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
Powdered cellulose
Filler
Starch
Also can be a filler
Lubricant
Used in tablet formulations to reduce friction during tablet compression
Magnesium stearate
Lubricant
Sodium stearyl fumarate
Lubricant
Stearic acid
Lubricant
Glidant
Used in tablet and capsule formulations to improve flow properties of the powder mixture
Colloidal silica
Glidant
Corn starch
Glidant
Talcum powder
Gildant
Coloring
Adds color
FD&C Red No. 3 FD&C Red No. 20 FD&C Yellow No. 6 FD&C Blue No. 2 Caramel
Colors
Ferric oxide
color
Titanium dioxide
color
Sweetners
Add sweetness to the formulation
Aspartame
Dextrose
Glycerin
Mannitol
Saccharin sodium
Sorbitol
Sucrose
sweetener
Preservative (Antioxidant)
Antioxidants are used to prevent the deterioration of preparations by oxidation.
Ascorbic acid
Butylated hydroxyanisole Butylated hydroxytoluene
Propyl gallate
Sodium ascorbate
Sodium bisulfite
Sodium metabisulfite
Preservatives
Preservative (Antimicrobial)
Used toprevent growth of microorganisms
Benzalkonium chloride
preservative
Preservative (Antifungal)
Used to prevent the growth of fungi
Butylparaben
Ethylparaben
Methylparaben
Propylparaben
Benzoic acid
Sodium benzoate
Antifungal preservatives
Suspending Agents
Viscosity-increasing agent used to reduce sedimentation rate of particles in a vehicle in which they are not soluble; suspension may be formulated for oral, parenteral, ophthalmic, topical, or other route
examples of Suspending Agents
Carbomer (e.g., Carbopol)
Carboxymethylcellulose sodium Hydroxyethyl cellulose Hydroxypropyl cellulose Hydroxypropyl methylcellulose Methylcellulose
Bentonite Veegum
Tablet Coating Agents
Used to coat a tablet to protect against decomposition by atmospheric oxygen or humidity, to provide a desired release pattern, to mask taste or odor, or for aesthetic purposes.
Tablet Coating Agents categories
sugar coated, film coated, and enteric coated
examples of film coating agents
Hydroxyethyl cellulose Hydroxypropyl cellulose
Hydroxypropyl methylcellulose Methylcellulose (e.g., Methocel) Ethylcellulose (e.g., Ethocel)
examples of sugar coated agents
Liquid glucose, Sucrose
examples of enteric coated
Hydroxypropyl methyl cellulose acetate succinate (HPMCAS)
Flavoring Agents
Flavoring agents are used to impart a pleasant flavor and often odor to a preparation.
Examples of flavoring agents
Anise oil
Cinnamon oil
Cocoa Menthol
Orange oil
Peppermint oil
Vanillin