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
A formulator observes caking in a reconstituted suspension after storage. Which formulation strategy BEST prevents this problem?
Answer: Adding a flocculating agent to create a loosely packed sediment
Controlled flocculation creates a loose, easily redispersible sediment (floccules) rather than a dense, hard cake that forms from deflocculated particles.
In parenteral formulation development, which parameter is adjusted using sodium chloride or dextrose to match the osmolarity of blood (~285–310 mOsm/kg)?
Answer: Tonicity
Tonicity adjusting agents like NaCl or dextrose are added to achieve isotonicity (~285–310 mOsm/kg) and prevent red blood cell lysis or crenation upon injection.
The Stokes' Law equation predicts that sedimentation rate in a suspension can be reduced by increasing which formulation parameter?
Answer: Medium viscosity
Stokes' Law shows sedimentation velocity is inversely proportional to medium viscosity; increasing viscosity with suspending agents like xanthan gum slows settling.
Which solid-state analytical technique is MOST useful for identifying polymorphic forms of a drug substance?
Answer: Differential scanning calorimetry (DSC)
DSC detects different melting points and enthalpies of transition for different polymorphs, making it the primary tool for polymorph identification.
A Quality by Design (QbD) approach to tablet development begins with defining which element?
Answer: Quality Target Product Profile (QTPP)
ICH Q8(R2) defines QbD as starting with the QTPP, which outlines the desired quality, safety, and efficacy attributes of the intended product.
Which type of granulation is MOST suitable for heat- and moisture-sensitive drugs?
Answer: Dry granulation (roller compaction or slugging)
Dry granulation avoids both heat and moisture by compacting powder mechanically, making it ideal for moisture- or thermolabile drug substances.
In an IVIVC (in vitro–in vivo correlation), a Level A correlation is considered MOST valuable because it:
Answer: Provides a point-to-point relationship between in vitro dissolution and in vivo absorption
A Level A IVIVC provides the highest predictive value by establishing a point-to-point relationship between the entire in vitro dissolution profile and the in vivo absorption profile.