Transdermal patch
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A transdermal patch or skin 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 such as oral, topical, etc is that it provides a controlled release of the medicament into the patient. A disadvantage to development however, stems from the fact that the skin is a very effective barrier. A wide variety of pharmaceuticals can be delivered by transdermal patches. The first commercially available prescription patch was approved by the U.S. Food and Drug Administration in December 1979, which administered scopolamine for motion sickness.[1][2]
Before these patches go into the market, they have to be carefully studied. One way to study these patches are through the use of Franz Diffusion Cell systems. This system is used to study the effects of temperature on the permeated amount of a specific drug on a certain type of membrane, which in this case would be the membrane that is used in the patches. A Franz Diffusion Cell system is composed of a receptor and a donor cell. In many of these research studies the following procedure is used. The donor cell is set at a specific temperature (the temperature of the body), while the receptor cell is set at different one (temperature of the environment).
Different runs are performed using different temperatures to study the impact of temperature on the release of a certain medicament through a certain type of membrane. Although different concentrations of the medicament are used in this study, they do not affect the amount permeated through the membrane (the process is constant). From Chemical kinetics it’s concluded that these studies are zero order, since the concentration plays no role in the permeated amount through the membrane.
The highest selling transdermal patch in the United States was the nicotine patch which releases nicotine to help with cessation of tobacco smoking, however, fentanyl (analgesic for severe pain) is now the number one selling patch. Other skin patches administer estrogen for menopause. This also seems to prevent osteoporosis after menopause. Nitroglycerin patches for angina and lidocaine patches to relieve the peripheral pain of shingles (herpes zoster) are also available. Recent developments expanded their use to the delivery of hormonal contraceptives, antidepressants and even pain killers and stimulants for Attention Deficit Hyperactivity Disorder/ADHD.
Some pharmaceuticals must be combined with substances, such as alcohol, within the patch to increase their ability to penetrate the skin in order to be used in a transdermal patch. Others can overwhelm the body if applied in only one place, and are often cut into sections and applied to different parts of the body to avoid this, such as nitroglycerin. Many molecules, however, such as insulin, are too large to pass through the skin.
In 2005, the Food and Drug Administration announced that they are investigating reports of death and other serious adverse events related to narcotic overdose in patients using Duragesic, the fentanyl transdermal patch for pain control. The Duragesic product label was subsequently updated to add safety information in June 2005.[3]
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[edit] Components
The main components to a transdermal patch are:
- Liner - Protects the patch during storage. The liner is removed prior to use.
- Drug - Drug solution in direct contact with release liner
- Adhesive - Serves to adhere the components of the patch together along with adhering the patch to the skin
- Membrane - Controls the release of the drug from the reservoir and multi-layer patches
- Backing - Protects the patch from the outer environment
[edit] Types
There are four main types of transdermal patches listed below.
[edit] 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.
[edit] 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. 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.
[edit] 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
[edit] 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.
[edit] Regulatory aspects
A transdermal patch is classified by the U.S. Food and Drug Administration as a combination product, consisting of a medical device combined with a drug or biological product that the device is designed to deliver. Prior to sale in the United States, any transdermal patch product must apply for and receive approval from the Food and Drug Administration, demonstrating safety and efficacy for its intended use.
[edit] Notes
- ^ Segal, Marian. Patches, Pumps and Timed Release: New Ways to Deliver Drugs. Food and Drug Administration. Retrieved on 2007-02-24.
- ^ FDA approves scopolamine patch to prevent peri-operative nausea. Food and Drug Administration (1997-11-10). Retrieved on 2007-02-12.
- ^ FDA ALERT (07/2005): Narcotic Overdose and Death. Food and Drug Administration (2005-07-15). Retrieved on 2007-02-24.
[edit] Further reading
- Transderm Scōp. Food and Drug Administration (1998). Retrieved on 2007-02-12. (Portable Document File)
[edit] See also
[edit] External links
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