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Slide 1 :

Transdermal Drug Delivery System (TDDS) Prepared By: Sujan Banik M.Pharm

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Introduction to TDDS Today about 74% of drugs are taken orally and are found not to be as effective as desired. To improve such characters transdermal drug delivery system was emerged. The first Transdermal system, Transderm-SCOP was approved by FDA in 1979 for the prevention of nausea and vomiting

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What is TDDS? This new technique are designed a method of drug delivery system in which a drug is administered through skin absorption (through its various layers) into the systemic circulation in the form of ointment or patch form.

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Penetration of Drug The main route for the penetration of drug is generally through the epidermal layers, rather than through the hair follicles or the gland ducts.

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Advantages of TDDS Transdermal drug delivery systems offer several important advantages over more traditional approaches, including: Avoid the risks and inconvenience of intravenous therapy. Bypass the variation in the absorption and metabolism associated with oral administration.

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Advantages......... Permit continuous drug administration and the use of drug with a short biological half-life. Avoid hepatic first-pass metabolism Improve the bioavailability and efficacy of the drugs. All-time leading to better patient compliance. More uniform plasma levels Longer duration of action resulting in a reduction in a dosing frequency.

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Oral versus Transdermal EE = Ethinyl Estradiol

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But it has some drawbacks Expensive Sophisticated technique required Heavy drug molecules (>500 Da) not administrated by this way Onset of action delay Local irritation at the site of application

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Properties of drug candidates for TDDS Pharmacological Potent (maximum 50 mg/day) Narrow therapeutic window Subject to extensive first-pass metabolism when given orally Must be given several times a day Cause side effects due to short half-life and fluctuating plasma levels Effective when delivered slowly over a long period of time Physiochemical Low molecular weight (generally less than 500 daltons) Correctly balanced partition coefficient Modest melting point

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Examples of Some Transdermal products with indication Nitroglycerine releasing TDDS (angina pectoris) Scopolamine releasing TDDS (motion sickness) Fentanyl releasing TDDS (pain relief-analgesic) Clonidine releasing TDDS (hypertension) Nictotine for smoking cessation Isosorbide dinitrate for angina pectoris Estradiol for the treatment of postmenopausal syndrome

Slide 11 :

Anatomy of the skin Skin is the largest organ in the body. It is a multilayered organ. Mainly divided into two main layers: Epidermis Stratum corneum Stratum lucidum Stratum granulosum Stratum spinosum Stratum basale 2. Dermis

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The stratum corneum is the outermost layer of the epidermis and is composed mainly of dead cells that lack nuclei.

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Factors Affecting Percutaneous Absorption Nature of the drug itself ( aqueous solubility, drug concentration, partition coefficient) Nature of the vehicle Nature of the skin (thickness of the skin, duration of contact with skin, rubbing of the skin) Presence of moisture

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Transdermal Patch Also known as skin patch It is a medicated adhesive patch Its placed on the skin to deliver a specific dose of the medication through the skin onto to the bloodstream A wide variety of pharmaceuticals can be delivered by transdermal patch such nitrodisc, nitrodur, frandol tape etc.

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Components of Transdermal Patch Transdermal patch may include the following components: Liner - Protects the patch during storage. This liner should removed prior to use. Drug - Drug is in direct contact with release liner Adhesive - Serves to adhere the patch to the skin for systemic delivery of drug. Ex: Acrylates, Silicones, polyisobutylenes etc.

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Membrane - Controls the release of the drug from the reservoir and multi-layer patches Backing - Protects the patch from the outer environment

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Film Backing Drug Layer Protective Peel Strip (removed prior to use) skin Schematic Drawing of the Reservoir type of patch. Rate-controlling Membrane Contact Adhesive

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Types of Transdermal Patch There are 5 different types of transdermal patch 1. Single layer drug in adhesive patch (simple) 2. Multi layer drug in adhesive patch (immediate + controlled release layer) 3. Reservoir system (drug embedded in reservoir) 4. Vapour patch (Adhesive act as release layer) 5. Matrix system (polymer used act as a matrix system to control drug release)

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Process of transdermal drug delivery Active process - Reservoir and matrix system (patch) Passive process Inotophoresis Electroporation Sonophoresis Heat or thermal energy Microneedles

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Iontophoresis involves the delivery of charged chemical compounds across the skin membrane using an applied electrical field.

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Sonophoresis Sonophoresis, or high-frequency ultrasound, is also being studied as a means to enhance transdermal drug delivery Examples: hydrocortisone, lidocaine, and salicylic acid in such formulations as gels, creams and lotions

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Evaluation of Transdermal Drug We evaluate the transdermal drug on the basis of some parameters: Interaction studies Thickness of the patch Weight uniformity Folding endurance Percentage of moisture content Drug content Skin irritation study

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Conclusion Transdermal drug delivery is a painless, convenient, and potentially effective way to deliver regular doses of many medications. Unfortunately, from the perspective of transdermal technology, the skin is impermeable to all but the smallest of molecules. Another reason is that only a limited number of drugs fit the molecular weight, lipophilicity, andpotency requirements for transdermal absorption. TDDs a realistic practical application as the next generation of drug delivery system

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