Understanding the Size of Soft Gelatin Capsules MCQs With Answer is essential for B.Pharm students focusing on dosage form design and pharmaceutical technology. Capsule size determines fill volume, drug content, dissolution rate, patient acceptability, packaging efficiency, and manufacturing parameters. Mastery of size codes, fill-volume calculations, density factors, shell composition, sealing integrity, and relevant USP/ICH tests aids formulation development and quality control. These MCQs go beyond basics to cover practical measurement methods, influence of shell thickness and plasticizers, impact of fill density and viscosity, and common manufacturing challenges encountered with softgels. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which capsule size is the largest commonly used size designation?
- 5
- 00
- 000
- 1
Correct Answer: 000
Q2. How does increasing capsule size generally affect fill volume?
- Fill volume decreases as size increases
- Fill volume is independent of capsule size
- Fill volume increases as capsule size increases
- Fill volume becomes zero for very large sizes
Correct Answer: Fill volume increases as capsule size increases
Q3. In which unit is soft gelatin capsule fill volume most commonly expressed?
- Milliliters (mL)
- Milligrams (mg)
- International Units (IU)
- Percentage (% w/w)
Correct Answer: Milliliters (mL)
Q4. Which instrument is typically used to measure external dimensions of a softgel?
- UV-visible spectrophotometer
- Dissolution tester
- Vernier caliper
- Disintegration apparatus
Correct Answer: Vernier caliper
Q5. Which expression correctly relates fill weight, fill volume and density?
- Fill weight = fill volume × density
- Density = fill volume × fill weight
- Fill volume = fill weight × surface area
- Fill weight = surface area ÷ density
Correct Answer: Fill weight = fill volume × density
Q6. Which plasticizer is most commonly used in soft gelatin shell formulations?
- Triethyl citrate
- Glycerol
- Polyvinyl alcohol
- Stearic acid
Correct Answer: Glycerol
Q7. What is the primary industrial manufacturing process for soft gelatin capsules?
- Rotary die encapsulation
- Wet granulation
- Compression molding
- Spray drying
Correct Answer: Rotary die encapsulation
Q8. Which QC test specifically detects leakage of fill material from softgels?
- Tensile strength test
- Dye penetration (dye ingress) test
- Potency assay
- Moisture sorption isotherm
Correct Answer: Dye penetration (dye ingress) test
Q9. How does a thinner gelatin shell typically affect drug release?
- Decreases release due to lower surface area
- Has no effect on release
- Increases release due to faster shell dissolution
- Prevents release completely
Correct Answer: Increases release due to faster shell dissolution
Q10. Which test is used to assess the rate and extent of drug release from soft gelatin capsules?
- Disintegration only
- Uniformity of diameter
- Dissolution testing
- Visual inspection
Correct Answer: Dissolution testing
Q11. Which storage condition is most likely to accelerate gelatin shell degradation?
- Low temperature and low humidity
- High temperature and high humidity
- Refrigeration at 4°C
- Dry, cool and dark environment
Correct Answer: High temperature and high humidity
Q12. What is a practical experimental method to determine fill volume of a softgel?
- Measure external diameter only
- Weigh filled and empty shell and divide weight difference by fill density
- Use UV spectroscopy of the shell material
- Estimate from capsule color
Correct Answer: Weigh filled and empty shell and divide weight difference by fill density
Q13. From a patient compliance perspective, which capsule size is preferred?
- The largest possible size
- Smallest effective size for the required dose
- Size does not influence compliance
- Only appearance matters
Correct Answer: Smallest effective size for the required dose
Q14. Soft gelatin shells are primarily composed of which combination?
- Gelatin, plasticizer and water
- Cellulose, starch and ethanol
- Polyethylene, talc and oil
- Magnesium stearate, gelatin and sucrose
Correct Answer: Gelatin, plasticizer and water
Q15. Which statement is NOT true regarding soft gelatin capsules?
