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Questions and Answers
What happens to capsules when they lose moisture content?
What happens to capsules when they lose moisture content?
Which size of capsule is the largest suitable for human use?
Which size of capsule is the largest suitable for human use?
What type of liquids can be used for filling capsules?
What type of liquids can be used for filling capsules?
How do surfactants like sodium lauryl sulfate impact drug release from capsules?
How do surfactants like sodium lauryl sulfate impact drug release from capsules?
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What is the primary purpose of gastro-retentive floating capsules?
What is the primary purpose of gastro-retentive floating capsules?
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What factor does NOT influence drug release from capsules?
What factor does NOT influence drug release from capsules?
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Which method of capsule filling can process the highest volume?
Which method of capsule filling can process the highest volume?
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What are specialized inhalation capsules primarily designed for?
What are specialized inhalation capsules primarily designed for?
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What is the primary component of hard capsules that gives them their flexibility and strength?
What is the primary component of hard capsules that gives them their flexibility and strength?
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Which type of hydrolysis is primarily used for preparing gelatin from porcine skin?
Which type of hydrolysis is primarily used for preparing gelatin from porcine skin?
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What is the purpose of using wetting agents in the manufacturing of hard capsules?
What is the purpose of using wetting agents in the manufacturing of hard capsules?
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What measure is used to evaluate the gel rigidity of gelatin for hard capsules?
What measure is used to evaluate the gel rigidity of gelatin for hard capsules?
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During the manufacturing of hard capsules, what temperature range is used to prepare the gelatin solution?
During the manufacturing of hard capsules, what temperature range is used to prepare the gelatin solution?
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Which of the following is not a type of colorant used in hard capsules?
Which of the following is not a type of colorant used in hard capsules?
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What is the role of preservatives in modern hard capsule manufacturing?
What is the role of preservatives in modern hard capsule manufacturing?
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What quality control method is commonly used to remove defective capsules during manufacturing?
What quality control method is commonly used to remove defective capsules during manufacturing?
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Study Notes
Hard Capsules: Detailed Explanation
- Capsules are containers for active pharmaceutical ingredients (APIs), designed for easy swallowing.
- Hard capsules consist of a cap (shorter, cylindrical) and a body (longer, holds medication).
- The main component is gelatin, derived from animal sources (skins and bones), making them strong and flexible.
Raw Materials in Hard Capsules
Gelatin
- Prepared by hydrolyzing collagen from animal skins and bones via two processes:
- Type A: Acid hydrolysis (faster, primarily for porcine skin).
- Type B: Basic hydrolysis (slower, used for bovine bones).
- Important properties include:
- Bloom strength: Measures gel rigidity (higher is better; 200-250g for hard capsules, more than soft capsules).
- Viscosity: Affects shell thickness and consistency.
Colorants
- Types include water-soluble dyes (synthetic, azo dyes with -N=N- linkage) and insoluble pigments (TiO2, iron oxides).
- Used to make capsules opaque or colored.
Wetting Agents
- Example: sodium lauryl sulfate.
- Ensures uniform coating of metal molds during dipping.
Preservatives
- Used to prevent microbial contamination. Modern manufacturing (with GMP adherence) regulates moisture content (13-16%) to minimize the need for preservatives.
Hard Capsule Manufacturing
- The process involves dipping metal molds into a hot gelatin solution, forming a film that dries and is cut to size.
- The process is fully automated for efficiency and consistency.
Detailed Steps in Manufacturing
- Gelatin solution preparation: Gelatin (35-40% w/v) dissolved in demineralized water (60-70°C). Dyes/pigments added, and viscosity adjusted for shell thickness control.
- Dipping and drying: Metal molds are dipped into the gelatin solution, and the solution is dried to form capsules.
Capsule Assembly & Quality Control
- Films are cut into caps and bodies, then assembled in a "prelocked" position to prevent separation.
- Defective capsules are removed mechanically or electronically. Modern capsules have self-locking features preventing spillage.
Properties of Empty Capsules
- Moisture Content: 13-16%, acting as a plasticizer. Loss of moisture makes them brittle, and excess moisture softens them.
- Solubility: Dissolves readily at 37°C (body temperature). Below 26°C, they absorb water and swell instead of dissolving.
Capsule Sizes
- Standard sizes range from size 0 (largest) to size 4 (smallest).
Volume Estimation
- For powders: Multiply capsule body volume by powder density.
- For liquids: Multiply liquid specific gravity by capsule volume, then adjust by 0.9.
Capsule Filling Materials
- Dry solids: Powders, granules, pellets, and tablets.
- Semi-solids: Thermo-softening mixtures, pastes.
- Liquids: Only non-aqueous liquids due to gelatin's sensitivity to water.
Filling Methods
- Bench-Scale: Manual devices (e.g., "Feton" device) spread powder over locked capsule bodies.
- Industrial-Scale: Machines fill 3,000-150,000 capsules per hour, using two dosing systems (dependent and independent).
Drug Release from Capsules
- Capsule shell disintegration in a liquid releases the contents.
- Key factors influencing drug release:
- Particle size (smaller dissolves faster).
- Diluent solubility (soluble diluents enhance release).
- Lubricants (excess levels slow drug release).
- Surfactants and disintegrants (improve dissolution).
Modified-Release Capsules
- Floating (Gastro-Retentive): Contain polymers (methyl cellulose) that swell and float in the stomach, prolonging drug release.
- Gastro-Resistant: Designed for acid-sensitive drugs or distal intestine delivery achieved via enteric coating.
Specialized Capsules
- Inhalation Capsules: Contain micronized APIs for inhalation devices. Fill weight is typically less than 25mg, requiring precise filling machines,.
Formulation Optimization
- Formulation must ensure:
- Uniform filling and stability.
- Effective release and absorption of API.
- Compliance with pharmacopoeial standards.
- Factors like lubricant concentration, particle size, and excipient selection are optimized using statistical tools.
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Description
Explore the fascinating world of hard capsules, their construction, and the raw materials involved. This quiz covers the composition of hard capsules, particularly focusing on gelatin types and colorants used in the manufacturing process. Test your knowledge on the critical properties that make hard capsules an essential pharmaceutical dosage form.
