Solid Dosage Forms - Tablets (Lecture 8)

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Questions and Answers

What is the primary purpose of the mixing step in tablet formulation?

  • To ensure uniform distribution of tablet constituents. (correct)
  • To reduce the manufacturing time.
  • To increase the weight of the tablet.
  • To enhance the aesthetic appeal of the tablets.

Which of the following methods is NOT used in tablet manufacturing?

  • Wet granulation
  • Dry granulation
  • Flash freezing (correct)
  • Direct compression

What factor does NOT affect the choice of tablet manufacturing method?

  • Availability of processing equipment
  • Physical and chemical stability of the drug
  • Cost of manufacturing process
  • Size of the tablet (correct)

What is the role of a binder in the wet granulation method?

<p>To achieve cohesion between powders. (A)</p> Signup and view all the answers

What can result from over mixing during tablet manufacturing?

<p>Lubricants entering tablet granules instead of staying on the surface. (C)</p> Signup and view all the answers

What is one advantage of the granulation step in tablet manufacturing?

<p>Enhanced flow properties from the tablet hopper (B)</p> Signup and view all the answers

What is typically used for drying the produced wet granules?

<p>Conventional oven design shelf or tray drier (D)</p> Signup and view all the answers

Which equipment is NOT used for reducing the granule size?

<p>High-speed blender (C)</p> Signup and view all the answers

Which of the following is a disadvantage of the wet granulation method in tablet manufacturing?

<p>Requires several proceeding steps (C)</p> Signup and view all the answers

What might be a consequence of using solvents in the wet granulation process?

<p>Increased risk of drug degradation (D)</p> Signup and view all the answers

What is the purpose of adding a lubricant to the granules before tablet pressing?

<p>To improve the flow of the granules into the tablet die (B)</p> Signup and view all the answers

Why is wet granulation a useful technique for tablets containing low concentrations of therapeutic agents?

<p>It prevents the need for additional excipients. (D)</p> Signup and view all the answers

What may affect the compression properties of a tablet?

<p>The type of therapeutic agent used (A)</p> Signup and view all the answers

Which of the following is NOT a basic component of a tablet press?

<p>Conveyor belt (A)</p> Signup and view all the answers

What is the primary function of the die in a tablet press?

<p>To define the size and shape of the tablet (C)</p> Signup and view all the answers

What happens if deep colorants are used in direct compression?

<p>Tablets may become mottled (A)</p> Signup and view all the answers

How does the single-punch machine prepare the powder for compression?

<p>By placing it in the die (A)</p> Signup and view all the answers

What distinguishes a multi-station tablet press from a single-punch press?

<p>Speed of production (C)</p> Signup and view all the answers

Which of these actions occurs first in the compression sequence of a single-punch machine?

<p>The upper punch is raised (B)</p> Signup and view all the answers

What is a potential drawback of using crystalline or amorphous drugs in compression?

<p>They may not have suitable physical properties (D)</p> Signup and view all the answers

What does the cam track in a tablet press do?

<p>Guides the movement of the punches (A)</p> Signup and view all the answers

What is the main advantage of dry granulation in tablet manufacturing?

<p>It requires no heat or solvents. (D)</p> Signup and view all the answers

Which of the following describes a disadvantage of dry granulation?

<p>It may lead to softer tablets that are harder to coat. (C)</p> Signup and view all the answers

What is a requirement for drugs to be suitable for the direct compression method?

<p>They should be crystalline in nature. (A)</p> Signup and view all the answers

Which of the following is an advantage of direct compression?

<p>There is a lower risk of batch-to-batch variation. (A)</p> Signup and view all the answers

What is a primary disadvantage of direct compression?

<p>It requires special excipients that are often more expensive. (B)</p> Signup and view all the answers

What is the term used for the process of forming granules by compacting powder mixtures?

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

Why might direct compression be increasingly used in recent years?

<p>Advancements in processing machinery. (A)</p> Signup and view all the answers

What can be a consequence of double lubrication and compaction in dry granulation?

<p>Altered disintegration and dissolution of the drug. (B)</p> Signup and view all the answers

Which of the following is NOT a characteristic of the direct compression method?

<p>It requires granulation. (B)</p> Signup and view all the answers

Flashcards

Mixing in Tablet Manufacturing

The process of combining tablet ingredients uniformly, ensuring proper distribution of components and preventing issues like poor content uniformity or flow properties.

Granulation

A key stage in tablet production where powder is combined with a binder, resulting in granules. This improves flowability and ensures consistent tablet formation.

Wet Granulation

A method of tablet manufacturing where a binder dissolves in a liquid to form a paste, the mix is then granulated, dried and compressed into tablets. This process is known for achieving consistent tablet properties.

High-Speed Mixer/Granulator

This method of tablet formulation involves creating a homogenous powder mix, then wet granulating it using a high-speed mixer/granulator to directly produce wet granules. It eliminates the need for separate mixing and granulation steps.

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Direct Compression

This method is used for tablet formulation where a powder mix is compressed directly into tablets without granulation. It's particularly suitable for materials that are already free-flowing and easily compressible.

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High Shear Mixer

A type of mixer used for wet granulation. It uses high speed and shear forces to create uniform granules.

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Shelf/Tray Drier

A method of drying wet granules where they are placed on trays or shelves in a heated chamber. Similar to a conventional oven.

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Milling of Granules

The process of reducing the size of granules to improve flowability and ensure they fit within the tablet die.

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Lubricant

A lubricant added to the granules before pressing to reduce friction and improve tablet ejection.

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Tablet Compression

The process of pressing granules into tablets using a tablet press.

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Dry Granulation

A tableting process where powder mixtures are compacted into large pieces, then broken down into granules.

