Tablet 01


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Tablet 01

  1. 1. Ta ble ts  Definition.  Half of all pharmaceutical products are for oral use (tablets or capsules)  The advantage is that they have high patient compliance, relatively easy to produce, easy to market  Disadvantage the conditions in the GI tract is difficult for some substance and all substances are not absorbed
  2. 2. What is a tabletA compresseddispersion ofparticles.
  3. 3. Different types of tabletsTablets that are taken  Other oralintact  Conventional tablets formulations  Coated Tablets  CapsulesTablets that are not  Oral solutionstaken intact  Chewable tablets  Effervescent tablets  Lozenges  Sublingual and buccal tablets  Fast dissolving tablets
  4. 4. Tablet Manufacture Procurement of raw Material Preformulation Studies Formulation Mixing/Blending Granulation Compression Coating Packaging
  5. 5. Three Principle Methods Of Developing Powders For Tablet Making Direct Compression Wet Granulating Dry Granulating
  6. 6. WHY GRANULATE? To improve powder flow. To improve compressibility. To reduce fines. To control the tendency of powders to segregate. To control density. To capture and fuse small quantities of active material.
  7. 7. WET GRANULATING PROCESS STEPS Pre-mix Wet massing Screening Drying Milling (Sieving) Final blend (Lubricant is added)
  8. 8. GRANULE FORMATION IN THE WETGRANULATING PROCESS  Nucleation  Transition in the . funicular and capillary stage  Ball growth
  9. 9. Rapid MixerGranulator(Wet Granulation)
  10. 10. DRY GRANULATING  Powders can be compacted using a tablet press; this is called Slugging.
  11. 11. Why Dry Granulating? Granulate materials which are sensitive to heat and/or moisture. Produce a uniform particle size range. Improve flow properties. Control dust. Control bulk density. Produce uniform blends Control particle hardness.
  12. 12. HOW GRANULES ARE TESTED LOD- water content (Loss on drying) Bulk Density, gm/ml Particle Size Distribution Angle of Repose.
  13. 13. What are a tablet composed of Active substances Filler Disintegrant Binder Gliadant Lubricant Antiadherent (Coating) (Colour, humectants)
  14. 14. Filler / Diluent Give a reasonable size for  Sugars the tablet ≥50 mg  Lactose Properties  Sucrose  Chemical inert  Mannitol  Non-hygroscopic  Salts  Water soluble or  Calcium phosphate hydrophilic  Calcium carbonate  Good mechanical  Polymers properties  Cellulose  Acceptable taste  Cheap
  15. 15. Dissintegrant Ensure that the tablet  Surfactants “small” breaks into small pieces molecules that are both when in contact with water water loving (hydrophilic) Addition of Disintegrant and oil loving  Intragranular addition (hydrophobic)  Extragranular addition  They will adsorb to Disintegration through interfaces and in water wetting increase the hydrofilicity of  Surfactant that interface Disintegration through  They will tend to form rupture associated structures  Starch above a certain  Cellulose derivates concentration
  16. 16. How to increase the release rate Increase the surface area (Disintegrant)  Starch  Cellulose materials (Avicel) Include wetting agents  Surfactants Increase solubility Avoid drug-excipient interactions Use solid dispersions or solid solutions
  17. 17. Binder A binder is added to  Dry powder that is mixed in with the granulate and increase the partly dissolved during cohesion between granulation  Wet binders that are particles in dissolved in granulation granulates to liquid  Gelatin and starch ensure mechanical  Polividon and cellulose stability of the  Dry binders that are used granulate in dry granulation Normal  Cross linked PVP  Microcrystalline concentration of cellulose binder is 2-10%
  18. 18. Lubricants and gliadants Gliadants included  Lubricants to increase included to flowability of facilitate tabletting powder and ejection of Excipients formed tablets  Colloidal silica  Excipients  Magnesium  Magnesium stearate stearate  Polyethylene glycol
  19. 19. General Formula for a Direct Compression Tablet DRUG 1 PART FILLER-BINDER 2 - 3+ PARTS DISINTEGRANT STARCH 10 - 20% OR SUPER DISINT. 2 - 5% GLIDANT COLLOIDAL SILICA 0.5 - 1% LUBRICANT MAG. STEARATE 0.5 - 1%
  20. 20. Advantages of Direct Compression over Granulation More economical (less  Disadvantages time, space, materials,  Problem of content personnel, fewer steps) uniformity for low dose Avoids heat and moisture drugs of wet granulation  Not practical for large Disintegrate more dose poorly directly into primary compactible /poorly particles flowing drugs  Requires tight control over physical properties of filler-binder
  21. 21. High Speed Production Rotary Tablet Press55 stations495,000 tabs/hour
  22. 22. Thank You…