39 Questions
What is the purpose of a binder or adhesive in tablet manufacturing?
To form granules
Which substances can be used as flow activators or antifrictional agents in tablet manufacturing?
Magnesium stearate
______ facilitates rupture of the tablet by swelling of the disintegrant particles during sorption of water.
Swelling
Why is lactose not usually preferred by manufacturers?
It is not suitable for patients with lactose intolerance
What is the purpose of a disintegrant in tablet manufacturing?
To facilitate rupture of the tablet
What type of disintegrant is added to the dry granules before compression?
Extragranular Disintegrant
Which of the following is an example of an intragranular disintegrant?
Dibasic Calcium Phosphate Dehydrate
What is the purpose of starch in tablet manufacturing?
As an inert substance
What is the classification of tablet compression machines based on?
Machine type
What is Sodium Bicarbonate (NaHCO3) commonly known as?
Baking Soda
What is the primary function of punches in tablet manufacturing?
To compress the granulation within the dies
What is the effect of Sodium Bicarbonate (NaHCO3) on the tablet?
It causes effervescence
What is the purpose of tablet compression machines?
To compress the ingredients
What is the purpose of cam tracks in tablet manufacturing?
To guide the movement of the punches
What is the purpose of the granulation feeding device?
To force granules into the die cavity
What is the result of compression in tablet manufacturing?
Formation of tablets
What is the result of the swelling of the disintegrant particles during sorption of water?
Tablet fragmentation
What type of tablet is designed to release the active ingredient immediately after ingestion?
Immediate-Release tablet
What is the primary function of a granulating agent in tablet manufacturing?
To act as a binder or adhesive
What facilitates transport of liquids into the pores of the tablet?
Wicking
What type of tablet is designed to release the active ingredient in a controlled manner over a prolonged period?
Coated tablet
What is the purpose of the binder in tablet manufacturing?
To facilitate the formation of granules
What is the primary function of dies in tablet manufacturing?
To define the size and shape of the tablet
What is the purpose of compaction in tablet manufacturing?
To create a solid dosage form
What is the purpose of a hopper in tablet manufacturing?
To hold and feed granulation to be compressed
Why are Sorbitol, Glucose, and Sucrose not suitable for patients with diabetes?
They can cause an increase in blood sugar levels
What is the purpose of ensuring that excipients are inert in tablet manufacturing?
To prevent degradation of the medicinal substances
What is the purpose of using chelating agents in tablet manufacturing?
To prevent incompatibility with calcium
What type of tablets are prepared by molding?
Soft tablets
What is the purpose of using U Dextrose, and Mannitol in tablet manufacturing?
To prepare chewable tablets
What is the name of the machines used to compact the powder mixture in tablet manufacturing?
Presses
What is the primary function of Risperidone in tablet manufacturing?
An active pharmaceutical ingredient
Which of the following substances can be used as a binder or adhesive in tablet manufacturing?
Sucrose Solution
What is the purpose of a tablet weight monitoring device in the manufacturing process?
To monitor the force at each compression station
Which of the following is an example of a less essential component in tablet manufacturing?
Colorant
What is the purpose of a tablet deduster in the manufacturing process?
To remove excess powder
Which of the following machines is capable of exerting great pressure in compacting the powdered or granulated material?
Fette Machine
What is the purpose of chilling the compression components in the manufacturing process?
To allow the compression of the material
What is the result of the swelling of the disintegrant particles during sorption of water?
Rupture of the tablet
Study Notes
Types of Excipients
- Lactose, Spray Dried Lactose, Starch, Dextrose, Mannitol, Sorbitol, Glucose, Sucrose, Avicel, Dibasic Calcium Phosphate Dehydrate, Calcium Carbonate, and Cellulose are examples of excipients used in tablet manufacturing.
Disintegrants
- Disintegrants are mixed with other ingredients prior to granulation and are incorporated within the granules.
- Examples of disintegrants include Intragranular Disintegrant and Extragranular Disintegrant.
Tablet Compression Machines
Components
- Hopper: holds and feeds granulation to be compressed.
- Dies: define the size and shape of the tablet.
- Punches: compress the granulation within the dies.
- Cam Tracks: guide the movement of the punches.
Auxiliary Equipment
- Granulation Feeding Device: regulates the flow of granulation into the compression machine.
- Tablet Weight Monitoring Devices: monitor the force at each compression station.
- Tablet Deduster: removes excess powder from the tablets.
- Fette Machine: chills the compression components to allow the powder to be compressed.
Granulating Agent (Binder or Adhesive)
- Examples: Water, Alcohol, Starch Paste, Acacia Mucilage, Gelatin Solution, Tragacanth Mucilage, Sucrose Solution, Methylcellulose Solution, Sodium CMC Solution, PVP Solution, and Sorbitol.
- Facilitates water uptake and facilitates rupture of the tablet.
Colorant
- Examples: FD&C & D&C dyes, Lakes (dyes that have been absorbed on a hydrous oxide and employed as dry powders for coloring).
- Used for disguising off-color drugs, product identification, and production of a more elegant product.
Tablet Press Classifications
Single Press
- Also known as Eccentric Press.
- Output: 200 tablets per minute.
- Suitable for small batches of tablets during research and development.
Manufacturing Pharmacy
- Examples of excipients: Lactose, Spray Dried Lactose, Starch, Dextrose, Mannitol, Sorbitol, Glucose, Sucrose, Avicel, and Dibasic Calcium Phosphate Dehydrate, Calcium Carbonate, Cellulose
- Lactose is not indicated for patients with lactose intolerance, but still can be used in the formulation
- Starch is inert and usually used by manufacturers
- Dextrose and Mannitol are intended to be used in chewable tablets
- Sorbitol, Glucose, and Sucrose are not indicated for patients with Diabetes Mellitus (DM)
Tablets
- Solid dosage forms prepared by compression (hard tablets) or molding (soft tablets)
- Contain medicinal substances (API) with/without suitable excipients and/or other pharmaceutical adjuncts
- Types of tablets: Compressed, Molded, Hypodermic, Dispensing, Coated, Immediate-Release, Chewable, Buccal, Sublingual, Vaginal, Extended-Release (ER)
Equipment
- Tablet Compression Machines: because tablets are made by "compression", the stamping machines are called presses
- Auxiliary Equipment:
- Hopper: for holding and feeding granulation to be compressed
- Dies: define the size and shape of the tablet
- Punches: for compressing granulation within the dies
- Cam Tracks: for guiding the movement of the punches
- Wicking: for forces granules into die cavity
- Granulation Feeding Device
- Tablet Weight Monitoring Devices: monitor the force at each compression station
- Tablet Deduster: removes excess powder
- Fette Machine: chills the compression components to allow the tablet to be formed
Granulating Agent
- Also known as Binder or Adhesive
- Mechanisms of Action (MOA):
- Facilitate water uptake: facilitate transport of liquids into the pores of the tablet to form smaller fragments
- Facilitate rupture of the tablet: swelling of the disintegrant particles during sorption of water
- Examples: Water, Alcohol, Starch Paste, Acacia Mucilage, Gelatin Solution, Tragacanth Mucilage, Sucrose Solution, Methylcellulose Solution, Sodium CMC Solution, PVP Solution, Sorbitol
Colorant
- Less essential
- Disguising of off-color drugs, product identification, and production of a more elegant product
- Examples: not specified, but Acacia Mucilage is not an option due to its poor color and quality
This quiz covers the various aspects of manufacturing pharmacy, including examples of excipients and types of equipment used in the process.
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