Hard gelatin capsules (HGCs) are a cornerstone of solid dosage formulation studied in pharmaceutical technology. This introduction covers shell composition, gelatin properties, manufacturing steps, filling techniques, capsule sizes, quality control tests (disintegration, dissolution, weight variation), moisture and stability concerns, and alternatives like HPMC shells. Key concepts include gelatin source and Bloom strength, pin-dipping shell formation, common filling methods (dosator, tamping, auger), sealing and microbial considerations, and formulation strategies to manage hygroscopic or poor-flow powders. Understanding these fundamentals helps B. Pharm students design, evaluate, and control capsule products effectively. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which material is the primary constituent of conventional hard gelatin capsule shells?
- Starch
- Hypromellose (HPMC)
- Gelatin derived from collagen
- Cellulose acetate
Correct Answer: Gelatin derived from collagen
Q2. What manufacturing step forms the two halves of a hard gelatin capsule shell?
- Compression molding of powder
- Pin-dipping into a gelatin solution
- Injection molding of plastic
- Extrusion followed by cutting
Correct Answer: Pin-dipping into a gelatin solution
Q3. Which property of gelatin is measured by Bloom strength?
- Viscosity of the gelatin solution
- Gel strength and firmness of the set gel
- Moisture content of the shell
- Melting point of gelatin
Correct Answer: Gel strength and firmness of the set gel
Q4. Which capsule size numbering indicates the largest hard gelatin capsule commonly used?
- Size 5
- Size 00
- Size 000
- Size 1
Correct Answer: Size 000
Q5. Which of the following is a common vegetarian alternative to gelatin capsules?
- Gelatin from fish
- Hypromellose (HPMC) capsules
- Casein-based capsules
- Pectin-based immediate-release capsules
Correct Answer: Hypromellose (HPMC) capsules
Q6. Which filling technique is most suitable for free-flowing powders in hard gelatin capsules at industrial scale?
- Dosator (puncture/dosing) method
- Capsule coating
- Wet granulation inside shell
- Solvent evaporation filling
Correct Answer: Dosator (puncture/dosing) method
Q7. What is the primary quality-control test to assess whether hard gelatin capsules disintegrate appropriately?
- Viscosity measurement
- Disintegration test in specified medium
- Loss on drying
- pH measurement of shell
Correct Answer: Disintegration test in specified medium
Q8. Excess moisture in the capsule shell generally causes which problem?
- Increased brittleness and cracking
- Enhanced friability of fill material only
- Softening and possible sticking of capsule halves
- Permanent coloration loss
Correct Answer: Softening and possible sticking of capsule halves
Q9. Which of these tests evaluates the shell’s residual water content?
- Disintegration time
- Loss on drying (LOD)
- Bacterial endotoxin test
- Assay of active drug
Correct Answer: Loss on drying (LOD)
Q10. Crosslinking of gelatin shells (e.g., by aldehydes) most likely affects which performance parameter?
- Improved color stability
- Slower or failed dissolution/disintegration
- Increased capsule size
- Enhanced capsule elasticity
Correct Answer: Slower or failed dissolution/disintegration
Q11. Which in-process control is essential to ensure uniform dose in filled capsules?
- Capsule shell color uniformity
- Weight variation of filled capsules
- Bloom strength of gelatin
- Viscosity of fill suspension
Correct Answer: Weight variation of filled capsules
Q12. Which excipient class is commonly added to powder fills to improve flowability for capsule filling?
- Lubricants and glidants (e.g., magnesium stearate, colloidal silica)
- Preservatives for microbial control
- Strong oxidizing agents
- High levels of water
Correct Answer: Lubricants and glidants (e.g., magnesium stearate, colloidal silica)
Q13. Which pharmacopeial apparatus is often used for dissolution testing of hard gelatin capsules?
- USP Apparatus I (basket) or II (paddle)
- HPLC autosampler only
- Friability tester
- UV-Vis spectrophotometer without dissolution vessel
Correct Answer: USP Apparatus I (basket) or II (paddle)
Q14. What is the typical effect on a gelatin capsule when filled with a highly hygroscopic powder?
- Capsule becomes more brittle and cracks
- No interaction; properties remain unchanged
- Moisture migration causes shell softening and deformation
- Immediate crosslinking of gelatin
Correct Answer: Moisture migration causes shell softening and deformation
Q15. Which sealing technique can be used to prevent tampering and reduce leakage between capsule halves?