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Roller Compaction

A technique in dry granulation using rollers to compress powder into sheets, which are then broken into granules.

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Advantage: No Heat or Solvents

Dry granulation doesn't require heat or solvents, preserving the stability of heat-sensitive ingredients.

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Disadvantage: Specialized Equipment

Dry granulation requires specialized equipment for compacting and breaking down the material.

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Advantage: Reduced Batch Variation

Direct compression minimizes handling steps, leading to less variation between batches.

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Advantage: Cost-Effective

Direct compression is cost-effective due to fewer steps and less labor required.

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Disadvantage: Specialized Excipients

Direct compression requires specific excipients with good compressibility, which can be more expensive.

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Application: Low Doses

Direct compression is often used when low drug doses are needed, ensuring better content uniformity.

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Tablet Press

The tablet press is a high-speed mechanical device that compresses powders or granules into desired shapes with precision.

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Station

A single station on a tablet press containing a die and punches for tablet formation.

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Die

The cylindrical metal piece where the tablet is formed.

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Punches

Plungers that move up and down to compress the powder into a tablet.

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Single Punch Machine

A single-punch press has one die and one pair of punches, allowing for the production of tablets one at a time.

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Multi-Station (Rotary) Machine

A type of tablet press with multiple stations (dies) and punches, capable of producing tablets at high speeds.

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Hopper

The part of the tablet press that holds the powder or granules to be compressed.

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Compression Sequence

The sequence of actions taken by the punches and die to create a tablet, from the feeding of the powdered or granulated material to the ejection of the finished tablet.

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Study Notes

Solid Dosage Forms - Tablets (Lecture 8)

  • Lecture delivered by Maha Mostafa Ghalwash, Department of Pharmaceutics & Drug Manufacturing
  • This lecture focuses on tablet manufacturing methods, processes, and quality control.

Tablet Manufacture: Main Processes

  • Tablet formulation typically involves several key processes:
    • Weighing
    • Granulation
    • Milling and Mixing
    • Compression

Mixing: A Critical Step

  • Mixing is crucial for uniform distribution of tablet constituents and lubricants.
  • Inadequate mixing can lead to issues with content uniformity and flow properties.
  • Overmixing can also cause problems, such as lubricants entering tablet granules instead of remaining on the surface.
  • Mixing validation is necessary to ensure proper mixing.

Tablet Manufacturing Methods

  • Wet granulation: Granules are formed by wetting powdered ingredients with a liquid binder.
  • Dry granulation: Large pieces of the mixture are compacted, then broken into granules.
  • Direct compression: Ingredients and excipients are mixed and directly compressed into tablets without granulation.

Factors Affecting Tablet Manufacture Method Choice

  • Drug stability
  • Equipment availability
  • Cost of manufacturing
  • Excipient properties

Tablet Compression Machine

  • The tablet press is a high-speed mechanical device.
  • The press compresses ingredients into the required shape.
  • Also, can include the manufacturer or product's name.
  • Tablet punching machines use compression principles.
  • Basic components: hopper, dies, punches, cams and feedframe(s).

Types of Tablet Presses

  • Single punch tablet press: Features one die and one pair of punches. Powder is held in a hopper connected to the hopper shoe located at the dispensing table.
  • Multistation rotary press: Employed for large-scale production. Contains a series of upper and lower punches housed in a circular die tablet. The head rotates.

Tablet Compression Cycle(Single Punch)

  • The upper punch is raised, and the lower punch is dropped.
  • The feed shoe moves, dispensing the granules to the die.
  • The upper punch compresses the granules.
  • The upper and lower punches move upwards; the tablet is ejected.
  • The cycle repeats.

Tablet Testing (Quality Control)

  • Non-official tests: General appearance, size, shape, thickness, hardness, and friability.
  • Official tests: Weight variation, disintegration, and dissolution tests.

Non-official tests

  • General appearance: evaluating a tablet's size, shape, color, taste/odor, and surface texture.
  • Size and shape: related to the die and punches utilized.
  • Thickness: must be within 5% of a reference value, measured using a micrometer or vernier caliper.
  • Hardness: mechanical strength of a tablet; measured to ensure uniform compression pressure during manufacturing, handling, packaging, etc.
  • Friability: the resistance of tablets to breakage during handling; the test measures the percentage of weight loss after a set number of rotations.

Official Tests:

  • Weight Variation: Ensuring tablets contain a consistent amount of the drug. The variation test is necessary for tablets with over 50mg of active drug ingredient.
  • Disintegration Test: Evaluating the time required for the entire tablet to disintegrate into smaller particles under specific conditions.
  • Dissolution Test: Evaluating the rate and degree at which the drug dissolves in a specified medium. This determines the drug's bioavailability, and the impact of particle size, shape etc..
  • Importance of the test and how it can be used to determine various stages of disintegration process like wetting, swelling, solubility, and diffusion.

Tablet Manufacturing Problems and Solutions

  • Pitting: Insufficient lubricant or rough punch surfaces. Solution: increased lubricant concentration and regular punch polishing.
  • Capping: Air entrapment during compression. Solution: Using flat punches.
  • Lamination: Air entrapment during compression and ejection/release. Solution: Increasing the speed of the turret.
  • Sticking (Filming): Insufficiently dried or lubricated granules. Solution: Proper drying and lubrication.
  • Cracking: Rapid expansion during manufacturing, especially with deep concave punches. Solution: adjusting manufacturing procedure/equipment.
  • Chipping: Incorrect machine settings. Solution: Correct machine settings.
  • Fluffy materials: Increase binder concentration or adjust solvent system.
  • Dry granulation: Ensure sufficient water content.
  • Hygroscopic substances: Add sorbitol, methylcellulose or polyethylene glycol to maintain the proper moisture levels.

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