Tablet Manufacturing Overview
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Questions and Answers

What does LOD measure in the context of manufacturing?

  • Bulk Density
  • Flow Gradient
  • Particle Size Distribution
  • Water Content (correct)
  • Which milling equipment function is not commonly associated with the process?

  • Enhancing drying
  • Reducing segregation
  • Checking tablet hardness (correct)
  • Improving flow
  • What type of energy is milling machinery categorized by?

  • Low, Medium, or High Energy (correct)
  • Physical, Chemical, and Biological
  • Mass, Weight, and Density
  • Operational, Functional, and Mechanical
  • What is essential to understand for effective tablet compression?

    <p>Machine Operation</p> Signup and view all the answers

    Which test is frequently performed in the QC lab, rather than on the production floor?

    <p>Angle of Repose</p> Signup and view all the answers

    What does the final blend represent in the manufacturing process?

    <p>The outcome of dispensing, granulating, and lubrication efforts</p> Signup and view all the answers

    What is one of the critical characteristics of a granulation that must be understood for successful tablet compression?

    <p>Flow, Compress, and Eject</p> Signup and view all the answers

    What is a potential consequence of having a poorly formulated product, even with a good tablet press?

    <p>Inconsistent tablet quality</p> Signup and view all the answers

    What is the primary purpose of using diluents in tablet formulations?

    <p>To increase the bulk volume of low-dose APIs</p> Signup and view all the answers

    Which manufacturing method is suitable for drugs that are sensitive to moisture and heat?

    <p>Dry granulation</p> Signup and view all the answers

    In the tablet pressing process, which of the following is not a requirement for the ingredients?

    <p>They must be brightly colored</p> Signup and view all the answers

    What is the role of binders in tablet formulation?

    <p>To promote adhesion of particles in the formulation</p> Signup and view all the answers

    Which component is used to improve the flow properties of powders in tablet manufacturing?

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

    For which type of tablet formulation is disintegration achieved primarily through the use of water swellable materials?

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

    Which attribute is essential for ensuring that tablets remain stable throughout their shelf life?

    <p>Chemical stability</p> Signup and view all the answers

    What is the primary function of lubricants in tablet manufacturing?

    <p>Reduce friction and prevent adhesion</p> Signup and view all the answers

    Which type of tablets is coated to prevent disintegration in gastric fluids?

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

    What is a common challenge faced during the blending process of tablet ingredients?

    <p>Separation of mixed particle sizes</p> Signup and view all the answers

    Which type of tablet is designed for rapid disintegration and absorption directly in the mouth?

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

    What type of excipients are used to mask the taste of the active ingredient in chewable tablets?

    <p>Sweetening agents</p> Signup and view all the answers

    What is the benefit of controlled release tablets?

    <p>They maintain therapeutic effect over a longer duration</p> Signup and view all the answers

    What is one of the primary factors in controlling weight variability in tablet manufacturing?

    <p>Product uniformity in particle size</p> Signup and view all the answers

    What can cause capping in tablet manufacturing?

    <p>Air entrapment between granules</p> Signup and view all the answers

    Which of the following strategies can help reduce lamination in tablets?

    <p>Increase dwell time</p> Signup and view all the answers

    What is a common result of tablets being too friable?

    <p>Tablets chip or break apart</p> Signup and view all the answers

    Which of the following factors can contribute to picking and sticking during tablet compression?

    <p>Improper drying of granules</p> Signup and view all the answers

    What practice can help prevent double impressions in tablet manufacturing?

    <p>Cleaning lower punch retainers</p> Signup and view all the answers

    Which method is typically used to determine the friability of tablets?

    <p>Tumbling tablets at set RPM and weighing before and after</p> Signup and view all the answers

    What is an effective way to overcome the issue of granules sticking to punch faces?

    <p>Increase hardness of the tablet</p> Signup and view all the answers

    What could cause chipping in tablets during production?

    <p>Loose punch retainer mechanisms</p> Signup and view all the answers

    What can be modified to help alleviate picking and sticking defects?

    <p>Punch face design and debossing</p> Signup and view all the answers

    Which condition is indirectly linked to capping defects in tablets?

    <p>Air not being removed during compression</p> Signup and view all the answers

    What is the main benefit of pre-compression in tablet manufacturing?

    <p>Compacts powder at a lower pressure</p> Signup and view all the answers

    What is one of the key reasons for tablet coating in manufacturing?

    <p>To improve tablet handling and stability</p> Signup and view all the answers

    Which of the following is NOT a common tablet defect?

