FPGEE Pharmaceutics 2

Question 1

Which dissolution model describes drug release that is proportional to the square root of time?

Accepted Answer

Higuchi model

Answer

The Higuchi model describes diffusion-controlled drug release from a matrix, where cumulative release is proportional to the square root of time.

Question 2

A tablet formulation requires a disintegrant that swells rapidly upon contact with water. Which excipient is MOST appropriate?

Accepted Answer

Sodium starch glycolate

Answer

Sodium starch glycolate is a superdisintegrant that rapidly swells in water, promoting tablet disintegration.

Question 3

What is the primary purpose of an enteric coating on an oral solid dosage form?

Accepted Answer

Prevent drug release in the stomach

Answer

Enteric coatings resist dissolution at low gastric pH but dissolve at the higher pH of the small intestine, protecting acid-labile drugs or preventing gastric irritation.

Question 4

In a parenteral emulsion intended for intravenous administration, the droplet size of the dispersed phase must not exceed:

Accepted Answer

5 microns

Answer

IV emulsions must have droplet sizes below 5 microns to prevent capillary occlusion and ensure safe intravenous administration.

Question 5

Which factor primarily determines whether a drug is classified as BCS Class I?

Accepted Answer

High solubility and high permeability

Answer

BCS Class I drugs have both high aqueous solubility and high intestinal permeability, making them ideal candidates for biowaivers.

FPGEE Exam Practice Test

FPGEE Exam Practice Test

FPGEE Pharmaceutics 2