Filling and finishing of hard gelatin capsules MCQs With Answer

Introduction: Filling and finishing of hard gelatin capsules is a core topic in pharmaceutics for B.Pharm students, covering capsule shell composition, filling techniques, excipient selection, machine types, and quality control tests. This topic explores encapsulation processes such as hand-filling, tamping, dosator and rotary capsule filling machines, as well as finishing operations like polishing, banding, sealing and storage considerations. Key concepts include fill weight calculation, powder flow, glidants, lubricants, moisture effects on gelatin, content uniformity, disintegration and dissolution testing, and common defects with troubleshooting. Mastery of these principles ensures safe, reproducible capsule dosage forms. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary function of a plasticizer in hard gelatin capsule shells?

• Increase capsule rigidity
• Reduce shell brittleness
• Act as a preservative
• Enhance disintegration time

Correct Answer: Reduce shell brittleness

Q2. Which excipient is commonly used to improve powder flow during capsule filling?

• Magnesium stearate
• Talc
• Colloidal silicon dioxide
• Sucrose

Correct Answer: Colloidal silicon dioxide

Q3. The dosator capsule filling method is best suited for which type of formulation?

• Free-flowing powders only
• Sticky pastes
• Granules and powders with moderate flow
• Liquid fills

Correct Answer: Granules and powders with moderate flow

Q4. Which test is most appropriate for assessing uniformity of fill weight in capsules?

• Friability test
• Weight variation test
• Disintegration test
• Assay by HPLC

Correct Answer: Weight variation test

Q5. Which property of gelatin most influences capsule shell moisture sensitivity?

• Bloom strength
• Viscosity of gelatin solution
• Protein content
• Plasticizer type and content

Correct Answer: Plasticizer type and content

Q6. What is the main purpose of banding or sealing finished hard gelatin capsules?

• Improve capsule color
• Prevent tampering and leakage
• Increase dissolution rate
• Enhance shell plasticity

Correct Answer: Prevent tampering and leakage

Q7. In capsule filling machines, what does a rotary capsule filling machine primarily increase?

• Formulation stability
• Production throughput
• Capsule dissolution speed
• Shell flexibility

Correct Answer: Production throughput

Q8. Which lubricant is commonly used to reduce die wall friction during capsule filling?

• Sodium lauryl sulfate
• Magnesium stearate
• Lactose monohydrate
• Methocel

Correct Answer: Magnesium stearate

Q9. Which factor most directly affects the choice of capsule size for a formulation?

• Capsule shell color
• Fill weight and bulk density
• Disintegration medium
• Number of excipients

Correct Answer: Fill weight and bulk density

Q10. What is the principal cause of capping or splitting of hard gelatin capsule shells during filling?

• Excessive shell moisture
• Insufficient fill weight
• Overlubrication of powder
• High fill speed and mechanical stress

Correct Answer: High fill speed and mechanical stress

Q11. Which finishing operation removes surface powder from capsules to improve appearance?

• Banding
• Polishing
• Coating
• Sealing

Correct Answer: Polishing

Q12. For content uniformity in low-dose potent drugs, which approach is most suitable during capsule filling?

• Direct compression into caps
• Use of granulation or carrier dilution
• Increasing capsule shell thickness
• Reducing capsule size

Correct Answer: Use of granulation or carrier dilution

Q13. What does the term “fill factor” refer to in capsule formulation?

• Ratio of capsule shell thickness to diameter
• Volume of powder occupied per unit capsule volume
• Percentage of plasticizer in the shell
• Time required for filling per batch

Correct Answer: Volume of powder occupied per unit capsule volume

Q14. Which environmental condition is most critical for storage of empty hard gelatin capsules?

• Light exposure
• Relative humidity and temperature
• Oxygen concentration
• Vibration

Correct Answer: Relative humidity and temperature

Q15. Which excipient is used to reduce static and improve flow during capsule filling?

