Pelletization process MCQs With Answer

Pelletization is a key unit operation in pharmaceutical technology that converts fine powders into free‑flowing, spherical aggregates (pellets) suitable for capsule filling, tableting, and modified‑release formulations. This process—using techniques like extrusion–spheronization, pan (disc) pelletizing, and layered pelletization—depends on controlled nucleation, accretion, and consolidation influenced by binders, granulation liquid, equipment speed, and drying method. Critical quality attributes include size distribution, sphericity, porosity, mechanical strength, and surface morphology, which affect dissolution, content uniformity, and stability. Mastery of process variables, troubleshooting common defects, and appropriate analytical tests is essential for formulation scientists. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of pelletization in pharmaceutical manufacturing?

  • To convert liquids into semi-solids
  • To produce spherical, free‑flowing granules for controlled dosing
  • To improve powder color and odor
  • To sterilize powders before tableting

Correct Answer: To produce spherical, free‑flowing granules for controlled dosing

Q2. Which mechanism is NOT typically involved in pellet growth during wet pelletization?

  • Nucleation
  • Accretion
  • Consolidation
  • Osmotic shocking

Correct Answer: Osmotic shocking

Q3. Which technique is best described as blending, wet massing, extrusion, spheronization, drying, and sizing?

  • Pan pelletizing
  • Fluidized bed layering
  • Extrusion–spheronization
  • Spray drying

Correct Answer: Extrusion–spheronization

Q4. In pan (disc) pelletizing, which parameter most directly affects pellet size?

  • Pan angle and rotational speed
  • Final drying temperature
  • Type of lubricant used in tableting
  • Tablet compression force

Correct Answer: Pan angle and rotational speed

Q5. Which binder property is most important for forming strong, coherent wet masses during pelletization?

  • High melting point
  • Appropriate viscosity and adhesive strength
  • Strong alkalinity
  • Low molecular weight volatile solvents

Correct Answer: Appropriate viscosity and adhesive strength

Q6. Which equipment is commonly used for layered (solution or suspension) pelletization?

  • Rotary tablet press
  • Fluidized bed coater/pelletizer
  • High-shear granulator only
  • Lyophilizer

Correct Answer: Fluidized bed coater/pelletizer

Q7. What is the role of spheronization in extrusion–spheronization?

  • To dry pellets at high temperature
  • To round extrudates into near‑spherical pellets by friction and rolling
  • To coat pellets with polymers
  • To mix active ingredients with filler

Correct Answer: To round extrudates into near‑spherical pellets by friction and rolling

Q8. Which attribute of pellets most strongly influences release rate for immediate release formulations?

  • Color
  • Porosity and surface area
  • Production date
  • Packaging material

Correct Answer: Porosity and surface area

Q9. Which test assesses mechanical robustness of pellets to simulate handling and coating stresses?

  • Viscosity measurement
  • Friability testing
  • Thermogravimetric analysis
  • pH titration

Correct Answer: Friability testing

Q10. High binder spray rate during layering commonly causes which defect?

  • Excessive sphericity
  • Agglomeration and sticking
  • Improved dispersibility
  • Reduced particle density only

Correct Answer: Agglomeration and sticking

Q11. What is the significance of pellet size distribution (PSD) in final dosage forms?

  • It only affects color uniformity
  • PSD affects content uniformity, release profile, and flow properties
  • PSD determines tablet hardness exclusively
  • PSD is irrelevant for coated pellets

Correct Answer: PSD affects content uniformity, release profile, and flow properties

Q12. Which measurement indicates pellet sphericity quantitatively?

  • Aspect ratio or circularity from image analysis
  • Melting point
  • Intrinsic viscosity
  • pKa of the drug

Correct Answer: Aspect ratio or circularity from image analysis

Q13. During drying of pellets, why is controlled drying rate important?

  • To maximize residual solvent content
  • To avoid cracking, shrinkage, and loss of mechanical strength
  • To cause complete amorphization of the API
  • To change the drug’s chemical identity

Correct Answer: To avoid cracking, shrinkage, and loss of mechanical strength

Q14. Which excipient is commonly used as a spheronization aid and filler in extrusion–spheronization?

  • Microcrystalline cellulose (MCC)
  • Magnesium stearate exclusively
  • Polyethylene glycol 4000 solely
  • Sodium chloride

Correct Answer: Microcrystalline cellulose (MCC)

Q15. What is the main advantage of pellet dosage forms over conventional granules?

