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Published byJase Grayson Modified over 10 years ago
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Transdermal Drug Delivery Systems Amit K. Mitra, Ph.D ONDC, CDER
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Transdermal Drug Delivery Systems Drug in adhesive Drug in reservoir with a membrane Drug in matrix with adhesive overlay
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Component/Composition Drug in adhesive Active, pressure sensitive adhesive, solvent, penetration enhancer, backing, release liner Drug in reservoir Active, gelling agent, solvent, penetration enhancer, adhesive, membrane, backing, release liner
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Quality Control of Components Functional components Adhesive, penetration enhancer, backing, release liner, membrane
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Equipment Involved Drug in adhesive- Mixer, dryer (explosion proof), coater-laminator, Slitter, die cutting, pouching equipment Drug in reservoir- Form-fill-seal, lamination, die cutting, pouching. Adhesive layer may be pre-formulated (mixing, drying, lamination)
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Hazard Involved Explosion proof oven Solvents, monomers Proper ventilation Training of the staff
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Quality Control of the Drug Product Content, content uniformity, release rate of the active and penetration enhancer Residual solvent, residual monomer Release liner peel, adhesion Microbiology Pouch integrity
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CONCLUSION The component and composition are complex The process and equipment are complex Quality control of the finished product is complex
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