Excipients review questions

Question 1

Define ‘excipient’

Answer 1

Excipients are pharmaceutical necessities, non-medicinal ingredients, inactive ingredients used to turn a drug compound into a product patients can use

Question 2

Why are excipients used for dosage form development?

Answer 2

promote solubility, improve taste, Improve shelf-life, provide bulk, adjust pH, viscosity or other organoleptic properties, modulate drug delivery (enteric coating, sustained release, penetration enhancer), aid in manufacturing

Question 3

What are the properties of ideal excipients?

Answer 3

Pharmacologically inert
Stable and batches are consistent/reliable
No interaction with drug or other components
Provide the required function
Does not contribute undesirable effects (color, odor, taste, etc) Inexpensive/cost effective

Question 4

what is meant by functional excipients?

Answer 4

There are two sets of functionalities – traditional and novel:

Traditional excipients: bulking agents, vehicles, preservatives, colors, flavors etc. Novel excipients: ‘smart’ materials for drug targeting and responsiveness to environment on the body and cells

Question 5

How can obtain information about the inactive ingredients in a drug product?

Answer 5

• On packaging
• Manufacturer Product Monographs
• Physicians Desk Reference
• FDA database
• Other professional databases: eg. drugs.com
• Compendium of Pharmaceuticals and Specialties (CPS)

Question 6

Generally, how many excipients can be used in a product? How do you determine this?

Answer 6

The most important principle is to use as many as you need, not more.

Question 7

Are nanomaterials used in novel delivery systems are excipients?

Answer 7

Yes, the nanomaterials used as building blocks for the drug delivery systems can be considered excipients

Question 8

Name and recognize the classes of excipients used in liquid and semisolid formulations.

Answer 8

-please see the Thompson chapter and slides 9-22

Question 9

How do you evaluate the quality of excipients and quantities to be used?

Answer 9

• Excipients are listed in pharmacopoeias each w/ a Monograph with the required quality and assays to characterize them.
• The acceptable usage ranges for each dosage form type are available from FDA databases (Inactive Ingredient Database); companies rarely go outside of these ranges for new products to avoid the extra work/expense to determine the new safety data associated with increased concentrations.

Question 10

Can excipients cause adverse reactions? Name a few.

Answer 10

Excipients can cause adverse reactions, depending on the patient, quantity used, or type of administration route.

Eg. certain preservatives in ophthalmics, various coloring agents and sweeteners in oral dosage forms, lactose in lactose-sensitive patients, sulfites in oral dosage forms.