Formulation of large volume parenterals MCQs With Answer

Formulation of large volume parenterals MCQs With Answer

Large volume parenterals (LVPs) are sterile, pyrogen-free aqueous preparations intended primarily for intravenous administration in volumes greater than 100 mL. Formulation of LVPs requires careful selection of solvents, electrolytes, buffers, osmotic agents, stabilizers and compatible container-closure systems to ensure physicochemical stability, sterility and patient safety. Key formulation topics include isotonicity, osmolarity, sterilization (terminal vs aseptic), sterile filtration, pyrogen control (endotoxin testing), particulate control, leachables from plastics, and regulatory quality control tests. These MCQs emphasize formulation principles, process validation, analytical tests and clinical considerations to deepen B.Pharm students’ practical understanding. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What volume threshold commonly defines a large volume parenteral (LVP)?

• Any parenteral >10 mL
• Parenterals intended for intramuscular use
• Parenterals intended for intravenous use in volumes greater than 100 mL
• Parenterals packaged in ampoules only

Correct Answer: Parenterals intended for intravenous use in volumes greater than 100 mL

Q2. Which container material is preferred for many LVPs due to chemical inertness and low leachables?

• Type I (borosilicate) glass
• Polyvinyl chloride (PVC) with DEHP
• Latex rubber
• Low-density polyethylene (LDPE) without barrier

Correct Answer: Type I (borosilicate) glass

Q3. Which agent is most commonly used to adjust tonicity of intravenous fluids?

• Magnesium sulfate
• Sodium chloride (0.9% NaCl)
• Calcium carbonate
• Polysorbate 80

Correct Answer: Sodium chloride (0.9% NaCl)

Q4. What is the preferred sterilization approach for heat-stable aqueous LVPs when feasible?

• Sterile filtration only
• Terminal sterilization (autoclaving) when product is heat-stable
• Aseptically filling without sterilization
• Dry heat at 60°C for 2 hours

Correct Answer: Terminal sterilization (autoclaving) when product is heat-stable

Q5. For heat-labile LVP formulations, which process is commonly used to achieve sterility?

• Dry heat sterilization
• Gamma irradiation of filled containers
• Sterile filtration through 0.22 µm filter followed by aseptic filling
• Boiling at 100°C for 30 minutes

Correct Answer: Sterile filtration through 0.22 µm filter followed by aseptic filling

Q6. Which assay is routinely used to detect bacterial endotoxins (pyrogens) in parenterals?

• Gram staining
• Limulus amebocyte lysate (LAL) test
• Sterility test by culture only
• pH measurement

Correct Answer: Limulus amebocyte lysate (LAL) test

Q7. Why are most LVPs formulated without added preservatives?

• Preservatives are too expensive
• LVPs are single-use, large-volume and preservatives can cause toxicity or incompatibility
• Preservatives increase osmolarity dramatically
• Preservatives cannot be sterilized

Correct Answer: LVPs are single-use, large-volume and preservatives can cause toxicity or incompatibility

Q8. Which test is used to quantify sub-visible particulate matter in LVPs?

• pH titration
• Light obscuration particle count test
• Viscosity measurement
• Thin layer chromatography

Correct Answer: Light obscuration particle count test

Q9. A key formulation concern for LVPs packaged in plastics is:

• Color change due to UV only
• Leaching of plasticizers and adsorption of drug to the container surface
• Excessive transparency
• Difficulty in sterilizing glass

Correct Answer: Leaching of plasticizers and adsorption of drug to the container surface

Q10. Why is pH control important in LVP formulation?

• Only to change color
• To maintain drug stability, minimize vascular irritation and ensure compatibility with blood
• To make solutions hypertonic
• To increase particulate formation

Correct Answer: To maintain drug stability, minimize vascular irritation and ensure compatibility with blood

Q11. What is the approximate osmolarity of a physiologically isotonic solution used for IV administration?

• 50 mOsm/L
• 150 mOsm/L
• Approximately 300 mOsm/L
• 1000 mOsm/L

Correct Answer: Approximately 300 mOsm/L

Q12. Endotoxins (pyrogens) are components primarily from which microorganisms?

• Gram-positive bacteria cell walls
• Fungal spores
• Viral envelopes
• Gram-negative bacteria outer membranes

Correct Answer: Gram-negative bacteria outer membranes

Q13. Which of the following is a classic example of an LVP used commonly in hospitals?

• 0.9% Sodium chloride (Normal saline) 1 L
• Insulin 10 mL vial
• Parenteral vitamin drops 2 mL
• Intramuscular diclofenac 3 mL ampoule

Correct Answer: 0.9% Sodium chloride (Normal saline) 1 L

Q14. To evaluate compatibility between an IV drug and an infusion fluid, which test is typically performed?

