MCQ Quiz: Nonsterile Compounding-Oral Liquids

Welcome, PharmD students, to this MCQ quiz focusing on the Nonsterile Compounding of Oral Liquids! Oral liquid dosage forms, such as solutions, suspensions, and emulsions, are essential for patients who have difficulty swallowing solid forms or require customized doses. Mastering the principles of formulating, preparing, and ensuring the quality of these compounded liquids is a key skill for pharmacists. This quiz will test your understanding of ingredients, techniques, calculations, quality control, and patient counseling related to compounded oral liquids. Let’s dive in!

1. Which of the following is a key advantage of oral liquid dosage forms?

• a) They always have better chemical stability than solid dosage forms.
• b) They are ideal for patients who have difficulty swallowing solid dosage forms, like pediatric or geriatric patients.
• c) They typically mask unpleasant tastes better than any other dosage form.
• d) They do not require any preservatives.

Answer: b) They are ideal for patients who have difficulty swallowing solid dosage forms, like pediatric or geriatric patients.

2. A clear liquid preparation in which the drug substance is completely dissolved in a solvent or mixture of mutually miscible solvents is known as a(n):

• a) Suspension
• b) Emulsion
• c) Solution
• d) Magma

Answer: c) Solution

3. A pharmaceutical suspension is a coarse dispersion in which insoluble solid particles are dispersed in a liquid medium. A critical quality attribute is that it must be:

• a) Perfectly clear.
• b) Able to be easily re-dispersed upon shaking to provide a uniform dose.
• c) Completely free of any visible particles.
• d) Miscible with oil.

Answer: b) Able to be easily re-dispersed upon shaking to provide a uniform dose.

4. Which excipient is added to oral liquid formulations to prevent the growth of microorganisms?

• a) Flavoring agent
• b) Sweetener
• c) Preservative (e.g., methylparaben, sodium benzoate)
• d) Coloring agent

Answer: c) Preservative (e.g., methylparaben, sodium benzoate)

5. When compounding an oral solution, the active pharmaceutical ingredient (API) must be:

• a) Insoluble in the chosen vehicle.
• b) Soluble in the chosen vehicle to the extent required by the dose.
• c) Present as fine, suspended particles.
• d) Coated to prevent dissolution.

Answer: b) Soluble in the chosen vehicle to the extent required by the dose.

6. Which type of oral liquid consists of at least two immiscible liquids, one of which is dispersed as globules (internal phase) within the other liquid (external phase), stabilized by an emulsifying agent?

• a) Elixir
• b) Syrup
• c) Emulsion
• d) Suspension

Answer: c) Emulsion

7. What is the primary purpose of a “Shake Well Before Use” auxiliary label on a compounded suspension or emulsion?

• a) To ensure the container is not leaking.
• b) To ensure uniform distribution of the dispersed phase (drug particles or oil globules) before administration.
• c) To activate the preservative.
• d) To cool down the medication.

Answer: b) To ensure uniform distribution of the dispersed phase (drug particles or oil globules) before administration.

8. According to USP <795> guidelines, the beyond-use date (BUD) for a water-containing oral formulation (when prepared from ingredients in solid form and no stability information is available) is generally:

• a) Not later than 6 months.
• b) Not later than 30 days when stored at controlled room temperature.
• c) Not later than 14 days when stored at controlled cold temperature.
• d) The same as the earliest expiration date of any ingredient.

Answer: c) Not later than 14 days when stored at controlled cold temperature.

9. Which of the following is a common vehicle used in the preparation of oral solutions and suspensions?

• a) Acetone
• b) Purified Water, USP
• c) Mineral oil
• d) Olive oil

Answer: b) Purified Water, USP

10. What is the role of a suspending agent (e.g., acacia, tragacanth, methylcellulose) in a pharmaceutical suspension?

• a) To increase the solubility of the drug.
• b) To reduce the particle size of the drug.
• c) To increase the viscosity of the vehicle and slow down the rate of settling of dispersed particles.
• d) To act as a preservative.

Answer: c) To increase the viscosity of the vehicle and slow down the rate of settling of dispersed particles.

11. The Continental (Dry Gum) method and English (Wet Gum) method are techniques used for preparing which type of oral liquid?

• a) Solutions
• b) Syrups
• c) Emulsions
• d) Elixirs

Answer: c) Emulsions (Specifically for o/w emulsions using acacia as emulsifier)

12. When compounding an oral liquid for a pediatric patient, which sweetener should generally be avoided in neonates due to its potential to cause osmotic diarrhea?

