Introduction to ophthalmic preparations MCQs With Answer

Introduction to ophthalmic preparations MCQs With Answer

This concise guide and question set is designed for B. Pharm students to deepen understanding of ophthalmic preparations, covering ophthalmic solutions, suspensions, ointments, gels, and inserts. Key concepts include sterility, preservatives, tonicity, pH, viscosity enhancers, particulate control, ocular bioavailability, aseptic processing, terminal sterilization, and packaging compatibility. Emphasis is placed on formulation strategies (buffers, polymers like carbomers and methylcellulose), common excipients, stability challenges, and regulatory expectations for sterile ophthalmic products. Applicable keywords: ophthalmic preparations, eye drops, ointments, preservatives, sterility, tonicity, pH, viscosity, ophthalmic formulation, aseptic technique. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of adding a preservative to a multi-dose ophthalmic solution?

• To adjust the pH of the formulation
• To increase the viscosity for longer retention
• To prevent microbial contamination during repeated use
• To enhance corneal penetration of the drug

Correct Answer: To prevent microbial contamination during repeated use

Q2. Which sterilization method is unsuitable for heat-sensitive ophthalmic solutions containing proteins?

• Membrane filtration
• Autoclaving (steam sterilization)
• Gamma irradiation
• Sterile aseptic processing without terminal sterilization

Correct Answer: Autoclaving (steam sterilization)

Q3. Which polymer is commonly used to increase viscosity and residence time of ophthalmic gels?

• Sodium chloride
• Carbomer
• Benzalkonium chloride
• Polysorbate 80

Correct Answer: Carbomer

Q4. Ideal tonicity for most ophthalmic solutions is approximately equivalent to which of the following?

• Hypotonic (100 mOsm/kg)
• Hypertonic (600 mOsm/kg)
• Isotonic (~300 mOsm/kg)
• Any tonicity is acceptable for eye drops

Correct Answer: Isotonic (~300 mOsm/kg)

Q5. Which preservative is frequently associated with toxicity to corneal epithelial cells with long-term use?

• Benzalkonium chloride (BAK)
• Chlorobutanol
• Phenylephrine
• Sodium hyaluronate

Correct Answer: Benzalkonium chloride (BAK)

Q6. What is the main reason ophthalmic suspensions require particle size control?

• To improve color stability
• To prevent corneal irritation and ensure uniform dosing
• To remove the need for preservatives
• To allow sterile filtration through 0.22 µm filters

Correct Answer: To prevent corneal irritation and ensure uniform dosing

Q7. Which volume per drop is typically assumed for standard ophthalmic dropper design during dosing calculations?

• 0.01–0.02 mL
• 0.05–0.07 mL
• 0.15–0.2 mL
• 0.5–1.0 mL

Correct Answer: 0.05–0.07 mL

Q8. Which excipient acts primarily as a mucoadhesive to increase ocular residence time?

• Hydroxypropyl methylcellulose (HPMC)
• Sodium chloride
• Sorbitol
• Chlorhexidine

Correct Answer: Hydroxypropyl methylcellulose (HPMC)

Q9. For sterile ophthalmic solutions, which microbial test is essential before release?

• pH determination
• Preservative efficacy test only
• Sterility test
• Viscosity measurement

Correct Answer: Sterility test

Q10. Which formulation type is most appropriate for delivering lipophilic drugs to the eye?

• Aqueous solution without solubilizers
• Ophthalmic ointment or oil-in-water emulsion
• Isotonic saline eye drops
• Immediate-release oral tablet

Correct Answer: Ophthalmic ointment or oil-in-water emulsion

Q11. Which pH range is generally best tolerated by the ocular surface for most ophthalmic drops?

• pH 1–2
• pH 3–4
• pH 6.5–8.5
• pH 11–12

Correct Answer: pH 6.5–8.5

Q12. Which preservative exhibits antimicrobial activity but can be inactivated by divalent cations and some buffers?

• Benzalkonium chloride
• Chlorhexidine gluconate
• EDTA (ethylenediaminetetraacetic acid)
• Chlorobutanol

Correct Answer: EDTA (ethylenediaminetetraacetic acid)

Q13. Terminal sterilization by autoclaving is preferred when:

• The product contains heat-labile proteins
• The final container-closure system and formulation are heat-stable
• Membrane filtration is feasible
• The product is a suspension with large particles

Correct Answer: The final container-closure system and formulation are heat-stable

Q14. Which ocular barrier primarily limits systemic absorption and increases local drug retention?