• Sensory evaluation only
• Y-site and admixture compatibility testing
• Skin patch test
• Oral bioavailability study

Correct Answer: Y-site and admixture compatibility testing

Q15. Which clinical therapy commonly uses LVPs as the delivery vehicle?

• Topical cream application
• Total parenteral nutrition (TPN)
• Sublingual tablets
• Inhalation aerosols

Correct Answer: Total parenteral nutrition (TPN)

Q16. What Sterility Assurance Level (SAL) is commonly targeted for terminal sterilization processes?

• SAL 10^0
• SAL 10^-3
• SAL 10^-6
• SAL 100

Correct Answer: SAL 10^-6

Q17. What pore size membrane is standard for sterile filtration of parenteral solutions?

• 5.0 µm
• 0.45 µm
• 0.22 µm
• 10.0 µm

Correct Answer: 0.22 µm

Q18. Which of the following best describes a pyrogenic reaction after IV administration?

• Immediate anaphylaxis due to IgE
• Fever caused by bacterial endotoxins
• Local skin redness at injection site only
• Delayed hypersensitivity at 48 hours

Correct Answer: Fever caused by bacterial endotoxins

Q19. One major advantage of glass containers for LVPs is:

• Their high gas permeability
• Low chemical reactivity and excellent barrier properties
• High tendency to leach plasticizers
• Flexibility for squeezing

Correct Answer: Low chemical reactivity and excellent barrier properties

Q20. Which official test confirms sterility of a parenteral batch according to pharmacopeial methods?

• pH test
• USP sterility test (membrane filtration or direct inoculation)
• Assay by HPLC only
• Visual color comparison

Correct Answer: USP sterility test (membrane filtration or direct inoculation)

Q21. Why is aseptic processing critical when terminal sterilization cannot be applied to an LVP?

• To reduce manufacturing costs only
• To prevent contamination because the product cannot withstand terminal heat sterilization
• To increase product viscosity
• To avoid performing any quality control tests

Correct Answer: To prevent contamination because the product cannot withstand terminal heat sterilization

Q22. Which preservative is commonly avoided in LVPs and can be problematic in neonates?

• Chlorhexidine
• Benzyl alcohol
• Sodium chloride
• Glucose

Correct Answer: Benzyl alcohol

Q23. What is the primary purpose of a media-fill test in parenteral manufacturing?

• To measure endotoxin levels
• To simulate aseptic production and validate aseptic technique by detecting microbial contamination
• To test plasticizer migration
• To determine pH stability

Correct Answer: To simulate aseptic production and validate aseptic technique by detecting microbial contamination

Q24. Visual inspection of LVPs is performed mainly to detect:

• Chemical assay variances
• Particulates, precipitates and container defects
• Endotoxin concentration
• Viscosity changes

Correct Answer: Particulates, precipitates and container defects

Q25. For IV electrolyte replacement fluids, the most critical formulation parameter is:

• Color of the solution
• Electrolyte concentration and osmolality
• Viscosity at 50°C
• Flammability

Correct Answer: Electrolyte concentration and osmolality

Q26. Which plasticizer in PVC infusion sets is known to potentially leach into solutions and raise safety concerns?

• Polyethylene glycol 400
• Di(2-ethylhexyl) phthalate (DEHP)
• Sorbitan monooleate
• Polyvinyl alcohol

Correct Answer: Di(2-ethylhexyl) phthalate (DEHP)

Q27. Lipid emulsions in parenteral nutrition are particularly susceptible to which quality risk?

• Becoming hypertonic at room temperature
• Supporting microbial growth and requiring strict aseptic handling
• Spontaneously solidifying
• Oxidizing into oxygen gas

Correct Answer: Supporting microbial growth and requiring strict aseptic handling

Q28. Typical autoclave conditions often used for terminal sterilization of LVPs are:

• 60°C for 60 minutes
• 100°C for 5 minutes
• 121°C for 15 minutes at appropriate pressure
• 180°C for 2 minutes

Correct Answer: 121°C for 15 minutes at appropriate pressure

Q29. Which specific LAL test format can be used to quantify bacterial endotoxins?

• Gram stain
• LAL gel-clot, turbidimetric or chromogenic assay
• Hemolysis test
• Protein nitrogen test

Correct Answer: LAL gel-clot, turbidimetric or chromogenic assay

Q30. Determination of shelf-life for an LVP batch typically requires:

• Only a single pH measurement
• Accelerated and long-term stability studies following ICH guidelines
• Just a visual inspection at release
• Only sterility testing without stability data

Correct Answer: Accelerated and long-term stability studies following ICH guidelines

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