What size of hard gelatin capsules is used for veterinary purposes?
Sizes larger than size 000.
p.19
Filling Techniques for Capsules
What is the primary focus of counting capsules and tablets?
To ensure accurate dosage and inventory management.
What are the two main types of capsules based on the properties of capsule shells?
Hard gelatin capsules and soft gelatin capsules.
p.14
Soft Gelatin Capsules
Can you name some products that use soft gelatin capsules?
Sandimmune®, Neoral®, Znrontin®, and fish oil.
p.8
Capsule Size and Dosage
How does the weight of capsule capacity depend on?
The density of the powder.
What should be added if the drug dose is inadequate to fill the hard gelatin capsules?
A diluent (e.g., lactose).
p.16
Compendial Requirements for Capsules
What is the purpose of the dissolution test?
To assess how well the capsule dissolves in a solution.
p.11
Filling Techniques for Capsules
What is a key characteristic of the capsule shell when filling with liquid?
The capsule shell is not soluble in the liquid.
What type of capsule allows for prolonged drug release?
Sustained release capsules.
p.16
Compendial Requirements for Capsules
What is a key requirement for the container of capsules?
It must meet specific compendial standards.
p.13
Filling Techniques for Capsules
What is a key advantage of using a capsule filling machine?
Increased efficiency and consistency in the filling process.
p.1
Definition and Purpose of Capsules
What is the primary intended use of capsules?
To be swallowed whole or to remove contents from the gelatin shell.
p.4
Composition of Capsule Shells
What are vegan alternatives for hard capsule shells?
Cellulose polymers, such as hydroxypropyl methyl cellulose (HPMC).
p.20
Packaging and Storage of Capsules
What materials are commonly used for packaging capsules?
Glass or plastic containers.
p.14
Filling Techniques for Capsules
What types of substances are usually filled in soft gelatin capsules?
Liquids, powder, and pastry.
p.10
Filling Techniques for Capsules
What is a method for inserting whole tablets into hard gelatin capsules?
Insert the whole tablets directly into the capsule.
p.9
Filling Techniques for Capsules
What is the first step in the punching method for filling hard gelatin capsules?
Separate the cap from the body.
p.21
Oral Administration Guidelines
What must not be done to capsules with special coatings?
They must not be chewed, broken, or crushed.
p.5
Composition of Capsule Shells
What is the purpose of lubricants/glidants in powder formulations?
To enhance the flow properties of powders.
p.11
Filling Techniques for Capsules
Why are gelatin capsules unsuitable for certain liquids?
They are unsuitable for aqueous liquids.
p.19
Filling Techniques for Capsules
What is a common challenge in counting capsules and tablets?
Avoiding miscounts due to the small size and shape of the dosage forms.
What are the two routes of administration for capsules?
Oral capsules and rectal capsules.
p.16
Compendial Requirements for Capsules
What should be observed in the disintegration test?
No firm core and only some fragments of the gelatin shell.
p.10
Filling Techniques for Capsules
What should be done with large or big tablets when filling hard gelatin capsules?
They should be split into two or more pieces.
p.13
Filling Techniques for Capsules
What is an important consideration when using a capsule filling machine?
Ensuring the correct dosage and uniformity of the filled capsules.
What are the different forms of capsules mentioned?
Powder capsules, granule capsules, and bead capsules.
p.15
Compendial Requirements for Capsules
What does the moisture permeation test evaluate in capsules?
The ability of the capsule to resist moisture penetration.
p.12
Filling Techniques for Capsules
How should nonpotent drugs in capsules be weighed?
Weigh the first filled capsule and periodically weigh others to check uniformity.
What type of capsule is designed for immediate drug release?
Immediate release capsule.
What should be done if the drug dose is too large for a single hard gelatin capsule?
Use two or more capsules.
p.10
Filling Techniques for Capsules
What is a common practice in blind studies regarding capsule filling?
Embedding a tablet or capsule in capsule powder.
p.13
Filling Techniques for Capsules
What types of substances can be filled into capsules using a filling machine?
Powders, granules, or liquids.
p.21
Oral Administration Guidelines
What alternatives should be suggested if solid dosage forms are not feasible?
Chewable or liquid forms.
p.15
Compendial Requirements for Capsules
What is the purpose of the weight variation test for capsules?
To ensure that the weight of capsules is within specified limits.
p.22
Definition and Purpose of Capsules
What are capsules?
Solid dosage forms enclosing medicinal or inert substances within a small gelatin shell, commonly used for oral administration.
How does the filling speed of hard gelatin capsules compare to tableting?
Filling machines for hard gelatin capsules are slower than those for tableting.
p.18
Compendial Requirements for Capsules
What does API stand for in the context of capsules?
Active Pharmaceutical Ingredient.
p.10
Filling Techniques for Capsules
How can crushed tablet powders be used in hard gelatin capsules?
They can be filled similarly to powders.
p.13
Filling Techniques for Capsules
What is the primary function of a capsule filling machine?
To fill capsules with various substances such as powders, granules, or liquids.
p.9
Filling Techniques for Capsules
How is the capsule body filled in the punching method?
Fill the capsule body with formulation to desirable weight.
p.9
Filling Techniques for Capsules
Is sealing capsules mandatory after filling?
No, sealing capsules is optional.
p.15
Compendial Requirements for Capsules
What is the significance of stability testing for capsules?
To determine how the quality of a capsule changes over time under various conditions.
p.22
Packaging and Storage of Capsules
How should capsules be stored?
In glass or plastic containers placed in a cool and dry area.
p.11
Filling Techniques for Capsules
What tools can be used to fill hard gelatin capsules with liquid ingredients?
