Transmucosal permeability and formulation factors MCQs With Answer

Transmucosal permeability and formulation factors is a vital topic for B. Pharm students focusing on mucosal absorption, drug delivery and bioavailability. This introduction explains how mucosal barriers, epithelial structure, paracellular and transcellular routes, and enzymatic degradation influence permeation. Key formulation factors — pH, drug ionization, molecular size, lipophilicity, partition coefficient, mucoadhesive polymers, permeation enhancers, and delivery systems (gels, patches, nanoparticles) — determine rate and extent of transmucosal uptake. Understanding experimental models (Franz cell, Ussing chamber), evaluation parameters (flux, permeability coefficient, lag time), and safety of enhancers is essential for rational design of transmucosal dosage forms. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which mucosal component primarily acts as the rate-limiting barrier for drug permeation across most mucosa?

  • Basement membrane
  • Epithelium
  • Lamina propria
  • Submucosal glands

Correct Answer: Epithelium

Q2. Which route is favored by small, hydrophilic drugs crossing mucosal tissues?

  • Transcellular diffusion
  • Paracellular diffusion
  • Endocytosis
  • Bulk flow

Correct Answer: Paracellular diffusion

Q3. Lipophilicity primarily enhances which aspect of transmucosal permeability?

  • Paracellular transport
  • Transcellular membrane permeation
  • Enzymatic stability
  • Mucoadhesion

Correct Answer: Transcellular membrane permeation

Q4. According to Fick’s first law, which parameter directly increases steady-state flux across mucosa?

  • Decreased concentration gradient
  • Increased permeability coefficient
  • Increased lag time
  • Decreased surface area

Correct Answer: Increased permeability coefficient

Q5. Which formulation strategy can avoid first-pass hepatic metabolism for systemic delivery?

  • Conventional oral tablet
  • Sublingual film
  • Rectal suppository only reaching upper rectum
  • Enteric-coated capsule targeting stomach

Correct Answer: Sublingual film

Q6. Which excipient class is commonly used as chemical permeation enhancers for mucosa?

  • Plasticizers
  • Surfactants
  • Diluent fillers
  • Antioxidants

Correct Answer: Surfactants

Q7. Which mechanism is NOT a typical action of permeation enhancers?

  • Lipid bilayer fluidization
  • Tight junction modulation
  • Enzyme induction to increase degradation
  • Mucus layer disruption

Correct Answer: Enzyme induction to increase degradation

Q8. Mucoadhesive polymers primarily improve transmucosal delivery by:

  • Increasing enzymatic degradation
  • Prolonging residence time at the absorption site
  • Reducing drug solubility
  • Denaturing epithelial proteins

Correct Answer: Prolonging residence time at the absorption site

Q9. Which experimental model is most suitable for measuring steady-state permeation and flux across excised mucosal tissue?

  • Dissolution apparatus USP II
  • Franz diffusion cell
  • High-performance liquid chromatography
  • Spray-drying chamber

Correct Answer: Franz diffusion cell

Q10. A drug with pKa 4.5 given to buccal mucosa at pH 6.5 will predominantly be in which form, affecting permeability?

  • Fully protonated
  • Predominantly unionized
  • Completely degraded
  • Complexed with mucin

Correct Answer: Predominantly unionized

Q11. Which statement best describes the paracellular route?

  • Transport through epithelial cells via endocytosis
  • Movement between cells through tight junctions
  • Passive diffusion through lipid bilayers only
  • Active transport via carrier proteins exclusively

Correct Answer: Movement between cells through tight junctions

Q12. Which parameter is determined from the slope of cumulative amount permeated versus time in steady-state permeation experiments?

  • Lag time
  • Steady-state flux
  • Partition coefficient
  • Mucoadhesive strength

Correct Answer: Steady-state flux

Q13. Which formulation form is most likely to provide controlled transmucosal release with prolonged contact?

  • Immediate-release tablet
  • Mucoadhesive patch
  • Oral solution
  • Injectable bolus

Correct Answer: Mucoadhesive patch

Q14. Cyclodextrins are used in transmucosal formulations mainly to:

  • Increase mucociliary clearance
  • Form inclusion complexes to enhance solubility
  • Cross-link mucin chains to increase viscosity
  • Denature epithelial tight junctions

Correct Answer: Form inclusion complexes to enhance solubility

Q15. Enzymatic degradation in mucosa can be reduced by which formulation approach?

