Welcome, PharmD students, to this MCQ quiz on Nonsterile Compounding of Capsules! Capsules are a versatile and commonly compounded oral dosage form, allowing for customized dosing and combinations of ingredients. Mastering the art and science of capsule compounding—from selecting the right capsule size and excipients to accurately filling and ensuring quality—is a vital skill for pharmacists. This quiz will test your understanding of the principles and techniques involved in preparing compounded capsules. Let’s dive in!
1. Which type of capsule is most commonly used for extemporaneous compounding in a pharmacy?
- a) Soft gelatin capsules
- b) Hard gelatin capsules
- c) Enteric-coated capsules only
- d) Liquid-filled capsules
Answer: b) Hard gelatin capsules
2. What is the primary material used to make the shells of hard gelatin capsules?
- a) Cellulose derivatives
- b) Gelatin (derived from collagen)
- c) Polyethylene glycol
- d) Starch
Answer: b) Gelatin (derived from collagen)
3. Capsule sizes are designated by numbers. Which of the following capsule sizes has the largest capacity?
- a) Size 5
- b) Size 3
- c) Size 1
- d) Size 000
Answer: d) Size 000 (Sizes range from 000 (largest) to 5 (smallest))
4. The “punch method” is a manual technique used for:
- a) Sealing capsules.
- b) Filling hard gelatin capsules with powder.
- c) Cleaning excess powder from filled capsules.
- d) Counting capsules.
Answer: b) Filling hard gelatin capsules with powder.
5. When compounding capsules, a diluent (filler) such as lactose or microcrystalline cellulose is often added to the formulation primarily to:
- a) Increase the potency of the active drug.
- b) Add color to the capsule contents.
- c) Achieve a fillable volume and ensure dose uniformity when the amount of active drug is small.
- d) Make the capsule taste better.
Answer: c) Achieve a fillable volume and ensure dose uniformity when the amount of active drug is small.
6. The first step in the manual “punch method” of filling capsules usually involves:
- a) Placing the capsule body on the base of a capsule machine.
- b) Arranging the empty capsule bodies on a clean surface or in a capsule holder.
- c) Triturating the powder blend to a uniform particle size and creating a compact powder cake.
- d) Locking the cap onto the body.
Answer: c) Triturating the powder blend to a uniform particle size and creating a compact powder cake.
7. Which of the following is an advantage of using capsules as a dosage form?
- a) They are always cheaper to compound than tablets.
- b) They can mask unpleasant tastes and odors of drugs.
- c) They are suitable for all types of liquid medications.
- d) They do not require any excipients.
Answer: b) They can mask unpleasant tastes and odors of drugs.
8. When calculating the amount of ingredients needed for compounded capsules, it is good practice to calculate for a few extra capsules (e.g., 5-10% extra or 2-3 extra capsules) to:
- a) Account for potential loss during the compounding process.
- b) Increase the final profit margin.
- c) Ensure the patient receives more medication than prescribed.
- d) Make the calculations more complex.
Answer: a) Account for potential loss during the compounding process.
9. The capacity of a given capsule size can be affected by the:
- a) Color of the capsule shell.
- b) Density and compressibility of the powder blend being filled.
- c) Room temperature.
- d) Pharmacist’s experience only.
Answer: b) Density and compressibility of the powder blend being filled.
10. Quality control for compounded capsules should include:
- a) Only checking the color of the capsules.
- b) Visual inspection for uniformity, proper closing, and potentially weight variation checks.
- c) Tasting the contents of one capsule.
- d) Ensuring the capsules are filled to the very top, regardless of weight.
Answer: b) Visual inspection for uniformity, proper closing, and potentially weight variation checks.
11. What is the primary purpose of “locking” hard gelatin capsules after filling?
- a) To make them easier to swallow.
- b) To ensure the cap and body are securely joined and prevent separation.
- c) To increase the drug’s dissolution rate.
- d) To make them tamper-evident.
Answer: b) To ensure the cap and body are securely joined and prevent separation. (Some have locking rings for this)
12. If the amount of active pharmaceutical ingredient (API) per capsule is very small (below the minimum weighable quantity of the balance), which technique should be used to ensure accurate dosing?
- a) Visually estimate the amount of API.
- b) Use a less sensitive balance.
- c) Prepare an aliquot of the API with a suitable diluent.
- d) Add extra API to compensate.
Answer: c) Prepare an aliquot of the API with a suitable diluent.
13. After filling, capsules are often cleaned to remove any extraneous powder from the outer surface. A common method for this is:
- a) Washing them with water.
- b) Gently rolling them on a clean cloth or towel, or using a soft brush.