  • Pellets always eliminate the need for coating
  • Improved uniformity, reduced dose dumping, and flexibility for modified release
  • Pellets are cheaper to produce in all cases
  • Pellets never require drying

Correct Answer: Improved uniformity, reduced dose dumping, and flexibility for modified release

Q16. Which parameter in a pan pelletizer helps control wetting and layering efficiency?

  • Binder spray position and spray rate
  • Ambient air pressure inside the capsule
  • Tablet compression dwell time
  • Color of the pan

Correct Answer: Binder spray position and spray rate

Q17. What effect does increasing pellet porosity generally have on drug release?

  • Slower release due to pore closure
  • Faster release because of greater solvent penetration
  • No effect on release kinetics
  • Causes immediate chemical degradation

Correct Answer: Faster release because of greater solvent penetration

Q18. Which troubleshooting measure is appropriate if pellets show excessive dusting after drying?

  • Increase drying temperature drastically
  • Adjust binder concentration or apply a light polymer coating
  • Replace API with a larger molecule
  • Reduce pellet porosity by adding volatile solvents

Correct Answer: Adjust binder concentration or apply a light polymer coating

Q19. Which polymer is commonly used for sustained‑release coatings on pellets?

  • Ethylcellulose
  • Sodium chloride
  • Magnesium stearate
  • Citric acid

Correct Answer: Ethylcellulose

Q20. In extrusion–spheronization, what is the consequence of an overly dry wet mass during extrusion?

  • Improved spheronization yield
  • Poor extrusion, irregular extrudates, and low sphericity
  • Faster drying time with no side effects
  • Enhanced binder adhesion

Correct Answer: Poor extrusion, irregular extrudates, and low sphericity

Q21. What is the purpose of size classification (sieving) after pellet production?

  • To selectively remove API from pellets
  • To obtain a defined size fraction for consistent dosing and coating
  • To change the chemical composition of pellets
  • To sterilize the pellets

Correct Answer: To obtain a defined size fraction for consistent dosing and coating

Q22. Which analytical technique is frequently used to study pellet surface morphology?

  • Scanning electron microscopy (SEM)
  • pH meter
  • UV–Vis spectroscopy
  • Karl Fischer titration

Correct Answer: Scanning electron microscopy (SEM)

Q23. What does a high SPAN value indicate about pellet size distribution?

  • Very narrow size distribution
  • Broad size distribution with wide variability
  • Complete uniformity of particle shape
  • Exclusive presence of nanoparticles

Correct Answer: Broad size distribution with wide variability

Q24. Which drying method is most suitable for heat‑sensitive pellets?

  • Tray drying at very high temperatures
  • Fluidized bed drying with controlled temperature and gentle air
  • Direct flame drying
  • Autoclave sterilization

Correct Answer: Fluidized bed drying with controlled temperature and gentle air

Q25. Which factor primarily influences the density and flowability of pellets?

  • Ambient light intensity during production
  • Compression force during tablet pressing only
  • Particle size, porosity, and surface roughness
  • Type of glassware used

Correct Answer: Particle size, porosity, and surface roughness

Q26. Layered pelletization in a fluidized bed often uses which mode to apply coating solution?

  • Top-spray or Wurster bottom-spray modes
  • Tablet press mode
  • Lyophilization mode
  • Rotary evaporation mode

Correct Answer: Top-spray or Wurster bottom-spray modes

Q27. Which issue is indicated by pellets with rough, pitted surfaces after drying?

  • Excessive binder causing smoothness
  • Too rapid drying causing surface collapse and voids
  • Perfect formulation and process control
  • Lack of API in the formulation

Correct Answer: Too rapid drying causing surface collapse and voids

Q28. For multiparticulate modified‑release systems, why are pellets preferred?

  • They always eliminate inter-patient variability
  • They allow dose flexibility, reduce local GI irritation, and provide predictable release
  • They ensure immediate release only
  • They are easier to sterilize than tablets

Correct Answer: They allow dose flexibility, reduce local GI irritation, and provide predictable release

Q29. Which change would typically reduce pellet friability?

  • Decrease binder concentration
  • Improve binder adhesion or increase drying consolidation
  • Increase porosity drastically
  • Remove all spheronization steps

Correct Answer: Improve binder adhesion or increase drying consolidation

Q30. Which of the following is an advantage of using multiparticulate pellets in capsule formulations?

  • Higher risk of dose dumping compared with single units
  • Uniform GI transit, reduced variability, and ability to mix pellets for combination therapy
  • Incompatibility with coatings
  • Inability to achieve modified release

Correct Answer: Uniform GI transit, reduced variability, and ability to mix pellets for combination therapy

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