Nature of soft capsule shell MCQs With Answer

Understanding the nature of soft capsule shell is essential for B.Pharm students studying dosage form design, formulation, and quality control. This introduction covers key concepts such as gelatin and non‑gelatin shells (HPMC), plasticizers and humectants, bloom strength, viscosity, moisture content, cross‑linking, microbial stability, and compatibility with liquid fills. Emphasis is placed on manufacturing processes, shell integrity, leakage mechanisms, analytical tests (dissolution, disintegration, DSC, FTIR), and regulatory considerations for safe, stable soft capsules. Mastering these topics helps predict stability issues, optimize formulations, and ensure patient safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary structural polymer traditionally used for soft capsule shells?

• Hydroxypropyl methylcellulose (HPMC)
• Polyethylene glycol (PEG)
• Gelatin
• Sorbitol

Correct Answer: Gelatin

Q2. Which component is added to gelatin to impart flexibility and prevent brittleness in soft capsule shells?

• Fill material
• Plasticizer (e.g., glycerol)
• Preservative
• Cross‑linking agent

Correct Answer: Plasticizer (e.g., glycerol)

Q3. Which non‑animal polymer is commonly used as an alternative to gelatin for vegetarian/vegan soft shells?

• Gelatin from fish
• Polyvinylpyrrolidone (PVP)
• Hydroxypropyl methylcellulose (HPMC)
• Sorbitol solution

Correct Answer: Hydroxypropyl methylcellulose (HPMC)

Q4. What is ‘bloom strength’ a measure of in gelatin?

• Viscosity of gelatin melt
• Gelling power or gel strength
• Moisture content
• Thermal degradation point

Correct Answer: Gelling power or gel strength

Q5. Excessive cross‑linking of gelatin shells typically leads to which problem?

• Increased solubility
• Improved microbial resistance without drawback
• Reduced dissolution and hardness increased
• Lower melting point

Correct Answer: Reduced dissolution and hardness increased

Q6. Which test is most relevant for assessing capsule shell disintegration and release of fill?

• Viscosity measurement
• Dissolution test
• FTIR spectroscopy
• Microbial limit test

Correct Answer: Dissolution test

Q7. Which of the following acts as a humectant commonly used in soft capsule shells?

• Sodium chloride
• Glycerol
• Calcium carbonate
• Magnesium stearate

Correct Answer: Glycerol

Q8. High moisture content in gelatin shells can cause which issue during storage?

• Improved oxidative stability
• Increased microbial growth and stickiness
• Lower flexibility
• Reduced plasticizer efficiency

Correct Answer: Increased microbial growth and stickiness

Q9. Which manufacturing process is commonly used for continuous production of soft gelatin capsules?

• Tablet compression
• Rotary die process
• Spray drying
• Freeze drying

Correct Answer: Rotary die process

Q10. Which analytical technique is useful for detecting chemical incompatibility between shell and liquid fill?

• Dissolution testing only
• Fourier transform infrared spectroscopy (FTIR)
• Tablet hardness tester
• Bulk density measurement

Correct Answer: Fourier transform infrared spectroscopy (FTIR)

Q11. Which plasticizer is known to be less hygroscopic and often used to reduce moisture uptake?

• Sorbitol
• Glycerol
• Polyethylene glycol (PEG) 400
• Water

Correct Answer: Sorbitol

Q12. A common visual defect of soft capsules caused by improper drying is:

• Tacky surface and sticking
• Perfectly round shape
• Improved dissolution profile
• Reduced microbial count

Correct Answer: Tacky surface and sticking

Q13. Which factor does NOT directly affect the mechanical strength of a soft capsule shell?

• Bloom strength of gelatin
• Plasticizer concentration
• Fill colorant concentration (if non-reactive)
• Moisture content

Correct Answer: Fill colorant concentration (if non-reactive)

Q14. Which environmental condition accelerates cross‑linking and toughening of gelatin shells?

• Low humidity storage
• High humidity and elevated temperature
• Refrigerated storage
• Inert nitrogen atmosphere

Correct Answer: High humidity and elevated temperature

Q15. Which additive is used in shell formulations to prevent microbial growth?

• Antioxidants only
• Preservatives such as parabens or sorbic acid
• Colorants
• Sodium chloride as filler

Correct Answer: Preservatives such as parabens or sorbic acid

Q16. What effect does PEG of higher molecular weight have when used in shell formulations?

