Tablet Machines and Manufacturing Problems
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Questions and Answers

What is the main purpose of the hopper shoe in a single punch tablet machine?

  • To hold the powder before it enters the die (correct)
  • To transport the finished tablet away
  • To compress the powder during tablet formation
  • To control the speed of tablet production

    • What distinguishes a rotary tablet machine from a single punch tablet machine?

  • Use of a strain gauge during compression
  • Operation with only one die
  • Application of lower pressure during compression
  • Production speed and number of dies used (correct)

    • What is a primary cause of capping in tablet manufacturing?

  • Low temperature during compression
  • Slow tablet compression speed
  • Excessive moisture in the powder
  • Entrapped air within the tablet (correct)

    • How can the force applied during tablet compression be measured in both single punch and rotary machines?

    <p>By a measurement device called strain gauge</p> Signup and view all the answers

    At what rate does a single punch tablet machine typically produce tablets?

    <p>200 tablets/min</p> Signup and view all the answers

    What is the role of the lower punch in a single punch tablet machine during compression?

    <p>It remains stationary and does not apply pressure</p> Signup and view all the answers

    What happens to the tablets in the single punch tablet machine after compression?

    <p>They are pushed away by the hopper shoe</p> Signup and view all the answers

    Which statement about rotary tablet machines is correct?

    <p>They can achieve an output of over 16,000 tablets/min.</p> Signup and view all the answers

    What is a potential solution to prevent capping caused by deep concave punches?

    <p>Use flat punches</p> Signup and view all the answers

    Which factor is essential for good compaction of granules?

    <p>Moisture content between 2-4%</p> Signup and view all the answers

    What is one solution for preventing the sticking of tablets to the punches?

    <p>Change to a chromium-coated punch</p> Signup and view all the answers

    What issue might arise if the dies are overworked?

    <p>Formation of wear rings leading to capping</p> Signup and view all the answers

    How can mottling on tablets be effectively addressed?

    <p>Incorporate coloring agents to mask uneven color</p> Signup and view all the answers

    What is a consequence of using materials with poor compressibility?

    <p>Capping during compression</p> Signup and view all the answers

    What can be done to address excessive moisture causing picking?

    <p>Further dry the granulation</p> Signup and view all the answers

    Which of the following is NOT a solution for reducing mottling in tablets?

    <p>Use darker dye for better coverage</p> Signup and view all the answers

    What primarily determines the weight of a tablet?

    <p>The amount of granules in the die at compression</p> Signup and view all the answers

    What is a key factor that can lead to weight variation in tablets?

    <p>Defects in punch tooling</p> Signup and view all the answers

    Which treatment is primarily used to improve poor flow of granules?

    <p>Incorporating glidants</p> Signup and view all the answers

    Which characteristic is not assessed in the general appearance evaluation of a tablet?

    <p>Dissolution rate</p> Signup and view all the answers

    Why is hardness important for the quality control of tablets?

    <p>It is related to the tablet's resistance to crushing</p> Signup and view all the answers

    How does increasing the compression force affect tablet dissolution rate?

    <p>It decreases the dissolution rate</p> Signup and view all the answers

    What could indicate a physical or chemical instability in a tablet?

    <p>Presence of abnormal odor</p> Signup and view all the answers

    Which aspect of tablet evaluation measures the force needed to crush a tablet?

    <p>Hardness (Crushing strength)</p> Signup and view all the answers

    What is the maximum accepted hardness for a conventional tablet?

    <p>8 kg</p> Signup and view all the answers

    What happens to the friability of tablets if the moisture content is not controlled?

    <p>Tablets may become friable.</p> Signup and view all the answers

    Which type of tablets are exempted from the friability test?

    <p>Orodipersible tablets</p> Signup and view all the answers

    Why is the disintegration test important?

    <p>It indicates the bioavailability of the active ingredient.</p> Signup and view all the answers

    What is the primary purpose of the dissolution test?

    <p>To measure the release of the active ingredient.</p> Signup and view all the answers

    Which method is considered more direct for measuring drug release?

    <p>In vivo method</p> Signup and view all the answers

    What is a disadvantage of the in vivo method for measuring drug release?

    <p>It requires highly skilled personnel.</p> Signup and view all the answers

    Which statement is true regarding the relationship between disintegration and dissolution?

    <p>Rapid disintegration often leads to rapid dissolution.</p> Signup and view all the answers

    What is the maximum weight variation limit for tablets averaging 250 mg?