  • Using enzyme inhibitors in the formulation
  • Reducing drug lipophilicity
  • Increasing formulation osmolarity only
  • Avoiding mucoadhesive polymers

Correct Answer: Using enzyme inhibitors in the formulation

Q16. Which factor does NOT generally increase transmucosal permeability?

  • Smaller molecular size
  • Higher hydrogen-bonding potential
  • Greater lipophilicity (within limits)
  • Use of permeation enhancers

Correct Answer: Higher hydrogen-bonding potential

Q17. For nasal delivery, what is a common safety concern with strong permeation enhancers?

  • Enhanced mucoadhesion only
  • Epithelial irritation and damage
  • Improved mucociliary clearance
  • Reduced systemic absorption permanently

Correct Answer: Epithelial irritation and damage

Q18. Which property of nanoparticles enhances transmucosal absorption of poorly permeable drugs?

  • Large particle size (>10 microns)
  • Surface modification for mucoadhesion or mucus penetration
  • Neutral density to sink in mucus
  • High crystallinity only

Correct Answer: Surface modification for mucoadhesion or mucus penetration

Q19. Which mucosal site typically has the fastest onset for systemic drug absorption?

  • Rectal (proximal part with portal drainage)
  • Oral (swallowed tablets)
  • Sublingual mucosa
  • Large intestine mucosa

Correct Answer: Sublingual mucosa

Q20. Which measurement describes the ease with which a drug partitions from vehicle into mucosal tissue?

  • Viscosity
  • Partition coefficient
  • pKa only
  • Surface tension

Correct Answer: Partition coefficient

Q21. Tight junction modulators mainly influence which transport route?

  • Transcellular lipophilic route
  • Paracellular aqueous pathway
  • Vesicular endocytosis
  • Active carrier-mediated uptake

Correct Answer: Paracellular aqueous pathway

Q22. Which of the following is a commonly used mucoadhesive polymer in buccal formulations?

  • Hydroxypropyl methylcellulose (HPMC)
  • Sodium lauryl sulfate
  • Polyethylene glycol 4000 (as sole adhesive)
  • Sucrose

Correct Answer: Hydroxypropyl methylcellulose (HPMC)

Q23. Lag time in a permeation study represents:

  • The time to reach steady-state flux across tissue
  • Maximum cumulative permeation value only
  • Time when drug degrades completely
  • Instantaneous permeation onset

Correct Answer: The time to reach steady-state flux across tissue

Q24. Prodrugs are used in transmucosal delivery mainly to:

  • Decrease membrane permeation
  • Increase enzymatic degradation intentionally
  • Improve lipophilicity or stability to enhance absorption
  • Make drugs more hygroscopic

Correct Answer: Improve lipophilicity or stability to enhance absorption

Q25. Which physiological factor reduces residence time of formulations on nasal mucosa?

  • Mucociliary clearance
  • Low enzymatic activity
  • High mucoadhesion
  • Reduced blood flow

Correct Answer: Mucociliary clearance

Q26. Which analytical parameter assesses drug amount absorbed per unit area per time?

  • Permeability coefficient (Papp)
  • Steady-state flux (Jss)
  • Partition coefficient (Log P)
  • Viscosity (η)

Correct Answer: Steady-state flux (Jss)

Q27. What effect does increasing formulation viscosity typically have on transmucosal drug delivery?

  • Always decreases permeation by blocking diffusion
  • May increase residence time but can slow drug diffusion
  • Eliminates need for permeation enhancers
  • Automatically increases systemic bioavailability

Correct Answer: May increase residence time but can slow drug diffusion

Q28. Which excipient can chelate calcium and transiently open tight junctions to enhance paracellular transport?

  • EDTA
  • Glycerin
  • Cellulose
  • Sucrose

Correct Answer: EDTA

Q29. Which factor is most important when designing a mucoadhesive buccal tablet for peptide drugs?

  • Enhancer toxicity only
  • Balancing enzyme inhibition, mucoadhesion and permeation enhancement
  • Maximizing tablet hardness above all
  • Minimizing residence time intentionally

Correct Answer: Balancing enzyme inhibition, mucoadhesion and permeation enhancement

Q30. Which regulatory consideration is critical for using novel permeation enhancers in transmucosal products?

  • Only the effect on drug potency matters
  • Comprehensive safety and local toxicity evaluation
  • Color and flavor acceptability only
  • Ignoring systemic exposure assessments

Correct Answer: Comprehensive safety and local toxicity evaluation

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