Active Pharmaceutical Ingredients (APIs)- Definition, Role, Excipients - imdip

Definition of Active Pharmaceutical Ingredients (APIs):

Active Pharmaceutical Ingredients (APIs) are those components in a medicine or healthcare product that produce the intended therapeutic effect.

Basically, the part of the medicine that works to treat the disorders.

Example of Active Pharmaceutical Ingredients (APIs)

A Paracetamol 500mg tablet contains,

• Paracetamol -500mg (Active Pharmaceutical Ingredient)

Here, paracetamol is the API that reduces fever and pain.

• Microcrystalline cellulose ~50–100mg (Excipients)
• Starch (maize/corn) ~20–30mg (Excipients)
• Povidone ~10–20mg (Excipients)
• Magnesium stearate ~5–1 mg (Excipients)
• Talc ~2–5mg (Excipients)

Definition of Excipients:

Excipients are those inactive substances added with active pharmaceutical ingredients to aid in the manufacturing process and enhance stability, bioavailability, and patient acceptability of the final dosage form of the drug product.

Excipients have no therapeutic effects. 

Role of Expients with function:

Binder:

Also known as Binding agents. It helps to hold the ingredients of a tablet together.
Example: Starch, polyvinylpyrrolidone (PVP), etc.

Disintegrant:

It helps enable tablets to break down after ingestion.
Example: Croscarmellose sodium

Diluent/Filler

Adds bulk to formulations for proper dose size.
Example: Lactose, MCC

Lubricant:

Prevents sticking during manufacturing
Example: Magnesium stearate

Glidant:

Glidents improve powder flow properties.
Example: Colloidal silica

Coating Agent:

Coating agents are used to mask taste, protect from moisture, or control release.
Example: Hydroxypropyl Methylcellulose (HPMC)

Preservative:

It helps to prevent microbial growth in dosage forms.
Example: Parabens

Sweetener/Flavoring Agent:

It improves palatability or taste.
Example: Aspartame, Sucralose

Colorant or Coloring Agent:

Enhances appearance and identification
Example: Titanium dioxide (white), Erythrosine (red)

Solubilizer:

Increases drug solubility and absorption
Example: PEG, surfactants

Pharmaceutical Coloring Agents - Types, Importance, Example.

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