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Transdermal drug delivery system

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Total general overview and discription of TDDS is given in presentation. Not more bulk in slides.

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Transdermal drug delivery system

  1. 1. A SEMINAR ON TRANSDERMAL DRUG DELIVERY SYSTEM PRESENTED BY: SHIRODE RAHUL A. M. Pharm.2nd sem.(2014-2015) (Department of Pharmaceutics) R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur 1
  2. 2. CONTENTS  Introduction  Advantages-Disadvantages  Comparison between IV, Oral and TDDS  Anatomy and Physiology of Skin  Permeation of Drug Molecule through Skin  Percutaneous Absorption  Classification of TDDS  Basic components of TDDS  Factors affecting Transdermal Permeation  Evaluation of TDDS  Application  Marketed Product  Conclusion  References. 2
  3. 3. INTRODUCTION  TDDS are topically administered medicaments in the form of patches that deliver drugs for systemic effects at predetermined and controlled rate.  Transdermal patch is an adhesive patch, that has a coating of medicine (drug), that is placed on the skin to deliver specific dose of the medicine, into the blood over a period of time. 3
  4. 4. ADVANTAGES  Avoidance of first-pass effect,  Long duration of action,  Comparable characteristics with IV infusion,  Ease of termination of drug action, if necessary,  No interference with gastric and intestinal fluids,  Suitable for administered of drug having- Very short half-life, e.g. nitroglycerine. Narrow therapeutic window. Poor oral availability. 4
  5. 5. DISADVANTAGES  Poor diffusion of large molecules,  Skin irritation,  Requires high drug load,  Unsuitable –If drug dose is large,  Absorption efficiency is vary with different sites of skin, 5
  6. 6. COMPARISON BETWEEN IV,ORAL AND TDDS ADVANTAGES IV ORAL TDD Avoid hepatic first-pass effects YES NO YES Constant drug levels YES NO YES Self- administration NO YES YES Termination of therapy NO YES YES 6
  7. 7. ANATOMY AND PHYSIOLOGY OF SKIN 7
  8. 8.  Skin is the part of Integrated system i.e. it helps to maintain body temp and protect It from surrounding environment.  It covers an area of about 2m2 and 4.5-5 kg i.e. about 16% of total body weight in adults.  Thickness is in range of 0.5mm (on eyelids ) to 4.0mm ( on heels ). 8
  9. 9.  Skin has mainly 3 layers… 1)Epidermis  Stratum Cornium  Stratum Granulosm  Stratum Spinosum  Stratum Basal 2)Dermis 3)Subcutaneous layer 9
  10. 10. EPIDERMIS  Stratum Cornium- consists of 25 to 30 layers of flattened dead keratinocytes. Which makes it water repellent.  Stratum Granulosm- consists of 3 to 5 layers and under goes Apoptosis. It contains granules known as Keratohyalin. These granules release Lipid rich secretion, which acts as the water repellent.  Stratum Spinosum- contains 8 to 10 layers of cells and it is closely arranged.  Stratum Basal- consists of single layer of cubical or columnar keratinocytes. 10
  11. 11. DERMIS  Composed of strong connective tissue containing collagen and elastic fibres, hence it can easily stretch and recoil easily.  Blood vessel, nerves gland and hair follicles are embedded in this layer. 11
  12. 12. SUBCUTANEOUS LAYER  It is also called as Hypodermis.  It is made up of loose connective tissue, including Adipose tissue.  This helps to insulate the body by monitoring heat gain and heat loss.  The dermis is the layer of tissue that is Deeper and Thicker than epidermis. 12
  13. 13. PERMEATION OF DRUG MOLECULE THROUGH SKIN  It express by Fick’s first law of Diffusion-Drug molecule diffuse from a region of higher conc. to one of lower conc. until equilibrium is attained.  The process of Diffusion of molecule is driven by gradient between high concentration to low concentration. 13
  14. 14.  Fick’s First law of Diffusion- dm/dt = J = D A K/h  Where, dm / dt =J= study state flux D = diffusion coefficient A = surface area K = partial coefficient between the Stratum corneum and the vehicle h = diffusional path length or membrane thickness 14
  15. 15. PERCUTANEOUS ABSORPTION 15
  16. 16.  Percutaneous absorption done by 2-ways- A. Transepidermal Absorption 16 Stratum Corneum Intracellular Pathway Intercellular Pathway Viable Epidermis Dermis Microcirculation
  17. 17.  B. Transfollicular Absorption 17 Pilosebaceous unit Eccrine Gland Hair Follicles Sebaceous Gland Dermis Microcirculation
  18. 18. CLASSIFICATION OF TDDS A. Rate-Programmed Systems  Drug in Reservoir  Drug in Matrix  Drug in Adhesive  Drug in Microreservoir B. Physical Stimuli- Activated Systems  Structure-Based Systems  Electrically-Based Systems  Iontophoresis  Electroporation  Sonophoresis 18
