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Questions and Answers
What is the first step in the manufacturing of empty gelatin shells?
What is the first step in the manufacturing of empty gelatin shells?
- Dipping the metal moulds in heated gelatin solution (correct)
- Passing the gelatin through drying ovens
- Removing dried films from the moulds
- Joining the two capsule parts together
How are the gelatin films dried during the manufacturing process?
How are the gelatin films dried during the manufacturing process?
- By rotating the moulds during transfer
- By exposing them to sunlight
- By freezing the gelatin solution
- By passing them through a series of drying ovens (correct)
What is the purpose of rotating the moulds during the manufacturing process?
What is the purpose of rotating the moulds during the manufacturing process?
- To form a film of uniform thickness (correct)
- To cool the gelatin quickly
- To accelerate the drying process
- To cut the films to the correct length
What happens to the dried films after they are removed from the moulds?
What happens to the dried films after they are removed from the moulds?
What occurs as the last step in the manufacturing of the empty gelatin shells?
What occurs as the last step in the manufacturing of the empty gelatin shells?
What are the main properties of gelatin as a capsule shell material?
What are the main properties of gelatin as a capsule shell material?
What is the primary source of gelatin?
What is the primary source of gelatin?
Which type of hydrolysis is used to produce Type A gelatin?
Which type of hydrolysis is used to produce Type A gelatin?
Which alternative material is commonly used for vegetarian capsules?
Which alternative material is commonly used for vegetarian capsules?
Why are water-insoluble pigments preferred for coloring capsules?
Why are water-insoluble pigments preferred for coloring capsules?
What happens to a gelatin solution when heated above 50°C?
What happens to a gelatin solution when heated above 50°C?
What is one reason for adding colorants to gelatin solutions during manufacturing?
What is one reason for adding colorants to gelatin solutions during manufacturing?
How long does the basic hydrolysis process for Type B gelatin typically take?
How long does the basic hydrolysis process for Type B gelatin typically take?
What is one of the advantages of capsules in medication?
What is one of the advantages of capsules in medication?
What type of drug should not be placed in capsules due to their interaction with gelatin?
What type of drug should not be placed in capsules due to their interaction with gelatin?
What characteristic is shared by both hard and soft gelatin capsules?
What characteristic is shared by both hard and soft gelatin capsules?
In what way are soft gelatin capsules different from hard gelatin capsules?
In what way are soft gelatin capsules different from hard gelatin capsules?
Which of the following is a disadvantage of using capsules?
Which of the following is a disadvantage of using capsules?
What is a primary ingredient of the capsule shells?
What is a primary ingredient of the capsule shells?
Which type of dosage form is NOT suitable for use with capsules?
Which type of dosage form is NOT suitable for use with capsules?
What makes capsules economical compared to tablets?
What makes capsules economical compared to tablets?
What is the primary function of plasticizers in gelatin capsules?
What is the primary function of plasticizers in gelatin capsules?
Which of the following is an example of a plasticizer used in soft gelatin capsules?
Which of the following is an example of a plasticizer used in soft gelatin capsules?
What type of process aid helps prevent microbiological contamination during capsule manufacture?
What type of process aid helps prevent microbiological contamination during capsule manufacture?
What is the role of glidants in the capsule manufacturing process?
What is the role of glidants in the capsule manufacturing process?
What type of gelatin capsule is typically softer and more flexible?
What type of gelatin capsule is typically softer and more flexible?
Which of the following is a diluent used to produce the proper capsule fill volume?
Which of the following is a diluent used to produce the proper capsule fill volume?
What is a common size characteristic of hard gelatin capsules?
What is a common size characteristic of hard gelatin capsules?
What is the primary use of surfactants in the gelatin solution during capsule manufacture?
What is the primary use of surfactants in the gelatin solution during capsule manufacture?
Which material is primarily used as the shell of hard gelatin capsules?
Which material is primarily used as the shell of hard gelatin capsules?
What is added to the gelatin solution to remove air bubbles during the manufacturing process?
What is added to the gelatin solution to remove air bubbles during the manufacturing process?
What percentage of the gelatin solution typically consists of gelatin?
What percentage of the gelatin solution typically consists of gelatin?
Which of the following is NOT a filling material suitable for hard gelatin capsules?
Which of the following is NOT a filling material suitable for hard gelatin capsules?
What is the purpose of adjusting the viscosity of the gelatin solution during production?
What is the purpose of adjusting the viscosity of the gelatin solution during production?
Which of the following statements about hard gelatin capsules is true?
Which of the following statements about hard gelatin capsules is true?
What temperature range is used for hot water when preparing the gelatin solution?
