Advanced study of pharmaceutical excipients in product development MCQs With Answer

Advanced study of pharmaceutical excipients in product development explores selection, functionality, characterization, and regulatory aspects of excipients used in formulations. This module for B.Pharm students emphasizes excipient roles—binders, disintegrants, lubricants, plasticizers, surfactants and polymers—plus preformulation testing, compatibility (DSC, FTIR, XRD), moisture sorption, particle engineering, hot-melt extrusion, QbD-based excipient risk assessment, and impact on stability, bioavailability, and manufacturability. Students learn excipient-driven critical quality attributes, extractables/leachables, safety/regulatory considerations (USP, IPEC), and analytical methods. The set of MCQs focuses on applied scenarios, analytical interpretation, formulation troubleshooting, and regulatory decision-making. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which primary mechanism best explains how sodium starch glycolate promotes tablet disintegration?

• Rapid swelling of particles on contact with water
• Solubilization of the tablet matrix
• Enzymatic degradation of binder
• Formation of a porous gel barrier

Correct Answer: Rapid swelling of particles on contact with water

Q2. Which analytical technique is most sensitive for detecting subtle interactions between drug and excipient via melting point shifts?

• Fourier-transform infrared spectroscopy (FTIR)
• Differential scanning calorimetry (DSC)
• Powder X-ray diffraction (XRD)
• High-performance liquid chromatography (HPLC)

Correct Answer: Differential scanning calorimetry (DSC)

Q3. For improving wetting and dissolution of a BCS Class II drug in a tablet, which excipient class is most appropriate?

• Surface-active agents/surfactants (e.g., sodium lauryl sulfate)
• Hydrophobic lubricants (e.g., magnesium stearate)
• Bulking diluents (e.g., microcrystalline cellulose)
• Antioxidants (e.g., BHT)

Correct Answer: Surface-active agents/surfactants (e.g., sodium lauryl sulfate)

Q4. Which powder property most directly influences suitability for direct compression?

• Particle size distribution and morphology
• Color and odor of the powder
• Solubility in organic solvents
• Melting point of the active drug

Correct Answer: Particle size distribution and morphology

Q5. Which commonly used lubricant is well known to cause increased tablet hydrophobicity and possible dissolution retardation?

• Magnesium stearate
• Sodium lauryl sulfate
• Polyvinylpyrrolidone (PVP)
• Microcrystalline cellulose

Correct Answer: Magnesium stearate

Q6. For hot-melt extrusion formulations, which excipient type is essential as a thermoplastic carrier polymer?

• Polyethylene oxide (PEO)
• Calcium carbonate
• Sodium bicarbonate
• Cellulose acetate phthalate

Correct Answer: Polyethylene oxide (PEO)

Q7. What does IPEC stand for in the context of excipient regulatory and quality guidance?

• International Pharmaceutical Excipients Council
• Institution for Pharmaceutical Excipient Compliance
• International Program for Excipient Characterization
• Institute for Pharmaceutical Excipients and Chemistry

Correct Answer: International Pharmaceutical Excipients Council

Q8. Which technique is specifically designed to measure dynamic moisture sorption isotherms of excipients?

• Dynamic vapor sorption (DVS)
• Thermogravimetric analysis (TGA)
• Differential scanning calorimetry (DSC)
• Near infrared spectroscopy (NIR)

Correct Answer: Dynamic vapor sorption (DVS)

Q9. Which excipient is commonly employed as a soluble pore former in matrix tablets to accelerate drug release?

• Lactose
• Magnesium stearate
• Povidone (PVP)
• Ethylcellulose

Correct Answer: Lactose

Q10. Which natural polymer is cationic and frequently used to impart mucoadhesive properties to oral and nasal formulations?

• Chitosan
• Hyaluronic acid
• Xanthan gum
• Sodium alginate

Correct Answer: Chitosan

Q11. Which analytical platform is most suitable for sensitive identification and quantification of low-level extractables/leachables from excipients and packaging?

• Liquid chromatography–tandem mass spectrometry (LC-MS/MS)
• Ultraviolet-visible spectrophotometry (UV-Vis)
• Fourier-transform infrared spectroscopy (FTIR)
• Polarimetry

Correct Answer: Liquid chromatography–tandem mass spectrometry (LC-MS/MS)

Q12. Which excipient is widely used as a film-coating plasticizer to improve flexibility and prevent cracking?

• Triethyl citrate
• Sodium starch glycolate
• Magnesium carbonate
• Colloidal silicon dioxide

Correct Answer: Triethyl citrate

Q13. Crospovidone (crospovidone) primarily enhances disintegration through which mechanism?

• Capillary action (wicking) and rapid fluid uptake
• Formation of a viscous gel layer
• Enzymatic breakdown of excipients
• Chelation of tablet binders

Correct Answer: Capillary action (wicking) and rapid fluid uptake

Q14. Which compaction analysis is commonly used to study powder densification behavior and plastic deformation during compression?

