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What are hard gelatin capsules primarily made from?
What are hard gelatin capsules primarily made from?
What is a primary feature of hard gelatin capsules?
What is a primary feature of hard gelatin capsules?
Which of the following describes the moisture content characteristics of hard gelatin capsules?
Which of the following describes the moisture content characteristics of hard gelatin capsules?
What is the role of desiccant material in the packaging of hard gelatin capsules?
What is the role of desiccant material in the packaging of hard gelatin capsules?
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What materials are used in vegetarian capsules?
What materials are used in vegetarian capsules?
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What is gamma scintigraphy used for in relation to hard gelatin capsules?
What is gamma scintigraphy used for in relation to hard gelatin capsules?
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What happens to hard gelatin capsules in a humid environment?
What happens to hard gelatin capsules in a humid environment?
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What is the main purpose of the spinning process in the manufacture of hard gelatin capsules?
What is the main purpose of the spinning process in the manufacture of hard gelatin capsules?
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How are hard gelatin capsules manufactured?
How are hard gelatin capsules manufactured?
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What is a key goal when developing and preparing the formulation for filled hard gelatin capsules?
What is a key goal when developing and preparing the formulation for filled hard gelatin capsules?
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Which step follows the drying process in the manufacturing of hard gelatin capsules?
Which step follows the drying process in the manufacturing of hard gelatin capsules?
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What types of materials might be used as diluents or fillers in filled hard gelatin capsules?
What types of materials might be used as diluents or fillers in filled hard gelatin capsules?
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What is the purpose of using disintegrants in hard gelatin capsules?
What is the purpose of using disintegrants in hard gelatin capsules?
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What must be controlled during the drying process of gelatin capsule production?
What must be controlled during the drying process of gelatin capsule production?
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Which of the following is an optional step in the preparation of filled hard gelatin capsules?
Which of the following is an optional step in the preparation of filled hard gelatin capsules?
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In the step of cutting and joining during capsule manufacturing, what happens to the caps and bodies?
In the step of cutting and joining during capsule manufacturing, what happens to the caps and bodies?
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What is the purpose of using lubricants or glidants in capsule formulation?
What is the purpose of using lubricants or glidants in capsule formulation?
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Which agent is specifically known for facilitating wetting by gastrointestinal fluids in capsule preparation?
Which agent is specifically known for facilitating wetting by gastrointestinal fluids in capsule preparation?
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What is the first step in the punch method for filling hard capsules?
What is the first step in the punch method for filling hard capsules?
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When weighing the first filled capsule with non-potent materials, what is the purpose of using an empty capsule on the opposite balance pan?
When weighing the first filled capsule with non-potent materials, what is the purpose of using an empty capsule on the opposite balance pan?
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How can the proper capsule size be determined before filling?
How can the proper capsule size be determined before filling?
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What should be done to check the uniformity of the filling process for non-potent materials?
What should be done to check the uniformity of the filling process for non-potent materials?
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What is a key step to ensure accuracy when filling capsules with potent materials?
What is a key step to ensure accuracy when filling capsules with potent materials?
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Which one of the following is NOT an example of a lubricant or glidant used in capsule formulation?
Which one of the following is NOT an example of a lubricant or glidant used in capsule formulation?
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What is the purpose of using a colored band of gelatin in capsule sealing?
What is the purpose of using a colored band of gelatin in capsule sealing?
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Which process is primarily used for creating soft gelatin capsules?
Which process is primarily used for creating soft gelatin capsules?
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What materials can be encapsulated in soft gelatin capsules?
What materials can be encapsulated in soft gelatin capsules?
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How does heat welding create a seal in hard gelatin capsules?
How does heat welding create a seal in hard gelatin capsules?
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Which of the following liquid types can be encapsulated into soft gelatin capsules?
Which of the following liquid types can be encapsulated into soft gelatin capsules?
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For large scale cleaning of capsules, which method is typically used?
For large scale cleaning of capsules, which method is typically used?
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What is the characteristic of soft gelatin capsules compared to hard capsules?
What is the characteristic of soft gelatin capsules compared to hard capsules?
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Which of the following best describes the sealing process of soft gelatin capsules?
Which of the following best describes the sealing process of soft gelatin capsules?
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Which of the following is NOT a requirement for added substances in capsules?
Which of the following is NOT a requirement for added substances in capsules?
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What is the purpose of immersing the basket rack assembly into a fluid at 37°C during the disintegration test?
What is the purpose of immersing the basket rack assembly into a fluid at 37°C during the disintegration test?
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Which of the following characteristics is NOT required for the containers of capsules?
Which of the following characteristics is NOT required for the containers of capsules?
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Which of the following tests is involved in evaluating the quality of capsules?
Which of the following tests is involved in evaluating the quality of capsules?
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What do compendial requirements for capsules ensure regarding the added substances?
What do compendial requirements for capsules ensure regarding the added substances?
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Study Notes
Hard Gelatin Capsules
- Hard capsules have a rigid shell in two separate pieces, hence also called two-piece capsules.
