Tablet 01
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Tablet 01 Tablet 01 Presentation Transcript

  • 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
  • What is a tabletA compresseddispersion ofparticles.
  • 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
  • Tablet Manufacture Procurement of raw Material Preformulation Studies Formulation Mixing/Blending Granulation Compression Coating Packaging
  • Three Principle Methods Of Developing Powders For Tablet Making Direct Compression Wet Granulating Dry Granulating
  • 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.
  • WET GRANULATING PROCESS STEPS Pre-mix Wet massing Screening Drying Milling (Sieving) Final blend (Lubricant is added)
  • GRANULE FORMATION IN THE WETGRANULATING PROCESS  Nucleation  Transition in the . funicular and capillary stage  Ball growth
  • Rapid MixerGranulator(Wet Granulation)
  • DRY GRANULATING  Powders can be compacted using a tablet press; this is called Slugging.
  • 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.
  • HOW GRANULES ARE TESTED LOD- water content (Loss on drying) Bulk Density, gm/ml Particle Size Distribution Angle of Repose.
  • What are a tablet composed of Active substances Filler Disintegrant Binder Gliadant Lubricant Antiadherent (Coating) (Colour, humectants)
  • 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
  • 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
  • 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
  • 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%
  • 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
  • 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%
  • 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
  • High Speed Production Rotary Tablet Press55 stations495,000 tabs/hour
  • Thank You…