KAPS Drug Formulation and Development 3

Question 1

Which preformulation study measures the intrinsic rate of drug dissolution independent of particle size effects?

Accepted Answer

Intrinsic dissolution rate (IDR) using a rotating disk

Answer

The intrinsic dissolution rate uses a compressed disk of pure drug at constant surface area, isolating the drug's inherent dissolution properties from particle size effects.

Question 2

In designing a transdermal drug delivery system, which property of the drug is MOST critical for passive permeation through skin?

Accepted Answer

Moderate lipophilicity (LogP 1–3)

Answer

Optimal transdermal permeation requires moderate lipophilicity (LogP 1–3) to partition into the lipid-rich stratum corneum while retaining enough aqueous solubility to partition into deeper aqueous layers.

Question 3

Which test is performed during tablet development to assess the ability of a tablet to withstand mechanical stress during manufacturing and shipping?

Accepted Answer

Friability test

Answer

The friability test tumbles tablets in a drum and measures % weight loss, evaluating resistance to abrasion and chipping during handling.

Question 4

A drug substance exhibits polymorphism. Which polymorph is PREFERRED for oral solid dosage form development from a thermodynamic stability standpoint?

Accepted Answer

The most thermodynamically stable polymorph

Answer

The most thermodynamically stable polymorph is preferred because it is least likely to convert to another form during storage, ensuring consistent dissolution and bioavailability.

Question 5

Which process converts a drug-polymer solution into a porous solid matrix by sublimation of the frozen solvent under vacuum?

Accepted Answer

Lyophilization (freeze-drying)

Answer

Lyophilization freezes the solution and then removes the solvent by sublimation under vacuum, producing a porous cake ideal for heat-sensitive biologics.

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

KAPS Drug Formulation and Development 3