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

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

6. 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)

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

8. 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

9. CONCLUSION The component and composition are complex The process and equipment are complex Quality control of the finished product is complex