Preformulation Testing: Master the Basics for Drug Development

Question 1

The process of determining the equilibrium solubility of a drug under different pH conditions is called:

Accepted Answer

Solubility profiling

Answer

Dissolution testing

Answer

Hygroscopicity assessment

Answer

Particle size analysis

Question 2

The ability of a drug substance to take up moisture from the surrounding environment is known as:

Accepted Answer

Hygroscopicity

Answer

Deliquescence

Answer

Efflorescence

Answer

Polymorphism

Question 3

The process of converting a drug substance from one crystalline form to another is called:

Accepted Answer

Polymorphism

Answer

Crystallization

Answer

Amorphization

Answer

Micronization

Question 4

Which preformulation test is used to assess the stability of a drug substance under different storage conditions?

Accepted Answer

Accelerated stability testing

Answer

Solubility profiling

Answer

Particle size analysis

Answer

Hygroscopicity assessment

Question 5

The ability of a drug substance to donate or accept protons is known as:

Accepted Answer

pKa

Answer

Solubility

Answer

Hygroscopicity

Answer

Polymorphism

Question 6

The process of optimizing the formulation of a drug product to ensure its safety, efficacy, and stability is:

Accepted Answer

Preformulation

Answer

Formulation

Answer

Manufacturing

Answer

Quality control

Question 7

Which preformulation test is specifically designed to determine the size distribution of particles within a drug substance?

Accepted Answer

Laser diffraction

Answer

Differential scanning calorimetry (DSC)

Answer

X-ray powder diffraction (XRPD)

Answer

Hygroscopicity

Question 8

Which preformulation test is employed to measure the tendency of a drug substance to absorb moisture from the surrounding environment?

Accepted Answer

Hygroscopy

Answer

Water content determination

Answer

Partition coefficient

Answer

Powder flowability

Question 9

Why is it crucial to determine the polymorphism of a drug substance during preformulation testing?

Accepted Answer

To identify potential stability issues

Answer

To ensure consistent drug delivery

Answer

To predict dissolution rate

Answer

To optimize manufacturing processes

Question 10

In preformulation testing, why is the density of a drug substance considered important?

Accepted Answer

It influences powder flowability and packing efficiency

Answer

It affects drug solubility and dissolution rate

Answer

It determines the drug's compatibility with excipients

Answer

It predicts the drug's stability

Question 11

Which preformulation test is used to determine the surface area of a drug substance?

Accepted Answer

Gas adsorption

Answer

Scanning electron microscopy (SEM)

Answer

X-ray powder diffraction (XRPD)

Answer

Hygroscopicity

Question 12

Which preformulation test is used to determine the solubility and dissolution rate of a drug substance?

Accepted Answer

Dissolution testing

Answer

Particle size analysis

Answer

Differential scanning calorimetry (DSC)

Answer

Hygroscopicity testing

Question 13

Which technique is used to determine the solubility of a drug substance in different solvents?

Accepted Answer

Solubility determination

Answer

High-Performance Liquid Chromatography (HPLC)

Answer

Ultraviolet-Visible (UV-Vis) spectroscopy

Answer

Melting point determination

Question 14

Which of the following techniques is NOT commonly utilized for crystallinity determination?

Accepted Answer

Gas chromatography

Answer

X-ray diffractometry

Answer

Differential scanning calorimetry

Answer

Microscopy

Question 15

Which method is NOT used to evaluate the stability of a drug substance?

Accepted Answer

Dissolution testing

Answer

Accelerated stability testing

Answer

Real-time stability testing

Answer

In vitro stability testing

Question 16

What is the overarching purpose of preformulation testing?

Accepted Answer

To gather data for developing a stable and effective drug product

Answer

To identify compatible excipients for the drug substance

Answer

To enhance the manufacturing process

Answer

To predict the clinical effectiveness of the drug product

Question 17

Which of the following properties is NOT evaluated in preformulation testing?

Accepted Answer

Pharmaceutical activity

Answer

Solubility

Answer

Particle size

Answer

Drug-excipient compatibility

Question 18

What is the primary purpose of particle size analysis in preformulation?

Accepted Answer

To predict drug dissolution rate

Answer

To determine drug bioavailability

Answer

To predict drug stability

Answer

To evaluate drug-excipient interactions

Question 19

Which instrument is primarily used to evaluate drug stability under accelerated conditions?

Accepted Answer

Stability chamber

Answer

Differential scanning calorimeter (DSC)

Answer

Atomic force microscope (AFM)

Answer

Gas chromatograph (GC)

Question 20

Which preformulation test provides insights into potential drug-excipient interactions?

Accepted Answer

Differential scanning calorimetry/thermogravimetric analysis (DSC/TGA)

Answer

Solubility studies

Answer

Particle size analysis

Answer

UV spectrophotometry

Question 21

Which of the following is a typical test performed during preformulation testing?

Accepted Answer

Solubility study

Answer

Tablet dissolution study

Answer

Particle size analysis

Answer

Hygroscopicity assessment

Question 22

The primary objective of solubility testing in preformulation is to:

Accepted Answer

Determine the amount of drug that can dissolve in a given solvent at a specific temperature

Answer

Predict the bioavailability of the drug

Answer

Identify polymorphic forms of the drug

Question 23

Which of the following is a common technique used for particle size analysis in preformulation?

Accepted Answer

Laser diffraction

Answer

Gas chromatography

Answer

Nuclear magnetic resonance

Answer

Mass spectrometry

Question 24

The process of determining the ability of a drug substance to adsorb moisture from the environment is known as:

Accepted Answer

Hygroscopicity assessment

Answer

Solubility study

Answer

Stability testing

Answer

Dissolution study

Question 25

Which of the following properties is critical in assessing the flowability of a powder?

Accepted Answer

Compressibility index

Answer

Angle of repose

Answer

Density

Answer

Particle size

Question 26

The purpose of polymorphic screening in preformulation is to:

Accepted Answer

Identify different solid forms of a drug and their potential impact on drug product performance

Answer

Assess the solubility of the drug

Answer

Determine the stability of the drug

Answer

Predict the bioavailability of the drug

Question 27

The stability of a drug substance to hydrolysis is commonly assessed using:

Accepted Answer

Forced degradation studies

Answer

Solubility testing

Answer

Hygroscopicity assessment

Answer

Particle size analysis