• Colloidal silicon dioxide
• Sodium chloride
• Hydroxypropyl methylcellulose
• Gelatin

Correct Answer: Colloidal silicon dioxide

Q16. What is the effect of excessive magnesium stearate on capsule dissolution?

• Speeds dissolution by improving wetting
• No effect on dissolution
• May retard dissolution by forming hydrophobic film
• Enhances capsule shell strength

Correct Answer: May retard dissolution by forming hydrophobic film

Q17. Which QC test determines the time taken for a capsule to break down into particles under specified conditions?

• Dissolution test
• Disintegration test
• Weight variation test
• Assay

Correct Answer: Disintegration test

Q18. When calculating fill weight for a given capsule size, which two parameters are essential?

• Capsule color and shell manufacturer
• Bulk density of fill and capsule fill volume
• Disintegration time and dissolution medium
• Plasticizer content and gelatin bloom

Correct Answer: Bulk density of fill and capsule fill volume

Q19. Which problem during filling indicates poor powder flow and rat-holing in the hopper?

• Overlubrication
• Variable fill weights
• Rapid machine speed
• High humidity only

Correct Answer: Variable fill weights

Q20. Which sealing method is used to prevent Tampering and microbial ingress in hard gelatin capsules?

• Banding with gelatin or polymer solution
• Simply polishing
• Reducing capsule size
• Adding more plasticizer

Correct Answer: Banding with gelatin or polymer solution

Q21. Why is moisture content of capsule shells controlled tightly?

• To increase coloring efficiency
• To maintain shell flexibility and prevent brittleness or stickiness
• To reduce capsule diameter
• To alter API potency

Correct Answer: To maintain shell flexibility and prevent brittleness or stickiness

Q22. Which filling technique is preferred for liquid or semi-solid fills into hard gelatin capsules?

• Dosator method
• Rotary tamping
• Sealed soft-gel encapsulation
• Liquid filling with sealing or banding after fill

Correct Answer: Liquid filling with sealing or banding after fill

Q23. What is a critical control point when operating automatic capsule filling machines?

• Shell color selection
• Control of fill weight and turret speed
• Disintegration medium temperature only
• Choice of polishing solvent

Correct Answer: Control of fill weight and turret speed

Q24. Which analytical method is commonly used to assay drug content in capsules?

• Microscopy
• High-performance liquid chromatography (HPLC)
• Loss on drying
• Friability testing

Correct Answer: High-performance liquid chromatography (HPLC)

Q25. What is the likely cause of mottling or discoloration on finished capsules?

• Incorrect fill weight
• Uneven coating or interaction between shell and fill components
• Excessive polishing only
• Too much glidant

Correct Answer: Uneven coating or interaction between shell and fill components

Q26. Which parameter is NOT typically evaluated during finished capsule QC?

• Dissolution
• Disintegration
• Capsule tensile strength
• Friability of tablets

Correct Answer: Friability of tablets

Q27. What is the role of diluents in capsule formulations?

• Act as preservatives
• Increase bulk to achieve workable fill weight
• Improve shell elasticity
• Reduce disintegration

Correct Answer: Increase bulk to achieve workable fill weight

Q28. Which excipient can act as both a binder in granules and a filler in capsules?

• Lactose
• Magnesium stearate
• Colloidal silicon dioxide
• Gelatin

Correct Answer: Lactose

Q29. For enteric protection of capsule fill, which finishing approach is applied?

• Immediate-release coating
• Enteric coating of capsule or sealing enteric-coated pellets inside
• Polishing with alcohol
• Increasing plasticizer content

Correct Answer: Enteric coating of capsule or sealing enteric-coated pellets inside

Q30. What is the recommended action if capsules show sticking to pins during filling?

• Increase turret speed
• Reduce humidity, use anti-adherent, or adjust formulation glidants
• Increase shell moisture dramatically
• Remove plasticizer from shells

Correct Answer: Reduce humidity, use anti-adherent, or adjust formulation glidants

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