• a) Sucrose
• b) Sorbitol (in large amounts)
• c) Aspartame
• d) Stevia

Answer: b) Sorbitol (in large amounts)

13. Levigation is a process used in compounding suspensions to:

• a) Dissolve the drug completely.
• b) Reduce the particle size of a powder and wet it with a small amount of a levigating agent (in which the drug is insoluble) before incorporating it into the vehicle.
• c) Increase the viscosity of the final product.
• d) Add flavor to the suspension.

Answer: b) Reduce the particle size of a powder and wet it with a small amount of a levigating agent (in which the drug is insoluble) before incorporating it into the vehicle.

14. The pH of an oral liquid formulation is important because it can affect the drug’s:

• a) Color and taste only.
• b) Solubility, stability, and palatability.
• c) Density only.
• d) Container compatibility only.

Answer: b) Solubility, stability, and palatability.

15. Which piece of equipment is essential for accurately measuring small volumes of liquids during compounding?

• a) Household teaspoon
• b) Beaker
• c) Calibrated oral syringe or pipette
• d) Graduated cylinder (for larger volumes, but syringe/pipette for small)

Answer: c) Calibrated oral syringe or pipette

16. If a drug is poorly soluble in water, which of the following might be added to an oral solution formulation to improve its solubility?

• a) A suspending agent
• b) A co-solvent (e.g., alcohol, glycerin, propylene glycol)
• c) A flocculating agent
• d) An insoluble filler

Answer: b) A co-solvent (e.g., alcohol, glycerin, propylene glycol)

17. What is “caking” in a suspension, and why is it undesirable?

• a) The formation of a thick, uniform dispersion; it is desirable.
• b) The formation of a dense, non-redispersible sediment of drug particles; it leads to dose non-uniformity.
• c) The drug completely dissolving in the vehicle.
• d) The growth of mold in the suspension.

Answer: b) The formation of a dense, non-redispersible sediment of drug particles; it leads to dose non-uniformity.

18. Syrups are concentrated aqueous preparations of a sugar or sugar substitute. Besides sweetness, the high sugar concentration also contributes to:

• a) Decreased viscosity.
• b) Some preservative action due to high osmotic pressure.
• c) Increased drug degradation.
• d) A very low pH.

Answer: b) Some preservative action due to high osmotic pressure.

19. Elixirs are clear, sweetened hydroalcoholic solutions intended for oral use. The alcohol content is primarily present to:

• a) Act as the main therapeutic agent.
• b) Serve as a solvent for water-insoluble or alcohol-soluble drug substances and aid in masking taste.
• c) Increase the product’s viscosity.
• d) Only as a preservative.

Answer: b) Serve as a solvent for water-insoluble or alcohol-soluble drug substances and aid in masking taste.

20. When preparing an oral suspension from tablets, it is crucial to ensure that:

• a) Only the active ingredient from the tablet is used, and excipients that might be problematic are considered or removed if possible.
• b) The tablets are simply dropped into water and allowed to dissolve on their own.
• c) The resulting suspension is very gritty.
• d) The color of the suspension matches the original tablet.

Answer: a) Only the active ingredient from the tablet is used, and excipients that might be problematic are considered or removed if possible. (And that there’s stability data or it’s for immediate use as per guidelines).

21. Which factor is LEAST likely to affect the physical stability of an emulsion?

• a) Globule size of the dispersed phase.
• b) The color of the external phase.
• c) The presence of an effective emulsifying agent.
• d) Storage temperature (extremes can cause breaking).

Answer: b) The color of the external phase.

22. “Creaming” in an emulsion refers to:

• a) The complete separation of the internal and external phases.
• b) The upward or downward movement of the dispersed globules to form a concentrated layer, which is usually redispersible.
• c) A change in the emulsion’s color.
• d) Microbial growth.

Answer: b) The upward or downward movement of the dispersed globules to form a concentrated layer, which is usually redispersible.

23. A common method to ensure all soluble ingredients are fully dissolved when preparing an oral solution is to:

• a) Add them all at once to the total volume of solvent.
• b) Dissolve ingredients individually or in order of solubility, often using stirring or gentle heat if appropriate and if it doesn’t degrade the drug.
• c) Use the minimum possible amount of solvent.
• d) Shake vigorously for only 10 seconds.

Answer: b) Dissolve ingredients individually or in order of solubility, often using stirring or gentle heat if appropriate and if it doesn’t degrade the drug.

24. What does HLB (Hydrophile-Lipophile Balance) system help in selecting for emulsion compounding?

• a) Preservatives
• b) Sweeteners
• c) Emulsifying agents
• d) Solvents

Answer: c) Emulsifying agents

25. A “wetting agent” (e.g., glycerin, propylene glycol, or a surfactant) is used in preparing suspensions to:

• a) Increase the solubility of the drug.
• b) Decrease the interfacial tension between the solid particles and the liquid vehicle, facilitating their dispersion.
• c) Make the suspension taste better.
• d) Act as the primary vehicle.

