Formulation of eye lotions MCQs With Answer

Formulation of eye lotions MCQs With Answer
Eye lotions are liquid ophthalmic preparations intended for application to eyelids and the conjunctival area; their safe formulation requires strict control of sterility, isotonicity, pH, preservative choice, viscosity, and packaging to ensure comfort, stability and optimal ocular bioavailability. This concise, keyword-rich introduction and question set addresses formulation principles for B. Pharm students, covering excipients (buffers, tonicity agents, chelators), preservatives, viscosity enhancers, sterile filtration, stability testing, particulate control, and regulatory/quality tests. Questions are designed to deepen understanding of practical challenges in ophthalmic lotion design and quality control. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary requirement for all ophthalmic lotions to ensure patient safety?

• Colour stability
• Sterility
• Sweet taste
• High viscosity

Correct Answer: Sterility

Q2. Which of the following is the typical isotonic concentration of sodium chloride for ophthalmic formulations?

• 0.45% w/v
• 0.9% w/v
• 1.8% w/v
• 3.0% w/v

Correct Answer: 0.9% w/v

Q3. Which preservative is most commonly used in multi-dose ophthalmic lotions?

• Benzalkonium chloride
• Sodium chloride
• Carbomer
• Boric acid

Correct Answer: Benzalkonium chloride

Q4. Which preservative is known to adsorb onto soft contact lenses and is often avoided in lens wearers?

• Thimerosal
• Benzalkonium chloride
• Parabens
• Sodium citrate

Correct Answer: Benzalkonium chloride

Q5. Which method is preferred for sterilizing heat-sensitive ophthalmic lotions?

• Autoclaving at 121°C
• Sterile filtration through 0.22 μm membrane
• Dry heat sterilization
• Gamma irradiation for all products

Correct Answer: Sterile filtration through 0.22 μm membrane

Q6. Which buffering system is commonly used in ophthalmic lotions to maintain pH and ocular comfort?

• Phosphate or borate buffers
• Sulfate buffer
• Carbonate/bicarbonate buffer for all products
• Strong mineral acid only

Correct Answer: Phosphate or borate buffers

Q7. What is the approximate comfortable pH range for most ophthalmic formulations?

• 2.0–4.0
• 4.5–5.5
• 6.5–8.5
• 9.0–10.5

Correct Answer: 6.5–8.5

Q8. Which polymer is commonly used as a viscosity enhancer and to increase ocular residence time in eye lotions?

• Hydroxypropyl methylcellulose (HPMC)
• Sodium chloride
• Potassium sorbate
• Glycerol

Correct Answer: Hydroxypropyl methylcellulose (HPMC)

Q9. What is the role of EDTA in ophthalmic lotions?

• Primary viscosity builder
• Preservative enhancer by chelating divalent ions
• Source of tonicity
• Main active drug substance

Correct Answer: Preservative enhancer by chelating divalent ions

Q10. Which test specifically detects microbial contamination in sterile ophthalmic products?

• Particulate matter test
• Sterility test
• Viscosity measurement
• pH determination

Correct Answer: Sterility test

Q11. What is the usual osmolarity value (approx.) for isotonic ophthalmic preparations in mOsm/L?

• 50 mOsm/L
• 150 mOsm/L
• 300 mOsm/L
• 900 mOsm/L

Correct Answer: 300 mOsm/L

Q12. Which statement about particulate matter in ophthalmic suspensions/lotions is correct?

• Large particles (>100 μm) are acceptable
• Particles must be controlled; typically mean size kept below 10 μm
• Particulate testing is not required for sterile products
• Particles improve corneal penetration

Correct Answer: Particles must be controlled; typically mean size kept below 10 μm

Q13. Which excipient functions primarily to adjust tonicity in eye lotions?

• NaCl (sodium chloride)
• Methylcellulose
• EDTA
• Preservatives

Correct Answer: NaCl (sodium chloride)

Q14. What is a common advantage of increasing viscosity in an ophthalmic lotion?

• Faster systemic absorption
• Increased ocular residence time and improved contact time
• Increased risk of sterility failure
• Guaranteed better drug stability

Correct Answer: Increased ocular residence time and improved contact time

Q15. Which packaging is most appropriate for preservative-free single-dose ophthalmic lotions?

