Hard Capsules and Their Components Quiz
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Questions and Answers

Why can formaldehyde not be used with deliquescent or efflorescent materials in capsule manufacturing?

  • It may cause hardening of the capsule shell.
  • It may cause discoloration of the capsule shell.
  • It may cause dryness of the capsule shell due to salts and potassium hydroxide (KOH). (correct)
  • It may cause softening of the capsule shell due to borax.

    • What raw materials are used in the production of empty hard capsules?

  • Gelatin, colorant, and process aids (correct)
  • Water soluble dyes, preservatives, and collagen
  • Collagen, pigments, and sodium lauryl sulfate
  • Gelatin, water soluble dyes, and preservatives

    • From where is gelatin sourced for making capsule shells?

  • Minerals
  • Plants
  • Synthetic chemical reactions
  • Animal bones and skin (correct)

    • What are the reasons for using gelatin in capsule manufacturing?

    <p>It is non-toxic, readily soluble in body fluids, and a good film-forming material.</p> Signup and view all the answers

    Why was sodium lauryl sulfate used as a process aid in capsule manufacturing?

    <p>To serve as a wetting agent and ensure uniform covering of the moulds with gelatin solutions</p> Signup and view all the answers

    Why are preservatives no longer added to empty hard capsules?

    <p>They are no longer needed due to modern manufacturing practices.</p> Signup and view all the answers

    How are the capsules rejoined after repositioning the cap plate over the body one?

    <p>Using manual pressure</p> Signup and view all the answers

    What is the dosing system in dependent systems based on?

    <p>Using the capsule body to measure the powder</p> Signup and view all the answers

    How is the weight of powder filled into the capsule body controlled in dependent systems?

    <p>By controlling the speed of rotation of the plate holder</p> Signup and view all the answers

    What is placed on top of the body plate that revolves underneath it in dependent systems?

    <p>Powder hopper</p> Signup and view all the answers

    What are empty capsules fed into in dependent systems before being filled with powder?

    <p>Ring holders</p> Signup and view all the answers

    What does the capsule filing machine use to separate the caps and bodies in dependent systems?

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

    What is the main difference between Type A and Type B gelatin?

    <p>Type A is derived from animal skins while Type B is derived from bovine bones</p> Signup and view all the answers

    How is the concentrated solution of gelatin prepared for capsule production?

    <p>Using hot demineralized water and stirring until dissolved</p> Signup and view all the answers

    What is the purpose of adding dye solutions or pigment suspensions to the gelatin solution?

    <p>To give color or appearance to the capsules</p> Signup and view all the answers

    How are the films formed during the manufacture of empty capsules?

    <p>By dipping pins into the solution and slowly rotating them during transfer</p> Signup and view all the answers

    What is the final step in the manufacture of empty capsules after drying the films?

    <p>Cutting the dried films into correct lengths and joining them together</p> Signup and view all the answers

    What raw materials are often used in manufacturing pharmaceuticals, as mentioned in the text?

    <p>Raw materials obtained from animal sources such as bovine origin</p> Signup and view all the answers

    What is the maximum temperature range used for thermally bonding the two parts of a hard gelatin capsule?

    <p>40°C to 45°C</p> Signup and view all the answers

    Which of the following is NOT a limitation for materials that can be filled into hard gelatin capsules?

    <p>The material must have a high level of free moisture</p> Signup and view all the answers

    Which of the following types of materials can be filled into hard gelatin capsules?

    <p>Dry solids, semisolids, and nonaqueous liquids</p> Signup and view all the answers

    What is the first step in the process of filling hard gelatin capsules using a capsule filling machine?

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

    What is the purpose of the 'rectification' step in the capsule filling process?

    <p>To orient the empty capsules to point in the same direction</p> Signup and view all the answers

    Which of the following methods is described for bench-scale filling of hard gelatin capsules with powder?

    <p>Using predrilled plastic plates to hold the capsules</p> Signup and view all the answers

    What is the relationship between the number of capsule sizes and the body volume?

