KAPS Drug Formulation and Development 2

Question 1

Which excipient class is primarily used to prevent crystal growth in amorphous solid dispersions?

Accepted Answer

Polymeric stabilizers like HPMC or PVP

Answer

Polymeric stabilizers such as HPMC and PVP inhibit recrystallization of amorphous drug by increasing viscosity and forming intermolecular interactions.

Question 2

A hot-melt extrusion process is BEST suited for drugs with which property?

Accepted Answer

Thermal stability at processing temperatures

Answer

Hot-melt extrusion requires the drug to be thermally stable at the elevated processing temperatures typically ranging from 80–200°C.

Question 3

In a spray-dried dispersion, which parameter most directly controls particle size distribution?

Accepted Answer

Atomization pressure or nozzle design

Answer

Atomization pressure and nozzle design determine droplet size, which directly dictates the final spray-dried particle size distribution.

Question 4

Which dissolution model describes drug release from a matrix tablet where release rate decreases over time proportionally to the square root of time?

Accepted Answer

Higuchi model

Answer

The Higuchi model (Q = A√Dt) describes diffusion-controlled release from a homogeneous matrix, where cumulative release is proportional to √t.

Question 5

The 'BCS classification' system categorizes drugs based on which two properties?

Accepted Answer

Solubility and permeability

Answer

The Biopharmaceutics Classification System (BCS) classifies drugs into four classes based on aqueous solubility and intestinal permeability.

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

KAPS Drug Formulation and Development 2