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Questions and Answers
The two types of capsules are hard gelatin and ______ capsules.
The two types of capsules are hard gelatin and ______ capsules.
soft
One of the advantages of capsules is that they can mask the ______ and/or taste of unpleasant drugs.
One of the advantages of capsules is that they can mask the ______ and/or taste of unpleasant drugs.
odor
Capsules are not suitable for administering very soluble ionic ______.
Capsules are not suitable for administering very soluble ionic ______.
salts
In addition to solid drug forms, capsules can contain ______ or semisolid drugs.
In addition to solid drug forms, capsules can contain ______ or semisolid drugs.
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The process of preparing capsules includes steps like comminution, blending, and ______.
The process of preparing capsules includes steps like comminution, blending, and ______.
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The ______ for capsules outlines the required standards to ensure safety and efficacy.
The ______ for capsules outlines the required standards to ensure safety and efficacy.
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A historical figure in the evolution of soft gelatin capsules is ______, a French pharmacist.
A historical figure in the evolution of soft gelatin capsules is ______, a French pharmacist.
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Capsules can be taken by placing them on the tongue and swallowing with ______.
Capsules can be taken by placing them on the tongue and swallowing with ______.
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The process of reducing particle size is called ______.
The process of reducing particle size is called ______.
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For uniform distribution of actives, ______ and spatula can be used.
For uniform distribution of actives, ______ and spatula can be used.
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According to the Rule of 6’s, a size 2 capsule can hold ______ grains of powder.
According to the Rule of 6’s, a size 2 capsule can hold ______ grains of powder.
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The nominal powder weight for a veterinary capsule size 10 is ______ ounces.
The nominal powder weight for a veterinary capsule size 10 is ______ ounces.
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In capsule packing statistics, 325 mg of ______ can be filled in a size 1 capsule.
In capsule packing statistics, 325 mg of ______ can be filled in a size 1 capsule.
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The process of filling capsules manually is known as ______ filling.
The process of filling capsules manually is known as ______ filling.
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The Rule of 7’s indicates to subtract from ______ when converting weight of powder.
The Rule of 7’s indicates to subtract from ______ when converting weight of powder.
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To clean capsules effectively, it is important to minimize traces of ______.
To clean capsules effectively, it is important to minimize traces of ______.
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Stability testing evaluates the intrinsic stability of the active drug ______.
Stability testing evaluates the intrinsic stability of the active drug ______.
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Packaging and storing capsules is generally done at ______ temperature.
Packaging and storing capsules is generally done at ______ temperature.
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Capsules #0 through #5 are not difficult to ______.
Capsules #0 through #5 are not difficult to ______.
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Morphine sulfate and dextromethorphan HBr capsules contain ______ mg and 30 mg respectively.
Morphine sulfate and dextromethorphan HBr capsules contain ______ mg and 30 mg respectively.
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The moisture permeation test is conducted on single- and unit-dose ______.
The moisture permeation test is conducted on single- and unit-dose ______.
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The filling of capsules requires accurate ______.
The filling of capsules requires accurate ______.
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Capsule quality control includes disintegration and ______ tests.
Capsule quality control includes disintegration and ______ tests.
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Soft gelatin capsules can accommodate water-immiscible volatile and ______ liquids.
Soft gelatin capsules can accommodate water-immiscible volatile and ______ liquids.
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Capsules should be stored in tight and well-closed ______.
Capsules should be stored in tight and well-closed ______.
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A method used to fill hard capsule shells is the ______ method.
A method used to fill hard capsule shells is the ______ method.
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One of the special applications for capsules is the ______ with a capsule.
One of the special applications for capsules is the ______ with a capsule.
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The ______ test ensures that capsules disintegrate fully into a soft mass.
The ______ test ensures that capsules disintegrate fully into a soft mass.
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Capsule sealing can be achieved using Kapseals or ______ bands.
Capsule sealing can be achieved using Kapseals or ______ bands.
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Study Notes
Capsules
- Hard gelatin capsules are capsules with a rigid shell made from gelatin
- Soft gelatin capsules are capsules with a pliable and less rigid shell made from gelatin
- Capsules can be used for oral, rectal and vaginal administration
- Capsules are convenient for patients as they mask the taste and smell of the active drug
Advantages of Capsule Dosage Form
- Easy to prepare
- Can vary dosage and drug combination
Disadvantages of Capsule Dosage Form
- Not suitable for administering very soluble ionic salts (e.g., potassium chloride, ammonium chloride)
Hard Gelatin Capsules
- The capsules are manufactured by creating a shell out of a gelatin solution
Steps Involved in Hard Gelatin Capsule Preparation
- Comminution: The process of reducing particle size of the drug to a uniform size
- Blending: The process of combining and ensuring uniform distribution of the active ingredients throughout the formulated mixture
- Determine capsule size: Ensure the correct size of the capsule is selected based on the drug or drugs being formulated
- Encapsulate: Filling the capsule shells with the formulated drug mixture by hand or using a capsule filling machine
- Clean: Capsules are cleaned to remove excess powder or debris adhering to the shell
- Quality control: Ensuring the final product meets the required specifications
Capsule Sizes for Human Use
- 000
- 00
- 0
- 1
- 2
- 3
- 4
- 5
Capsule Sizes for Veterinary Use
- 7
- 10
- 11
- 12
- 13
Rules for Capsule Sizes
- Rule of 6's: a rule to approximate the weight of powder that will fit in a specific capsule size
- Rule of 7's: a rule to approximate the weight of powder that will fit in a specific capsule size
Important Considerations when Developing the Formulation and Choosing Capsule Size
- Accurate Dosage: Ensure the final capsule dosage is correct and represents the desired amount of the drug
- Bioavailability: The capsule's formulation must allow for good and consistent absorption of the drug by the body
- Ease of filling and Manufacturing: The formulation must be easy to fill into the capsule shells, both on a small scale and for large-scale manufacturing
- Stability: The formulation should be stable over time, meaning it should not deteriorate or change significantly in terms of its composition or effectiveness.
