Evaluation of suppositories MCQs With Answer

Introduction: Evaluation of suppositories is a key B. Pharm competency that connects formulation science with therapeutic performance. This topic focuses on quality control tests such as appearance, weight variation, content uniformity, displacement value, softening/liquefaction time, disintegration and dissolution, in vitro drug release, mechanical strength (breaking/brittleness), and stability (rancidity, syneresis, polymorphism). You will relate base properties of cocoa butter (theobroma oil), polyethylene glycol (PEG), and glycerinated gelatin to drug release, select suitable analytical methods (HPLC/UV), and apply microbial limits, packaging, and storage conditions. Emphasis is placed on interpreting results and troubleshooting manufacturing defects to ensure safe, effective rectal, vaginal, and urethral dosage forms. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which test best assesses the performance of fatty-base suppositories at body temperature?

• Disintegration time at 25°C
• Softening (liquefaction) time at 37°C
• Friability in a tablet friabilator
• Melting range by capillary method at 60°C

Correct Answer: Softening (liquefaction) time at 37°C

Q2. A 2.0 g blank suppository must carry 300 mg of a drug with displacement value (DV) = 1.5. How much base is required per unit?

• 1.80 g
• 1.85 g
• 1.90 g
• 2.00 g

Correct Answer: 1.80 g

Q3. For PEG-based suppositories, the primary in vivo mechanism of drug release is:

• Melting followed by diffusion
• Dissolution of base followed by diffusion
• Sublimation followed by erosion
• Immediate partition into rectal fluid without base change

Correct Answer: Dissolution of base followed by diffusion

Q4. The “breaking strength” test in suppository evaluation primarily measures:

• Resistance to oxidative rancidity
• Force required to fracture the dosage unit
• Rate of drug release in dissolution
• Extent of weight variation among units

Correct Answer: Force required to fracture the dosage unit

Q5. According to pharmacopeial guidance on uniformity of mass for suppositories, which criterion is appropriate?

• Test 10 units; none may deviate by more than ±2%
• Test 20 units; not more than 2 deviate by >±5% and none by >±10%
• Test 30 units; mean mass must equal label claim ±1%
• Test 5 units; RSD must be below 3%

Correct Answer: Test 20 units; not more than 2 deviate by >±5% and none by >±10%

Q6. When is weight variation an acceptable surrogate for content uniformity in suppositories?

• When the drug is molecularly dispersed (solution) in the base
• When the drug is a coarse suspension in the base
• When the drug is adsorbed on a carrier
• When the suppository contains multiple active ingredients

Correct Answer: When the drug is molecularly dispersed (solution) in the base

Q7. Which storage condition best minimizes polymorphic changes and rancidity in cocoa butter suppositories?

• Warm, humid storage (30–35°C, high RH)
• Cool, dry storage with temperature stability (≤25°C)
• Direct sunlight exposure in clear blisters
• Frozen storage at −20°C

Correct Answer: Cool, dry storage with temperature stability (≤25°C)

Q8. The desirable crystalline form of cocoa butter in suppositories is the:

• Gamma form, m.p. ~18°C
• Alpha form, m.p. ~23°C
• Beta-prime form, m.p. ~28°C
• Beta form, m.p. ~34–36°C

Correct Answer: Beta form, m.p. ~34–36°C

Q9. For a lipophilic drug in a fatty base, drug release is often improved by:

• Increasing particle size of the drug
• Adding a suitable surfactant to enhance partitioning
• Raising storage temperature to near melting point
• Switching to a denser mold

Correct Answer: Adding a suitable surfactant to enhance partitioning

Q10. Exudation of oily droplets from fatty-base suppositories during storage is termed:

• Syneresis
• Bleeding
• Blooming
• Crazing

Correct Answer: Bleeding

Q11. Which index is most appropriate to monitor oxidative rancidity in fatty bases?

• Loss on drying
• Peroxide value
• Viscosity at 60°C
• Conductivity

Correct Answer: Peroxide value

Q12. Which suppository base commonly requires antimicrobial preservatives due to water content?

• Cocoa butter (theobroma oil)
• PEG blend (PEG 1000/4000)
• Glycerinated gelatin
• Hydrogenated vegetable oil

Correct Answer: Glycerinated gelatin

Q13. Mold lubrication is most critical for which base?

