Implantable Drug Delivery

Systems
Prepared by: Tejas J. Patel
Associate Professor
Department of Pharmaceutics
SNLPCP, Umrakh.
Introduction
• In 1861 Lafarge developed a subcutaneously
implantable drug pellet for long term
continuous drug administration.
• In 1936 Deanesly and Parkes developed
crystalline hormones in the form of solid
steroid pellets for hormone substitution
therapy.
• Implants are small sterile solid masses
consisting of a highly purified drug made by
compression or molding or extrusion.
• Implants are typically placed subcutaneously
to sustain drug release via the mechanisms of
drug diffusion, polymer dissolution or both.
• More recent implants usually contain the
drug in a rate controlling systems. These
systems are available in a variety of sizes and
shapes.
• Well suited for the drug delivery
requirements of insulin, steroid,
chemotherapeutics, antibiotics, analgesics,
total parenteral nutrition and heparin.
• Some of the approved implant products
include Leuprolide acetate and Nafarelin
acetate in biodegradable PLGA copolymer for
one-month release.
• Also new on the market is a silicone polymer
 Ideal Properties
• The dosing frequency should be reduced to
increase patient compliance and should
release the drug during the entire treatment
period.
• The implant should be easy to develop and
should not be expensive.
• The implant should be easily removable by
medical personnel to discontinue treatment.
• The implant should release the drug in a
zero-order manner or in a controlled
manner that leads to effective treatment and
 Ideal Properties
• The implant should be safe, stable, and
effective and should have enough
mechanical strength.
• The implant should be easy to administer
and would not require any special
procedure for application.
• The implant should free from any potential
problem.
 Advantages
• Improved patient compliance.
• By passes first pass metabolism.
• The drug is distributed locally or in systemic
circulation with least interference by metabolic or
biological barriers.
• Implants are available which deliver drugs by zero-
order controlled release kinetics.
• Decrease side effects.
• Effective concentration of drug in the blood can be
maintained for longer period of time.
• Improve stability of drugs.
• Improve bioavailability of drugs.
Disadvantages
• Surgery is needed for large implants.
• Painful.
• Therapy can not be simply discontinued.
• Reactions occur between host and implants.
• Limited drug loading capacity.
• Inadequate release of API.
• Appropriate surgical personnel is required.
• Uncomfortable feeling for the patient
wearing the device.
Implantable Osmotic pump system
• The primary characteristic that distinguishes a
pump from other controlled-release systems is
that the primary driving force for delivery by
a pump is not the concentration difference of
the drug between the concentration and
surrounding tissue, but rather, a pressure
difference.
• The pump must be convenient to use by both
the patient and the health professional, have
long reservoir and battery life, easy
programmability, and be implantable under
local anaesthesia.
• There must also be a simple means to monitor
the status and performance of the pump, and
• The DUROS® implant is a miniature
cylinder made from a titanium alloy, which
protects and stabilizes the drug inside, using
ALZA's proprietary formulation technology.
• Water enters into one end of the cylinder
through a semi-permeable membrane; the
drug is delivered from a port at the other
end of the cylinder at a controlled rate
appropriate to the specific therapeutic agent.

• The delivery can be over a period of 12

months.
• This non-biodegradable, osmotically driven
system is intended to enable delivery of
small drugs, peptides, proteins, DNA and
Features of Pump:
• DUROS® can be designed to deliver up to 1,000 mg of
concentrated drug from months to one year.
• The engine can generate pressure sufficient to deliver
highly concentrated, viscous and non-water-based
drug formulations.
• The system can be engineered to accurately deliver a
drug formulation at dosing rates down to 1/100 of a
drop per day on a continuous basis.
• The titanium shell of the system protects the drug
formulation inside from contact with body fluids, thus
protecting it from degradation by enzymes, water and
clearance processes within the body.
• The delivery rate is typically designed to be constant ±
10% for better than 95% of its drug content.
• The delivery rate in vivo is equal to the delivery rate in
Application:

• The potential of the DUROS® technology,

licensed from ALZA, was demonstrated by
the Food and Drug Administration’s
approval in March 2000 of ALZA
Corporation’s Viadur™ product for the
treatment of prostate cancer, the first
product utilizing the DUROS® platform.
Alzet Osmotic Pump
• Osmotic pumps manufactured by ALZA
Corporation (Palo Alto, CA) are designed for
constant rate delivery of test solutions over a
period of days or weeks.
• Pumps are implanted SC or IP for systemic
delivery.
• Drugs can be delivered to the central nervous
system (ICV or intraparenchymally), by attaching
the delivery port of the pump (implanted SC) to a
centrally implanted cannula via a small length of
vinyl tubing.
• The principal of pump operation is straight
forward. An inner reservoir made of a
biologically inert and impermeable synthetic
elastomer is filled with the solution to be
delivered.
• The outer wall of the pump comprises a rigid
semipermeable membrane.
• Between the inner reservoir and the outer wall
of the pump is an ‘osmotic sleeve’ which
expands as water passes into it, compressing the
inner reservoir and displacing the drug solution.
• The inner pump reservoir is compatible with
most drugs and drug diluents, except aliphatic
and aromatic hydrocarbons and natural oils.
• Alzet pumps are available with a variety of
delivery rates (0.5 - 10 µl/hr) with delivery
durations of between 3 days and 4 weeks
Evaluation of Implant
• Size and shape
• Uniformity of thickness
• Uniformity of weight
• % Swelling Index
• In-vitro dissolution studies
• Drug and polymer interaction study
• Stability Studies.
Thank You