Formulation of buccal DDS MCQs With Answer

Formulation of Buccal DDS MCQs With Answer is crafted for M. Pharm students to deepen their understanding of buccal drug delivery systems from a formulation and evaluation perspective. The buccal route offers distinct advantages like avoidance of hepatic first-pass metabolism, rapid onset, and the potential for controlled release—yet it demands meticulous control over polymer selection, mucoadhesion, permeation, taste masking, and mechanical properties. This quiz focuses on critical design aspects: choosing appropriate mucoadhesive and backing polymers, optimizing plasticizers and enhancers, evaluating release kinetics, and applying robust in vitro/ex vivo tests. Each question is designed to test higher-order cognition and practical decision-making in Drug Delivery Systems (MPH 102T), while reinforcing clinically relevant formulation strategies.

Q1. The primary formulation advantage of buccal drug delivery systems (DDS) is:

• Bypass hepatic first-pass and provide prolonged residence for controlled release
• Increase gastric residence time
• Deliver large-dose drugs (>500 mg)
• Completely eliminate salivary dilution

Correct Answer: Bypass hepatic first-pass and provide prolonged residence for controlled release

Q2. Ideal physicochemical criteria for a drug intended for buccal delivery typically include:

• Dose ≤ 25 mg, logP 1–3, MW < 500 Da, pKa allowing partial unionization at salivary pH
• Dose > 200 mg, logP < 0, MW > 1500 Da
• Dose ≤ 10 mg, logP > 7
• Dose any, irrespective of solubility

Correct Answer: Dose ≤ 25 mg, logP 1–3, MW < 500 Da, pKa allowing partial unionization at salivary pH

Q3. Which mucoadhesive polymer is cationic and can transiently open tight junctions to enhance buccal permeation?

• Chitosan
• HPMC
• Sodium alginate
• Carbopol 934P

Correct Answer: Chitosan

Q4. Which excipient is commonly used as a plasticizer to improve flexibility in solvent-cast buccal films?

• PEG 400
• Talc
• Microcrystalline cellulose
• Lactose monohydrate

Correct Answer: PEG 400

Q5. Which penetration enhancer class primarily acts by extracting lipids and increasing membrane fluidity in buccal epithelium?

• Bile salts such as sodium deoxycholate
• Mannitol
• Sodium starch glycolate
• Magnesium stearate

Correct Answer: Bile salts such as sodium deoxycholate

Q6. The main function of an impermeable backing layer in a buccal patch is to:

• Create unidirectional release and shield the drug from saliva wash-out
• Prevent mucoadhesion
• Increase gustatory perception
• Act as a superdisintegrant

Correct Answer: Create unidirectional release and shield the drug from saliva wash-out

Q7. A suitable method to quantify mucoadhesive strength of buccal films is:

• Texture analyzer detachment test using excised porcine buccal mucosa
• Loss on drying
• Friability test
• Brookfield viscosity alone

Correct Answer: Texture analyzer detachment test using excised porcine buccal mucosa

Q8. The typical pH range of human saliva relevant to buccal formulation design is:

• 1.0–2.0
• 3.0–4.0
• 6.2–7.4
• 8.5–9.5

Correct Answer: 6.2–7.4

Q9. Drug release from a hydrophilic matrix-type buccal film is most often governed by:

• Fickian diffusion through the swollen polymer network
• Zero-order erosion-independent release
• Immediate release via disintegration
• Carrier-mediated transport with saturation kinetics

Correct Answer: Fickian diffusion through the swollen polymer network

Q10. Carbopol-based buccal gels are often neutralized (e.g., with triethanolamine) primarily to:

• To ionize carboxyl groups and maximize swelling/viscosity and mucoadhesion
• To precipitate the polymer and reduce viscosity
• To increase hydrophobicity
• To form covalent crosslinks with mucin

Correct Answer: To ionize carboxyl groups and maximize swelling/viscosity and mucoadhesion

Q11. The most appropriate ex vivo model to study buccal permeation is:

• Franz diffusion cell with porcine buccal mucosa
• USP Apparatus II dissolution using water only
• Intragastric perfusion model
• Parallel artificial membrane permeability assay (PAMPA) alone

Correct Answer: Franz diffusion cell with porcine buccal mucosa

Q12. Which strategy best minimizes drug crystallization in hydrophilic buccal films during storage?

• Incorporating PVP as crystallization inhibitor
• Eliminating plasticizer
• Compressing into tablets
• Reducing polymer molecular weight dramatically

Correct Answer: Incorporating PVP as crystallization inhibitor

Q13. The practical upper limit for drug loading in buccal films/patches without compromising comfort and adhesion is approximately:

• About 5–10 mg
• About 25–30 mg
• About 100–200 mg
• No practical limit

Correct Answer: About 25–30 mg

Q14. For peptide delivery via buccal route, the most rational formulation approach is to use:

• Enzyme inhibitor with permeation enhancer
• Superdisintegrant with effervescent agent
• High concentration of talc with colorant
• Surfactant with antifoam

Correct Answer: Enzyme inhibitor with permeation enhancer

Q15. The surface pH of buccal films should ideally be maintained at:

• 6.0–7.0 to minimize irritation and optimize comfort
• 1.0–2.0 to aid stability
• 9.0–10.0 to increase permeability
• Irrelevant because saliva buffers instantly

Correct Answer: 6.0–7.0 to minimize irritation and optimize comfort

Q16. Which statement about swelling and mucoadhesion is TRUE?

• Moderate swelling increases polymer chain interpenetration and adhesion; excessive swelling may cause erosion and loss of adhesion
• Greater swelling always improves adhesion indefinitely
• Non-swelling hydrophobic polymers are ideal mucoadhesives
• Swelling index has no correlation with residence time

Correct Answer: Moderate swelling increases polymer chain interpenetration and adhesion; excessive swelling may cause erosion and loss of adhesion

Q17. A common choice for an impermeable backing layer in buccal patches is:

• Ethyl cellulose film
• Sodium alginate film
• HPMC E5 film
• Gelatin film

Correct Answer: Ethyl cellulose film

Q18. The most effective taste-masking approach for a bitter, basic drug in buccal films is:

• Complexation with cation-exchange resin
• Addition of sodium lauryl sulfate
• Increasing drug particle size only
• Use of citric acid alone

Correct Answer: Complexation with cation-exchange resin

Q19. Which drug-release model yields a straight line when cumulative drug released is plotted against square root of time?

• Higuchi model
• Zero-order model
• First-order model
• Hixson–Crowell model

Correct Answer: Higuchi model

Q20. Appropriate packaging to ensure stability of moisture-sensitive buccal films is:

• Individually sealed aluminum foil sachets with desiccant
• HDPE bottle with cotton plug only
• Paper envelopes
• Open blister trays without lidding

Correct Answer: Individually sealed aluminum foil sachets with desiccant

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