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Transdermal Drug Delivery Systems

Transdermal Drug Delivery Systems. Amit K. Mitra, Ph.D ONDC, CDER. Transdermal Drug Delivery Systems. Drug in adhesive Drug in reservoir with a membrane Drug in matrix with adhesive overlay. Component/Composition. Drug in adhesive

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Transdermal Drug Delivery Systems

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  1. Transdermal Drug Delivery Systems Amit K. Mitra, Ph.D ONDC, CDER

  2. Transdermal Drug Delivery Systems • Drug in adhesive • Drug in reservoir with a membrane • Drug in matrix with adhesive overlay

  3. 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

  4. Quality Control of Components • Functional components • Adhesive, penetration enhancer, backing, release liner, membrane

  5. 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)

  6. Hazard Involved • Explosion proof oven • Solvents, monomers • Proper ventilation • Training of the staff

  7. 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

  8. 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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