excipients Flashcards
Maillard Reaction
can lead to ineffective drugs - A chemical reaction between amino acids and carbohydrates
Compendial
USP or NF standards
GRAS
only for food additives
How can we petition for new Food additives?
petition (21 CFR 171)
If an excipient is found to have another use, how can we apply for it to be used in that other way
in an NDA
Tablet Binders
Substances used to cause adhesion of powder particles in tablet granulations
Carboxymethylcellulose sodium (sodium CMC)
Tablet Binders
Ethylcellulose
Tablet Binders
Methylcellulose
Tablet Binders
PVP
Tablet Binders
Pregelatinized starch
Tablet Binders
Tablet Disintegrant
Substances used in solid form to promote the disruption of the mass into smaller particles that are more readily dispersed or dissolved include:
Cross-povidone (cross-linked PVP)
Tablet Disintegrant
Sodium starch glycolate
Tablet Disintegrant
Starch
Tablet Disintegrant
Tablet and Capsule Diluents (Fillers)
An inert filler is used to create the desired bulk, flow properties, and compression characteristics of tablets and capsules
Dibasic calcium phosphate
Filler
Lactose
Fillera
Mannitol
Filler
Microcrystalline cellulose
Filler