Answer: b) Decrease the interfacial tension between the solid particles and the liquid vehicle, facilitating their dispersion.

26. Which of the following is a critical patient counseling point for a newly compounded oral suspension?

• a) “Store in the freezer for best results.”
• b) “This medication does not need to be shaken.”
• c) “Shake well before each use and use the provided calibrated measuring device for accurate dosing.”
• d) “It is okay to share this medication with family members if they have similar symptoms.”

Answer: c) “Shake well before each use and use the provided calibrated measuring device for accurate dosing.”

27. If a prescription calls for 50 mg of drug per 5 mL, and you need to prepare 120 mL of the oral liquid, how much drug is needed?

• a) 500 mg
• b) 600 mg
• c) 1000 mg
• d) 1200 mg

Answer: d) 1200 mg (50 mg / 5 mL = X mg / 120 mL; X = (50*120)/5 = 1200 mg)

28. Antioxidants like ascorbic acid or sodium metabisulfite may be added to oral liquids to:

• a) Improve the flavor.
• b) Prevent the degradation of drugs susceptible to oxidation.
• c) Increase the viscosity.
• d) Sweeten the preparation.

Answer: b) Prevent the degradation of drugs susceptible to oxidation.

29. When compounding oral liquids for diabetic patients, which type of sweetener is generally preferred over sucrose?

• a) High fructose corn syrup
• b) Honey
• c) Non-caloric artificial sweeteners (e.g., sucralose, aspartame) or sugar alcohols like sorbitol (in moderation).
• d) Molasses

Answer: c) Non-caloric artificial sweeteners (e.g., sucralose, aspartame) or sugar alcohols like sorbitol (in moderation).

30. The “final q.s. to volume” step in preparing an oral solution means:

• a) Adding enough solvent to reach the final desired volume after all ingredients have been dissolved.
• b) Adding a specific, pre-calculated volume of solvent at the beginning.
• c) Using a quick solvent for rapid preparation.
• d) Adding a quantity of sugar.

Answer: a) Adding enough solvent to reach the final desired volume after all ingredients have been dissolved.

31. A flocculating agent is sometimes added to a suspension to:

• a) Cause the particles to aggregate into loose, easily redispersible flocs, preventing caking.
• b) Completely dissolve the drug particles.
• c) Make the suspension clear.
• d) Reduce the viscosity to that of water.

Answer: a) Cause the particles to aggregate into loose, easily redispersible flocs, preventing caking.

32. Which physical stability issue in an emulsion involves the merging of small globules into larger ones, which is an irreversible process?

• a) Creaming
• b) Sedimentation
• c) Coalescence (leading to breaking)
• d) Flocculation

Answer: c) Coalescence (leading to breaking)

33. When selecting a flavor for a compounded oral liquid, it is important to consider:

• a) Only the pharmacist’s favorite flavor.
• b) The inherent taste of the drug, patient age, and any known patient preferences or allergies.
• c) The color of the final product.
• d) The cost of the flavoring agent only.

Answer: b) The inherent taste of the drug, patient age, and any known patient preferences or allergies.

34. If an active ingredient is a salt form (e.g., ondansetron HCl), calculations for the amount of active moiety (ondansetron base) may require using its:

• a) Color
• b) Melting point
• c) Molecular weight and the molecular weight of the salt form
• d) pH

Answer: c) Molecular weight and the molecular weight of the salt form

35. The primary quality concern if a compounded solution is not perfectly clear is:

• a) It might taste bad.
• b) Undissolved drug particles may be present, leading to inaccurate dosing or irritation.
• c) The color is off.
• d) The viscosity is too high.

Answer: b) Undissolved drug particles may be present, leading to inaccurate dosing or irritation.

36. What is the most appropriate glassware for accurately measuring and mixing ingredients to a final volume for an oral solution?

• a) Erlenmeyer flask
• b) Beaker
• c) Graduated cylinder (or a calibrated bottle for final q.s.)
• d) Test tube

Answer: c) Graduated cylinder (or a calibrated bottle for final q.s.)

37. Why is it important to avoid introducing air (e.g., by excessive shaking that creates foam) when compounding some oral liquids?

• a) It makes the liquid taste better.
• b) It can lead to inaccurate volume measurement and may affect stability or appearance.
• c) It increases the drug’s potency.
• d) It is a required step for all oral liquids.

Answer: b) It can lead to inaccurate volume measurement and may affect stability or appearance.

38. For a compounded oral liquid containing a drug known to be light-sensitive, what type of container should be used for dispensing?

• a) A clear glass bottle.
• b) An amber or other light-resistant plastic or glass bottle.
• c) An open beaker.
• d) A large-mouth jar.

Answer: b) An amber or other light-resistant plastic or glass bottle.