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

    Study Notes

    Tablet Manufacturing

    • Learning outcomes include discussion of compacted tablets' advantages and disadvantages as a pharmaceutical dosage form, identification of key tablet quality attributes, explanation of excipient uses in formulations, tablet classification, and explanation of compression and compaction mechanisms.
    • Tablets were patented in 1843. The initial machine consisted of a metal die with a hole drilled through it, which compressed powder between cylindrical punches. It was first used to produce potassium bicarbonate compacts.
    • Tablets are solid preparations containing one or more active substances. They are obtained by compressing uniform volumes of particles or by other methods like extrusion, moulding, or freeze-drying.
    • Advantages of tablets include large-scale, low-cost production, easy packaging and transport, high stability compared to liquids, and ease of handling for patients, doctors, and pharmacists.
    • Disadvantages include inability to use during unconsciousness or vomiting, potential for tablets to cement during long-term storage, and a series of unit operations during manufacturing. Tablets may include harmful auxiliary substances, have slow action, or exhibit poor bioavailability for poorly water-soluble/absorbed drugs, and potential for local irritation from API.
    • Desired tablet attributes include correct API dose, elegant appearance, consistent weight/size/appearance, controlled reproducible release, biocompatibility, sufficient mechanical strength, microbiological stability, patient acceptability, and safe packaging.
    • Different types of tablets exist, including oral, vaginal, and implantation (pellets).
    • Immediate release tablets include chewable, effervescent, coated, sugar-coated, film-coated, enteric-coated, buccal, sublingual, and controlled release tablets.
    • Dissolution and absorption of tablets are affected by factors like API solubility, addition of salts during dissolution, API surface area, lipophilicity, and substances that alter GIT cell membrane permeability and absorption enhancers.
    • Chewable tablets, compressed lozenges, and effervescent (carbonate/bicarbonate reaction with weak acid) tablets have specific characteristics.
    • Buccal and sublingual tablets are small, flat, and oval, dissolve and absorb in the mouth, and skip the first-pass metabolism in the liver.
    • Coated tablet types include sugar-coated, film-coated, and enteric-coated tablets with various uses like masking tastes, providing colour, and protecting ingredients.
    • Excipients are inert materials within tablets, categorized for their role in processing (e.g. diluents, binders, disintegrants, lubricant) or for physical characteristics (e.g. colours, flavours).
    • Diluents like lactose, kaolin, and calcium phosphate ensure bulk and accurate dosing in tablets, important especially for low-dose API formulations.
    • Binders maintain the integrity for the tablet and are responsible for maintaining granules.
    • Disintegrants ensure the breakup of tablets into smaller particles, with important mechanisms facilitating water uptake and tablet rupture.
    • Lubricants reduce friction (avoid tablet adhesion), optimize pressure distribution during compression, and increase density before compression. Glidants improve powder flow.
    • Antiadherents prevent tablet adhesion to dies or presses, and helpful for engraved punches.
    • Adsorbents are used when liquid or semi-solid components are in the formulation, while sweetening agents are added for taste improvement for unpalatable API.
    • Flavours/colours/fragrances are added to tablets for better taste and appearance. Surface active agents enhance the wettability and dissolution rates of API or other excipients.
    • Different tablet manufacturing methods exist, including granulation and direct compression. Granulation involves forming granules from powders (wet or dry), while direct compression involves directly compressing powders without granulation.
    • Tablet machines are classified. Granulation, direct compression, different types of presses, etc.
    • Tablet quality standards include appearance, friability, resistance to crushing, uniformity in mass and content. Common defects include weight variation, friability variation, picking and sticking, capping and lamination, chipping, and double pressing.
    • Important factors when controlling weight variability include product uniformity in particle size, uniformity in particle density, proper setup of the tablet press, and flow rates into the die cavity.
    • Issues like friability, picking/sticking, capping, and lamination or chipping are common issues during tablet manufacturing. These issues need careful consideration in machine operations and powder formulation.
    • Double impressions can occur when punches twist or jump during compression.
    • Different types of tablet coatings like sugar coatings, and film coatings exist with various purposes, including protection and masking.
    • There are processes for coating tablets that involve spraying a solution to create films.
    • Coating process involves loading tablets, tumbling, and introducing warm air for drying.
    • Factors for milling include mechanical energy, and the various mills used for different purposes and stages of processing.
    • The final blend is the outcome of the granulation, dispensing, and lubrication phases. Blending time, uniformity, and lack of segregation are key considerations for quality.

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    Description

    This quiz explores the fundamentals of tablet manufacturing, focusing on the advantages and disadvantages of compacted tablets as a pharmaceutical dosage form. You'll learn about tablet classification, quality attributes, excipient roles in formulations, and compression mechanisms. Perfect for those seeking to understand the manufacturing process of solid medications.

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