Methods of preparation of ophthalmic products MCQs With Answer

Methods of preparation of ophthalmic products cover the principles and practical steps for developing sterile, safe, and effective eye formulations. B.Pharm students should understand sterile technique, formulation design, isotonicity, pH control, selection of buffers, preservatives, viscosity modifiers, and suitable packaging for eye drops, ointments, suspensions, emulsions and gels. Key topics include sterilization methods (autoclaving, filtration, radiation), aseptic processing, particulate control, sterility testing, validation, and quality control. Emphasis on compatibility, ocular tolerability, and regulatory requirements prepares students for formulation and manufacturing roles. This guide focuses on core methods, critical parameters and common pitfalls in ophthalmic manufacturing. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which pH range is generally considered most comfortable and safe for most ophthalmic solutions?

• pH 3.0–4.5
• pH 5.5–8.0
• pH 8.5–10.0
• pH 10.5–12.0

Correct Answer: pH 5.5–8.0

Q2. What is the commonly used sterilizing-grade membrane pore size for filtration of ophthalmic solutions?

• 0.45 µm
• 0.8 µm
• 0.22 µm
• 1.2 µm

Correct Answer: 0.22 µm

Q3. Which method is preferred for sterilizing heat-sensitive ophthalmic solutions?

• Autoclaving at 121°C
• Dry heat sterilization
• Membrane filtration
• Boiling for 30 minutes

Correct Answer: Membrane filtration

Q4. Which preservative is commonly used in multi-dose ophthalmic formulations but may cause ocular sensitivity in some patients?

• Benzalkonium chloride (BAK)
• Sodium chloride
• Glycerin
• Sorbitol

Correct Answer: Benzalkonium chloride (BAK)

Q5. For sterile filling of ophthalmic drops under aseptic conditions, which environment is typically required to provide ISO 5 air quality?

• General laboratory room
• ISO 8 cleanroom
• ISO 5 laminar flow hood (Class 100)
• Open bench near window

Correct Answer: ISO 5 laminar flow hood (Class 100)

Q6. What is the primary purpose of tonicity adjustment in ophthalmic formulations?

• To improve color stability
• To make solution hypertonic for preservative effect
• To ensure patient comfort and prevent osmotic damage
• To enhance microbial growth

Correct Answer: To ensure patient comfort and prevent osmotic damage

Q7. Which excipient is commonly used to increase viscosity in eye drops to prolong precorneal residence time?

• Methylcellulose
• Sodium chloride
• Polysorbate 80
• Benzyl alcohol

Correct Answer: Methylcellulose

Q8. Which autoclave condition is a standard cycle for terminal sterilization of heat-stable ophthalmic glass vials?

• 121°C for 15 minutes at 15 psi
• 100°C for 60 minutes
• 160°C for 2 hours
• 80°C for 30 minutes

Correct Answer: 121°C for 15 minutes at 15 psi

Q9. Which test is used to detect bacterial endotoxin contamination in ophthalmic products?

• Staining with crystal violet
• Limulus Amebocyte Lysate (LAL) test
• pH measurement
• Preservative efficacy test

Correct Answer: Limulus Amebocyte Lysate (LAL) test

Q10. For ophthalmic suspensions, controlling particle size is critical because excessive particles can cause:

• Increased solubility
• Improved sterilization
• Ocular irritation and blurred vision
• Reduced viscosity

Correct Answer: Ocular irritation and blurred vision

Q11. Which suspending agent is commonly used in ophthalmic suspensions to maintain uniform dispersion?

• Carboxymethylcellulose (CMC)
• Sodium chloride
• Ethyl alcohol
• Polyvinyl chloride

Correct Answer: Carboxymethylcellulose (CMC)

Q12. What is the role of a buffer system in ophthalmic formulations?

• To increase particulate load
• To maintain pH for stability and ocular comfort
• To act as a preservative
• To reduce viscosity

Correct Answer: To maintain pH for stability and ocular comfort

Q13. Which packaging material is preferred for preservative-free single-dose ophthalmic containers to minimize adsorption of drug?

• Polyvinyl chloride (PVC)
• Low-density polyethylene (LDPE)
• Glass Type I vials
• Metal cans

Correct Answer: Glass Type I vials

Q14. What is the main advantage of preservative-free unit-dose eye drops?

• Longer shelf life after opening
• Reduced risk of preservative-related ocular toxicity
• Lower manufacturing cost
• Better taste

Correct Answer: Reduced risk of preservative-related ocular toxicity

Q15. Which method is commonly used to validate aseptic filling operations in ophthalmic manufacturing?