- They are suitable for liquid and semi-solid fills
- They provide tamper-evident dosage forms
- They are ideal for high-dose bulk dry powders
- They can improve bioavailability for lipophilic drugs
Correct Answer: They are ideal for high-dose bulk dry powders
Q16. Which compendial reference lists official tests and standards for soft gelatin capsules in the United States?
- WHO Technical Report Series only
- European Pharmacopoeia exclusively
- United States Pharmacopeia (USP)
- ISO 9000
Correct Answer: United States Pharmacopeia (USP)
Q17. Excessively high sealing temperature during encapsulation is most likely to cause:
- Improved shell flexibility without downside
- Shell deformation and increased leakage
- Lower production speed only
- Reduced fill density
Correct Answer: Shell deformation and increased leakage
Q18. Which on-line or at-line test is commonly used to detect leaks during production?
- Helium mass spectrometry (advanced) or dye ingress offline test
- IR spectroscopy for shell plasticizer
- Optical rotation measurement
- pH titration of the shell
Correct Answer: Helium mass spectrometry (advanced) or dye ingress offline test
Q19. For the same fill volume, what happens to the mass of the fill if its density increases?
- Mass decreases
- Mass remains unchanged
- Mass increases
- Mass becomes zero
Correct Answer: Mass increases
Q20. Which analytical technique is most commonly used to assay the active pharmaceutical ingredient in softgel fills?
- High-performance liquid chromatography (HPLC)
- Thermogravimetric analysis (TGA)
- Karl Fischer titration only
- Refractive index measurement
Correct Answer: High-performance liquid chromatography (HPLC)
Q21. Which of the following factors is least relevant when selecting capsule size?
- Therapeutic dose and potency
- Patient swallowing ability and compliance
- Packaging line capabilities
- Intrinsic color of the active ingredient
Correct Answer: Intrinsic color of the active ingredient
Q22. How many common capsule size designations exist from largest (000) to smallest (5)?
- 5
- 6
- 8
- 10
Correct Answer: 8
Q23. Which tool is most appropriate for measuring gelatin shell thickness accurately?
- Micrometer
- pH meter
- UV lamp
- Analytical balance only
Correct Answer: Micrometer
Q24. Which component is added to the shell formulation to reduce brittleness and increase flexibility?
- Plasticizer
- Disintegrant
- Colorant
- Antioxidant
Correct Answer: Plasticizer
Q25. Which process parameter should be tightly controlled to ensure consistent fill weight in softgel production?
- Viscosity of the fill material
- Color of the shell
- Laboratory room occupancy
- Supplier logo on packaging
Correct Answer: Viscosity of the fill material
Q26. Which condition most increases the risk of leakage in soft gelatin capsules?
- Excessive shell thickness
- Low shell thickness
- High fill viscosity
- Use of appropriate plasticizer
Correct Answer: Low shell thickness
Q27. Why do many liquid-filled softgels provide faster in vitro release than equivalent hard gelatin capsules containing powder?
- Solid cores always dissolve slower due to formulation only
- Softgels contain dissolved or solubilized drug leading to immediate availability
- Hard capsules disintegrate instantly and release faster
- Softgels prevent any contact with dissolution medium
Correct Answer: Softgels contain dissolved or solubilized drug leading to immediate availability
Q28. Which packaging choice best protects softgel capsules from moisture uptake during storage?
- Perforated cardboard box
- Aluminum foil blister with desiccant
- Open tray storage
- Non-sealed plastic bag
Correct Answer: Aluminum foil blister with desiccant
Q29. The numerical size label of a capsule primarily corresponds to which practical attributes?
- Color and taste only
- Fill volume and external dimensions
- Manufacturing date and batch number
- Regulatory category only
Correct Answer: Fill volume and external dimensions
Q30. What is the formula to compute experimental fill volume from weights if density is known?
- Fill volume = (Weight_empty ÷ Density)
- Fill volume = (Weight_filled – Weight_empty) ÷ Density
- Fill volume = Weight_filled × Density
- Fill volume = Density ÷ (Weight_filled – Weight_empty)
Correct Answer: Fill volume = (Weight_filled – Weight_empty) ÷ Density
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