Introduction: The production of hard gelatin capsule shells involves controlled formulation and manufacturing steps—selection of gelatin (bloom strength, viscosity), use of plasticizers (sorbitol, glycerol), colorants, opacifiers, and precise dipping & drying operations. For B.Pharm students, understanding gelatin chemistry, pin dipping technique, drying parameters, moisture content, quality control (disintegration, dissolution, microbial limits) and regulatory standards (USP/BP) is essential. This topic links material science with process engineering to ensure shell strength, flexibility and drug compatibility. These MCQs focus on practical production variables, testing methods and troubleshooting common problems like cross-linking, sticking and humidity effects. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which primary raw material is used to produce traditional hard gelatin capsule shells?
- Hydroxypropyl methylcellulose
- Gelatin
- Polyvinyl alcohol
- Cellulose acetate
Correct Answer: Gelatin
Q2. What does “Bloom strength” of gelatin measure?
- The gelatin’s melting point
- The firmness of a standardized gel
- The gelatin’s pH stability
- The protein purity
Correct Answer: The firmness of a standardized gel
Q3. Which property of gelatin critically affects capsule shell formation and mechanical strength?
- Color index
- Viscosity and Bloom strength
- Particle size
- Optical rotation
Correct Answer: Viscosity and Bloom strength
Q4. Which plasticizer is commonly used in hard gelatin capsule shell formulations to reduce brittleness?
- Sorbitol
- Polyethylene glycol 4000
- Calcium stearate
- Lactose monohydrate
Correct Answer: Sorbitol
Q5. What is the standard industrial method for forming hard gelatin capsule shells?
- Spray drying
- Pin dipping (dip-coating) process
- Compression molding
- Extrusion and cutting
Correct Answer: Pin dipping (dip-coating) process
Q6. Why is the drying step essential after dipping capsule pins in gelatin solution?
- To dissolve the gelatin
- To remove residual solvent and set the film
- To increase gelatin viscosity
- To add color uniformly
Correct Answer: To remove residual solvent and set the film
Q7. What is the typical acceptable moisture content range for finished hard gelatin capsule shells?
- 1–3% w/w
- 5–8% w/w
- 12–16% w/w
- 25–30% w/w
Correct Answer: 12–16% w/w
Q8. The main functional role of colorants and opacifiers in capsule shells is to:
- Increase tensile strength
- Enhance solubility
- Provide identification and light protection
- Act as a preservative
Correct Answer: Provide identification and light protection
Q9. Chemical cross-linking of gelatin shell proteins commonly leads to which manufacturing problem?
- Increased moisture uptake
- Decreased solubility and slower disintegration
- Enhanced transparency
- Reduced bloom strength
Correct Answer: Decreased solubility and slower disintegration
Q10. Which microbiological test is commonly used to assess microbial quality of finished capsule shells?
- Zone of inhibition test
- Total aerobic microbial count (TAMC)
- Gram staining only
- Endotoxin pyrogen test
Correct Answer: Total aerobic microbial count (TAMC)
Q11. What is a common Bloom strength range preferred for gelatin used in hard capsule production?
- 20–50 Bloom
- 60–100 Bloom
- 150–250 Bloom
- 400–500 Bloom
Correct Answer: 150–250 Bloom
Q12. According to standard pharmacopeial expectations, typical disintegration time for immediate-release hard capsules should be within:
- 5 minutes
- 30 minutes
- 2 hours
- 24 hours
Correct Answer: 30 minutes
Q13. Which animal source of gelatin may be restricted for religious or cultural reasons in some countries?
- Bovine
- Porcine
- Aquatic fish
- Avian
Correct Answer: Porcine
Q14. What is a widely used non-gelatin alternative for producing hard capsule shells suitable for vegetarians?
- Collagen from bovine skin
- Hydroxypropyl methylcellulose (HPMC)
- Polyethylene glycol
- Gelucire
Correct Answer: Hydroxypropyl methylcellulose (HPMC)
Q15. Storing hard gelatin capsules under high relative humidity commonly results in:
- Increased brittleness
- Softening and sticking of shells
- Permanent cross-linking
- Loss of color only
Correct Answer: Softening and sticking of shells
Q16. Which manufacturing parameter most directly controls the thickness of the gelatin shell during the dip-coating process?
