Advanced granulation and pelletization technologies MCQs With Answer

Introduction: Advanced granulation and pelletization technologies MCQs With Answer is designed for M.Pharm students aiming to deepen their understanding of modern particle engineering techniques used in pharmaceutical manufacturing. This collection focuses on principles, process variables, equipment, and critical quality attributes of granules and pellets, including fluid-bed granulation, high-shear wet granulation, extrusion–spheronization, melt granulation, and layering techniques. Questions emphasize mechanism of granule formation, binder selection, process optimization, scale-up considerations, PAT tools, and troubleshooting common defects. The MCQs are tailored to challenge analytical thinking and prepare students for exams and practical applications in formulation development and continuous manufacturing environments.

Q1. What is the primary mechanism of particle aggregation during high-shear wet granulation?

• Electrostatic attraction between dry particles
• Capillary forces and liquid bridges formed by binder solution
• Thermal fusion due to high process temperature
• Mechanical interlocking from irregular particle shapes

Correct Answer: Capillary forces and liquid bridges formed by binder solution

Q2. In extrusion–spheronization, which step most critically determines final pellet sphericity?

• Drying rate after spheronization
• Wet massing and pellet plasticity before extrusion
• Extrusion die geometry alone
• Coating applied after pellet formation

Correct Answer: Wet massing and pellet plasticity before extrusion

Q3. Which advantage is most associated with melt granulation compared to aqueous wet granulation?

• Requires more solvent handling and drying time
• Avoids use of water or organic solvents and reduces drying step
• Produces larger, more friable granules
• Is incompatible with thermolabile drugs due to high temperatures

Correct Answer: Avoids use of water or organic solvents and reduces drying step

Q4. During fluid-bed pellet coating in a Wurster column, which parameter most influences coating uniformity?

• Tablet hardness prior to coating
• Atomization droplet size and spray rate
• Core color
• Coating pan rotation speed

Correct Answer: Atomization droplet size and spray rate

Q5. Which characterization parameter best indicates the tendency of pellets to segregate during processing?

• Bulk density and particle size distribution
• Melting point of drug
• Tablet disintegration time
• API molecular weight

Correct Answer: Bulk density and particle size distribution

Q6. Which binder property is most important to control during granulation to achieve robust granules?

• Color and taste
• Viscosity and concentration of binder solution
• Optical clarity
• Thermal conductivity

Correct Answer: Viscosity and concentration of binder solution

Q7. In twin-screw extrusion for pellet formation, what is the primary role of screw configuration?

• To change the chemical composition of API
• To control residence time, shear, and distributive/kneading intensity
• To reduce API solubility
• To permanently cool the mass

Correct Answer: To control residence time, shear, and distributive/kneading intensity

Q8. Which PAT (Process Analytical Technology) tool is commonly used online to monitor moisture during fluid-bed granulation?

• Near-infrared spectroscopy (NIR)
• High-performance liquid chromatography (HPLC)
• Gas chromatography (GC)
• Inductively coupled plasma (ICP)

Correct Answer: Near-infrared spectroscopy (NIR)

Q9. What is the main reason for spray drying to produce spherical microparticles relative to other methods?

• Low evaporation rates yield porous irregular shapes
• Rapid solvent evaporation from droplets promotes rapid solidification into spherical shapes
• Mechanical compression forms spheres
• Use of surfactants forces crystallization into rods

Correct Answer: Rapid solvent evaporation from droplets promotes rapid solidification into spherical shapes

Q10. During scale-up of a wet granulation process, which dimensionless number helps maintain similarity in granule growth behavior?

• Reynolds number and Froude number combinations for mixing and fluidization
• pH number
• API Biopharmaceutics Classification System (BCS) class
• Glass transition temperature only

Correct Answer: Reynolds number and Froude number combinations for mixing and fluidization

Q11. Which defect in pellets is most likely caused by excessive spray liquid addition during layering?

• Hard, non-disintegrating pellets
• Sticking and agglomeration leading to oversized pellets
• Complete dissolution during layering
• Loss of API potency due to oxidation

Correct Answer: Sticking and agglomeration leading to oversized pellets

Q12. What does a high friability value indicate about pellets?

• Pellets are mechanically robust and hard
• Pellets are likely to break or generate fines during handling
• Pellets have very low porosity
• Pellets will not disintegrate in GI tract

Correct Answer: Pellets are likely to break or generate fines during handling

Q13. In formulation of sustained-release pellets, which polymer property is most critical for controlling drug release?

• Thermal conductivity
• Polymer permeability and erosion characteristics
• Optical reflectivity
• Magnetic susceptibility

Correct Answer: Polymer permeability and erosion characteristics

Q14. Which parameter best describes the internal structure affecting dissolution of pellets: porosity, particle size, or density?

• Only particle color matters
• Porosity primarily determines internal surface area and solvent ingress
• Density has no role in dissolution
• Particle size alone fully predicts dissolution

Correct Answer: Porosity primarily determines internal surface area and solvent ingress

Q15. What is the nucleation-dominant stage in granule growth during sprayed liquid addition?

• When large aggregates break down mechanically
• Initial formation of small nuclei as binder wets primary particles
• Only after complete drying of the bed
• After coating is applied to tablets

Correct Answer: Initial formation of small nuclei as binder wets primary particles

Q16. For pellet coating to achieve enteric release, which coating property is most essential?

• High water solubility at pH 1
• pH-dependent solubility that resists gastric pH and dissolves at intestinal pH
• Low melting point to dissolve at body temperature
• High oxygen permeability

Correct Answer: pH-dependent solubility that resists gastric pH and dissolves at intestinal pH

Q17. Which process variable is most directly related to granule density in fluid-bed granulation?

• API pKa
• Binder spray rate and droplet penetration leading to densification
• Tablet compression force
• Ambient light intensity

Correct Answer: Binder spray rate and droplet penetration leading to densification

Q18. In extrusion–spheronization, which excipient is commonly used to provide plasticity and aid spheronization?

• Lactose monohydrate only
• Microcrystalline cellulose (MCC)
• Sodium chloride
• Talc as the primary binder

Correct Answer: Microcrystalline cellulose (MCC)

Q19. Which analytical method can quantify layering uniformity in multi-layered pellets non-destructively?

• Disintegration test
• X-ray computed tomography (micro-CT)
• Simple visual inspection only
• Melting point analysis

Correct Answer: X-ray computed tomography (micro-CT)

Q20. When designing continuous granulation processes, what is a key advantage over batch granulation?

• Greater batch-to-batch variability
• Improved process control, consistent product quality, and easier scale-up
• Higher solvent usage and longer drying times
• Incompatibility with PAT tools

Correct Answer: Improved process control, consistent product quality, and easier scale-up

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