Vehicles for parenteral formulations MCQs With Answer

Introduction: Vehicles for parenteral formulations are sterile, pyrogen-free excipients that carry active drugs for intravenous, intramuscular, or subcutaneous administration. B.Pharm students must understand aqueous vehicles (Water for Injection, normal saline, dextrose), non‑aqueous/oily vehicles (sesame, soybean oil), co‑solvents (PEG, propylene glycol), surfactants, buffers, tonicity agents, preservatives and antioxidants. Key considerations include sterility, isotonicity, solubility enhancement, compatibility, stability and safety for specific routes (e.g., intrathecal, neonatal). Mastery of vehicle selection and formulation principles is essential for designing safe, effective injectables. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary role of a vehicle in parenteral formulations?

  • To provide a sterile, isotonic, non‑reactive medium for drug delivery
  • To act as the active pharmaceutical ingredient
  • To increase tablet compressibility
  • To prevent oral absorption of the drug

Correct Answer: To provide a sterile, isotonic, non‑reactive medium for drug delivery

Q2. What does WFI mean in the context of parenteral vehicles?

  • Water for Injection (WFI)
  • Weighted Formulation Ingredient
  • Water for Infusion
  • Weak Friction Inhibitor

Correct Answer: Water for Injection (WFI)

Q3. Which method is commonly used to manufacture Water for Injection to ensure pyrogen removal?

  • Distillation or reverse osmosis with appropriate microbial control
  • Simple tap filtration only
  • Autoclaving of raw seawater
  • Addition of preservatives to tap water

Correct Answer: Distillation or reverse osmosis with appropriate microbial control

Q4. Which of the following is a commonly used isotonic aqueous vehicle for parenteral use?

  • 0.9% w/v sodium chloride (Normal saline)
  • 10% sodium chloride
  • Distilled water with no salt
  • 50% ethanol solution

Correct Answer: 0.9% w/v sodium chloride (Normal saline)

Q5. Which oily vehicle is traditionally used for depot intramuscular injections to prolong drug release?

  • Sesame oil
  • Glycerin
  • Water for Injection
  • 0.9% sodium chloride

Correct Answer: Sesame oil

Q6. Which vehicle should be avoided for neonatal injections due to toxicity concerns?

  • Bacteriostatic water containing benzyl alcohol
  • Sterile Water for Injection (single use)
  • 0.9% sodium chloride
  • Water for Injection prepared by distillation

Correct Answer: Bacteriostatic water containing benzyl alcohol

Q7. Which co‑solvent is commonly employed to solubilize poorly water‑soluble drugs for parenteral administration?

  • Polyethylene glycol (PEG)
  • Sodium chloride 0.9%
  • Distilled water without sterilization
  • Calcium carbonate

Correct Answer: Polyethylene glycol (PEG)

Q8. Surfactants used in parenteral formulations (e.g., polysorbate 80) primarily serve to:

  • Stabilize emulsions and solubilize lipophilic drugs
  • Increase microbial growth
  • Act as primary active pharmaceutical ingredients
  • Raise formulation pH to 12

Correct Answer: Stabilize emulsions and solubilize lipophilic drugs

Q9. Which emulsion type is suitable for intravenous lipid nutrition and many parenteral lipid products?

  • Oil-in-water (O/W) emulsion
  • Water-in-oil (W/O) emulsion
  • Microcrystalline suspension
  • Solid dispersion

Correct Answer: Oil-in-water (O/W) emulsion

Q10. Which parameter is most critical to match when preparing parenteral solutions to avoid hemolysis or irritation?

  • Isotonicity (osmolarity/osmolality)
  • Color of the solution
  • Molecular weight of the solvent
  • Melting point of the solvent

Correct Answer: Isotonicity (osmolarity/osmolality)

Q11. Which preservative is often present in bacteriostatic water for multi‑dose parenteral use?

  • Benzyl alcohol
  • Ascorbic acid
  • Hydrochloric acid
  • Sodium chloride

Correct Answer: Benzyl alcohol

Q12. Which analytical test is commonly used to detect bacterial endotoxins (pyrogens) in parenteral vehicles?

  • Limulus amebocyte lysate (LAL) test
  • Biuret protein test
  • Ninhydrin test
  • pH meter reading only

Correct Answer: Limulus amebocyte lysate (LAL) test

Q13. Which antioxidant is commonly used to protect parenteral formulations from oxidation?

  • Sodium metabisulfite
  • Sodium chloride
  • Benzyl alcohol
  • Magnesium stearate

Correct Answer: Sodium metabisulfite

Q14. What is the primary function of tonicity-adjusting agents in parenteral vehicles?

  • To match osmotic pressure to body fluids and prevent cell damage
  • To increase the color intensity of the solution
  • To act as the main surfactant
  • To sterilize the formulation

Correct Answer: To match osmotic pressure to body fluids and prevent cell damage

Q15. Which chelating agent is used in some parenteral formulations to bind metal ions and enhance stability?

  • Disodium EDTA
  • Sodium chloride
  • Calcium hydroxide
  • Polyvinylpyrrolidone (PVP)

Correct Answer: Disodium EDTA

Q16. Which phospholipid is a major constituent of liposomal parenteral vehicles?

