Excipient

General

A pharmacologically inactive substance included in a drug formulation to serve as a vehicle, binder, filler, disintegrant, lubricant, preservative, flavoring agent, or other functional role. Must be individually evaluated for safety, compatibility with the active ingredient, and regulatory acceptability. Listed in the FDA Inactive Ingredient Database (IID) with maximum potencies per route of administration.

Contoh

  • Lactose monohydrate as tablet filler
  • Polyethylene glycol (PEG) as solubilizer in injectables
  • Microcrystalline cellulose as binder-disintegrant

Tahukah Anda?

A pharmacologically inactive substance included in a drug formulation to serve as a vehicle, binder, filler, disintegrant, lubricant, preservative, flavoring agent, or other functional role. Must be individually evaluated for …