Question 1
Shelf-life is the period during which a DS and DP remains within the approved specifications, provided that it is stored under the approved conditions in the approved packaging.
Correct Answer:
True
Explanation:
Shelf-life is defined by how long the drug substance and the drug product stay within their approved quality specifications when stored under the specified conditions in the approved packaging. This concept hinges on stability data: the product is tested over time under defined temperatures, humidity, light, and packaging to ensure it continues to meet identity, potency, purity, and safety limits. If these criteria remain met, the product is considered suitable for use for that period; once they shift outside the specifications, the product is no longer within its shelf-life. The packaging and storage conditions are integral because they influence the rate of degradation. Packaging that provides adequate protection and storage that keeps conditions constant help maintain quality for the stated shelf-life. Choices referencing surface area of packaging or packaging cost are not related to how long the product remains within specifications, so they don’t define shelf-life. Therefore, the statement is true.
Question 2
A 45-year-old mechanically ventilated patient receives propofol 200 mg/h in a 10 mg/mL formulation in a 10% lipid emulsion. How many calories per day does this provide?
Correct Answer:
528
Explanation:
Propofol is given in a lipid emulsion, so the calories come from the fat in that emulsion. Convert the dose to volume: 200 mg/h at 10 mg/mL equals 20 mL/h. A 10% lipid emulsion provides about 1.1 kcal per mL, so hourly calories are 20 mL/h × 1.1 kcal/mL = 22 kcal/h. Over 24 hours, 22 × 24 = 528 kcal/day.
Question 3
Which statement about powder weight and compression in wet granulation is correct?
Correct Answer:
Heavier powder makes compression easier
Explanation:
The main idea is how the mass per unit volume of the powder (bulk density) influences how a powder compacts during wet granulation. When powder is heavier, it has higher bulk density, meaning more material sits in the same die volume. That closer packing and higher initial solid fraction allow particles to come into contact and deform or bond more readily under the same compression; moisture from wet granulation also helps form capillary bridges between particles, strengthening the compact. So, for a given compression force, a heavier powder generally densifies and strengthens more easily, making compression easier. The idea that heavier powder would make compression harder would require less contact or more friction, which isn’t typical for higher bulk density. Saying powder weight has no effect ignores the role of packing density in compression. And claiming heavier powder prevents granulation isn’t accurate—granulation depends on moisture, binder, and process conditions, not simply on powder weight.
Question 4
What excipient is commonly found in chewable tablets?
Correct Answer:
Mannitol
Explanation:
Chewable tablets rely on excipients that provide sweetness and a pleasant mouthfeel, since the dosage form is designed to be chewed rather than swallowed with water. Mannitol fits this role well: it is a sugar alcohol that delivers non-cariogenic sweetness and a cool, smooth mouthfeel. It also doubles as a diluent and compresses well, helping form a robust chewable tablet. Among alternatives, sorbitol is another sweetener used in chewables, but mannitol is favored for its better mouthfeel and lower hygroscopicity, which aids stability and handling. Lactose can serve as a filler in many tablets but is less ideal for chewables due to potential lactose intolerance issues and a lack of the distinctive mouthfeel mannitol provides. Microcrystalline cellulose mainly offers structure as a filler and binder and does not contribute significant sweetness or mouthfeel. Therefore, mannitol is commonly found in chewable tablets.
Question 5
Which dissolution apparatus is best for poorly soluble or controlled-release forms?
Correct Answer:
Apparatus III (Reciprocating Cylinder) for poorly soluble or controlled-release forms
Explanation:
Dissolution effectiveness hinges on how well the surrounding fluid can contact the solid surface and remove dissolved drug, especially when solubility is limited or the release is controlled. The reciprocating cylinder setup provides a carefully controlled hydrodynamic environment: the cylinder moves up and down in the dissolution medium, creating a dynamic flow around the dosage form that reduces the stagnant boundary layer and delivers fresh solvent consistently. This combination helps reveal the true dissolution behavior of poorly soluble drugs and, at the same time, lets the release mechanism of a controlled‑release form proceed without being overly disrupted by aggressive mixing. In practice, this means you get more representative, reproducible dissolution data for forms that are hard to dissolve or designed to release drug over time. The other apparatus have their uses—for example, baskets and paddles are common for conventional tablets and capsules, but their agitation can risk damaging coatings or displacing non-disintegrating forms; the flow‑through setup is excellent for truly solubility‑limited scenarios and nontraditional dosage forms, but it’s more complex and may not mimic the specific hydrodynamics that CR or poorly soluble systems benefit from as effectively. So, the reciprocating cylinder is the best match for poorly soluble or controlled‑release forms.
Question 1
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Prepare with the Pharmaceutics ll Exam 2 Practice practice quiz. This question bank includes 10 questions covering approved, within, compression, granulation, and dissolution. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

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Pharmaceutics ll Exam 2 Practice

This practice set contains 10 questions from the matching question bank and focuses on approved, within, compression, granulation, and dissolution. Work through each question carefully, review the provided solutions, and revisit topics that need more study before your next attempt.

This is an independent study resource intended for practice and review; it is not an official examination or an endorsement by any organization named in the title.

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