Tablets

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Author:
ANVigil
ID:
121590
Filename:
Tablets
Updated:
2011-12-07 15:54:42
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Dose Form Final
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Dose Form Final
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  1. Definition of Tablets
    Solid Dosage forms prepared by compression or molding of powdered/granulatied drugs and with the aid of suitable pharmaceutical excipients
  2. Charactistics of Tablets
    • Most Frequently prescribed commerical dosage form
    • Stable, elegant, and effective
    • Convenient for handling, indentification and administration
    • Commercially available only in fixed dosage strengths
    • Many formats, sizes, colors, shapes, scoring, engraving
  3. How is format and size determined?
    By the die and punch used, by the amount of fill and mount of pressure applied to the fill
  4. What are the types of tablets?
    • Compressed
    • Multiple Compressed
    • Sugar-coated tablets
    • Film-coated tablets
    • Gelatin-coated (caplets)
    • Enteric Coated
    • Buccal
    • Sublingual
    • Chewable
    • Lozenges, Troches, Drops or Pastilles
    • Lollipops
    • Effervescent
    • Molded
    • Triturates
    • Rapid Dissolving
    • Extended Release
    • Vaginal
  5. Compressed Tablets
    • Single compression of all ingedients
    • Simple tablets
  6. Multiple Compressed Tablets
    • For separation of incompatible drugs or for modified release
    • Multiple-layered tablets: multiple feed and multiple compression of fill within a single die
    • Tablet-within-a-tablet: core tablet is placed precisely within the die for compression with surrounding fill
  7. Sugar Coated Tablets
    • Several Layers of colored or uncolored sugar solutions (sucrose, gelatin, acacia or PVP)
    • Time and expertise
    • Final table: increase up to 50% of size and weight of uncoated tablet
    • Imprinting (FDA 1995) product specific identification codes and distinctive symbols
    • Polishing: cloth of canvas impregnated with carnauba wax/beeswax or spraying with wax dissolved in acetone
    • Final tumbling with talc for high luster
  8. Film-Coated tablets
    • Thin layer of aqueous or non-aqueous polymer solution (plastic-like material): cellulose acetate phthalate; cellulose ether polymers
    • Protection, Color, Durability, less bulkiness, less time consuming
  9. Gelatin-Coated (Caplet)
    Capsule-shaped compressed tablet coated with gelatin
  10. Enteric coated tablets
    • Protection of drug, patient gastric mucosa, or enhance absorption
    • Based on transit time required for the passage of the dosage form from the stomach into the intestines or based upon the pH of environment
    • Delayed-release features
    • Whole tablet or drug particles or granules: single or multiple layers
    • Materials: shellac, phthalate derivatives
  11. Buccal Tablets
    Placed in the cheek pouch, dissolved slowly, absorption through the oral mucosa
  12. Sublingual Tablets
    Placed under the tongue, prompt dissolution, absorption throughout the oral mucosa
  13. Chewable tablets
    Chewed/dissolved in the mouth; made with creamy base, negative heat of solution leaves cool mouth feeling upon dissolution; flavored and colored; children and adults who have difficulty swallowing
  14. What are the creamy bases used in chewable tablets?
    • mannitol
    • sorbitol
    • xylitol
  15. Lozenges, Troches, Drops or Pastilles
    • Hard candy-like (sugar or sugar-free) or gummy-like (gelatin-based)
    • Dissolved or disintegrate slowly in the oral cavity
    • High degree of compression
    • Heat stable active ingredients
    • Local effects
  16. Lollipops
    Sugar-based lozenge on a stick (or sugarfree!)
  17. Fentanyl Actiq
    • Used to relieve breakthrough chronic cancer pain
    • Lollipops
  18. Effervescent Tablets
    Cpmpression of effervescent salts that liberate carbon dioxide when dissolved in water, should NOT be swallowed whole
  19. Molded tablets
    Molding and soft compaction: hand operated tablet press
  20. Tablet triturates
    "Old Fashion" tablets containing small amounts of potent drugs and prepared with minimal compression to allow ease of crushing for compounding or rapid dissolution
  21. Rapid Dissolving Tablets
    • Superdisintegrants
    • Dissolution within 15-30 seconds and swallowing of the liquid
    • Very water soluble excipients that attract water into the tablet
    • children and elderly
    • inherent problems, drug loading, taste masking, firability
  22. Zydis technology
    lyophilization (foaming of a mixture of gelatin, sugars, drugs, etc and pouring into a mold)
  23. DuraSolv, OraSolv, Flashtab, Wowtab technologies
    Compression (super-disintegrants + small quantity of effervescent material)
  24. Extended release Tablets
    release of medication in a predetermined manner over an extended period
  25. Vaginal Tablets (inserts)
    • Uncoated
    • Vullet-shaped or ovoid
    • Plastic/carboard inserter devices for admin.