39. Which of these is NOT a desired characteristic of a well-formulated pharmaceutical suspension?

• a) Particles settle rapidly and form a hard cake.
• b) Particles are uniformly dispersed with adequate shaking.
• c) The suspension pours readily and evenly from its container.
• d) It is physically, chemically, and microbiologically stable during its intended shelf life.

Answer: a) Particles settle rapidly and form a hard cake.

40. If a compounded oral liquid requires refrigeration for stability, what auxiliary label is essential?

• a) “For External Use Only”
• b) “May Cause Drowsiness”
• c) “Refrigerate; Do Not Freeze”
• d) “Take With Food”

Answer: c) “Refrigerate; Do Not Freeze”

41. The Stokes’ equation describes the sedimentation rate of particles in a suspension. According to this equation, decreasing which factor would reduce the settling rate?

• a) Viscosity of the medium
• b) Particle size of the dispersed phase
• c) Density difference between dispersed phase and dispersion medium
• d) Gravitational constant

Answer: a) Viscosity of the medium (Actually, increasing viscosity reduces settling. Decreasing particle size or density difference reduces settling). Let’s rephrase based on what reduces settling:

Revised Question 41: 41. According to Stokes’ Law, which factor, if increased, would help to reduce the rate of particle settling in a suspension?

• a) Particle size of the drug
• b) Density of the drug particles (if greater than vehicle)
• c) Viscosity of the dispersion medium
• d) Temperature of the suspension

Answer: c) Viscosity of the dispersion medium

42. When is a preservative generally NOT required in a compounded oral liquid?

• a) If the preparation is aqueous and will be used for more than a few days.
• b) If the preparation is for immediate use (e.g., single dose or used within 24 hours under specific conditions).
• c) If the preparation contains a high concentration of sugar (e.g., some syrups).
• d) Both b and c.

Answer: d) Both b and c.

43. What is a key consideration when choosing a flavoring agent for an oral liquid for a child?

• a) The flavor should be very bitter to discourage overuse.
• b) The child’s preference and the inherent taste of the drug (e.g., salty drugs might pair well with citrus or raspberry).
• c) Only artificial flavors should be used.
• d) The flavor must be red.

Answer: b) The child’s preference and the inherent taste of the drug (e.g., salty drugs might pair well with citrus or raspberry).

44. The compounding record for an oral liquid should include the results of any quality control tests performed, such as:

• a) The patient’s blood pressure after taking the medication.
• b) pH measurement, final volume, and appearance.
• c) The cost of the ingredients.
• d) The pharmacist’s preferred flavor.

Answer: b) pH measurement, final volume, and appearance.

45. Which statement is true regarding the use of alcohol in compounded pediatric oral elixirs?

• a) It is always contraindicated in children.
• b) It can be used as a solvent, but its concentration should be minimized, and potential toxicity in young children considered.
• c) It is the preferred sweetener for children.
• d) It increases the stability of all drugs.

Answer: b) It can be used as a solvent, but its concentration should be minimized, and potential toxicity in young children considered.

46. To ensure accurate dosing of a compounded oral liquid at home, patients or caregivers should be counseled to use:

• a) A household tablespoon or teaspoon.
• b) A calibrated measuring device such as an oral syringe, dosing spoon, or medicine cup.
• c) Their best guess.
• d) The bottle cap.

Answer: b) A calibrated measuring device such as an oral syringe, dosing spoon, or medicine cup.

47. If an oral liquid is labeled as “100 mg/5 mL,” how many milligrams of drug are in a 7.5 mL dose?

• a) 100 mg
• b) 150 mg
• c) 75 mg
• d) 200 mg

Answer: b) 150 mg (100 mg / 5 mL = X mg / 7.5 mL; X = (100 * 7.5) / 5 = 150 mg)

48. Buffers are added to some oral liquid formulations to:

• a) Increase the sweetness.
• b) Resist changes in pH, which can affect drug stability and/or solubility.
• c) Act as the primary solvent.
• d) Make the liquid opaque.

Answer: b) Resist changes in pH, which can affect drug stability and/or solubility.

49. One of the challenges in compounding oral suspensions from commercial tablets is that:

• a) Tablets never contain active drug.
• b) Excipients in the tablet (e.g., binders, coatings) may not be suitable for suspension or may alter stability.
• c) Suspensions are always less stable than solutions.
• d) It’s impossible to achieve the correct dose.

Answer: b) Excipients in the tablet (e.g., binders, coatings) may not be suitable for suspension or may alter stability.

50. The ultimate responsibility for ensuring the safety, quality, and appropriateness of a compounded oral liquid preparation lies with the:

• a) Patient
• b) Prescriber
• c) Compounding pharmacist
• d) Wholesaler supplying the ingredients

Answer: c) Compounding pharmacist