- c) Exposing them to high heat.
- d) Shaking them vigorously in a sieve.
Answer: b) Gently rolling them on a clean cloth or towel, or using a soft brush.
14. Which factor is LEAST critical when selecting a diluent for a capsule formulation?
- a) Compatibility with the active drug.
- b) The color of the diluent matching the capsule shell.
- c) Inertness and lack of therapeutic activity.
- d) Good flow properties and compressibility (if using a machine).
Answer: b) The color of the diluent matching the capsule shell.
15. The USP chapter that provides general guidelines for nonsterile compounding is:
- a) USP <71> Sterility Tests
- b) USP <797> Pharmaceutical Compounding – Sterile Preparations
- c) USP <795> Pharmaceutical Compounding – Nonsterile Preparations
- d) USP <800> Hazardous Drugs—Handling in Healthcare Settings
Answer: c) USP <795> Pharmaceutical Compounding – Nonsterile Preparations
16. One method to determine the appropriate capsule size for a specific formulation is to:
- a) Always use the largest capsule size available.
- b) Calculate the bulk volume of the powder blend for one capsule and select a size that can accommodate it.
- c) Choose the capsule size based on the color of the drug.
- d) Ask the patient for their preferred size.
Answer: b) Calculate the bulk volume of the powder blend for one capsule and select a size that can accommodate it. (Often involves trial packing as well).
17. If two powders in a capsule formulation are known to form a eutectic mixture, what measure can be taken during compounding?
- a) Triturate them together vigorously to ensure mixing.
- b) Add an adsorbent diluent (like magnesium carbonate or light magnesium oxide) separately to each problematic ingredient before mixing them together.
- c) Moisten the powders slightly before filling.
- d) Heat the capsule shells.
Answer: b) Add an adsorbent diluent (like magnesium carbonate or light magnesium oxide) separately to each problematic ingredient before mixing them together.
18. The “body” and “cap” are the two parts of which type of capsule?
- a) Soft gelatin capsule
- b) Hard gelatin capsule
- c) Enteric-coated tablet
- d) Suppository
Answer: b) Hard gelatin capsule
19. When using a manual capsule filling machine, the powder blend is typically spread evenly into the:
- a) Capsule caps.
- b) Capsule bodies that are oriented in the machine.
- c) A separate weighing boat.
- d) The hopper of a tablet press.
Answer: b) Capsule bodies that are oriented in the machine.
20. What is a potential disadvantage of compounding capsules?
- a) They cannot mask unpleasant tastes.
- b) The process can be time-consuming for manual filling of large quantities.
- c) They are unsuitable for potent drugs.
- d) They always provide slower drug release than tablets.
Answer: b) The process can be time-consuming for manual filling of large quantities.
21. Before filling capsules, it’s crucial that the powder blend is:
- a) As coarse as possible.
- b) Homogenous to ensure dose uniformity.
- c) Slightly damp for better packing.
- d) A different color than the capsule shell.
Answer: b) Homogenous to ensure dose uniformity.
22. What information is typically required on the label of a compounded capsule prescription?
- a) Only the patient’s name.
- b) Patient’s name, active ingredients and strengths, quantity, directions, pharmacy details, date, and beyond-use date.
- c) Only the beyond-use date.
- d) The color of the capsules.
Answer: b) Patient’s name, active ingredients and strengths, quantity, directions, pharmacy details, date, and beyond-use date.
23. The beyond-use date (BUD) for compounded non-aqueous formulations like powder-filled capsules, according to USP <795> (if no stability data is available), is generally:
- a) 14 days when stored at controlled cold temperature.
- b) Not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier.
- c) 30 days at room temperature.
- d) 1 year from the date of compounding.
Answer: b) Not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier.
24. Which of the following would be a reason to select capsules over tablets for a compounded preparation?
- a) The drug is extremely bitter and needs to be taste-masked.
- b) A very rapid onset of action, like a sublingual tablet, is required.
- c) The dose is extremely large and cannot fit into a capsule.
- d) The drug is only stable as a compressed powder.
Answer: a) The drug is extremely bitter and needs to be taste-masked. (Capsules can achieve this).
25. When determining the fill weight of a capsule, if the density of the powder blend is low, a _______ capsule size might be needed for a given weight compared to a denser powder.
- a) smaller
- b) larger
- c) clear
- d) opaque
Answer: b) larger
26. What is a key patient counseling point for orally administered capsules?
- a) Always chew the capsule before swallowing.
- b) Swallow the capsule whole with a sufficient amount of water, unless otherwise directed.
- c) Store all capsules in the refrigerator.
- d) Capsules can be opened and the contents mixed with any food or beverage.
