Transdermal drug delivery system

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1 Seminar on …………….. Transdermal Drug Delivery Systems (Tdds) Pynda Sindhuka Pharmaceutical Technology Aditya institute of pharmaceutical sciences and research ,Surampalem

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Aditya institute of pharmaceutical sciences and research,Surampalem 2 CONTENTS : 1.Introduction 2.Advantages and disadvantages of TDDS 3.Cross-section of human skin 4.Mechanisms of drug permeation 5.Factors affecting percutaneous absorption 6.Strategies for the enhancement of drug permeability 7.Basic components of TDDS 8.Evaluation of TDDS 9.Conclusion 10.References

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Introduction Transdermal drug delivery is hardly an old technology, since 1800’s and the technology is no longer just adhesive patches. Due to recent advances in technology and the ability to apply the drug to the site of action without rupturing the skin membrane, transdermal route is becoming a widely accepted route of drug administration. Over the last two decades more than 35 Transdermal patch products have been approved . Definition: Transdermal drug delivery system can deliver the drugs through the skin portal to systemic circulation at a predetermined rate and maintain clinically the effective concentrations over a prolonged period of time. 3 Aditya institute of pharmaceutical sciences and research,Surampalem

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Advantages of TDDS Avoids chemically hostile GI environment. Avoidance of significant presystemic metabolism Allows effective use of drugs with short biological half-life and narrow therapeutic window. Reduction of dosing frequency and enhancement of patient compliance. Provides controlled plasma levels of very potent drugs. Avoids the risk and inconveniences of parenteral therapy. Drug input can be promptly interrupted simply by removal of the patch when toxicity occurs. Provides suitability of self medication. . 4 Aditya institute of pharmaceutical sciences and research,Surampalem

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Disadvantages of TDDS Drugs that require high blood levels cannot be administered – limited only to potent molecules, those requiring a daily dose of 10mg or less. Transdermal administration is not a means to achieve rapid bolus type drug input, rather it is usually designed to offer slow, sustained drug delivery. Adequate solubility of the drug is required. The molecular size of the drug should be reasonable. Difficulty of permeation of the drug through human skin –barrier function of the skin. Skin irritation or dermatitis is another major limitation. Adhesive may not adhere well to all types of skin. May not be economical. 5 Aditya institute of pharmaceutical sciences and research,Surampalem

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Aditya institute of pharmaceutical sciences and research,Surampalem 6

Cross-section of human skin:

Cross-section of human skin 7 Aditya institute of pharmaceutical sciences and research,Surampalem

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Stratum Corneum (topmost 15 μ m layer) is the main barrier 8 Aditya institute of pharmaceutical sciences and research,Surampalem

1.Through stratum corneum 2.Transfollicular 3.Through sweat gland:

1.Through stratum corneum 2.Transfollicular 3.Through sweat gland Pathways of drug penetration 9 Aditya institute of pharmaceutical sciences and research,Surampalem

Mechanisms of drug permeation:

Mechanisms of drug permeation 10 Hydrophilic drugs permeates by Intercellular pathway and Lipophilic drugs permeates by Intracellular (Transcellular) mechanism. Aditya institute of pharmaceutical sciences and research,Surampalem

Skin permeability kinetics:

Skin permeability kinetics Fick’s First Law of Diffusion Percutaneous absorption of most drugs is a passive-diffusion process that can be described by Fick’s first law of diffusion dQ/dt = J T = PA Δ C J T is the total flux transported through a unit area of skin per unit time in steady state (µg/hr) A is area of the skin P is the effective permeability coefficient ΔC is the drug concentration gradient across the skin 11 Aditya institute of pharmaceutical sciences and research,Surampalem

Factors affecting percutaneous absorption:

Factors affecting percutaneous absorption Physicochemical properties of Penetrant Physiological and pathological conditions of skin Physicochemical properties of Drug Delivery System 12 Aditya institute of pharmaceutical sciences and research,Surampalem

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Physicochemical factors of penetrant/drug Partition coefficient Drug properties Dose deliverable : ≤ 10mg Aqueous solubility : >1mg/ml Lipophilicity : log P (1-3) Molecular size : < 500 Daltons Melting point : < 200°C Drug should not be an irritant to skin. The drug should not stimulate an immune reaction in the skin. Along with these properties the drug should be potent, having short half life 13 Aditya institute of pharmaceutical sciences and research,Surampalem