- Elegance: The final product should have a pleasing and appealing appearance
Considerations for Capsule Formulation
- Incompatibilities: Checking for any potential incompatibilities between drug ingredients
- Hygroscopic: Determines if the raw materials are hygroscopic, meaning they attract and absorb moisture from the air
- Deliquescent: Determine if the raw materials are deliquescent, meaning they absorb moisture from the air to the point they dissolve
- Eutectic: Checking for eutectic mixtures, where two ingredients in a mixture lower the melting point of each other
- Diluents and Adsorbents: Determining the need to use diluents and adsorbents to adjust the bulk volume and flow characteristics of the final formulation
- Special Applications: Special considerations for potent powders, tablets within capsules, capsules within capsules, and altered-release capsule formulations.
Methods for Filling Hard Capsule Shells
- Punch method
- Capsule filling machines
- Automated filling machines
Capsule Sealing Techniques
- Kapseals
- Gelatin bands
Methods for Cleaning Capsules
- Cleaning Vacuum
Soft Gelatin Capsules
- Soft gelatin capsules are made by manufacturing a film-like shell of gelatin and filling with the final formulation
- Soft gelatin capsules can contain water immiscible volatile liquids, nonvolatile liquids, water-miscible nonvolatile liquids and water-miscible nonvolatile compounds
Steps Involved in Soft Gelatin Capsule Preparation
- Plate process
- Molds
- Rotary die process
Capsule Quality Control
- This ensures the quality and safety of the final product
- Drug Content: Analyzing the amount of active drug inside the capsule
- Fill Weight: Measuring the weight of the contents in each capsule
- Disintegration: Testing the capsule's ability to break down in the appropriate time frame
- Dissolution: Assessing the rate and amount of active drug dissolving from the capsule
- Stability: Evaluating the capsule's shelf life and how it maintains its potency and quality over time
Important Compendial Requirements
- Containers for Dispensing Capsules: Requirements for the type of container used to package capsules and how they protect the contents from environmental factors
- Tight
- Well-closed
- Light resistant
Disintegration Testing
- Ensures the capsule breaks down into a soft mass and no undissolved core is present remaining.
Dissolution Testing
- This test assesses how well the drug dissolves from the capsule to ensure its bioavailability
- To ensure the capsule meets quality control requirements.
Weight Variation
- This test measures the weight of the contents in each capsule.
- The test is required for hard and soft gelatin capsules.
Content Uniformity
- This test determines the range of active drug variation in each capsule.
- The test is required for hard and soft gelatin capsules.
Content Labeling Requirement
- Required for all official capsules
- The quantity of each active ingredient in each dosage unit must be expressed on the container label
Stability Testing
- The capsule's stability testing ensures the product’s effectiveness and safety over time
- Factors that affect stability include temperature, humidity, light, formulation components, the container and closure system.
Moisture Permeation Test
- This test is used to measure the amount of moisture that can penetrate single- and unit-dose containers.
Packaging and Storage
- Capsules are generally stored at room temperature,
- Specific storage conditions may be required depending on the active drug.
Patient Counseling for Capsules
- Provide information about swallowing capsules
- If the capsule is larger than size #5, recommend methods to help patients take the capsule such as using syrup, honey, or liquid candy
- Instruct patients to be cautious when emptying the contents of capsules into food, etc.
- Inform patients about the different routes of administration (oral, rectal, vaginal).
Administration of Capsules
- Swallow capsule with liquid
- Dissolve contents in water or mix contents with food
Example Formulations
- Morphine Sulfate 10-mg and Dextromethorphan HBr 30-mg Capsules
- Progesterone 100 mg in Peanut Oil Capsules
- Triple Estrogen Capsules, Semisolid Fill
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Description
This quiz covers the essential aspects of capsule dosage forms, including hard and soft gelatin capsules. It discusses their advantages, disadvantages, and the processes involved in the preparation of hard gelatin capsules. Test your knowledge on this convenient method of drug administration!
