Pharmaceutical Sciences Flashcards

What is the key principle behind solid-state drug stability testing according to ICH guidelines?

Answer: Accelerated and real-time stability studies at defined temperature and humidity conditions (ICH Q1A)

ICH Q1A guidelines require both real-time and accelerated stability studies under defined temperature and humidity conditions to predict drug shelf life and storage requirements.

Which process in tablet manufacturing ensures uniform drug content throughout a batch?

Answer: Blending/mixing step

The blending step uniformly distributes the active pharmaceutical ingredient throughout the excipient mixture, ensuring content uniformity across all tablets in the batch.

What does the term 'efflux transporter' mean in the context of drug absorption?

Answer: A membrane protein that actively pumps drugs out of cells, reducing their absorption or distribution

Efflux transporters like P-glycoprotein actively export drugs from enterocytes back into the intestinal lumen, significantly reducing oral bioavailability of their substrates.

What is the definition of a 'prodrug'?

Answer: An inactive compound that is converted in the body to the active pharmacological form

A prodrug is a pharmacologically inactive compound that undergoes biotransformation (usually by metabolism) to release the active drug inside the body.

Which test is used to assess the in vitro drug release from a solid oral dosage form?

Answer: Dissolution testing (USP Apparatus 1 or 2)

Dissolution testing measures how quickly and completely a drug releases from its dosage form under simulated physiological conditions, predicting in vivo absorption performance.

What is the significance of the 'critical quality attribute' (CQA) concept in pharmaceutical manufacturing?

Answer: A CQA is a physical, chemical, biological, or microbiological property that must be within an appropriate limit to ensure desired product quality

CQAs are properties directly impacting drug safety, efficacy, and quality; they are identified during development and controlled throughout manufacturing to ensure consistent product performance.