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
Which regulatory pathway allows a sponsor to request FDA feedback on the appropriateness of dissolution as a surrogate for bioequivalence studies during scale-up and post-approval changes?
Answer: SUPAC (Scale-Up and Post-Approval Changes) guidance
FDA's SUPAC guidance provides tiered recommendations for dissolution testing as a surrogate for in vivo bioequivalence studies following manufacturing changes.
A liposomal drug formulation is used primarily to achieve which therapeutic objective?
Answer: Enable passive targeting to tumor tissue via the EPR effect
Liposomes accumulate in tumor tissue through the Enhanced Permeability and Retention (EPR) effect due to leaky tumor vasculature and poor lymphatic drainage.
In biopharmaceutics, the term 'flip-flop pharmacokinetics' describes a situation where:
Answer: The terminal half-life is controlled by absorption, not elimination
Flip-flop kinetics occurs when absorption is rate-limiting (ka < ke), so the terminal slope reflects the slow absorption rate rather than the elimination rate constant.
Which excipient is classified as a superdisintegrant and works primarily by rapid water absorption and swelling?
Answer: Croscarmellose sodium
Croscarmellose sodium (Ac-Di-Sol) is a superdisintegrant that swells rapidly in water due to its cross-linked structure, promoting rapid tablet disintegration.
During forced degradation studies, which stress condition is used to identify hydrolytic degradation pathways of a drug substance?
Answer: Acid and base hydrolysis conditions
Acid and base hydrolysis (e.g., 0.1 M HCl and 0.1 M NaOH) are used in forced degradation studies to identify products formed by hydrolytic cleavage of susceptible bonds.
The concept of 'critical quality attributes' (CQAs) in ICH Q8(R2) refers to physical, chemical, biological, or microbiological properties that should be within what?
Answer: An appropriate limit, range, or distribution to ensure the desired product quality
CQAs must be within an appropriate limit, range, or distribution to ensure the desired product quality, safety, and efficacy as defined by the QTPP.
Which technique measures the molecular weight and size distribution of polymers used in controlled-release formulations, such as PLGA microspheres?
Answer: Gel permeation chromatography (GPC)
GPC (also called size exclusion chromatography) separates polymers by hydrodynamic volume to determine molecular weight distribution, which directly affects PLGA degradation rate and drug release.