  • Phosphatidylcholine
  • Sodium lauryl sulfate
  • Polysorbate 80
  • Ethyl cellulose

Correct Answer: Phosphatidylcholine

Q17. For terminal sterilization of heat‑sensitive parenteral drugs, which aseptic process is typically used?

  • Sterile filtration through 0.22 µm membrane followed by aseptic filling
  • Autoclaving at 121°C for 30 minutes after filling
  • Dry heat sterilization of the final vial at 200°C
  • Exposure to tap water for dilution

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

Q18. Which statement describes the Hydrophilic–Lipophilic Balance (HLB) concept used for selecting surfactants in parenteral emulsions?

  • HLB indicates the balance between hydrophilic and lipophilic character to choose appropriate emulsifiers
  • HLB measures the microbial contamination level
  • HLB is a pH scale for aqueous vehicles
  • HLB specifies the particle size in suspensions

Correct Answer: HLB indicates the balance between hydrophilic and lipophilic character to choose appropriate emulsifiers

Q19. Which buffer system is commonly used to maintain pH in parenteral formulations?

  • Phosphate buffer system
  • Acetone buffer
  • Sugar alcohol buffer
  • Hydrochloric salt buffer (non‑standard term)

Correct Answer: Phosphate buffer system

Q20. Which of the following is a parenteral lipid vehicle used in injectable lipid emulsions for nutrition?

  • Soybean oil stabilized with egg phospholipids
  • Polyethylene glycol 400 only
  • Distilled water with added sugar
  • Isopropyl alcohol

Correct Answer: Soybean oil stabilized with egg phospholipids

Q21. Which statement about preservatives in parenteral vehicles is correct?

  • Preservatives are generally avoided in intrathecal and neonatal products
  • All parenteral products must contain preservatives
  • Preservatives increase the sterility assurance to 100%
  • Preservatives make solutions hypertonic by default

Correct Answer: Preservatives are generally avoided in intrathecal and neonatal products

Q22. Which medium‑chain triglyceride brand or type is commonly used as a non‑reactive oily vehicle?

  • Miglyol (medium‑chain triglycerides)
  • Sodium lauryl sulfate
  • Polyvinyl alcohol
  • Hydrochloric acid solution

Correct Answer: Miglyol (medium‑chain triglycerides)

Q23. Why are parenteral emulsions required to have controlled droplet size distribution?

  • To prevent embolism and ensure physical stability
  • To improve taste for oral administration
  • To increase tablet hardness
  • To promote microbial growth

Correct Answer: To prevent embolism and ensure physical stability

Q24. Which solvent is UNSUITABLE as a parenteral vehicle due to toxicity when used systemically?

  • Absolute ethanol at high concentrations
  • Sterile Water for Injection (single use)
  • 0.9% sodium chloride
  • Phosphate buffered saline

Correct Answer: Absolute ethanol at high concentrations

Q25. Which of the following is an effect of incorrect tonicity in parenteral vehicles?

  • Local tissue irritation, pain, or hemolysis
  • Improved drug potency always
  • Guaranteed extended shelf life
  • Automatic sterilization

Correct Answer: Local tissue irritation, pain, or hemolysis

Q26. Which additive is commonly used to chelate trace metals and improve parenteral formulation stability?

  • EDTA (ethylenediaminetetraacetic acid)
  • Glycerol
  • Magnesium stearate
  • Sodium chloride

Correct Answer: EDTA (ethylenediaminetetraacetic acid)

Q27. Which choice is the best approach to solubilize a lipophilic drug for parenteral injection when aqueous solubility is very low?

  • Use co‑solvents (PEG, propylene glycol) or suitable surfactants to form a safe injectable solution or emulsion
  • Dilute the drug in tap water without sterilization
  • Mix the drug with table salt to increase solubility
  • Freeze the drug until it dissolves

Correct Answer: Use co‑solvents (PEG, propylene glycol) or suitable surfactants to form a safe injectable solution or emulsion

Q28. What is a key safety requirement for parenteral vehicles regarding microorganisms?

  • They must be sterile and free of pyrogens
  • They must contain live cultures to stimulate immunity
  • They should always include a nutrient medium
  • They must be opaque to light

Correct Answer: They must be sterile and free of pyrogens

Q29. Which statement about liposomal vehicles for parenteral drug delivery is TRUE?

  • Liposomes encapsulate drugs in phospholipid bilayers to modify pharmacokinetics and reduce toxicity
  • Liposomes are identical to simple oil droplets with no bilayer
  • Liposomes are always contaminated with endotoxins
  • Liposomes cannot be sterilized or used parenterally

Correct Answer: Liposomes encapsulate drugs in phospholipid bilayers to modify pharmacokinetics and reduce toxicity

Q30. What is the standard autoclave condition commonly used for terminal sterilization of heat‑stable parenteral containers and solutions?

  • 121°C for 15 minutes at approximately 15 psi
  • 60°C for 5 minutes at atmospheric pressure
  • 200°C for 1 minute
  • Storage at room temperature for 24 hours

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

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