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Physiological and pathological conditions of skin P H of the skin Area of application Age, Sex, Race Condition of the skin Integrity and Thickness of stratum corneum Trauma Hydration Metabolism Temperature 14 Aditya institute of pharmaceutical sciences and research,Surampalem

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Physicochemical properties of Drug Delivery System Vehicle-solubility of the drug Lipophilicity of the solvent Affinity of the vehicle Composition of drug delivery system Surfactants 15 Aditya institute of pharmaceutical sciences and research,Surampalem

Strategies for the enhancement of drug permeability:

Strategies for the enhancement of drug permeability 16 Aditya institute of pharmaceutical sciences and research,Surampalem

Chemical permeation enhancers:

Chemical permeation enhancers A substance that will increase the permeability of the epithelial barrier by modifying its structure also termed as accelerants or sorption promoters-can enhance drug flux. Ideal Penetration Enhancer Non-toxic, non-irritating, non-allergenic. Immediate onset of increased permeability. Immediate recovery of normal barrier properties upon removal (reversible). Physically and Chemically compatible with a wide range of drugs. 17 Aditya institute of pharmaceutical sciences and research,Surampalem

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Solvents - Ethanol, acetone, polyethylene glycol, glycerol, propylene glycol ,dimethyl sulfoxide Surfactants - Brij30, brij72,Pluronic, Sodium lauryl sulphate, Span 20,Tween 80. Azones - N- Acyl hexahydro-2-oxo-1H-azepines, N-Alkylmorpholine-2,3-diones. Terpenes - Limonene,Carvone Fatty alcohols - Lauryl alcohol, linolenyl alcohol, oleicacid fatty acids and lauric acid. Miscellaneous - Lecithin, sodium deoxycholate, L-amino acid, acid phosphatase,phospholipase & calonase 18 Aditya institute of pharmaceutical sciences and research,Surampalem

Electrically Assisted methods:

Electrically Assisted methods 1.Ultrasound (Phonophoresis / Sonophoresis) Used originally in physiotherapy and sports medicine, applies a preparation topically and massages the site with an ultrasound source. The ultrasonic energy (at low frequency) disturbs the lipid packing in stratum corneum by cavitation. Sonicators operating at frequencies in the range of 20kHz to 3MHz are available commercially and can be used for Sonophoresis. Therapeutic ultrasound (1–3MHz) - for massage, Low-frequency ultrasound (23-40kHz) High-frequency ultrasound (3–10 MHz) - diagnostic purposes. 19 Aditya institute of pharmaceutical sciences and research,Surampalem

Enhanced Transdermal Permeation by Cavitation of stratum corneum upon application of Ultrasound. :

Enhanced Transdermal Permeation by Cavitation of stratum corneum upon application of Ultrasound. 20 Aditya institute of pharmaceutical sciences and research,Surampalem

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Ultrasound to Enhance Skin Permeability 21 Aditya institute of pharmaceutical sciences and research,Surampalem

2.Iontophoresis :

2.Iontophoresis Limitations: Hair follicle damage is possible. 22 Aditya institute of pharmaceutical sciences and research,Surampalem Def:It is the facilitation of (ionizable)drug permeation across the skin by an applied electrical potential. The main mechanisms enhance molecular transport: Charged species are driven primarily by electrostatic repulsion. Flow of electric current may increase the permeability of skin

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3.Electroporation :

3.Electroporation Skin electroporation (electropermeabilization) creates transient aqueous pores in the lipid by application of high voltage of electrical pulses of approximately 100–1000 V for short time(milliseconds). These pores provide pathways for drug penetration that travel straight through the horny layer. 24 Aditya institute of pharmaceutical sciences and research,Surampalem

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Basic components of TDDS :

Basic components of TDDS Drug Polymer matrix Penetration enhancers Other Excipients Rate controlling membrane Adhesive Release liner Backing membrane 26 Aditya institute of pharmaceutical sciences and research,Surampalem

Types of Transdermal delivery devices:

Types of Transdermal delivery devices 27 Aditya institute of pharmaceutical sciences and research,Surampalem