    <p>The body volume decreases with increasing number of capsule sizes</p> Signup and view all the answers

    Which of the following is the simplest way to estimate the fill weight for a powder?

    <p>Multiplying the bulk tapped density by the capsule body volume</p> Signup and view all the answers

    How are filled capsules sealed to prevent them from coming apart during the filling and packaging process?

    <p>They are sealed through a heat-welding process that fuses the cap to the body</p> Signup and view all the answers

    What was the main reason for the introduction of self-locking capsules?

    <p>To prevent the filled capsules from coming apart and spilling their contents during the filling and packaging process</p> Signup and view all the answers

    What is the relationship between the specific gravity of a liquid and the fill weight of a liquid-filled capsule?

    <p>The fill weight is calculated by multiplying the specific gravity of the liquid by the capsule body volume and then multiplying by 0.8</p> Signup and view all the answers

    Study Notes

    Formaldehyde and Deliquescent Materials

    • Formaldehyde cannot be used with deliquescent or efflorescent materials
    • Deliquescent materials (e.g. KOH, salts) may cause dryness of the capsule shell
    • Efflorescent materials (e.g. borax) may cause softening of the capsule shell

    Hard Capsules

    • Manufactured empty and then filled with product
    • Raw materials used in empty capsules:
      • Gelatin
      • Colorant (water-soluble dyes or insoluble pigments)
      • Process aids (e.g. sodium lauryl sulfate, not more than 0.15%)

    Gelatin

    • Main constituent of capsule shell
    • Sources of gelatin: collagen of animal bones and skin
    • Reasons for using gelatin:
      • Nontoxic and widely used in food
      • Readily soluble in body fluids
      • Good film-forming material
      • Solutions at high concentrations are mobile at 50°C

    Capsule Sizes and Filling

    • Capsule size and body volume:
      • Size 0: 0.69 ml
      • Size 1: 0.50 ml
      • Size 2: 0.37 ml
      • Size 3: 0.28 ml
      • Size 4: 0.20 ml
    • Fill weight calculation:
      • For powders: bulk tapped density x body volume
      • For liquids: specific gravity x body volume x 0.8

    Capsule Locking (Sealing)

    • Methods of sealing:
      • Colored band of gelatin
      • Heat-welding process
      • Liquid wetting agent and thermal bonding

    Capsule Filling Materials

    • Types of materials for filling:
      • Dry solids
      • Powders
      • Pellets
      • Granules
      • Tablets
      • Semisolids
      • Thixotropic mixtures
      • Pastes
      • Liquids
      • Nonaqueous liquids

    Capsule Filling Machines

    • Basic operations:
      • Rectification
      • Separation
      • Filling
      • Closing
      • Ejection
    • Types of machines:
      • Bench scale filling
      • Industrial scale filling
    • Dependent systems:
      • Dosing system uses the capsule body to measure the powder
    • Independent systems:
      • Powder is measured independently of the capsule body volume

    Gelatin Types

    • Type A gelatin:
      • Derived by acid treatment of the precursor
      • Takes 7-10 days for preparation
      • Mainly for animal skins
    • Type B gelatin:
      • Obtained by alkali treatment of the precursor
      • Takes 10 times as long as Type A
      • Mainly for bovine bones

    Manufacture of Empty Capsules

    • Steps:
      1. Concentrated solution of gelatin (35-40%) is prepared
      2. Solution is stirred until gelatin has dissolved and vacuum is applied
      3. Dye solutions or pigment suspensions are added
      4. Viscosity is measured and adjusted
      5. Pins of machine are dipped into the solution and slowly withdrawn
      6. Films are dried by blowing air over the pins
      7. Dried films are removed from moulds, cut to correct length, and joined together

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    Description

    Test your knowledge on hard capsules and their components, including raw materials such as gelatin, colorants, and process aids. Learn about the manufacturing process of hard capsules and how they are filled with products.

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