• Heckel analysis
• Carr’s index calculation
• Friability testing
• Dissolution profiling

Correct Answer: Heckel analysis

Q15. Which excipient additive is typically used to chelate metal ions and reduce metal-catalyzed oxidative degradation?

• EDTA (disodium edetate)
• Sorbitol
• Magnesium stearate
• Hydroxypropyl methylcellulose (HPMC)

Correct Answer: EDTA (disodium edetate)

Q16. Which compendium is most commonly referenced for official excipient monographs and purity standards?

• United States Pharmacopeia (USP)
• International Council for Harmonisation (ICH)
• European Medicines Agency (EMA)
• World Health Organization Technical Report Series (WHO TRS)

Correct Answer: United States Pharmacopeia (USP)

Q17. The superior tableting performance of microcrystalline cellulose is largely due to which deformation behavior?

• Plastic deformation under compression
• Brittle fracture leading to fragmentation
• Elastic rebound after compression
• Glass transition-mediated flow

Correct Answer: Plastic deformation under compression

Q18. Which technique is the most direct method to distinguish crystalline from amorphous form in an excipient sample?

• Powder X-ray diffraction (XRD)
• Ultraviolet-visible spectroscopy (UV-Vis)
• Karl Fischer titration
• Optical rotation

Correct Answer: Powder X-ray diffraction (XRD)

Q19. Which excipient is commonly added as an anti-caking agent and to reduce hygroscopicity in powder blends?

• Colloidal silicon dioxide (Aerosil)
• Sodium lauryl sulfate
• Sucrose
• Calcium stearate

Correct Answer: Colloidal silicon dioxide (Aerosil)

Q20. In a QbD approach, variability in excipient physicochemical properties is considered a type of which element?

• Critical material attribute (CMA)
• Process analytical technology (PAT)
• Critical process parameter (CPP)
• Design of experiment (DoE)

Correct Answer: Critical material attribute (CMA)

Q21. Which polymeric excipient is commonly selected as a suspending agent in oral suspensions for its rheological and pseudoplastic properties?

• Xanthan gum
• Magnesium stearate
• Lactose monohydrate
• Tribasic calcium phosphate

Correct Answer: Xanthan gum

Q22. Which of the following is NOT a typical function of pharmaceutical excipients?

• Providing intrinsic pharmacological activity
• Improving manufacturability and stability
• Enhancing organoleptic properties (taste, mouthfeel)
• Modifying drug release profiles

Correct Answer: Providing intrinsic pharmacological activity

Q23. For taste masking of a strongly basic bitter drug by ionic interaction, which excipient strategy is most appropriate?

• Use of ion-exchange resins to bind the drug
• Addition of hydrophobic lubricants
• Inclusion of water-soluble fillers
• Use of effervescent agents

Correct Answer: Use of ion-exchange resins to bind the drug

Q24. Which accelerated storage condition is typically used to evaluate moisture-driven instability from hygroscopic excipients?

• 40°C / 75% relative humidity (accelerated stability)
• 5°C refrigerated storage
• Room temperature, dry cabinet
• −20°C deep freeze

Correct Answer: 40°C / 75% relative humidity (accelerated stability)

Q25. Which polymer is widely used as an enteric coating excipient to ensure pH-dependent dissolution in the intestine?

• Eudragit L (methacrylic acid co-polymer)
• Polyethylene glycol 4000
• Hydroxypropyl methylcellulose (HPMC) E5
• Magnesium stearate

Correct Answer: Eudragit L (methacrylic acid co-polymer)

Q26. Which excipient is known to transiently enhance membrane permeability and is therefore used cautiously to improve oral absorption?

• Polysorbate 80 (Tween 80)
• Microcrystalline cellulose
• Sodium starch glycolate
• Calcium phosphate

Correct Answer: Polysorbate 80 (Tween 80)

Q27. Lubricant sensitivity is commonly assessed by measuring which tablet property after blending with the lubricant?

• Decrease in tablet tensile strength (hardness)
• Increase in melting point of the drug
• Change in tablet color
• Reduction in dissolution media pH

Correct Answer: Decrease in tablet tensile strength (hardness)

Q28. For sterile parenteral excipients, which test is mandatory to ensure safety against pyrogenic reactions?

• LAL (Limulus Amebocyte Lysate) endotoxin test
• Loss on drying
• Assay by UV-Vis
• Melting point determination

Correct Answer: LAL (Limulus Amebocyte Lysate) endotoxin test

Q29. Which excipient is often chosen as an effective cryo/lyo-protectant for biologics during freeze-drying?

• Trehalose
• Magnesium oxide
• Propylene glycol
• Starch

Correct Answer: Trehalose

Q30. Which analytical method is standard for determining molecular weight distribution of polymeric excipients used in formulations?

• Gel permeation chromatography (GPC/SEC)
• Karl Fischer titration
• Atomic absorption spectroscopy (AAS)
• Polarimetry

Correct Answer: Gel permeation chromatography (GPC/SEC)

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