• Conjunctival blood flow
• Blood-aqueous barrier and corneal epithelium
• Liver metabolism
• Gastric pH

Correct Answer: Blood-aqueous barrier and corneal epithelium

Q15. Which ophthalmic formulation requires dosing at bedtime to maximize ocular contact time?

• Sterile aqueous drops
• Ophthalmic ointment
• Preservative-free single-dose drops
• Topical nasal spray

Correct Answer: Ophthalmic ointment

Q16. What is the main advantage of using preservative-free single-dose containers?

• Lower manufacturing cost than multi-dose systems
• Reduced risk of preservative-related ocular toxicity
• Longer shelf-life after opening
• Ability to use terminal sterilization only

Correct Answer: Reduced risk of preservative-related ocular toxicity

Q17. Which method is used to sterilize ophthalmic solutions containing small molecules that are heat-stable?

• Membrane filtration through 0.22 µm followed by aseptic fill
• Autoclaving (steam sterilization) as terminal sterilization
• Dry heat at 200°C
• Ultrafiltration through 10 kDa membranes

Correct Answer: Autoclaving (steam sterilization) as terminal sterilization

Q18. Which excipient is commonly used to adjust isotonicity in ophthalmic preparations?

• Sodium chloride
• Benzalkonium chloride
• Citric acid
• Polyethylene glycol 400

Correct Answer: Sodium chloride

Q19. What is the primary role of chelating agents like EDTA in ophthalmic formulations?

• To act as the main preservative
• To chelate metal ions and enhance preservative effectiveness
• To increase solution viscosity
• To serve as a tonicity agent

Correct Answer: To chelate metal ions and enhance preservative effectiveness

Q20. Which packaging material is preferred for light-sensitive ophthalmic solutions?

• Clear glass bottles
• Amber glass or opaque containers
• Thin polyethylene with high oxygen permeability
• Metal cans

Correct Answer: Amber glass or opaque containers

Q21. In ophthalmic suspensions, what critical parameter ensures redispersion after settling?

• Appropriate particle size and use of suspending agents
• Elimination of preservatives
• High osmolarity
• Use of ionic buffers only

Correct Answer: Appropriate particle size and use of suspending agents

Q22. Which regulatory requirement is essential for sterile ophthalmic products before market release?

• Only visual inspection for clarity
• Certified sterility testing, endotoxin testing, and stability data
• No microbiological testing required if preservative present
• Only pH and tonicity measurements

Correct Answer: Certified sterility testing, endotoxin testing, and stability data

Q23. Which excipient helps to reduce lacrimation by increasing viscosity and is also biocompatible?

• Carbomer
• Sodium lauryl sulfate
• Isopropyl alcohol
• Sodium hypochlorite

Correct Answer: Carbomer

Q24. Which ocular dosage form provides the longest contact time but may blur vision?

• Eye drops
• Ophthalmic ointment
• Preservative-free single-dose drops
• Buffered saline spray

Correct Answer: Ophthalmic ointment

Q25. What is the main concern when using benzalkonium chloride in glaucoma therapy long term?

• It increases aqueous humor production
• It may cause chronic ocular surface toxicity
• It improves systemic absorption of drug
• It neutralizes the active drug

Correct Answer: It may cause chronic ocular surface toxicity

Q26. Which formulation strategy can enhance corneal penetration of hydrophilic drugs?

• Increase drug particle size
• Use of prodrugs or penetration enhancers
• Decrease viscosity to zero
• Eliminate buffering capacity

Correct Answer: Use of prodrugs or penetration enhancers

Q27. Which test specifically detects bacterial endotoxins relevant to ophthalmic parenteral products?

• Sterility test
• Rabbit pyrogen test
• LAL (Limulus Amebocyte Lysate) test
• pH stability test

Correct Answer: LAL (Limulus Amebocyte Lysate) test

Q28. Which factor most strongly influences the choice between aseptic processing and terminal sterilization?

• Color of the formulation
• Heat stability of formulation and container-closure system
• Molecular weight of the active ingredient only
• Presence of preservatives

Correct Answer: Heat stability of formulation and container-closure system

Q29. Which additive is used to increase wetting of poorly soluble drugs in ophthalmic suspensions?

• Wetting agents like polysorbate 80
• Sodium chloride as tonicity agent
• Benzalkonium chloride as preservative
• Pure water only

Correct Answer: Wetting agents like polysorbate 80

Q30. Which patient counseling point is critical when prescribing an ophthalmic ointment?

• Instill a large volume to ensure effect
• Expect temporary blurred vision after application
• Use ointment during daytime driving for clarity
• Mix ointment with eye drops in the same bottle

Correct Answer: Expect temporary blurred vision after application

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com