1.Matrix Diffusion-Controlled TDDS:

1 . Matrix Diffusion-Controlled TDDS 28 Polymers: PVC, PVP, Ethylene vinylacetate, microporous polypropylene. Initially the drug is released rapidly, then rate declines as matrix is depleted. Rate controlling factors Drug concentration in polymer matrix Chemical nature of polymer matrix Geometry of device Aditya institute of pharmaceutical sciences and research ,Surampalem Ex: Nitro Dur®

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Aditya institute of pharmaceutical sciences and research,Surampalem 29

2.Membrane Moderated TDDS:

2 . Membrane Moderated TDDS 30 Rate controlling factors Membrane thickness Membrane permeability Polymers: Cellulosic esters, polyamides or PVC. Aditya institute of pharmaceutical sciences and research, Surampalem Ex: TransdermScop® TransdermNitro®

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Aditya institute of pharmaceutical sciences and research,Surampalem 31

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Aditya institute of pharmaceutical sciences and research,Surampalem 32 3.Adhesive Dispersion type TDDS Ex: Deponit®

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Aditya institute of pharmaceutical sciences and research,Surampalem 33

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Aditya institute of pharmaceutical sciences and research,Surampalem 34 4.Microreservoir type TDDS Ex: Nitro Dur®

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Release liners Protects the skin-contacting adhesive during storage. Substrate carries a very thin release coating. Provides low energy surface for ease of removal. e.g.: polyester or polystyrene based films. Backing material Contains formulation throughout shelf life and during wear period. They have laminate structure. They must be compatible with the formulation (nonadsorptive). They are occlusive and completely water impermeable in nature. e.g.: Poly urethane films, Ethyl vinyl acetate, Poly olefins. Adhesive layer Acrylic copolymers, polyisobutylene and polysiloxane. 35 Aditya institute of pharmaceutical sciences and research,Surampalem

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Aditya institute of pharmaceutical sciences and research,Surampalem 36 Evaluation of TDDS : 1.Physicochemical Evaluation: Weight variation Drug content %Moisture content %Moisture uptake Patch thickness %flatness Folding endurance Tensile strength Skin irritancy studies 2.Evaluation of Adhesive : Peel adhesion properties Tack properties Shear strength properties 3. In vitro drug Release Evaluation (Skin permeation study) 4.In vivo Evaluation

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Transdermal patches available in the market 37 Aditya institute of pharmaceutical sciences and research,Surampalem

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Aditya institute of pharmaceutical sciences and research,Surampalem 38

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Aditya institute of pharmaceutical sciences and research,Surampalem 39 A Novel Transdermal Delivery System In parT-Ionic Nano particle Technology Clinical Investigation : Topical Lidocaine Hyaluronic acid Benzoyl peroxide.

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Aditya institute of pharmaceutical sciences and research,Surampalem 40 Saturday, April 26, 2014 Artificial skin layer grown in lab: In a major breakthrough, scientists have been successful in developing the first lab-grown epidermis — the outermost skin layer — which could replace animals in drug and cosmetics testing. The new epidermis, grown from human pluripotent stem cells (iPSC) Produce an unlimited supply of pure keratinocytes — the predominant cell type in the outermost layer of skin. The research, done by King’s College London and the San Francisco Veteran Affairs Medical Center (SFVAMC)

Conclusion :

Conclusion Transdermal drug delivery technologies are becoming one of the fastest growing sectors within the pharmaceutical industry. Advances in drug delivery systems have increasingly brought about rate controlled delivery with fewer side effects as well as increased efficacy and constant drug delivery. The market value for transdermal delivery was $12.7 billion in 2005, and is expected to increase to $21.5 billion in the year 2010 and $31.5 billion in the year 2015 – suggesting a significant growth potential over the next 10 years. 41 Aditya institute of pharmaceutical sciences and research,Surampalem

References :

References Controlled drug delivery –concepts and advances – by S.P.Vyas R.K.Khar . Controlled and Novel drug delivery edited by N.K.Jain reprint 2007 Encyclopedia of controlled drug delivery volume 2 encyclopedia of controlled drug delivery Y.W.Chein , Novel Drug Delivery Systems,2 nd edition. 42 Aditya institute of pharmaceutical sciences and research,Surampalem

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