A syringe, graduated dropper, or pipette.
p.19
Filling Techniques for Capsules
What methods can be used for counting capsules and tablets?
Manual counting, automated counting machines, or visual inspection.
p.14
Soft Gelatin Capsules
What is the purpose of adding glycerin and/or sorbitol to soft gelatin capsules?
To make the shells elastic.
p.16
Compendial Requirements for Capsules
What is the disintegration test for capsules?
A test where capsules are immersed 30 times per minute.
p.1
Composition of Capsule Shells
What types of substances can be enclosed in capsules?
Powder, compact, beads, or granulation.
p.4
Composition of Capsule Shells
What happens to capsules in extreme dryness?
They become brittle and crumble.
p.5
Composition of Capsule Shells
What role do disintegrants play in tablets and capsules?
They assist in the breakup and distribution of the tablet/capsule content in the stomach.
What are the visual characteristics of hard gelatin capsules?
They can be clear, colorless, colored, or opaque.
p.18
Compendial Requirements for Capsules
What is the requirement for content uniformity in capsules?
API concentrations must be between 85% and 115% of the label claim.
p.19
Filling Techniques for Capsules
Why is accurate counting of capsules and tablets important?
To prevent dosage errors and ensure patient safety.
What is necessary to calculate when using multiple hard gelatin capsules?
The number of extra capsules needed.
p.17
Compendial Requirements for Capsules
How is the net weight of a soft capsule calculated?
Net weight = Capsule weight – Empty shell weight.
p.1
Definition and Purpose of Capsules
What are capsules?
Solid dosage forms enclosing medicinal or inert substances within a small gelatin shell.
p.4
Composition of Capsule Shells
What is the primary material used in hard capsule shells?
Gelatin, typically derived from pork skin.
What is the difference between hard gelatin and soft gelatin capsules?
Hard gelatin capsules have hard shells, while soft gelatin capsules have elastic shells made from glycerin and/or sorbitol.
Are hard gelatin capsules generally more or less costly than tablets?
Generally more costly than tablets.
p.20
Packaging and Storage of Capsules
What conditions should be avoided when storing capsules?
Excessive humidity or dryness.
p.10
Filling Techniques for Capsules
What is one method for filling hard gelatin capsules?
Using manufactured tablets or capsules.
p.17
Compendial Requirements for Capsules
How is the net weight of a hard capsule calculated?
Net weight = Capsule weight – Empty shell weight.
p.21
Oral Administration Guidelines
What should be considered regarding drug administration?
Be careful with drug-food interactions.
p.9
Filling Techniques for Capsules
What should be avoided when handling filled capsules?
Fingerprints; use gloves.
p.15
Compendial Requirements for Capsules
What does content labeling refer to in the context of capsules?
The information provided on the capsule packaging regarding its contents.
p.5
Composition of Capsule Shells
What is the function of diluents/fillers in tablets and capsules?
To produce proper volume and provide cohesion to the powder, aiding in the transfer of the powder blend into tablets or capsule shells.
p.22
Compendial Requirements for Capsules
What must capsules meet according to USP compendial requirements?
Requirements regarding containers, disintegration test, dissolution test, weight variation, content uniformity, labeling, stability testing, and moisture permeation test.
p.14
Soft Gelatin Capsules
What are soft gelatin capsule shells composed of?
Similar to hard gelatin, with added glycerin and/or sorbitol for elasticity.
p.21
Oral Administration Guidelines
What is the first step in the oral administration of capsules?
Place the dose upon the tongue.
p.9
Filling Techniques for Capsules
How should capsules be cleaned after filling?
Clean and polish capsules using clean gauze or cloth.
What is a disadvantage of using hard gelatin capsules for certain materials?
They are difficult to formulate for very bulky materials.
p.17
Compendial Requirements for Capsules
What is the procedure for checking weight variation in hard capsules?
Weigh individually 10 hard capsules, remove contents, and weigh individually 10 empty shells.
p.21
Oral Administration Guidelines
Why is it dangerous to swallow capsules without water?
It can cause esophageal ulceration.
p.13
Filling Techniques for Capsules
How does a capsule filling machine contribute to pharmaceutical manufacturing?
By automating the capsule filling process, it enhances productivity and reduces human error.
p.4
Packaging and Storage of Capsules
How should capsules be stored to maintain their integrity?
In an environment free from excessive humidity or dryness.
p.5
Composition of Capsule Shells
What is the function of wetting agents in drug formulations?
To enhance drug dissolution, especially when magnesium stearate is used as a lubricant.
How do sealed hard gelatin capsules protect their contents?
They serve as good barriers to atmospheric oxygen.
p.17
Compendial Requirements for Capsules
What is the procedure for checking weight variation in soft capsules?
Cut open each capsule, remove content, and weigh individually 10 empty shells.
p.9
Filling Techniques for Capsules
What is the next step after filling the capsule body?
Reattach the cap to the body and lock the capsule.
p.4
Composition of Capsule Shells
What additional components can be found in capsule shells?
Sugar, dyes, colorants, opaque agents, and preservatives.
What is one advantage of hard gelatin capsules?
They offer flexible formulation.
p.22
Composition of Capsule Shells
What are the major excipients included in capsules?
Diluents/fillers, disintegrants, lubricants/glidants, and wetting agents.
p.22
Oral Administration Guidelines
How should oral capsules be taken?
They must be swallowed whole with a glass of water and not broken, chewed, or crushed unless instructed otherwise.
In what applications are hard gelatin capsules commonly used?
In most commercial medicated capsules, clinical trials, and extemporaneous compounding prescriptions.