    • Local effects
  26. Types of Preparation of Compressed Tablets
    • Wet Granulation
    • All-in-One Granulation
    • Dry Granulation
    • Direct Compression
    • Molding
  27. Tablets dedusting is done to
    • remove loose powders
    • elegance
    • prior to coating
  28. What is Wet Granulation?
    • Weighing and blending of powdered ingredients (drugs + fillers + disintegrating agents + others)
    • Sifting of powders to eliminate clumps
    • Mixing with liquid binders or adhesive mixture
    • Damp mass
    • pass through screen (6-8 mesh size)
    • Dry themostatically controlled oven
    • Sizing (12-20 mesh)
    • Blending (granules + dry lubricants)
    • Compression (tablet machine)
  29. Types of tablet machines?
    • Single punch tablet press
    • rotary tablet machine with multiple punches
  30. All-in-one-Granulation Method
    • Sophisticated Machinery
    • Granulation prepared by Fluid=bed process or Microwave vacumm process
  31. Dry granulation
    • For materials that are degraded in presence of moisture or high heat
    • Weighting and blending of powdered incredients: cohesive properties
    • Binding agents
    • powders compressed in slugging maching or roller compactor
    • flat slugs or pellets
    • slgs crushed and sized
    • granuels and dry lubricant
    • compression in tableting machine
  32. What are dry libricants
    Mg/Ca/Zn Stearate/talc
  33. Direct compression
    • Excipients have free-flowing and cohesive properties
    • Potasium chloride, Methenamine, Dibasic calcium phosphate
  34. Molding
    • Focing of a dampened mass into the cavities of a tablet mold (plastic or metal)
    • Mold consists of two plates, one with a hole and the other with a peg
  35. Types of tablet coating?
    • Sugar
    • Film
    • Enteric
  36. Why are tablets coated?
    • For protection of drug from air and humidity
    • To protect gastruc mucosa of irritating drugs
    • to mask taste
    • For special release of drug (enteric coated)
    • To provide aesthetics and distinction to a product (color, imprinting of manufacturer's symbol or information
  37. What does the USP need for quality control of tablets?
    • Weight
    • Content Uniformity
    • Hardness, Breaking Strengh, Friabilty
    • Thickness
    • Disintegration
    • Dissolution
  38. Weight
    • Determined by the quantity of fill in the die of press
    • Weight Variation for dosage form uniformity
    • Assay for homogeneous drug distribution
  39. Content uniformity
    active ingredient +/- 10%
  40. Hardness, Breaking Stregth, Friabilty
    • Measurement of pressure/force to break each tablet
    • Dpendons on type of tablet and degree of compression used during manufacture
  41. Friabilator does what?
    • Measures the tendency of a tablet to crumle (rotaing tumbling conbtainer)
    • Teablets are weighed before and after rotations and weight loss is determined (maximum loss allowed is 1%)
  42. Thickness
    • Caliper, hang gauge or automated equipment
    • Depends on:
    • Diameter of the die
    • Amount of fill
    • Compaction characterists of fill
    • Pressure applied
  43. Disintegration
    Time required for a tablet to disintegrate
  44. Disintegration testing for compressed tab
    appartus contiang water (30 min 37 C) or simulated gastric fluid 1 hr
  45. Disintegration testing for enteric coated tablets
    simulated gastric fluid (1 hr) and intestingal fluid at 37 C
  46. Dissolution
    • In vitro testing
    • Product development
    • quality assurance during manufacturing
    • Bioequivalence from batch to batch: scale-up batches
    • Mandatory for approval of marketing: FDA and regulatory agencies of other countires
    • Influences the absorption and bioavailabilty
  47. Tablets packaged and stored?
    • Contianers: Bottles, blister
    • Light-resistant
    • Desicant packet and cotton ball
    • Types of container, reduced potency of volatile drugs
  48. How should nitroglycerin be packaged?
    Glass container and no packing materials in contact with tabs

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