• Glass multi-dose bottle with dropper
• Aluminum tube
• Single-dose plastic ampoules
• Opaque metal canister

Correct Answer: Single-dose plastic ampoules

Q16. Which of the following is a purpose of penetration enhancers in ophthalmic formulations?

• To inactivate the drug
• To increase corneal permeability for better drug absorption
• To neutralize preservatives
• To reduce sterility

Correct Answer: To increase corneal permeability for better drug absorption

Q17. Which agent provides both mild antiseptic action and buffering/isotonic properties in some ophthalmic lotions?

• Boric acid/borates
• Propylene glycol only
• Sucrose
• Magnesium sulfate

Correct Answer: Boric acid/borates

Q18. Which quality control test is used to detect particulate contamination in ophthalmic lotions?

• Viscosity by Brookfield only
• Light obscuration test
• Assay by HPLC only
• pH meter

Correct Answer: Light obscuration test

Q19. Which polymer is considered anionic and may interact with cationic preservatives like benzalkonium chloride?

• Carboxymethylcellulose (CMC)
• Hydroxyethyl cellulose (neutral)
• Glycerol
• Sodium chloride

Correct Answer: Carboxymethylcellulose (CMC)

Q20. Which statement about preservatives in ophthalmic lotions is correct?

• Preservatives are unnecessary in all multi-dose eye lotions
• Preservative efficacy can be affected by pH and formulation components
• All preservatives are effective against spores
• Preservatives increase corneal penetration uniformly

Correct Answer: Preservative efficacy can be affected by pH and formulation components

Q21. Which sterilization validation method is used to demonstrate aseptic filling and processing for ophthalmic products?

• Media fill (process simulation)
• Thermal death time only
• pH change test
• UV-visible spectroscopy

Correct Answer: Media fill (process simulation)

Q22. For maximizing corneal penetration of a lipophilic drug in an ophthalmic lotion, which route is most important?

• Transcellular route through corneal epithelial cells
• Transdermal route
• Paracellular route only for lipophilic drugs
• Nasolacrimal absorption primarily

Correct Answer: Transcellular route through corneal epithelial cells

Q23. Which parameter is critical to monitor during long-term stability studies of an ophthalmic lotion?

• Colour, clarity, pH, and preservative potency
• Only the smell of the product
• Packaging weight only
• Ingredient melting point

Correct Answer: Colour, clarity, pH, and preservative potency

Q24. What is the typical volume of one ophthalmic drop delivered from a standard dropper?

• 0.5–1.0 mL
• 25–50 μL
• 200–500 μL
• 1–2 mL

Correct Answer: 25–50 μL

Q25. Which excipient is primarily used as a humectant and osmotic agent in eye lotions?

• Glycerin (glycerol)
• Magnesium stearate
• Polyvinyl chloride
• Hydrochloric acid

Correct Answer: Glycerin (glycerol)

Q26. Which of the following is a common adverse effect related to inappropriate pH or tonicity of an ophthalmic lotion?

• Ocular irritation and burning
• Improved visual acuity
• Enhanced systemic absorption without local effects
• Increased shelf life only

Correct Answer: Ocular irritation and burning

Q27. Which statement correctly describes the role of borate buffer in ophthalmic lotions?

• Borate buffer provides buffering capacity and may have mild antimicrobial action
• Borate buffer acts as a primary preservative competing with benzalkonium chloride
• Borate buffer is a strong acid that reduces pH below 3
• Borate buffer is used to increase particle size in suspensions

Correct Answer: Borate buffer provides buffering capacity and may have mild antimicrobial action

Q28. Which test ensures that an ophthalmic lotion container-closure system maintains sterility during shelf life?

• Container-closure integrity (CCI) testing
• Only pH testing
• Melting point determination
• Viscosity at 200°C

Correct Answer: Container-closure integrity (CCI) testing

Q29. Which of the following is NOT an intended function of preservatives in multi-dose ophthalmic lotions?

• Prevent microbial growth during use
• Enhance formulation tonicity
• Maintain product safety between uses
• Protect the patient from contamination

Correct Answer: Enhance formulation tonicity

Q30. Which quality test simulates worst-case contamination to validate aseptic filling of ophthalmic lotions?

• Media fill test (process simulation)
• Assay by spectrophotometry
• Density measurement
• Drop shape analysis

Correct Answer: Media fill test (process simulation)

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