• Glycerinated gelatin
• Cocoa butter (self-lubricating)
• High-PEG formulations (non-adhesive)
• Compressed vaginal tablets

Correct Answer: Glycerinated gelatin

Q14. A commonly used apparatus for in vitro dissolution/release testing of suppositories is:

• USP Apparatus 2 (paddle) with sinker at 37°C
• USP Apparatus 4 (flow-through) at 60°C
• Disintegration tester at 25°C
• Cone-and-plate viscometer at 37°C

Correct Answer: USP Apparatus 2 (paddle) with sinker at 37°C

Q15. For membrane-controlled release evaluation of suppositories/ovules, a widely used setup is:

• Penetrometer
• Franz diffusion cell at 37°C
• Polarimeter
• Karl Fischer titrator

Correct Answer: Franz diffusion cell at 37°C

Q16. Why are “blank” suppositories prepared during displacement value calculations?

• To determine assay recovery
• To estimate the volume (mass) of base per mold cavity
• To evaluate microbial limits
• To test surfactant compatibility

Correct Answer: To estimate the volume (mass) of base per mold cavity

Q17. For suspended drug particles in a suppository, reducing particle size generally:

• Slows dissolution due to agglomeration
• Increases surface area and enhances release
• Has no effect on release
• Prevents sedimentation entirely

Correct Answer: Increases surface area and enhances release

Q18. Which step primarily limits sedimentation of suspended drug during pour-molding?

• Using a higher pouring temperature
• Increasing melt viscosity before pouring
• Avoiding any agitation
• Reducing mold cavity depth

Correct Answer: Increasing melt viscosity before pouring

Q19. Most performance-related tests for suppositories are conducted at:

• 25 ± 2°C
• 32 ± 2°C
• 37 ± 0.5°C
• 45 ± 1°C

Correct Answer: 37 ± 0.5°C

Q20. A physiologically relevant medium often used to assess rectal drug release is:

• 0.1 N HCl
• Phosphate buffer pH ~7.2
• Distilled water at pH 5.0
• Acetate buffer pH 4.5

Correct Answer: Phosphate buffer pH ~7.2

Q21. The typical sample size for the uniformity of mass test for suppositories (Ph. Eur.) is:

• 10 units
• 15 units
• 20 units
• 30 units

Correct Answer: 20 units

Q22. For content uniformity of an API in suppositories, the preferred analytical technique is:

• Polarimetry
• HPLC with suitable detection
• Conductometry
• Refractometry

Correct Answer: HPLC with suitable detection

Q23. A commonly cited minimum acceptable breaking strength for suppositories at room temperature is approximately:

• 0.5 kg
• 1.0 kg
• 1.8–2.0 kg
• 3.5 kg

Correct Answer: 1.8–2.0 kg

Q24. Which statement about PEG-based suppositories is most accurate?

• They melt rapidly at body temperature
• They dissolve in rectal fluids rather than melt
• They require refrigeration to be effective
• They cannot carry hydrophilic drugs

Correct Answer: They dissolve in rectal fluids rather than melt

Q25. To minimize irritation with glycerinated gelatin suppositories prior to administration, patients should:

• Freeze the suppository
• Moisten with water before insertion
• Coat with mineral oil
• Heat to 40°C

Correct Answer: Moisten with water before insertion

Q26. Which packaging best protects PEG/glycerinated gelatin suppositories from moisture exchange?

• Paper wraps in cardboard box
• PVC-only blister
• Alu–Alu (double aluminum) blister
• Perforated polyethylene sleeve

Correct Answer: Alu–Alu (double aluminum) blister

Q27. A rapid preformulation tool to detect drug–base incompatibility (e.g., with PEG) is:

• Polarized light microscopy only
• Differential scanning calorimetry (DSC)
• Osmometry
• Gas chromatography with FID

Correct Answer: Differential scanning calorimetry (DSC)

Q28. Regarding sterility/microbial quality, most rectal and vaginal suppositories are:

• Required to be sterile
• Non-sterile but must meet microbial limits
• Exempt from any microbial testing
• Sterile only if cocoa butter is used

Correct Answer: Non-sterile but must meet microbial limits

Q29. Under USP uniformity of dosage units, the Stage 1 Acceptance Value (AV) for content uniformity should be:

• AV ≤ 6.0
• AV ≤ 10.0
• AV ≤ 15.0
• AV ≤ 25.0

Correct Answer: AV ≤ 15.0

Q30. A blank suppository weighs 2.0 g. Each medicated unit contains 500 mg drug with DV = 0.8. How much base is needed per unit?

• 1.25 g
• 1.375 g
• 1.50 g
• 1.60 g

Correct Answer: 1.375 g

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