• Increases hydrophilicity and decreases film strength
• Acts as a volatile solvent
• Provides plasticizing with lower hygroscopicity and higher viscosity
• Always causes shell brittleness

Correct Answer: Provides plasticizing with lower hygroscopicity and higher viscosity

Q17. Which compatibility issue arises when an aqueous shell encloses an oxidizable liquid fill?

• Reduced oxidation risk due to water barrier
• Increased oxidation due to permeation of oxygen through shell
• Immediate polymerization of fill
• No interaction expected

Correct Answer: Increased oxidation due to permeation of oxygen through shell

Q18. Which test helps determine the thermal behavior and glass transition of shell materials?

• UV spectroscopy
• Differential scanning calorimetry (DSC)
• pH measurement
• Friability test

Correct Answer: Differential scanning calorimetry (DSC)

Q19. For enteric protection of a soft capsule, which approach is commonly used?

• Reducing shell thickness only
• Applying an enteric coating over the shell
• Increasing glycerol content
• Using unmodified gelatin alone

Correct Answer: Applying an enteric coating over the shell

Q20. Which property of gelatin influences the viscosity of shell mass during manufacturing?

• Bloom strength and molecular weight distribution
• Tablet hardness
• Color of gelatin
• Packaging material

Correct Answer: Bloom strength and molecular weight distribution

Q21. Which failure mode indicates inadequate sealing of soft capsules?

• Leakage or fill migration at seam
• Improved dissolution time
• Reduced moisture content
• Higher bloom strength

Correct Answer: Leakage or fill migration at seam

Q22. Which excipient in the fill can cause shell softening or swelling if it migrates into the shell?

• Nonvolatile oils with no affinity for shell
• Low molecular weight alcohols or solvents
• Inert pigments
• Solid fillers

Correct Answer: Low molecular weight alcohols or solvents

Q23. Which regulatory consideration is important when selecting gelatin source for soft capsules?

• Color only
• Animal origin (bovine, porcine, fish), religious and safety concerns
• Melting point exclusively
• All gelatin sources are interchangeable without documentation

Correct Answer: Animal origin (bovine, porcine, fish), religious and safety concerns

Q24. Which parameter is critical for ensuring consistent fill weight in rotary die soft gelgers?

• Die temperature and pump/flow rate control
• Color of the shell mass
• Packaging speed only
• Ambient light level

Correct Answer: Die temperature and pump/flow rate control

Q25. What is a common analytical method to detect residual solvents or volatile impurities in soft capsule fills?

• Gas chromatography (GC)
• Disintegration testing
• FTIR in solid phase only
• Microscopy

Correct Answer: Gas chromatography (GC)

Q26. Which antioxidant is often used in oil fills to prevent oxidation without affecting the shell?

• Ascorbyl palmitate or tocopherol (vitamin E)
• Sorbitol
• High concentration of glycerol
• Sodium chloride

Correct Answer: Ascorbyl palmitate or tocopherol (vitamin E)

Q27. What does a tack test evaluate for soft capsule shells?

• Chemical compatibility only
• Surface stickiness and tendency to adhere
• Colorfastness under light
• Microbial contamination

Correct Answer: Surface stickiness and tendency to adhere

Q28. Which storage condition is generally recommended to maintain soft capsule shell quality?

• High temperature, high humidity
• Controlled cool, low to moderate humidity
• Direct sunlight and heat
• Freezing temperatures for all formulations

Correct Answer: Controlled cool, low to moderate humidity

Q29. Why is microbial control particularly important for gelatin‑based shells?

• Gelatin is highly acidic and self‑sterilizing
• Gelatin is a proteinaceous substrate that can support microbial growth
• Microbes cannot survive in gelatin films
• Gelatin always contains preservatives inherently

Correct Answer: Gelatin is a proteinaceous substrate that can support microbial growth

Q30. When evaluating a soft capsule formulation for long‑term stability, which of the following should be monitored?

• Only color changes
• Physical integrity, moisture content, dissolution, and chemical degradation of fill and shell
• Only initial appearance at time zero
• Only packaging aesthetics

Correct Answer: Physical integrity, moisture content, dissolution, and chemical degradation of fill and shell

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