Answer: b) Swallow the capsule whole with a sufficient amount of water, unless otherwise directed. (Opening capsules is sometimes done, but should not be assumed without specific instruction/assessment).
27. Gelatin, the primary component of hard capsule shells, is derived from:
- a) Plant cellulose
- b) Synthetic polymers
- c) Animal collagen
- d) Seaweed extracts
Answer: c) Animal collagen
28. If a pharmacist needs to compound a very small dose of a drug into capsules and direct weighing is not feasible, they might first prepare a trituration. A common ratio for a 10% trituration is:
- a) 1 part drug to 10 parts diluent.
- b) 1 part drug to 9 parts diluent.
- c) 10 parts drug to 1 part diluent.
- d) 1 part drug to 100 parts diluent.
Answer: b) 1 part drug to 9 parts diluent. (Making a total of 10 parts, where drug is 1/10th or 10%).
29. A “Certificate of Analysis” (CoA) for a bulk drug substance used in compounding provides information about its:
- a) Therapeutic indications.
- b) Identity, purity, quality, and compliance with specifications.
- c) Patient counseling points.
- d) Pharmacokinetic profile.
Answer: b) Identity, purity, quality, and compliance with specifications.
30. One way to assess weight uniformity of compounded capsules in a pharmacy setting (as a quality check) might involve:
- a) Weighing each individual filled capsule and comparing it to the target weight plus excipients.
- b) Only weighing the empty capsule shells.
- c) Visually estimating the fill level.
- d) Asking the patient if they feel the dose is correct.
Answer: a) Weighing each individual filled capsule and comparing it to the target weight plus excipients. (More practically, weigh a number of capsules individually, and also an average weight).
31. Which of these is an opacifying agent sometimes added to capsule shells?
- a) Sucrose
- b) Titanium dioxide
- c) Lactose
- d) FD&C Red No. 40
Answer: b) Titanium dioxide
32. The selection of capsule size is critical. If too small a capsule is chosen for the required amount of powder:
- a) The capsule will be too potent.
- b) The powder will not fit, or the capsule cannot be properly closed.
- c) The drug will dissolve too quickly.
- d) The beyond-use date will be shorter.
Answer: b) The powder will not fit, or the capsule cannot be properly closed.
33. What is the primary reason for avoiding the compounding of capsules with highly hygroscopic or deliquescent powders without proper precautions or excipients?
- a) They can make the capsule shells brittle or cause them to absorb moisture and soften/deform.
- b) They increase the potency of the drug.
- c) They improve the taste.
- d) They always make the powder flow better.
Answer: a) They can make the capsule shells brittle or cause them to absorb moisture and soften/deform.
34. The “Rule of Sixes” or “Rule of Sevens” can be used as an approximate guide for:
- a) Determining the beyond-use date.
- b) Calculating the minimum weighable quantity.
- c) Estimating the powder capacity of different capsule sizes based on bulk density (though less precise than direct measurement/calculation).
- d) Selecting the appropriate colorant.
Answer: c) Estimating the powder capacity of different capsule sizes based on bulk density (though less precise than direct measurement/calculation).
35. When compounding capsules containing a controlled substance, what additional requirement is crucial?
- a) Using only clear capsule shells.
- b) Storing them at frozen temperatures.
- c) Maintaining meticulous records of inventory, compounding, and dispensing as per legal regulations.
- d) Ensuring the capsule is extra large.
Answer: c) Maintaining meticulous records of inventory, compounding, and dispensing as per legal regulations.
36. If a powder blend for capsules has poor flowability, what problem might occur during manual or machine filling?
- a) The capsules will be too potent.
- b) Inconsistent fill volumes and weights, leading to dose non-uniformity.
- c) The capsules will dissolve too slowly.
- d) The powder will change color.
Answer: b) Inconsistent fill volumes and weights, leading to dose non-uniformity.
37. What is the significance of the “cap” of a hard gelatin capsule being slightly wider than the “body”?
- a) It makes the capsule harder to swallow.
- b) It allows the cap to slide over and securely close the body after filling.
- c) It indicates the capsule size.
- d) It improves the drug’s stability.
Answer: b) It allows the cap to slide over and securely close the body after filling.
38. For drugs that are sensitive to light, what type of hard gelatin capsule shell would be most appropriate?
- a) Clear, transparent shells.
- b) Opaque or colored shells.
- c) Very small shells (size 5).
- d) Shells made of soft gelatin.
Answer: b) Opaque or colored shells.
39. The term “compounding record” or “log sheet” for a capsule preparation should detail:
- a) Only the patient’s allergies.
