Practice Test Geeks(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test
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Drug Formulation and Development Flashcards

7 cards from real KAPS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Drug Formulation and Development flashcards as text

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

    Answer: Intrinsic dissolution rate (IDR) using a rotating disk

    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.

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

    Answer: Moderate lipophilicity (LogP 1–3)

    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.

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

    Answer: Friability test

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

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

    Answer: The most thermodynamically stable polymorph

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

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

    Answer: Lyophilization (freeze-drying)

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

  6. During stability testing per ICH Q1A(R2), what are the storage conditions for long-term stability testing of a drug product intended for storage in a refrigerator (2–8°C)?

    Answer: 5°C ± 3°C

    ICH Q1A(R2) specifies 5°C ± 3°C for long-term stability testing of refrigerated drug products.

  7. Which in vitro dissolution apparatus is MOST appropriate for testing soft gelatin capsules and suppositories due to minimal mechanical agitation?

    Answer: USP Apparatus II (paddle)

    USP Apparatus II (paddle) is recommended for soft gelatin capsules and suppositories, with sinker devices used to prevent floating of the dosage form.