Introduction: Granulation methods in tablet manufacturing are essential processes that convert fine powders into free-flowing, compressible granules. For B.Pharm students, understanding wet granulation, dry granulation (roller compaction and slugging), and advanced techniques like fluid bed and high-shear granulation is vital. Key concepts include binders, plastic and brittle deformation, granule size distribution, moisture control, drying, and how granulation affects tablet hardness, disintegration, and dissolution. Equipment parameters, process variables, and common defects (capping, lamination) are critical for quality-by-design and scale-up. Mastery of granule properties, analytical tests, and formulation strategies ensures robust tablet manufacturing. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which granulation method is most suitable for moisture-sensitive drugs?
- Wet granulation using aqueous binder
- Fluid bed granulation
- Dry granulation by roller compaction
- Spray drying
Correct Answer: Dry granulation by roller compaction
Q2. What is the primary role of a binder in wet granulation?
- Reduce particle size
- Promote interparticle adhesion to form granules
- Increase tablet disintegration time intentionally
- Act as a lubricant during compression
Correct Answer: Promote interparticle adhesion to form granules
Q3. Which parameter in a high-shear granulator most directly affects granule density and size?
- Impeller speed
- Tablet press compression force
- Coating pan rotation speed
- Lyophilization temperature
Correct Answer: Impeller speed
Q4. Roller compaction is a form of dry granulation; which property of the ribbons is most critical for producing uniform granules?
- Ribbon tensile strength and density
- Binder viscosity
- Spray rate of aqueous binder
- Coating spray temperature
Correct Answer: Ribbon tensile strength and density
Q5. Which mechanism best describes particle growth in wet granulation during nucleation stage?
- Size reduction by milling
- Aggregation of primary particles facilitated by liquid bridges
- Compression into tablets
- Evaporation of solvent only
Correct Answer: Aggregation of primary particles facilitated by liquid bridges
Q6. In fluid bed granulation, what is the primary function of inlet air temperature?
- Increase tablet hardness directly
- Control solvent evaporation rate and drying of granules
- Provide oxygen for binder polymerization
- Act as a granulating binder
Correct Answer: Control solvent evaporation rate and drying of granules
Q7. Which test is commonly used to assess granule flowability?
- Loss on drying
- Tapped density and angle of repose
- Disintegration time
- UV absorption
Correct Answer: Tapped density and angle of repose
Q8. What is a common disadvantage of wet granulation compared to dry granulation?
- Lower tablet uniformity
- Exposure of drug to moisture and heat
- Inability to use binders
- Produces highly friable granules always
Correct Answer: Exposure of drug to moisture and heat
Q9. Which excipient commonly acts as a filler and disintegrant and is widely used in granulation?
- Magnesium stearate
- Microcrystalline cellulose (MCC)
- Polytetrafluoroethylene
- Silicone oil
Correct Answer: Microcrystalline cellulose (MCC)
Q10. During wet granulation, over-wetting typically results in which granule characteristic?
- Excessively hard, dense granules that may over-compress
- Highly porous, weak granules
- No change in granule properties
- Immediate powder sublimation
Correct Answer: Excessively hard, dense granules that may over-compress
Q11. Which instrument is used to monitor granule moisture content during drying as a PAT tool?
- Near-infrared (NIR) spectroscopy
- Mass spectrometer for volatile organics only
- Atomic absorption spectrometer
- pH meter
Correct Answer: Near-infrared (NIR) spectroscopy
Q12. What is the main advantage of twin-screw granulation over single-screw extrusion for continuous wet granulation?
- Lower initial investment always
- Better control of residence time and mixing intensity
- Requires no binder
- Produces smaller tablets directly
Correct Answer: Better control of residence time and mixing intensity
Q13. Which binder property is most important to achieve good granule strength?
- Color intensity
- Adhesive strength and solubility/viscosity profile
- Magnetic susceptibility
- Boiling point above 300°C
Correct Answer: Adhesive strength and solubility/viscosity profile
Q14. Granules with high friability are likely to cause which tablet manufacturing issue?
- Improved dissolution only
- Segregation, weight variation, and increased fines
- No impact on downstream processing
- Enhanced tablet hardness always
Correct Answer: Segregation, weight variation, and increased fines
Q15. Which phenomenon causes capping and lamination in tablets related to granulation?
