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Transdermal drug delivery system thesis Pharma Tips
Singhal P, Singhal R, Kumar V, Goel KK, Jangra AK, Yadav R. Transdermal drug delivery system; A novel technique to enhance therapeutic efficacy and safety of drugs. Am J Pharmtech Res 2012;2(1):105-25.
ABSTRACT: 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. Transdermal drug delivery offers controlled release of the drug into the patient, it enables a steady blood level profile, resulting in reduced systemic side effects and, sometimes, improved efficacy over other dosage forms. The main objective of transdermal drug delivery system is to deliver drugs into systemic circulation through skin at predetermined rate with minimal inter and intrapatient variations.
Transdermal route and drug delivery prospects
Gannu R, Vamshi YV, Kishan V, Rao YM. Development of Nitrendipine transdermal Patches: In vitro and Ex vivo Characterization. Curr Drug Delivery 2007;4:69-76.
The final stage of the development of a transdermal device involves collection of pharmacokinetic and pharmacodynamic data following application of the patch to human volunteers.39 Clinical trials have been conducted to assess the efficacy, risk involved, side effects, patient compliance etc. Phase I clinical trials are conducted to determine mainly safety in volunteers and phase II clinical trials determine short term safety and mainly effectiveness in patients. Phase III trials indicate the safety and effectiveness in large number of patient population and phase IV trials at post marketing surveillance are done for marketed patches to detect adverse drug reactions. Though human studies require considerable resources best to assess the performance of the drug.26
Tiwary AK, Sapra B, Jain S. Innovations in transdermal drug delivery:
Dermis is the layer of skin just beneath the epidermis which is 3 to 5 mm thick layer and is composed of a matrix of connective tissues, which contains blood vessels, lymph vessels, and nerves. The cutaneous blood supply has essential function in regulation of body temperature. It also provides nutrients and oxygen to the skin, while removing toxins and waste products. Capillaries reach to within 0.2 mm of skin surface and provide sink conditions for most molecules penetrating the skin barrier. The blood supply thus keeps the dermal concentration of permeate very low, and the resulting concentration difference across the epidermis provides the essential driving force for transdermal permeation. In terms of transdermal drug delivery, this layer is often viewed as essentially gelled water, and thus provides a minimal barrier to the delivery of most polar drugs, although the dermal barrier may be significant when delivering highly lipophillic molecules.13
The hypodermis or subcutaneous fat tissue supports the dermis and epidermis. It serves as a fat storage area. This layer helps to regulate temperature, provides nutritional support and mechanical protection. It carries principal blood vessels and nerves to skin and may contain sensory pressure organs. For transdermal drug delivery, drug has to penetrate through all three layers and reach in systemic circulation.14
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Nimesulide transdermal drug delivery systems. Indian J Pharm Sci
Shivaraj A, Selvam RP, Mani TT, Sivakumar T. Design and evaluation of transdermal drug delivery of ketotifen fumarate. Int J Pharm Biomed Res 2010;1(2):42-7.
of transdermal drug delivery system of etoricoxib using modified
Considerable time and resources are required to carry out human studies, so animal studies are preferred at small scale. The most common animal species used for evaluating transdermal drug delivery system are mouse, hairless rat, hairless dog, hairless rhesus monkey, rabbit, guinea pig etc. Various experiments conducted leads to a conclusion that hairless animals are preferred over hairy animals in both in vitro and in vivo experiments. Rhesus monkey is one of the most reliable models for in vivo evaluation of transdermal drug delivery in man.26
6 Advantages of transdermal drug delivery: (1, 8, 16, 17, 18, 19)
Research Interest: Design and Evaluation of Nanoparticles, Dendrimers, Resealed erythrocytes, Conjugated novel carriers, Liposomes, Nanosponges, Nanoparticles loaded creams, New binding agents for tablets, Novel Transdermal Drug Delivery Systems, Targeted Drug Delivery Systems, Ethosomes, Lipid Carriers, Dental Implants.
7 Disadvantages of transdermal drug delivery: 8, 17, 19
Transdermal drug delivery system may produce unstable matrices if the loading dose is greater than 10 mg. Aluminium backed adhesive film method is a suitable one for preparation of same, chloroform is choice of solvent, because most of the drugs as well as adhesive are soluble in chloroform. The drug is dissolved in chloroform and adhesive material will be added to the drug solution and dissolved. A custammade aluminium former is lined with aluminium foil and the ends blanked off with tightly fitting cork blocks.3, 6
12 Formulation of transdermal drug delivery system:
In order to prepare the target transdermal therapeutic system, 1% carbopol reservoir gel, polyethelene (PE), ethylene vinyl acetate copolymer (EVAC) membranes can be used as rate control membranes. If the drug is not soluble in water, propylene glycol is used for the preparation of gel. Drug is dissolved in propylene glycol, carbopol resin will be added to the above solution and neutralized by using 5% w/w sodium hydroxide solution. The drug (in gel form) is placed on a sheet of backing layer covering the specified area. A rate controlling membrane will be placed over the gel and the edges will be sealed by heat to obtain a leak proof device.3
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