Tablet Subcoating Process
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Questions and Answers

What is the purpose of the subcoating in tablet manufacturing?

  • To remove imperfections in tablet surface
  • To round the edges and build up tablet size (correct)
  • To add color to the tablets
  • To make the tablets shiny

    • What is the main function of smoothing in tablet manufacturing?

  • To add color to the tablets
  • To remove imperfections in tablet surface (correct)
  • To make the tablets shiny
  • To round the edges and build up tablet size

    • Which solution is typically used in the final syruping step of coloring tablets?

  • Grossing syrup
  • Dye-containing syrup (correct)
  • Beeswax solution
  • Sugar syrup

    • What is the primary purpose of polishing tablets in the manufacturing process?

    <p>To make the tablets shiny</p> Signup and view all the answers

    Which ingredient is NOT commonly used in subcoating tablets?

    <p>Beeswax</p> Signup and view all the answers

    What distinguishes the grossing syrup from other sugar syrups used in tablet manufacturing?

    <p>It has suspended particles</p> Signup and view all the answers

    What can cause cracking, chipping, and splitting of sugar coatings on tablets?

    <p>Expansion of tablet cores</p> Signup and view all the answers

    What is a common problem associated with non-drying sugar coatings?

    <p>Sugar inversion</p> Signup and view all the answers

    What can cause uneven color in sugar-coated tablets?

    <p>Poor distribution of coating liquids</p> Signup and view all the answers

    Which problem arises from residual moisture in sugar-coated tablets?

    <p>Formation of beads of perspiration</p> Signup and view all the answers

    What is the result of tablet cores expanding in sugar-coated tablets?

    <p>Cracking of the coating</p> Signup and view all the answers

    Why does the addition of a small quantity of polymer often help improve the structure integrity of sugar-coated tablets?

    <p>To strengthen the coating against cracking</p> Signup and view all the answers

    What is the main purpose of press coating in tablet manufacturing?

    <p>To compact granular material around an already performed core</p> Signup and view all the answers

    Which type of tablets must comply with the uniformity of mass test?

    <p>Film coated tablets</p> Signup and view all the answers

    What is a challenge test done for enteric coated tablets?

    <p>Testing the tablets in acidic medium</p> Signup and view all the answers

    Which factor contributes to the disadvantages of press coating?

    <p>Complexities of the mechanism in the compressing machine</p> Signup and view all the answers

    What is the primary purpose of two steps of press coating with an inert middle layer?

    <p>To provide perfect separation between two ingredients</p> Signup and view all the answers

    How long should immediate release film-coated tablets take to disintegrate?

    <p>30 minutes</p> Signup and view all the answers

    What is the advantage of multiparticulates over conventional non-disintegrating tablets?

    <p>Multiparticulates are smaller in size, allowing for more consistent gastrointestinal transit.</p> Signup and view all the answers

    How are drug loaded nonpareils typically prepared?

    <p>Extrusion/spheronization or rotor granulation methods are used.</p> Signup and view all the answers

    Why are irregular granules difficult to coat uniformly?

    <p>Their shape does not allow for proper adhesion of the coating.</p> Signup and view all the answers

    What happens if whole non-disintegrating tablets lodge in restriction within the gastrointestinal tract?

    <p>This can lead to ulcerative mucosal damage.</p> Signup and view all the answers

    Why are multiparticulates less likely to have issues related to film failure or poor coating uniformity?

    <p>Because they have a smaller size and more uniform shape.</p> Signup and view all the answers

    What is a common application of multiparticulates in dosage forms?

    <p>Extended or delayed release formulations.</p> Signup and view all the answers

    What is the advantage of using fluidized bed coating over pan coating for multiparticulates?

    <p>Minimizes the risk of agglomeration</p> Signup and view all the answers

    Which method involves tablets being coated by dipping them into a coating solution?

    <p>Dip coating</p> Signup and view all the answers

    What materials are commonly used in hot melt coating for tablets with melting points between 55-65 degrees Celsius?

    <p>Synthetic monoglyceride and diglycerides</p> Signup and view all the answers

    Which recent innovation allows a coated product to be about one-third smaller than an equivalent powder-filled capsule?

    <p>Gelatin-coated tablets</p> Signup and view all the answers

    What advantage does gelatin coating provide in terms of swallowing the tablets?

    <p>Facilitates swallowing</p> Signup and view all the answers

    Which method uses principles similar to those used in photocopying for tablet coating?

