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 excipient class is primarily used to prevent crystal growth in amorphous solid dispersions?
Answer: Polymeric stabilizers like HPMC or PVP
Polymeric stabilizers such as HPMC and PVP inhibit recrystallization of amorphous drug by increasing viscosity and forming intermolecular interactions.
A hot-melt extrusion process is BEST suited for drugs with which property?
Answer: Thermal stability at processing temperatures
Hot-melt extrusion requires the drug to be thermally stable at the elevated processing temperatures typically ranging from 80–200°C.
In a spray-dried dispersion, which parameter most directly controls particle size distribution?
Answer: Atomization pressure or nozzle design
Atomization pressure and nozzle design determine droplet size, which directly dictates the final spray-dried particle size distribution.
Which dissolution model describes drug release from a matrix tablet where release rate decreases over time proportionally to the square root of time?
Answer: Higuchi model
The Higuchi model (Q = A√Dt) describes diffusion-controlled release from a homogeneous matrix, where cumulative release is proportional to √t.
The 'BCS classification' system categorizes drugs based on which two properties?
Answer: Solubility and permeability
The Biopharmaceutics Classification System (BCS) classifies drugs into four classes based on aqueous solubility and intestinal permeability.
Which approach is used to improve the dissolution rate of a poorly water-soluble drug by reducing its particle size to the nanometer range?
Answer: Nanosuspension technology
Nanosuspension technology reduces drug particle size to 100–1000 nm, dramatically increasing surface area and dissolution rate per the Noyes-Whitney equation.
A formulator wants to delay drug release until the tablet reaches the small intestine. Which coating polymer is MOST appropriate?
Answer: Eudragit L100 (methacrylic acid copolymer)
Eudragit L100 dissolves above pH 6.0, making it an enteric polymer that protects the drug in the acidic stomach and releases it in the small intestine.