- Drug particle size
- Dip time and gelatin solution concentration/viscosity
- Ambient light intensity
- Capsule fill weight
Correct Answer: Dip time and gelatin solution concentration/viscosity
Q17. Titanium dioxide is commonly added to capsule shell formulations primarily to:
- Act as a plasticizer
- Provide opacity and protect against light
- Increase bloom strength
- Reduce microbial load
Correct Answer: Provide opacity and protect against light
Q18. The main purpose of adding plasticizers (e.g., sorbitol, glycerol) to gelatin solutions is to:
- Improve color uniformity
- Increase film flexibility and reduce brittleness
- Accelerate drying time
- Make shells water-insoluble
Correct Answer: Increase film flexibility and reduce brittleness
Q19. Typical shell thickness for commercially produced hard gelatin capsules is usually expressed in which approximate range?
- 1–5 micrometers
- 50–200 micrometers
- 0.5–1 millimeter
- 1–2 centimeters
Correct Answer: 50–200 micrometers
Q20. Capsule locking or snap-fit designs are incorporated primarily to:
- Speed up capsule filling
- Prevent separation of cap and body and deter tampering
- Increase shell porosity
- Reduce shell moisture
Correct Answer: Prevent separation of cap and body and deter tampering
Q21. What is the most common cause of gelatin sticking to dipping pins during production?
- Over-diluted gelatin solution
- Insufficient drying of the gel film
- Excessive opacifier concentration
- Use of HPMC instead of gelatin
Correct Answer: Insufficient drying of the gel film
Q22. Gelatin is produced industrially by hydrolysis of which structural protein?
- Keratins
- Elastin
- Collagen
- Actin
Correct Answer: Collagen
Q23. Which instrument is commonly used to measure the viscosity of a gelatin solution in the capsule industry?
- High-performance liquid chromatograph
- Brookfield viscometer
- UV-Visible spectrophotometer
- Karl Fischer titrator
Correct Answer: Brookfield viscometer
Q24. Which of the following is NOT typically used as an ingredient in hard gelatin capsule shell formulations?
- Gelatin
- Glycerol
- Titanium dioxide
- Lactose monohydrate
Correct Answer: Lactose monohydrate
Q25. Which factor does NOT significantly influence gelatin gelation and shell properties?
- pH of the solution
- Temperature during setting
- Ionic strength of solution
- API particle size in capsule fill
Correct Answer: API particle size in capsule fill
Q26. Which technique is used to permanently seal capsule joints to prevent leakage or tampering?
- Banding
- Lyophilization
- Sonication
- Fluid bed coating of the fill material
Correct Answer: Banding
Q27. Between disintegration and dissolution tests, which one directly measures the rate at which the active pharmaceutical ingredient becomes available in solution?
- Disintegration test
- Dissolution test
- Friability test
- Moisture content test
Correct Answer: Dissolution test
Q28. Exposure to aldehydes (e.g., formaldehyde) during storage can cause which adverse effect on gelatin capsules?
- Plasticization
- Cross-linking of gelatin proteins
- Increased bloom strength beneficially
- Instant dissolution
Correct Answer: Cross-linking of gelatin proteins
Q29. Which official compendia define quality standards, tests and limits for hard gelatin capsules in most regulated markets?
- Textbooks only
- Pharmacopoeias such as USP and BP
- Internal company memoranda only
- Local newspapers
Correct Answer: Pharmacopoeias such as USP and BP
Q30. Recommended storage conditions to maintain integrity of hard gelatin capsules are generally described as:
- Hot and humid (40–45°C, >80% RH)
- Cold and wet (0–5°C, >70% RH)
- Cool, dry place (about 15–25°C, 35–65% RH)
- Direct sunlight at room temperature
Correct Answer: Cool, dry place (about 15–25°C, 35–65% RH)
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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