• pH stability testing
• Media fill (process simulation)
• Visual inspection only
• Endotoxin challenge

Correct Answer: Media fill (process simulation)

Q16. Which preservative efficacy test assesses antimicrobial activity in ophthalmic multi-dose products?

• Antioxidant assay
• Preservative Efficacy Test (PET) / Challenge test
• Particulate count test
• Viscosity measurement

Correct Answer: Preservative Efficacy Test (PET) / Challenge test

Q17. EDTA is often added to ophthalmic formulations primarily to:

• Act as a primary preservative
• Chelate divalent metal ions and enhance preservative activity
• Increase tonicity
• Degrade the API

Correct Answer: Chelate divalent metal ions and enhance preservative activity

Q18. Which of the following is a common isotonicity agent used in eye drops?

• Sodium chloride
• Calcium carbonate
• Magnesium sulfate
• Sodium lauryl sulfate

Correct Answer: Sodium chloride

Q19. For ophthalmic ointments, which base is typically used to provide prolonged contact time on the ocular surface?

• Polyethylene glycol (PEG) base
• White soft paraffin and liquid paraffin (hydrocarbon ointment)
• Gelatin base
• Aqueous starch paste

Correct Answer: White soft paraffin and liquid paraffin (hydrocarbon ointment)

Q20. Which quality attribute is most critical to check for ophthalmic emulsions?

• Color only
• Emulsion droplet size and physical stability
• Acidity of container cap
• Packaging weight

Correct Answer: Emulsion droplet size and physical stability

Q21. What is the acceptable sterility assurance level (SAL) commonly targeted for terminally sterilized pharmaceuticals?

• 10^0
• 10^-2
• 10^-6
• 10^2

Correct Answer: 10^-6

Q22. Which of the following is a critical concern when formulating ophthalmic solutions in plastic containers?

• Leaching of plasticizers and adsorption of drug to container walls
• Increase in glass content
• Rapid autoclave sterilization of plastic
• Improvement in drug solubility

Correct Answer: Leaching of plasticizers and adsorption of drug to container walls

Q23. Which cleaning/sterilization technology is effective for sterilizing heat-sensitive ophthalmic single-dose containers on a large scale?

• Ethylene oxide sterilization
• Autoclaving at 134°C
• Boiling in water
• Microwave heating

Correct Answer: Ethylene oxide sterilization

Q24. Which parameter is essential to monitor during manufacturing to minimize particulate contamination in ophthalmic products?

• Particle count and air cleanliness (cleanroom monitoring)
• Color of the operator gowns
• Ambient humidity only
• Size of storage shelves

Correct Answer: Particle count and air cleanliness (cleanroom monitoring)

Q25. Which surfactant is frequently used to improve wetting and stability in ophthalmic emulsions?

• Polysorbate 80 (Tween 80)
• Sodium chloride
• Cellulose powder
• Bentonite clay

Correct Answer: Polysorbate 80 (Tween 80)

Q26. Which in-process test helps ensure uniformity of dose in ophthalmic multi-dose dispensers?

• Weight variation and drop size consistency testing
• Color comparison
• Noise level of filling machine
• Cap torque only

Correct Answer: Weight variation and drop size consistency testing

Q27. Which animal test historically evaluated ocular irritation potential of formulations (though alternative in vitro tests are now encouraged)?

• Skin sensitization test
• Draize rabbit eye test
• Oral LD50
• Inhalation challenge

Correct Answer: Draize rabbit eye test

Q28. Why are chelating agents like EDTA sometimes included in ophthalmic formulations aside from enhancing preservative action?

• To act as a primary solvent
• To complex trace metal ions that catalyze degradation
• To increase osmolarity dramatically
• To cause coloration

Correct Answer: To complex trace metal ions that catalyze degradation

Q29. What is a primary consideration when formulating contact lens care solutions?

• Use of strong acids for disinfection
• Compatibility with lens material and safe antimicrobial efficacy
• Addition of preservatives toxic to cornea
• High osmolarity above 1000 mOsm/kg

Correct Answer: Compatibility with lens material and safe antimicrobial efficacy

Q30. For stability and patient safety, ophthalmic products should generally be stored:

• At uncontrolled outdoor conditions
• Per manufacturer instructions, often at controlled room temperature and protected from light
• In direct sunlight to maintain sterility
• At freezing temperatures always

Correct Answer: Per manufacturer instructions, often at controlled room temperature and protected from light

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