    <p>± 7.5%</p> Signup and view all the answers

    When conducting a dissolution test, which of the following is NOT a parameter specified in the monograph?

    <p>Type of drug</p> Signup and view all the answers

    If a tablet weighs 500 mg, what is the acceptable weight range for passing the weight variation test?

    <p>475-525 mg</p> Signup and view all the answers

    Why is the dissolution test preferred over the disintegration test?

    <p>It gives a clearer picture of drug release and bioavailability.</p> Signup and view all the answers

    According to the weight variation test, how many individual tablets can be outside the limits for the batch to pass?

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

    Which analysis method is NOT mentioned as acceptable for testing dissolution amounts?

    <p>Mass spectrometry</p> Signup and view all the answers

    What is the minimum amount of methyl dopa that must be dissolved after 20 minutes to pass the dissolution test?

    <p>80%</p> Signup and view all the answers

    For which type of drugs is the weight variation test deemed valuable?

    <p>High dose drugs with ≥ 90% active ingredient</p> Signup and view all the answers

    Study Notes

    Tablet Machines

    • Two types of tablet machines exist: single punch and rotary.
    • Single punch machines have one die and a pair of punches, producing about 200 tablets per minute.
    • Single punch machines are generally used for small-scale production and research.
    • Rotary machines are used for large-scale production, outputting over 16,000 tablets per minute.
    • Rotary machines have multiple dies and punches arranged in a circle.
    • Both the die table and punches rotate during operation, ensuring each die is paired with punches.
    • Strain gauge measures the force applied during tablet compression in both types of machines.

    Manufacturing Problems

    • Capping: Partial or complete separation of the tablet crown from the main body.
      • Causes: High tableting rate, high compression pressure, over-dried granules, deep concave punches, die wear.
      • Solutions: Reduce tableting rate, decrease pressure, control granulation moisture content, use flat punches, rotate the die.
    • Picking: Sticking of part of the tablet to the punch surface.
      • Solutions: Use chromium-coated punches, increase lubricant, increase binder, dry granulation.
    • Mottling: Uneven distribution of color on the tablet.
      • Causes: Color difference between drug and excipients, dye migration during drying.
      • Solutions: Use a coloring agent, change solvent, reduce drying temperature, reduce colorant particle size.
    • Weight Variation: Individual tablets have different weights.
      • Causes: Non-uniform granule size distribution, lower punch defects, poor flow.
      • Solutions: Ensure uniform granule size, address punch defects, use glidants to improve flow.
    • Hardness Variation: Differences in tablet hardness.
      • Causes: Same as weight variation.
      • Solutions: Same as weight variation.

    Tablet Evaluation & Quality Control

    • General Appearance: Assesses physical attributes like shape, size, color, odor, taste, and texture.
    • Hardness (Crushing Strength): Measures force required to crush a tablet.
      • Factors affecting hardness: Compression force, die filling (weight).
      • Accepted Hardness Ranges:
        • Conventional tablets: 4-8 kg
        • Chewable tablets: 3 kg
        • Sustained release tablets: 10-20 kg
    • Friability Test: Measures mechanical strength of the tablet surface, evaluating powdering from friction.
      • Factors affecting friability: Moisture content of tablets.
      • Accepted Friability Range: ≤ 1%
    • Disintegration Test: Measures time for a tablet to break into fragments passing a specific sieve size.
    • Dissolution Test: Determines the amount of active ingredient released over a specific time.
      • Methods: In vivo (blood sample analysis) and in vitro (using dissolution test apparatus).
      • USP/BP Monographs: Specify conditions for dissolution tests (medium, volume, speed, time intervals, analysis method, apparatus).
      • Dissolution Profile: Can be plotted to show drug release over time.
    • Weight Variation Test: Ensures tablets contain the proper amount of active ingredient.
      • Procedure: Weigh 20 tablets individually, calculate average weight, compare individual weights to the average.
      • Passing Criteria: No more than 2 tablets outside the limit.
      • Limits: Depend on tablet weight (e.g., ± 10% for 130 mg or less, ± 5% for 324 mg or more).
    • Content Uniformity Test: Critical for moderate and low dose drugs.

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    Tablet Machines PDF

    Description

    This quiz explores the types of tablet machines used in pharmaceutical manufacturing, including single punch and rotary machines. It also covers common manufacturing problems such as capping, identifying causes and solutions for these issues.

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