- Excessive tablet coating thickness
- Entrapped air, overstressed bonds, or inadequate granule plasticity
- Use of immediate-release excipients only
- Overuse of glidant leading to too much lubrication
Correct Answer: Entrapped air, overstressed bonds, or inadequate granule plasticity
Q16. Which of the following is an advantage of fluid bed granulation?
- Requires no heat
- Simultaneous granulation and drying with good control over particle size
- Produces the hardest possible granules regardless of formulation
- Always cheaper than high-shear granulation
Correct Answer: Simultaneous granulation and drying with good control over particle size
Q17. What role do glidants like colloidal silicon dioxide play in granules?
- Increase granule binding strength significantly
- Improve powder flow and reduce interparticle friction
- Act as primary diluents for tablets
- Function as disintegrants
Correct Answer: Improve powder flow and reduce interparticle friction
Q18. Which test measures the tendency of granules to form dust or break down under stress?
- Friability test
- Moisture sorption isotherm only
- FTIR spectrum
- Polarimetry
Correct Answer: Friability test
Q19. During roller compaction, which factor increases granule density?
- Decrease in roll pressure
- Increase in roll speed only
- Increase in compaction force/roll pressure
- Adding volatile solvents
Correct Answer: Increase in compaction force/roll pressure
Q20. Which granulation endpoint indicator is commonly used in a high-shear wet granulation batch?
- Visual appearance only
- Torque/power consumption of the impeller and granule size distribution
- Ambient humidity reading only
- Color change of binder
Correct Answer: Torque/power consumption of the impeller and granule size distribution
Q21. Which binder is water-soluble and frequently used in aqueous wet granulation?
- Polyvinylpyrrolidone (PVP)
- Magnesium stearate
- Calcium carbonate
- Sodium lauryl sulfate
Correct Answer: Polyvinylpyrrolidone (PVP)
Q22. What effect does increasing binder solution viscosity typically have on granulation?
- Less nucleation and formation of larger, denser granules
- Always increases tablet disintegration speed
- Decreases granule size uniformly
- Removes the need for drying
Correct Answer: Less nucleation and formation of larger, denser granules
Q23. Which granulation method best suits very cohesive APIs that exhibit poor flow?
- Direct compression without granulation
- Wet granulation using high-shear granulator
- Freeze-drying into tablets
- Topical ointment formulation
Correct Answer: Wet granulation using high-shear granulator
Q24. Which is a critical quality attribute (CQA) of granules affecting tablet uniformity?
- Granule color only
- Granule size distribution and assay uniformity
- Ambient room décor
- Packaging label font
Correct Answer: Granule size distribution and assay uniformity
Q25. Which lubricant is most commonly used in tablet formulations to reduce ejection force?
- Microcrystalline cellulose
- Magnesium stearate
- Polyethylene glycol 6000 as primary filler
- Hydroxypropyl methylcellulose as glidant
Correct Answer: Magnesium stearate
Q26. In granulation, what does porosity of granules influence most directly?
- Tablet color only
- Liquid penetration, dissolution rate, and compressibility
- Binder chemical stability only
- pH of the tablet core
Correct Answer: Liquid penetration, dissolution rate, and compressibility
Q27. Which statement about slugging (a dry granulation technique) is true?
- It produces highly uniform ribbons directly without milling
- It compacts powder into large compacts (slugs) which are milled to granules
- It requires wetting with organic solvents
- It is identical to spray drying
Correct Answer: It compacts powder into large compacts (slugs) which are milled to granules
Q28. Which process variable must be optimized to avoid thermal degradation during fluid bed drying?
- Binder chemical structure only
- Inlet air temperature and residence time
- Tablet coating bed speed
- Granule color
Correct Answer: Inlet air temperature and residence time
Q29. What is the likely consequence of excessive use of magnesium stearate in granules?
- Improved dissolution rate
- Hydrophobic layer formation leading to reduced tablet hardness and slower dissolution
- Increased binder activity
- Complete elimination of friability
Correct Answer: Hydrophobic layer formation leading to reduced tablet hardness and slower dissolution
Q30. Which analytical measurement helps predict compression behavior of granules?
- Fourier-transform infrared spectroscopy alone
- Compressibility index and tensile strength of compacts
- Colorimetric pH strip reading
- Optical rotation
Correct Answer: Compressibility index and tensile strength of compacts
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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