What temperature range is used for hot water when preparing the gelatin solution?
What is one of the main steps in the manufacturing of hard gelatin capsules?
What is one of the main steps in the manufacturing of hard gelatin capsules?
What are the primary steps involved in capsule manufacturing?
What are the primary steps involved in capsule manufacturing?
Which of the following describes a fully manual capsule filling process?
Which of the following describes a fully manual capsule filling process?
What is one method of automatic capsule filling mentioned?
What is one method of automatic capsule filling mentioned?
What is the purpose of weighing the empty capsule before and after filling?
What is the purpose of weighing the empty capsule before and after filling?
Which step is NOT a part of the semi-automated filling process?
Which step is NOT a part of the semi-automated filling process?
What method is used in manual filling to ensure that the powder fills the capsule correctly?
What method is used in manual filling to ensure that the powder fills the capsule correctly?
What is a distinguishing feature of fully automated filling machines?
What is a distinguishing feature of fully automated filling machines?
In the automatic filling process, what occurs after the filling of the bodies?
In the automatic filling process, what occurs after the filling of the bodies?
Flashcards
Capsules
Capsules
Solid dosage forms containing drugs and excipients inside a gelatin shell, designed for oral administration.
Hard Gelatin Capsules
Hard Gelatin Capsules
Capsules with two parts: a body and a cap, usually holding powders, granules, or small pellets.
Soft Gelatin Capsules
Soft Gelatin Capsules
Capsules made of a single piece of gelatin, typically holding liquids or semi-solids.
Gelatin
Gelatin
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Plasticizers
Plasticizers
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Capsules: Advantage 1
Capsules: Advantage 1
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Capsules: Advantage 2
Capsules: Advantage 2
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Capsules: Advantage 3
Capsules: Advantage 3
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What are plasticizers?
What are plasticizers?
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Where are plasticizers used more?
Where are plasticizers used more?
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What are Process Aids?
What are Process Aids?
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What are Preservatives in capsule production?
What are Preservatives in capsule production?
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What are Surfactants in capsule production?
What are Surfactants in capsule production?
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What are Glidants used for?
What are Glidants used for?
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What are Diluents/Fillers used for?
What are Diluents/Fillers used for?
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What determines the size of a capsule?
What determines the size of a capsule?
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What is Gelatin?
What is Gelatin?
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What is Type A Gelatin?
What is Type A Gelatin?
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What is Type B Gelatin?
What is Type B Gelatin?
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What is HPMC?
What is HPMC?
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What are Colorants?
What are Colorants?
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Why are pigments preferred in capsule shells?
Why are pigments preferred in capsule shells?
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Why is Gelatin a good material for capsules?
Why is Gelatin a good material for capsules?
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How are capsules colored?
How are capsules colored?
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Metal moulds (pins)
Metal moulds (pins)
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Dipping Metal pins in heated gelatin solution
Dipping Metal pins in heated gelatin solution
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Gelatin forming films on moulds
Gelatin forming films on moulds
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Rotating the moulds
Rotating the moulds
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Joining capsule parts
Joining capsule parts
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Capsule Filling
Capsule Filling
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Fully Manual Capsule Filling
Fully Manual Capsule Filling
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Hand-Operated Capsule Filling Machine
Hand-Operated Capsule Filling Machine
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Automatic Capsule Filling (Industrial Filling)
Automatic Capsule Filling (Industrial Filling)
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Semi-Automated Filling
Semi-Automated Filling
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Fully Automated Filling Machines
Fully Automated Filling Machines
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Manual Capsule Filling: Using a Spatula
Manual Capsule Filling: Using a Spatula
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Automatic Capsule Filling: Industrial Filling Process
Automatic Capsule Filling: Industrial Filling Process
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Gelatin Solution Preparation
Gelatin Solution Preparation
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Empty Capsule Shell Manufacturing
Empty Capsule Shell Manufacturing
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What are possible capsule fillings?
What are possible capsule fillings?
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How does viscosity impact capsule shells?
How does viscosity impact capsule shells?
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What are some additional ingredients in capsules?
What are some additional ingredients in capsules?
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What determines capsule size?
What determines capsule size?
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What is the size range for veterinary capsules?
What is the size range for veterinary capsules?
