Active Pharmaceutical Ingredients (API) & Excipients

DEPTH OF BIOLOGY

The term “Active Pharmaceutical Ingredient (API)” refers to a substance that:

Provides the intended pharmacological or therapeutic effect

Improves only the colour and appearance of a dosage form

Acts only as a preservative in the formulation

Increases the bulk of the formulation without therapeutic action

Which of the following is the BEST example of an excipient function?

Producing the primary therapeutic effect

Providing pharmacological activity

Improving stability, manufacturability or acceptability of the dosage form

Acting as the principal active substance

Which characteristic is most important for an ideal pharmaceutical excipient?

It should be pharmacologically active

It should be toxic at the required concentration

It should be compatible with the API and other formulation ingredients

It should undergo rapid degradation during storage

Why are excipients important in pharmaceutical formulations?

They eliminate the need for an API

They help convert the API into a stable, usable and acceptable dosage form

They are responsible for all therapeutic effects

They always increase the dose of the API

Which statement BEST describes an ideal API?

It should have predictable therapeutic activity and suitable stability

It should have no therapeutic activity

It should be incompatible with formulation ingredients

It should readily decompose during storage

Active Pharmaceutical Ingredients (API) & Excipients

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