图生 国生 Co-processed excipients Advantages of direct compression Coprocessed excipients are a"preblend"of two or more excipients that are commonly used in conjunction ·Simplicity with each other.(usually a diluent and binder, ·Economy sometimes a disintegrant) ·Improved stability Advantages to using coprocessed excipients Improved dissolution rate include Disadvantages of direct compression A reduction in the number of raw materials and processing time High requirement of flow and compaction properties .Improved batch-to-batch consistency Possibility of segregation Improved quality of products 国生一 Instruments for granulation High-shear granulator @@ Tablet manufacture ·Fluid Bed granulator ·Wet granulation Extrusion/Spheronization ·Dry granulation ·Roller compaction ·Direct compression 山的品 WET GRANULATION DRY GRANULATION DIRECT COMPRESSION Premixing drg with other Premixing dnug with other Premixing drug with ingredients other ingredients 2.Transferring the mixhure int 2. Transferring the miture 2.Adding a luhricant t Tablet apparatus a container into a roller compactor the granles Single punch press Milling/sieving of the 1 A binder solution is added under a mechanical shear resuting flakes or ribbons ·Rotary press 2 into granules 4. Adding lubricant and/oe d screen sin 5. 6 Dry sieving of granules Adding a lubricantand/or disintegrant to thed女y granules Compressing the granules 33 Shanghai Jiao Tong University Co-processed excipients • Coprocessed excipients are a “preblend” of two or more excipients that are commonly used in conjunction with each other. (usually a diluent and binder, sometimes a disintegrant) Advantages to using coprocessed excipients include • A reduction in the number of raw materials and processing time • Improved batch-to-batch consistency • Improved quality of products Shanghai Jiao Tong University Tablet manufacture • Wet granulation • Dry granulation • Direct compression WET GRANULATION DRY GRANULATION DIRECT COMPRESSION 1. Premixing drug with other ingredientss 1. Premixing drug with other ingredients 1. Premixing drug with other ingredients 2. Transferring the mixture into a container 2. Transferring the mixture into a roller compactor 2. Adding a lubricant to the granules 3. A binder solution is added under a mechanical shear 3. Milling/sieving of the resulting flakes or ribbons into granules 3. Compressing the granules 4. Wet sieving of granules through a desired screen size 4. Adding lubricant and/or disintegrant to granules 5. Drying of granules in a tray￾oven dryer 5. Compressing the granules into tablets 6. Dry sieving of granules 7. Adding a lubricantand/or disintegrant to the dry granules 8. Compressing the granules into tablets Shanghai Jiao Tong University Advantages of direct compression • Simplicity • Economy • Improved stability • Improved dissolution rate Disadvantages of direct compression • High requirement of flow and compaction properties • Possibility of segregation Instruments for granulation • High-shear granulator • Fluid Bed granulator • Extrusion/Spheronization • Roller compaction Shanghai Jiao Tong University Tablet apparatus • Single punch press • Rotary press