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IMPLANTABLE DRUG DELIVERY
SYSTEMS (IDDSs)
Dr. P.S.GANGANE ASSOCIATE PROFESSOR DADASAHEB BALPANDE COLLEGE OF PHARMACY, BESA,NAGPUR Implantable Drug Delivery System
Implant is a single unit drug that has been designed to
deliver a drug moiety at a therapeutically desired rate over a prolonged period of time. Intended for implantation subcutaneously in the body for continuous release of drug over extended period of time .
• IDDSs are very attractive for a number of classes of
drugs, particularly those that
• Cannot be delivered via the oral route, are irregularly
absorbed via the gastrointestinal tract, • or that benefit from site-specific dosing. • Examples include steroids, chemotherapeutics, Implantable Drug Delivery System
Implantable drug delivery systems are
placed completely under the skin — usually in a convenient but inconspicuous location or located in a body in/nearby particular organ. Designed to transmit drugs and fluids into the bloodstream without the repeated insertion of needles. Implantable Drug Delivery System Well suited to the drug delivery requirements of insulin, steroids, chemotherapeutics, antibiotics, analgesics ,total parenteral nutrition, and heparin. Little chance of infection or interference with daily activities as the device is completely subcutaneous, with no opening in the skin. Advantages 1. Localized delivery Drug(s) are released in immediate vicinity of implant. Action may be diffusion, limited to the specific location of implantation
2. Improved patient compliance
Patient does not need to comply with repeated and timely intake of medication throughout the implantation period. Compliance is limited to one-time implantation (and potential removal in the case of nonbiodegradable Advantages 3. Minimized systemic side effects Controlled release for extended periods of time and localized dosing possible with at site of action; adverse effects away from site of action are minimized; peaks and valleys in plasma drug concentration from repeated intermediate release dosing are avoided.
4. Lower dose Localized implantation of site specific drugs can avoid first pass hepatic effects, thereby reducing dose required to ensure Advantages 5. Improved drug stability Protection of drug undergoing rapid degradation in the gastrointestinal and hepato-biliary system.
6. Suitability over direct administration
Hospital stay or continuous monitoring by healthcare staff may not be required for chronic illnesses.
7. Facile termination of drug delivery
If allergic or other adverse reaction to drug is experienced, discontinuation of therapy by implant removal is Disadvantages 1. Surgery is needed for large implants. It’s painful.
2. Therapy can not be simply
discontinued.
3. Reaction between host and
implants.
4. Inadequate release of API.
Disadvantages 5. Limited to potent drugs.
6. Biocompatibility issue.
7. Possibility of adverse reactions.
8. Enormous amount of R&D
investment, efforts and time is required in the development. Number of approaches have been developed to achieve controlled administration of drugs via implantation
Controlled drug delivery by diffusion process
Release of the drug from the device is preprogrammed at a specific rate profile. This is accomplished by a system design which controls molecular diffusion of drug in or and/or across barrier medium surrounding the system. This systems can be further sub classified in to number of classes. Polymer membrane permeation- controlled drug delivery using 1. Non porous membrane 2. Micro porous membrane 3. Semi permeable membrane Here the drug formulation is totally or partially encapsulated within a drug reservoir compartment and the drug release surface is covered by a rate limiting polymeric membrane having a specific permeability for drug drug reservoir polymeric membrane Drug contained in a The dug reservoir can exist in to a solid , suspension or in a solution form.
Polymeric membrane fabricated in the
form of non porous{homogenous or heterogeneous}, micro porous or semipermiable membrane. Methods of Encapsulation
dispersion of drug particles in a rate controlling polymer matrix.
• Polymer matrix fabricated from either a
lipophillic or a hydrophilic polymer. Drug reservoir{dispersion} Drug release
Gel layer Drug depleted zone
Drug release
Hydrophilic polymer Lipophillic polymer Swellable matrix Non swellable matrix Microreservior partition-controlled drug delivery system
Drug reservoir is fabricated by ….