- They are more versatile than soft gels.
- Empty capsule shells are made up of gelatin, sugar, and water.
- Capsules can be clear, colorless, and essentially tasteless.
- They can be colored with FD&C and D&C dyes and made opaque by adding agents such as titanium dioxide.
- Gelatin is obtained by the partial hydrolysis of collagen obtained from the skin, connective tissue, and bones of animals.
- Vegetarian capsules generally consist of hydroxypropyl methylcellulose (HPMC) and water.
- They are fast dissolving, easily digestible, Kosher and Halal certified, GMO free, gluten free, and contain no preservatives.
- Hard capsules are stable in air when dry.
- They contain 13% to 16% moisture.
- Moisture can cause capsules to absorb moisture and distort - losing their rigidity.
- Dryness can cause capsules to lose moisture and become brittle/crumbly.
- Hard capsules are often packaged with a desiccant to protect against the absorption of atmospheric moisture.
- Gamma Scintigraphy is a non-invasive procedure to track the passage of capsules and tablets through the GI tract, to map their transit time and drug release patterns.
Hard Gelatin Capsule Manufacture
- Shells are manufactured in two sections: the capsule body and a shorter cap.
- The process includes dipping, spinning, drying, stripping, cutting, and joining.
- Dipping involves dipping pegs into temperature-controlled melted gelatin mixture.
- Spinning distributes the gelatin coating evenly and removes excess gelatin.
- Drying solidifies the gelatin coating into a firm, rigid capsule shell.
- Stripping separates the solidified gelatin shells from the molds.
- Cutting and joining trims the caps and bodies to appropriate length, and then pre-locks them.
Hard Gelatin Capsule Preparation
- The preparation of hard gelatin capsules involves 4 main steps: developing and preparing the formulation, selecting the capsule size, filling the capsule shells, capsule sealing (optional), and cleaning/polishing.
- Developing and preparing the formulation and selecting the capsule size requires an accurate dosage, good bioavailability, ease of filling and production, stability, and elegance.
- Diluents or fillers are added to achieve the proper capsule fill volume. Examples: lactose, microcrystalline cellulose, starch
- Disintegrants break up and distribute the capsule’s contents in the stomach. Examples: pregelatinized starch, croscarmellose, sodium starch glycolate
- Capsule sealing is used to maintain the integrity of capsule contents.
- Cleaning and polishing removes extraneous materials from the capsules after filling.
Soft Gelatin Capsules
- Soft gelatin capsules are made of gelatin with glycerin or a polyhydric alcohol such as sorbitol added.
- They contain more moisture than hard capsules.
- They may be oblong, oval, or round.
- They encapsulate and hermetically seal liquids, suspensions, pasty materials, dry powders, and preformed tablets.
Soft Gelatin Capsule Preparation
- The rotary die process is used to manufacture soft gelatin capsules.
- Two continuous ribbons of liquid gelatin are formed by a rotary die machine.
- The ribbons are brought together between twin rotating dies.
- Metered fill material is injected between the ribbons precisely at the moment the dies form pockets.
- The pockets are sealed by pressure and heat, and then severed from the ribbon.
- Using ribbons of two different colors results in bicolored capsules.
Soft Gelatin Capsule Use
- Liquids encapsulated include:
- Water-immiscible volatile and nonvolatile liquids such as oils, hydrocarbons, chlorinated hydrocarbons, ethers, esters, alcohols, and organic acids.
- Water-miscible nonvolatile liquids, such as polyethylene glycols, and nonionic surface-active agents, such as polysorbate 80.
- Water-miscible and relatively nonvolatile compounds such as propylene glycol and isopropyl alcohol.
Compendial Requirements for Capsules
- Added Substances:
- Must be harmless in the quantities used.
- Do not exceed the minimum amounts required to provide their intended effect.
- Do not impair the product's bioavailability, therapeutic efficacy, or safety.
- Do not interfere with required compendial assays and tests.
- Containers must be tight, well closed, light resistant, or a combination of these.
- Disintegration Test for Capsules is performed by placing capsules in a device known as a basket rack assembly, immersed in a fluid at controlled temperature, simulating the conditions in the digestive system.
- Dissolution Test for Capsules tests the rate and extent to which the drug substance dissolves from the capsule dosage form under specific conditions.
- Weight and Content Uniformity tests ensure the consistency of drug content within capsules.
- Content Labeling Requirement ensures accurate labeling of the product's content.
- Stability Testing evaluates the stability of the capsule product over time under various conditions.
- Moisture Permeation Test assesses the capsule's resistance to moisture ingress.
Official and Commercially Available Capsules
- This section provides details about official and commercially available capsules.
- Details covered include the variety of capsules available, their characteristics, and their applications.
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Description
Explore the characteristics and benefits of hard gelatin capsules in this informative quiz. Learn about their composition, versatility, and stability under various conditions. Perfect for students or professionals interested in pharmaceutical sciences.