    <p>Electrostatic powder coating process</p> Signup and view all the answers

    Study Notes

    Subcoating in Tablet Manufacturing

    • Purpose of Subcoating: To create a barrier layer between the tablet core and the sugar coating, preventing interactions and improving the uniformity and appearance of the final product.
    • Common Ingredients for Subcoating:
      • Shellac: Provides smooth, hard layers
      • Hydroxypropyl methylcellulose (HPMC): Acts as a binder and film-forming agent.
      • Talc: Acts as a filler and helps with smooth surface.
    • Ingredient NOT commonly used in Subcoating: Starch

    Smoothing in Tablet Manufacturing

    • Main Function: To achieve a smooth and uniform surface on the tablet core, preparing it for the subsequent coating application.

    Final Syruping Step in Tablet Coloring

    • Solution Typically Used: A concentrated sugar solution, often with additional colors and flavoring agents.

    Polishing Tablets

    • Primary Purpose: Enhance the appearance of the sugar-coated tablets, giving them a shiny and smooth finish.

    Gressing Syrup

    • Key Difference from Other Sugar Syrups: Higher concentration of sugar, typically used in the final syruping step of tablet coating to create a smooth, hard, and shiny finish.

    Sugar Coating Issues

    • Cracking, Chipping and Splitting: These issues occur during drying and can be caused by:
      • Uneven coating layers
      • Improper drying conditions
      • Rapid temperature changes
    • Common Problem with Non-Drying Sugar Coatings: The coating remains sticky, attracts moisture, and may become unusable.
    • Uneven Color: May be caused by:
      • Insufficient agitation during the coating process
      • Inconsistent color distribution in the syrup
    • Residual Moisture: Creates a risk of microbial growth and can compromise tablet stability.
    • Tablet Core Expansion: Can cause cracks and distortions in the sugar coating, compromising its integrity.
    • Adding Polymers to Sugar Coating: Can improve the structural integrity, enhancing its resilience to cracking and chipping.

    Press Coating

    • Primary Purpose: Applying a coating to tablets using a compression process.
    • Compliant Tablets: All tablets that undergo press coating must comply with the uniformity of mass test.
    • Challenge Test for Enteric Coated Tablets: Testing tablets' resistance to acidic environments before releasing the drug in the intestine.
    • Disadvantages of Press Coating: Difficulty in achieving a uniform coating, potential for tablet core cracking, and limitations in coating thickness.
    • Two-Step Press Coating: Typically involves an inert middle layer to provide a barrier between the tablet core and the final outer layer.

    Film Coating

    • Disintegration Time for Immediate Release Tablets: Ideally, the film coating should disintegrate within 30 minutes.
    • Multiparticulates vs. Non-disintegrating Tablets: Multiparticulates offer benefits like:
      • Faster dissolution and absorption
      • Reduced risk of gastrointestinal irritation
    • Drug Loaded Nonpareils Preparation: Typically carried out using a process called "spheronization," where drug particles are mixed with binders and excipients to create spherical granules.
    • Difficulty with Coating Irregular Granules: Uneven coating distribution can occur leading to inconsistent drug release.
    • Non-disintegrating Tablets Lodging in the GI tract: Can cause obstruction, highlighting the importance of disintegration.
    • Multiparticulates Benefits: Reduced risk of film failure and improved coating uniformity.
    • Common Multiparticulates Application: Oral controlled-release drug delivery.

    Coating Methods

    • Fluidized Bed Coating: Offers advantages over pan coating for multiparticulates, including:
      • Faster processing time
      • Improved coating uniformity
      • Greater control over process parameters
    • Dipping Method: Involves dipping tablets into a coating solution.
    • Hot Melt Coating: Uses materials with melting points between 55-65 degrees Celsius, allowing for a quick and efficient coating application.
    • Recent Innovation in Tablet Coating: A process that reduces the size of a coated product by one-third compared to a powder-filled capsule.
    • Gelatin Coating Advantages: Improved swallowability and aesthetics
    • Photocopying Principle in Tablet Coating: A novel method that uses electrostatic principles to apply coatings to tablets, mimicking the process used in photocopiers.

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    Description

    Learn about the tablet subcoating process, where sugar, gelatin, or acacia solutions are applied to tablets followed by the addition of bulking agents like calcium carbonate or talc. Discover how subsequent subcoats are applied to achieve the desired thickness.

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