Micro-dispersion of aqueous suspension of a drug using a high energy dispersion technique in to a biocompatible polymer such as silicone elastomer to form a homogenous dispersion of many discrete , unleachable microscopic drug reservoir. Polymer matrix
Microscopic Drug reservoir {liquid compartment}
Coating membrane
Polymer -solution interface Membrane matrix hybrid-type drug delivery system Drug reservoir is formed by dispersion of drug in to a polymer matrix which is further coated by a semi permeable polymeric membrane Example is a Norplant II sub dermal system Controlled drug delivery by activation process Drug is activated by some physical , chemical, or biological process and/or by the energy supplied externally. Rate of release is then regulated by the processes applied or input of energy. 1. Osmotic pressure activated 2. Vapor pressure activated 3. Magnetically activated 4. Hydrolytic-activated 5. Hydration activated Osmotic pressure activated drug delivery system In this type of controlled drug delivery system the release of the drug takes place due to osmotic pressure. Drug reservoir which can be either a solid or a suspension is contained in a semipermeable housing. The release is activated through a specially formed orifice and rate of release is modulated by controlling the osmotic gradient. Osmotic pressure activated drug delivery system Thus release rate is dependent on water permeability of membrane, solubility of osmogen, effective surface area of semipermiable housing as well as osmotic gradient. Representative example of this type of implantable controlled release drug delivery system is Duros and Alzet osmotic pump. OSMOTIC PUMP Pump systems have been used to provide the higher precision and remote control needed in these situations. Additionally, they offer a number of advantages, such as , avoidance of the GI tract, avoidance of repeated injections, and improved release rates (faster than diffusion-limited systems). OSMOTIC PUMP Osmotic pumps have found wide acceptability among all active IDDSs The first osmotic pump was devised by Australian pharmacologists, Rose and Nelson, who developed an implantable osmotic pump in 1955, named Rose and Nelson osmotic pump OSMOTIC PUMP The design comprises a drug reservoir surrounded by a semipermeable membrane, which allows a steady inflow of surrounding fluids into the reservoir through osmosis. A steady efflux of the drug then ensues via the drug portal, an opening in the membrane, as a result of the hydrostatic pressure built on the drug reservoir. OSMOTIC PUMP Nearly constant or zero-order drug release is maintained until complete depletion of the drug packaged in the reservoir. The DUROS leuprolide implant, named Viadur, was approved as the first implantable osmotic pump for humans in the United States in the year 2000. OSMOTIC PUMP-DUROS It is particularly suitable for potent peptides and proteins that require chronic dosing. The cylindrically shaped device consists of a reservoir made of an inert titanium alloy, capped at one end by a water-permeable membrane. At the other end, a diffusion moderator, through which drug formulation is released from the drug reservoir, caps the reservoir. Duros pump OSMOTIC PUMP-DUROS The drug formulation, piston, and osmotic engine are contained inside the cylinder. The piston separates the drug formulation from the osmotic engine and seals the osmotic engine compartment from the drug reservoir. The diffusion moderator is designed, in conjunction with the drug formulation, to prevent body fluid from entering the drug reservoir through the orifice. OSMOTIC PUMP-ALZET This device operates by osmotic displacement and is able to deliver drug at controlled rates over delivery windows between 24 h and 6 weeks. The drug to be delivered is filled into a core reservoir, which is isolated from a chamber, containing an osmotic salt, by a semipermeable membrane. OSMOTIC PUMP-ALZET Due to the presence of a high concentration of salt in a chamber surrounding the reservoir, water enters the pump through the semipermeable layer. The entry of water increases the volume in the salt chamber, causing compression of the flexible reservoir and delivery of the drug solution into the host via the exit port. OSMOTIC PUMP-ALZET ALZET pumps were able to release 262 mg/h of the opioid hydromorphone over 2 weeks, to produce stable plasma concentrations of approximately 30-40 mcg/mL. Thanks References Parenteral Drug Delivery System, Novel Drug Delivery Systems by Yie.W. Chien. pp. 441-452 Implantable Therapeutic Systems, Controlled Drug Delivery by Joseph R. Robinson. Pp. 482-516