- Thermal fusion or banding with gelatin solution
- Omitting cap from capsule design
- Increasing Bloom strength only
- Adding magnesium stearate to shell
Correct Answer: Thermal fusion or banding with gelatin solution
Q16. Which analytical parameter of gelatin influences the viscosity of the dipping solution?
- Bloom strength and concentration
- Capsule colorant type
- Fill powder particle size
- Capsule size number
Correct Answer: Bloom strength and concentration
Q17. Why are crosslinking reactions between gelatin and aldehyde-containing drugs a concern?
- They improve capsule dissolution
- They can reduce enzymatic degradation of drug
- They may form insoluble complexes, delaying drug release
- They enhance capsule color stability
Correct Answer: They may form insoluble complexes, delaying drug release
Q18. For quality assurance, which microbial test is relevant for hard gelatin capsules?
- Total aerobic microbial count (TAMC) and absence of specified pathogens
- Endotoxin testing only for capsules
- Viscosity test of the filling powder
- Disintegration test only
Correct Answer: Total aerobic microbial count (TAMC) and absence of specified pathogens
Q19. Which environmental condition is most critical to control during manufacturing and storage of hard gelatin capsules?
- Ambient light intensity
- Relative humidity and temperature
- Atmospheric CO2 concentration
- Background acoustic noise
Correct Answer: Relative humidity and temperature
Q20. What is the main advantage of using two-piece hard gelatin capsules versus tablets?
- They always provide sustained release
- Easier taste masking, flexibility of formulation and dose adjustment
- They are more environmentally stable than all tablets
- They never require stability testing
Correct Answer: Easier taste masking, flexibility of formulation and dose adjustment
Q21. Which characteristic of a powder formulation is most detrimental to automatic capsule filling performance?
- Good flow and low cohesion
- High bulk density with uniform particles
- High cohesion and poor flowability
- Low static charge and free-flowing nature
Correct Answer: High cohesion and poor flowability
Q22. What is the role of an enteric coating or enteric capsule shell?
- To release drug immediately in the stomach
- To mask color only
- To resist gastric fluid and release drug in the intestine
- To accelerate capsule dissolution in acidic media
Correct Answer: To resist gastric fluid and release drug in the intestine
Q23. Which excipient in the fill can accelerate moisture-induced capsule shell crosslinking?
- Sugar alcohols that retain water
- Desiccants included in the fill
- Inert pigments only
- Non-hygroscopic glidants
Correct Answer: Sugar alcohols that retain water
Q24. Which statement best describes capsule tamper-evident banding?
- A decorative paint applied to capsule surface
- A gel or polymer band applied at the junction to show tampering
- Removal of cap to reduce leakage
- An inner seal inside the fill material
Correct Answer: A gel or polymer band applied at the junction to show tampering
Q25. Which factor is assessed by a friability test for capsules?
- Moisture content only
- Susceptibility to abrasion and mechanical damage during handling
- Chemical stability against oxidation
- Bloom strength of gelatin
Correct Answer: Susceptibility to abrasion and mechanical damage during handling
Q26. During stability studies, which observation indicates gelatin shell degradation?
- Consistent disintegration times over time
- Unchanged capsule weight and appearance
- Capsule brittleness, cracking, or excessive softening
- Improved dissolution rate compared to initial
Correct Answer: Capsule brittleness, cracking, or excessive softening
Q27. Which analytical parameter of the filling process helps detect content uniformity issues?
- Visual inspection of unfilled shells
- Assay of active ingredient in individual capsules
- Bloom strength measurement
- Capsule color measurement
Correct Answer: Assay of active ingredient in individual capsules
Q28. Why might a formulator choose a two-part fill (pellets plus powder) for a capsule?
- To guarantee immediate release of all actives
- To allow multiparticulate controlled release or separation of incompatible actives
- To reduce manufacturing steps by dissolving pellets into shell
- To ensure capsule halves fuse permanently
Correct Answer: To allow multiparticulate controlled release or separation of incompatible actives
Q29. Which of the following is a common cause of poor dissolution from gelatin capsules unrelated to the active ingredient?
- Crosslinking of gelatin shell during storage
- Use of high purity gelatin with correct moisture
- Proper capsule sealing technique
- Low fill weight uniformity
Correct Answer: Crosslinking of gelatin shell during storage
Q30. Which regulatory or safety consideration is especially relevant for gelatin sourced from animals?
- Ensuring gelatin has the highest Bloom only
- Source traceability, BSE/TSE risk mitigation and supplier certification
- Always using porcine gelatin regardless of patient preference
- Ignoring microbial testing for animal-derived materials
Correct Answer: Source traceability, BSE/TSE risk mitigation and supplier certification
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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