Non-sterile manufacturing – tablets and capsules MCQs With Answer

Introduction: This set of MCQs on non-sterile manufacturing — focused on tablets and capsules — is designed for M.Pharm students to strengthen practical and theoretical understanding of formulation, processing, and quality control. Questions probe critical topics such as powder flow, granulation techniques (wet, dry, direct compression), compression mechanics, excipient selection, in-process controls, common defects (capping, lamination, sticking), capsule filling technologies, and coating principles. Each question emphasizes applied knowledge useful for manufacturing decisions, scale-up, troubleshooting, and regulatory compliance. Use these MCQs to test readiness for exams and industry roles, and to identify areas needing deeper study in pharmaceutical manufacturing technology.

Q1. Which primary objective does granulation serve in tablet manufacturing?

• Improve powder flow and compressibility for uniform tablet weight and content
• Increase active pharmaceutical ingredient (API) chemical stability against oxidation
• Reduce tablet disintegration time to less than 30 seconds
• Completely eliminate the need for lubricants in compression

Correct Answer: Improve powder flow and compressibility for uniform tablet weight and content

Q2. Which excipient is commonly used as a dry binder in direct compression formulations?

• Microcrystalline cellulose (MCC)
• Sodium lauryl sulfate (SLS)
• Magnesium stearate
• Croscarmellose sodium

Correct Answer: Microcrystalline cellulose (MCC)

Q3. During rotary tablet compression, which parameter most directly affects tablet hardness and thickness?

• Compression force (upper punch pressure)
• Feed frame speed
• Lactose particle size
• Coating pan rotation speed

Correct Answer: Compression force (upper punch pressure)

Q4. Which phenomenon is characterized by separation of a tablet into layers during or after compression?

• Capping
• Twinning
• Lamination
• Picking

Correct Answer: Lamination

Q5. Which of the following glidants is most commonly used to improve powder flow in tablet blends?

• Colloidal silicon dioxide (Aerosil)
• Sodium starch glycolate
• Povidone (PVP)
• Stearic acid

Correct Answer: Colloidal silicon dioxide (Aerosil)

Q6. In wet granulation, what is the primary role of a binder solution?

• Promote adhesion between powder particles to form granules
• Act as a disintegrant to speed dissolution
• Provide lubrication of punch surfaces
• Reduce API solubility in the granules

Correct Answer: Promote adhesion between powder particles to form granules

Q7. Which in-process control is essential to monitor during tablet compression to ensure content uniformity?

• Weight variation of tablets
• Tablet coating color intensity
• Dissolution at 60 minutes only
• pH of granulation binder

Correct Answer: Weight variation of tablets

Q8. Which lubricant is most likely to cause a pronounced decrease in tablet hardness and slower dissolution when overused?

• Magnesium stearate
• Microcrystalline cellulose
• Sodium chloride
• Sorbitol

Correct Answer: Magnesium stearate

Q9. Which capsule shell material is derived from animal sources and is sensitive to humidity?

• Gelatin
• HPMC (hypromellose)
• Pullulan
• Ethylcellulose

Correct Answer: Gelatin

Q10. What is the main purpose of adding a disintegrant to a tablet formulation?

• Promote break-up of the tablet into primary particles to aid dissolution
• Increase powder flow to the dies
• Act as a primary diluent to reduce potency
• Control the pH of the dissolution medium

Correct Answer: Promote break-up of the tablet into primary particles to aid dissolution

Q11. Which of the following is a common cause of tablet sticking to the punch face?

• High tackiness due to inadequate lubrication or sticky granules
• Excessive cooling of granules
• Using too much antiadherent silica
• Very low tablet compression force

Correct Answer: High tackiness due to inadequate lubrication or sticky granules

Q12. In capsule filling, what distinguishes the tamping vs. dosator filling methods?

• Tamping compresses powder into a confined volume; dosator uses a measured powder plug in a tube
• Tamping injects molten material; dosator is for liquid fills only
• Tamping is used exclusively for softgels; dosator is for hard capsules
• Tamping produces sealed capsules; dosator produces unsealed capsules

Correct Answer: Tamping compresses powder into a confined volume; dosator uses a measured powder plug in a tube

Q13. Which property of granules best correlates with decreased tablet capping and lamination?

• Optimal granule density and controlled porosity
• Extremely low moisture (<0.1%) in granules
• Very large single-particle size (>2000 µm)
• High surface oil content from excessive lubricant

Correct Answer: Optimal granule density and controlled porosity

Q14. Which test is most appropriate to assess the mechanical strength of a tablet?

• Tablet hardness/tensile strength test
• Friability test only
• Disintegration time test only
• pH of dissolution medium

Correct Answer: Tablet hardness/tensile strength test

Q15. Which coating type is primarily used to protect acid-labile APIs from gastric degradation?

• Enteric coating
• Immediate-release sugar coating
• Opacifying cosmetic coating
• Polyethylene glycol film-coating for taste-masking

Correct Answer: Enteric coating

Q16. The Heckel analysis is used to characterize which aspect of powder compaction?

• Plastic deformation and compressibility behavior of powders
• Surface roughness of punch tooling
• Permeability of coated films
• Viscosity of granulation binders

Correct Answer: Plastic deformation and compressibility behavior of powders

Q17. Which parameter is most critical to control during drying of wet granules to avoid over-drying?

• Final granule moisture content
• Binder molecular weight only
• Ambient room lighting
• Tablet hardness before compression

Correct Answer: Final granule moisture content

Q18. What is the principal advantage of direct compression over wet granulation?

• Simpler process with fewer unit operations and reduced heat/moisture exposure
• Always results in faster dissolution than granulated tablets
• Eliminates need for lubricants and glidants
• Allows use of any powder regardless of flow or compressibility

Correct Answer: Simpler process with fewer unit operations and reduced heat/moisture exposure

Q19. Which quality attribute of capsules is critical for patients requiring consistent dosing and is routinely tested?

• Uniformity of dosage units (content uniformity or weight variation)
• Elastic modulus of the capsule material
• Optical clarity of the capsule shell
• Electrical conductivity of the fill material

Correct Answer: Uniformity of dosage units (content uniformity or weight variation)

Q20. Which corrective action is most appropriate when tablets show unacceptable friability after compression?

• Increase compression force or adjust binder level to improve tablet hardness
• Remove all disintegrant from formulation
• Decrease punch speed without any formulation changes
• Switch to a softer coating polymer

Correct Answer: Increase compression force or adjust binder level to improve tablet hardness

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