Formulation of eye ointments MCQs With Answer

Formulation of eye ointments MCQs With Answer is a focused review designed for B. Pharm students covering ophthalmic ointments, ointment bases, sterility, preservative needs, viscosity control, and ocular bioavailability. This introduction links formulation principles with manufacturing steps, quality control tests (sterility, viscosity, particle size, spreadability), stability challenges, packaging choices, and regulatory expectations. Emphasis is on sterile technique, base selection (hydrocarbon, absorption, water-soluble), drug release, and patient safety to prepare you for compounding and industrial practice. Relevant keywords: ophthalmic formulation, ointment base, sterility, preservative, viscosity, bioavailability, stability, packaging. These MCQs include answers to reinforce learning and prepare you for exams and practicals. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary formulation objective of an ophthalmic ointment?

• To provide immediate systemic drug delivery
• To increase ocular residence time and provide sustained drug release
• To increase tear production
• To convert the drug into an aqueous solution

Correct Answer: To increase ocular residence time and provide sustained drug release

Q2. Which ointment base is most commonly used for ophthalmic ointments due to its inertness and occlusive properties?

• White petrolatum (petrolatum)
• Polysorbate 80
• Glycerin
• Hydroxypropyl methylcellulose

Correct Answer: White petrolatum (petrolatum)

Q3. Why are antimicrobial preservatives often unnecessary in ophthalmic ointments?

• Because ointments are always sterile after packaging
• Because the non-aqueous base does not support microbial growth
• Because preservatives evaporate from ointments
• Because preservatives react with petrolatum

Correct Answer: Because the non-aqueous base does not support microbial growth

Q4. Which sterilization method is NOT suitable for sterilizing a finished ophthalmic ointment?

• Autoclaving (if base is stable)
• Gamma irradiation
• Sterile filtration through 0.22 µm filter
• Dry heat sterilization (if compatible)

Correct Answer: Sterile filtration through 0.22 µm filter

Q5. For a heat-sensitive drug intended for an ophthalmic ointment, which incorporation method is preferred?

• Fusion (melting the base)
• Levigation with a suitable levigating agent
• Autoclave mixing
• High-temperature homogenization

Correct Answer: Levigation with a suitable levigating agent

Q6. Which ingredient acts primarily as a stiffening agent to increase the viscosity of an ophthalmic ointment?

• Mineral oil
• Beeswax
• Benzalkonium chloride
• Sorbitol

Correct Answer: Beeswax

Q7. What packaging is most suitable to maintain sterility and ease of dosing for ophthalmic ointments?

• Glass jar with lid
• Aluminum collapsible tube with threaded cap
• Plastic sachets that must be cut open
• Open-top pots

Correct Answer: Aluminum collapsible tube with threaded cap

Q8. Which USP ointment base is water-soluble and often used when easier removal from the eye is desired?

• White petrolatum
• Mineral oil
• Polyethylene glycol (PEG) ointment
• Lanolin

Correct Answer: Polyethylene glycol (PEG) ointment

Q9. How does using a highly lipophilic ointment base affect the release of a hydrophilic drug?

• It accelerates release of hydrophilic drugs
• It has no effect on drug release
• It slows down release of hydrophilic drugs
• It converts the drug into a solution

Correct Answer: It slows down release of hydrophilic drugs

Q10. What is the role of mineral oil in a petrolatum-based ophthalmic ointment?

• Preservative against microbes
• Plasticizer and low-viscosity liquid phase to adjust consistency
• Primary drug solubilizer for hydrophilic drugs
• pH adjuster

Correct Answer: Plasticizer and low-viscosity liquid phase to adjust consistency

Q11. Why is controlling particle size of a suspended drug important in ophthalmic ointments?

• Large particles improve ocular retention
• Smaller particles reduce irritation and improve dissolution and bioavailability
• Particle size does not affect ointment behavior
• Smaller particles increase contamination risk

Correct Answer: Smaller particles reduce irritation and improve dissolution and bioavailability

Q12. Which quality control test is absolutely essential for all ophthalmic ointments before release?

• Viscosity only
• Sterility test
• Weight variation only
• Sensory evaluation only

Correct Answer: Sterility test

Q13. Which antimicrobial agent is commonly used in aqueous ophthalmic preparations but less relevant in non-aqueous ointments?

• Butylated hydroxytoluene (BHT)
• Benzalkonium chloride (BAC)
• Mineral oil
• Polyethylene glycol

Correct Answer: Benzalkonium chloride (BAC)

Q14. What is the desired melting behavior of an ophthalmic ointment base for patient comfort?