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Study Notes
Capsules
- Solid dosage forms intended for oral administration
- Contain one or more drugs and excipients enclosed in a shell or container, typically gelatin
- Medication can be powder, liquid, or semi-solid
Advantages of Capsules
- Mask unpleasant taste and odor of drugs
- Easy to swallow, especially with water since the shell dissolves quickly
- Rapid onset of action
- Gelatin shells are physiologically inert, preventing interactions with drugs
- Elegant appearance, more visually appealing and aesthetically pleasing
- More economical compared to tablets, requiring fewer excipients
- Simple to handle, accurate dosing, and easier to carry
- Shells can be colored or opacified (with titanium dioxide) for light protection
Disadvantages of Capsules
- Not suitable for drugs that dissolve gelatin (water or hydro-alcoholic solutions)
- Poorly suited for hygroscopic drugs (absorb water causing them to become brittle)
- Some medications interact poorly with gelatin
- Some drugs can cause gastric irritation due to rapid release in the stomach (e.g., NSAIDs)
- Drugs such as bromides or iodides are rapid release, quickly causing gastric irritation
Types of Capsules
- Hard Gelatin Capsules: Two-piece design (body and cap)
- Soft Gelatin Capsules: One-piece design, typically holding liquid or semi-solid medications
Common Feature
- Both types use a gelatin shell
Capsule Shell Composition
- Primarily gelatin
- Water
- Colorants
- Plasticizers (mostly in soft capsules)
- Optional excipients (processing aids).
Gelatin
- A translucent, brittle, odorless, colorless, or slightly yellow solid often used in capsule shells
- Safe, non-toxic, non-irritating, widely used in food products
- Inert, generally doesn't interact with drugs inside the capsule
- Good film-forming material to produce strong, flexible films
- Easily manufactured, highly concentrated solutions easily converted into a gel using heat
- Readily soluble in biological fluids at body temperature
Gelatin Types
- Type A: Produced by acid hydrolysis; primarily used for animal skins needing less pre-treatment than bones (7-10 days)
- Type B: Produced by basic hydrolysis; primarily used for animal bones (10 times longer process than acid)
Alternative Capsule Materials
- Hypermellose (HPMC): A semi-synthetic, inert, and viscoelastic polymer often used to create vegetarian capsules
Colorants
- Added to identify the product (e.g., the brand name)
- Often added during manufacturing to the gelatin solution
- Water-soluble dyes (e.g., erythrosine)
- Water-insoluble pigments(e.g., iron oxides, titanium dioxide), preferred for better light protection and opaqueness
Plasticizers
- Low-molecular-weight polymers that make gelatin shells more flexible and less brittle
- Important components in gelatin capsule shells, particularly in soft gelatin capsules
- Examples include glycerol, sorbitol, and PG (polyols)
Process Aids
- Materials added during capsule manufacture to aid in processing
- Preservatives: Prevent microbial contamination (ideal environment for growth, warm gelatin solutions)
- Surfactants: Act as wetting agents to ensure uniform coating on the capsule's surfaces
Other Capsule Additives
- Glidants: Improve the flow properties of the powder mix during filling (helps powder efficiently move into the capsule)
- Diluents/Fillers: Help meet proper capsule filling volume for small-dose drugs (e.g., lactose, microcrystalline cellulose, starch).
Hard Gelatin Capsule Sizes (HGC)
- Available in various sizes determined by the amount of material needed (000 to 5)
- Larger sizes available for veterinary use
Hard Gelatin Capsule Filling Materials
- Dry Solids: Powders; granules; pellets; mini-tablets
- Semisolids: Suspensions or pastes
- Liquids: Non-aqueous liquids; often converted into dry powders suitable for capsule filling
Hard Gelatin Capsule Manufacturing
- A- Preparation of the Gelatin Solution: Mixing Gelatin and hot water
- B- Manufacturing of Empty Hard Gelatin Shells: Gelatin solution formed into shell using metal moulds that creates a gel film
- C- Capsule Filling: Adding the drug contents to the empty gelatin capsules-- Manual or automatic (fully/semi)
Capsule Filling Steps (Manual)
- Powder placed on a sheet
- Capsule body filled, cap placed
- Weighing to ensure proper filling amount
Capsule Filling Steps (Automatic)
- Caps and drug bodies separated
- Bodies filled
- Caps replaced
- Filled capsules ejected
Locking and Sealing of Capsules
- Caps and bodies joined together (band of gelatin or polymer)
- Tamper-resistant seal created (capsules' contact areas are moistened with water/ethanol then sealed), at 40-45°C
Self-Sealing Capsule Designs
- Hard gelatin capsules' interiors are indented and grooved to create self-locking joints between the caps and bodies, ensuring a tight seal.
Sustained-Release Capsules (Spansules)
- Hard gelatin capsules with two forms of medication:
- One part providing immediate release
- Another part with coatings for delayed release (coated beads/pellets).
- Suitable for antibiotics
- More convenient since it provides all-day or all-night medication
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