasing of the drug. The
adhesive layer is surrounded by a temporary liner and a
backing.
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19. Multi-layer Drug-in-Adhesive
The multi-layer drug-in adhesive patch is similar to the single-
layer system in that both adhesive layers are also responsible for
the releasing of the drug.One of the layers is for immediate
release of the drug and other layer is for control release of drug
from the reservoir. The multi-layer system is different however
that it adds another layer of drug-in-adhesive, usually separated
by a membrane (but not in all cases). This patch also has a
temporary liner-layer and a permanent backing.
20. Reservoir
Unlike the Single-layer and Multi-layer Drug-in-adhesive
systems the reservoir transdermal system has a separate drug
layer. The drug layer is a liquid compartment containing a drug
solution or suspension separated by the adhesive layer. This
patch is also backed by the backing layer. In this type of system
the rate of release is zero order.
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21. Matrix
The Matrix system has a drug layer of a semisolid matrix
containing a drug solution or suspension. The adhesive layer in
this patch surrounds the drug layer partially overlaying it. Also
known as a monolithic device.
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22. Vapour Patch
In this type of patch the adhesive layer not only serves to adhere
the various layers together but also to release vapour. The
vapour patches are new on the market and they release essential
oils for up to 6 hours. The vapour patches release essential oils
and are used in cases of decongestion mainly. Other vapour
patches on the market are controller vapour patches that
improve the quality of sleep. Vapour patches that reduce the
quantity of cigarettes that one smokes in a month are also
available on the market.
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23. The Manufacturing
Process
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The preparation and homogeneity of the bulk
drug containing
or non bulk drug containing adhesive mass
the coating process , including those
parameters to control layer thickness
drying , curing and removal of residual
solvent
lamination steps
the storage and handling of intermediate rolls
roll conversion to patches
primary packing
24. Popular uses
The highest selling transdermal patch in USA is the
nicotine patch,
Hormonal patches
Estrogen patches
contraceptive patch
testosterone patches for both men and women
Nitroglycerin patches
Transdermal scopolamine
The anti-hypertensive drug Clonidine
Vitamin B12 may also be administered through a
transdermal patch.
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25. Advantages of Transdermal Drug Delivery
do not put too much load on digestive
system and liver
avoid the pain on injection
eliminate the adverse effects associated
with excessive absorption of drugs taken
orally
thereby alleviate anxiety
offer more comfort to patients
produce excellent prolonged effects
administration can be visually confirmed
27. Transdermal Drug Delivery patches
May cause side effects
difficulty in breathing or swallowing
o light headedness
o dizziness
o redness or irritation of the skin ( covered by the
patch )
o flushing
some other side effects cab be serious
slow or fast heart beat
worsening chest pain
fainting
rash
itching
28. 1517-06-2013
symptoms of
overdose
may include
Transdermal Drug Delivery patches The patient can suffer a
overdose
• Headache
• confusion
• Fever
• dizziness
• slow or pounding heartbeat
• nausea
• Vomiting
• fainting
• shortness of breath
• sweating
• Flushing
• cold and clammy skin