- b) The specific ingredients, quantities, lot numbers, procedures followed, and checks performed for that particular batch.
- c) The wholesale cost of the ingredients.
- d) The anticipated therapeutic outcome.
Answer: b) The specific ingredients, quantities, lot numbers, procedures followed, and checks performed for that particular batch.
40. One key aspect of ensuring “quality of mixing powders” for capsule compounding is achieving:
- a) A layered appearance in the powder bed.
- b) A homogenous distribution of the active pharmaceutical ingredient(s) throughout the diluent(s).
- c) The largest possible particle size for all components.
- d) A significantly different color for each ingredient.
Answer: b) A homogenous distribution of the active pharmaceutical ingredient(s) throughout the diluent(s).
41. If a prescribed dose of a drug for a capsule is 7 mg, but the minimum weighable quantity (MWQ) on the available balance is 20 mg with 5% error, the pharmacist must:
- a) Weigh 7 mg directly and accept a larger percentage error.
- b) Prepare an aliquot or trituration of the drug to accurately obtain 7 mg.
- c) Ask the prescriber to change the dose to 20 mg.
- d) Use a household spoon to estimate 7 mg.
Answer: b) Prepare an aliquot or trituration of the drug to accurately obtain 7 mg.
42. The environment for nonsterile compounding of capsules should be:
- a) The same area used for preparing food.
- b) A clean, well-lit area, separate from dispensing activities, with appropriate equipment and surfaces.
- c) A sterile cleanroom under ISO Class 5 conditions.
- d) Any available counter space.
Answer: b) A clean, well-lit area, separate from dispensing activities, with appropriate equipment and surfaces.
43. What is the role of a glidant (e.g., colloidal silicon dioxide) when added to a powder formulation for capsules?
- a) To increase the cohesiveness of the powder.
- b) To improve the flowability of the powder mixture.
- c) To act as a binder.
- d) To provide color.
Answer: b) To improve the flowability of the powder mixture.
44. Before dispensing compounded capsules, a final check by the pharmacist typically includes verifying:
- a) The prescription, calculations, ingredients used, compounded product appearance, and labeling.
- b) Only that the correct number of capsules was made.
- c) Only the patient’s insurance information.
- d) Only the color of the capsule.
Answer: a) The prescription, calculations, ingredients used, compounded product appearance, and labeling.
45. Which factor would generally make a powder more difficult to pack uniformly into a capsule shell using the punch method?
- a) Good flowability and moderate cohesiveness.
- b) Very fluffy, light powder with poor flow and high static charge.
- c) Granular powder.
- d) Slightly moist powder.
Answer: b) Very fluffy, light powder with poor flow and high static charge.
46. When compounding capsules, if you calculate that you need 12.5 mg of active drug per capsule and 3.125 g of diluent for a batch of 100 capsules, this means the total powder weight per capsule will be:
- a) 12.5 mg
- b) 31.25 mg
- c) 43.75 mg (12.5 mg drug + 31.25 mg diluent)
- d) Cannot be determined.
Answer: c) 43.75 mg (12.5 mg drug + 31.25 mg diluent) (3.125 g = 3125 mg for 100 caps, so 31.25 mg diluent/cap. Total = 12.5 + 31.25)
47. One reason a prescriber might order compounded capsules is to:
- a) Obtain a medication that is commercially available in the exact required strength.
- b) Provide a dose or combination of ingredients not commercially available, or to avoid excipients to which a patient is allergic.
- c) Ensure the patient receives a placebo.
- d) Increase the cost of therapy.
Answer: b) Provide a dose or combination of ingredients not commercially available, or to avoid excipients to which a patient is allergic.
48. What is an important consideration for the storage of compounded capsules containing hygroscopic materials?
- a) Store in an open container to allow air circulation.
- b) Store in a tightly sealed container, possibly with a desiccant, in a cool, dry place.
- c) Store in a very humid environment.
- d) Freeze the capsules.
Answer: b) Store in a tightly sealed container, possibly with a desiccant, in a cool, dry place.
49. The USP General Chapter <1160> “Pharmaceutical Calculations in Prescription Compounding” provides guidance on:
- a) Therapeutic uses of compounded drugs.
- b) Calculations necessary for accurate compounding, including aliquot method and percentage error.
- c) Marketing compounded preparations.
- d) Sterile compounding techniques only.
Answer: b) Calculations necessary for accurate compounding, including aliquot method and percentage error.
50. The final responsibility for the quality and accuracy of a compounded capsule preparation rests with the:
- a) Patient
- b) Prescriber
- c) Compounding pharmacist
- d) Pharmaceutical manufacturer of the raw ingredients
Answer: c) Compounding pharmacist