• High melting point >100°C
• Melts at or slightly below ocular surface/eyelid temperature to soften on contact
• Remains solid at body temperature
• Evaporates after application

Correct Answer: Melts at or slightly below ocular surface/eyelid temperature to soften on contact

Q15. Which formulation type generally provides the longest ocular residence time?

• Ophthalmic solution
• Ophthalmic suspension
• Ophthalmic ointment
• Eye drops with low viscosity

Correct Answer: Ophthalmic ointment

Q16. In ophthalmic ointments, why is pH measurement less critical than in aqueous eye drops?

• Because ointments are swallowed, not applied to eye
• Because non-aqueous bases do not provide a defined aqueous phase for pH measurement
• Because pH is always neutral in ointments
• Because pH only affects color, not safety

Correct Answer: Because non-aqueous bases do not provide a defined aqueous phase for pH measurement

Q17. Which additive is commonly used to prevent oxidative rancidity in ointment bases containing unsaturated oils?

• Preservatives like chlorobutanol
• Antioxidants such as butylated hydroxytoluene (BHT)
• Acidifiers like citric acid
• Humectants like glycerin

Correct Answer: Antioxidants such as butylated hydroxytoluene (BHT)

Q18. Compared with an ophthalmic cream, an ophthalmic ointment is generally:

• Less occlusive and more watery
• More occlusive and greasier
• Identical in texture and removal
• Always aqueous

Correct Answer: More occlusive and greasier

Q19. Which test assesses the ease of spreading of an ophthalmic ointment on the ocular surface?

• Sterility test
• Spreadability or extrudability test
• Loss on drying
• Gluten content test

Correct Answer: Spreadability or extrudability test

Q20. Which excipient functions as a wetting agent to aid incorporation of a powdered drug into an ointment base?

• Polysorbate 80 (Tween 80)
• White petrolatum
• Beeswax
• Mineral oil only

Correct Answer: Polysorbate 80 (Tween 80)

Q21. What are standard autoclave conditions often used if an ophthalmic ointment base is heat-stable?

• 100°C for 60 minutes
• 121°C for 15 minutes at 15 psi
• 60°C for 2 hours
• 200°C for 5 minutes

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

Q22. Where is an ophthalmic ointment intended to be applied?

• Corneal stroma by injection
• Conjunctival sac (lower eyelid pouch)
• Systemic circulation via oral route
• Inside the lacrimal gland only

Correct Answer: Conjunctival sac (lower eyelid pouch)

Q23. Excessively large suspended particles in ophthalmic ointments can cause which problem?

• Improved drug potency
• Reduced ocular irritation
• Increased ocular irritation and blurred vision
• Faster systemic absorption

Correct Answer: Increased ocular irritation and blurred vision

Q24. Which type of ointment base generally facilitates easier removal from the eyelids and is less greasy?

• Hydrocarbon base (petrolatum)
• Absorption base with lanolin
• Water-soluble base such as PEG
• Mineral oil alone

Correct Answer: Water-soluble base such as PEG

Q25. Why might nitrogen blanketing be used during manufacturing of ophthalmic ointments?

• To introduce oxygen for sterilization
• To prevent oxidation and maintain product stability
• To increase microbial load
• To reduce viscosity drastically

Correct Answer: To prevent oxidation and maintain product stability

Q26. Which regulatory requirement must be met for ophthalmic ointments before they are released to the market?

• Color matching to standard
• Sterility assurance and appropriate microbial limits
• Inclusion of flavors
• Maximum pH of 9 only

Correct Answer: Sterility assurance and appropriate microbial limits

Q27. Which instrument is commonly used in QC labs to measure the viscosity of ophthalmic ointments?

• Spectrophotometer
• Brookfield viscometer
• pH meter
• Gas chromatograph

Correct Answer: Brookfield viscometer

Q28. Which formulation factor is a known cause of ocular irritation in ophthalmic preparations?

• Use of suitable ointment base only
• Presence of certain preservatives like benzalkonium chloride
• Sterile processing
• Appropriate particle size

Correct Answer: Presence of certain preservatives like benzalkonium chloride

Q29. Which storage instruction is generally recommended for ophthalmic ointments to maintain stability?

• Store in direct sunlight at high temperature
• Store in a tight, light-resistant container at controlled room temperature
• Store open at any humidity
• Freeze before use

Correct Answer: Store in a tight, light-resistant container at controlled room temperature

Q30. Compared to ointments, ophthalmic gels are typically:

• More greasy and harder to remove
• Water-based, less greasy, and more comfortable for patients
• Always non-sterile
• Made only from petrolatum

Correct Answer: Water-based, less greasy, and more comfortable for patients

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