Wattle Pharmacy Prep

Pharmaceutical excipients
Practice questions with explanations

Pharmaceutical excipients belongs to Medicinal chemistry and biopharmaceutics, which makes up about 10% of the Overseas Pharmacist Readiness Assessment (OPRA®). Answer each question yourself before opening the explanation.

1. Which excipient consideration applies to a medicine given to a neonate?

  1. Excipient content is irrelevant at any age
  2. Benzyl alcohol, propylene glycol and ethanol can accumulate to toxic levels because of immature metabolism
  3. Excipients are metabolised faster in neonates
  4. Neonates tolerate all excipients better than adults
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B. Benzyl alcohol, propylene glycol and ethanol can accumulate to toxic levels because of immature metabolism

Benzyl alcohol caused fatal gasping syndrome in neonates, and propylene glycol accumulates because of limited alcohol dehydrogenase activity and immature renal clearance, causing hyperosmolality, acidosis and central depression. Neonatal formulations are therefore chosen with the excipient profile in mind, not only the active ingredient.

2. What is the role of a glidant such as colloidal silicon dioxide?

  1. It preserves against microbial growth
  2. It causes the tablet to disintegrate
  3. It improves powder flow during manufacture, ensuring consistent die filling and dose uniformity
  4. It masks unpleasant taste
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C. It improves powder flow during manufacture, ensuring consistent die filling and dose uniformity

Poorly flowing powder fills the die inconsistently, producing tablets of varying weight and therefore varying dose. Glidants reduce interparticle friction to keep flow uniform. They are distinct from lubricants, which reduce friction between the powder and the die wall and punches, though a single material can sometimes serve both purposes.

3. What is the purpose of a film coating on a tablet?

  1. To provide the active ingredient
  2. To delay release until the intestine in every case
  3. To make the tablet dissolve in the mouth
  4. To protect from moisture and light, mask taste, ease swallowing and aid identification, without delaying release
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D. To protect from moisture and light, mask taste, ease swallowing and aid identification, without delaying release

An ordinary film coat dissolves quickly and does not modify release, unlike an enteric or modified-release coat. It nonetheless serves several purposes, and it also protects handlers from potent or irritant drugs, which is why finasteride tablets should not be handled by women of childbearing potential if the coating is broken.

These are 3 of the 20 questions on pharmaceutical excipients in the app.

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More topics in Medicinal chemistry and biopharmaceutics

Dosage form design · Drug stability and degradation · Functional groups and drug classes · Solubility and partitioning · Sterile products · Structure-activity relationships