  19. 19. 1.Drug in Reservoir 2.Drug in Matrix A.RATE-PROGRAMMED SYSTEMS- 19
  20. 20. 3.Drug in Adhesive 4.Drug in Microreservoir 20
  21. 21. B. Physical Stimuli-Activated Systems- 1. Iontophoresis- 2. Electoporation- 21
  22. 22. 3. Sonophoresis- 4.Microneedles- 22
  23. 23. BASIC COMPONENTS OF TDDS Polymer matrix / Drug reservoir Drug Permeation enhancers Pressure sensitive adhesive (PSA) Backing laminate Liner 23
  24. 24. Polymer matrix / Drug reservoir-  Penetration Enhancers- Chemical Enhancers-eg.- Azone, Pyrrolidone, Fatty acids, Essential oils, terpenes, organic solvents Physical Enhancers-eg.- Iontophoresis, electroporation, Microneedles Natural Polymer Synthetic Elastomer Synthetic Polymer Gelatin Neoprene Polyethylene Gum Arabic Silicone rubber Polystyrene Starch Butyl rubber PVC Shellac Chloroprene PVP zein Polysiloxane Polyster 24
  25. 25. Pressure Sensitive Adhesives (PSA)-  A PSA is a material that helps in maintaining an intimate contact between transdermal system and the skin surface.  Some widely used pressure sensitive adhesives are-  Eg- Polyisobutylenes, Polyacrylates, Silicones. Backing Laminate: Hold and protect the drug reservoir from exposure to atmosphere. Avoid loss of drug Accept printing High flexibility Eg- vinyl, polyethylene and polyester films, aluminium foil, foam pad, metallic plastic laminate. 25
  26. 26. Liner- Protects the patch during storage. The liner is removed prior to use. Drug – Drug solution in direct contact with release liner. 26
  27. 27. FACTORS AFFECTING TRANSDERMAL PERMEATION  Physicochemical property of Drug molecule,  Partition co-efficient,  pH Condition,  Drug Concentration,  Molecular weight.  Physicochemical property of Drug Delivery System,  Release characteristics,  Use of permeation enhancer,  Composition of Drug Delivery System. 27
  28. 28.  Pathophysiological condition of Skin,  Reservoir effect of Horney Layer,  Hydration of skin,  Lipid Film,  Skin Temperature,  Pathological Injury to Skin,  Regional variation. 28
  29. 29. Evaluation of TDDS 1. Evaluation of Adhesive a. Peel Adhesion Properties- It is the force required to remove coating from a test substrate. b. Tack Properties- It is the ability of polymer to adhere to a substrate with little contact pressure.  Thumb tack test  Rolling ball tack test  Quick-Stick test  Probe tack test c. Shear Strength Properties- It is the measurement of the cohesive strength of an adhesive polymer. 29
  30. 30. In vitro drug release evaluation A. In vitro Permeation Studies-  In-Vitro skin Diffusion cells,  Skin-stripping,  Autoradiography. B. In vitro Release Studies-  Paddle Over Disc Apparatus (USP Apparatus 5),  Reciprocating Disc (USP Apparatus 7). 30
  31. 31. In vivo evaluation  Animal models,  Skin-Stripping In vivo,  Microdialysis, 31
  32. 32. APPLICATIONS  For treatment of Angina Pectoris,  Smoking cessation(Nicotine Patch),  Contraceptive,  Antiemetic,  Anti-inflammatory,  Cosmetics. 32
  33. 33. MARKETED PRODUCT DRUG BRAND NAME MANUFACTURER Nicotine Nicoderm gsk Nicotine Habitraol Novartis Nitroglycerine Transderm nitro Novartis Insulin SonoDerm Imarx Testosterone Testoderm Alza Corporation Diclofenac diethyl amine NuPatch 100 Zudus Cadilla 33
  34. 34. CONCLUSION  As we know, the basic functions of the skin is protection and hence it is difficult to target the skin for drug delivery. Because skin having numerous layers. But using novel techniques in TDDS we have successfully penetrate the drug into systemic circulation. 34
  35. 35. REFERENCES  Brahmankar D. M., Jaiswal Sunil B.(2009) Biopharmaceutics and Pharmacotherapeutics-A Treatise, 2nd edition, pp-495-501.  Chien Yie W.(2002), Novel Drug Delivery Systems, Marcel Dekkar, Inc Publication, volume-50, 2nd edition, pp-301.  Walters Kenneth A.(2002), Dermatological and Transdermal Formulations, Marcel Dekkar, Inc Publications, volume-119, pp-1,319. 35
  36. 36.  Robert’s Michael s., Walters Kenneth A.(2002), Dermal Absorption and Toxicity Assessment, Marcel Dekker, Inc Publications, volume-91, pp-1, 189.  Dr. Patel Upendra, Bhavin Bhimani(2012) Transdermal Drug Delivery System As Prominent Dosage Form For The Highly Lipophilic Drugs. International Journal Of Pharmaceutical Research And Bio-Science. Volume 1(3)42:65. pp- 1-6.  Jain, N.K. (1997) Controlled and novel drug delivery. 1st ed. New Delhi: CBS publishers and distributors, pp. 100- 127. 36
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