excipients Flashcards

(51 cards)

1
Q

Maillard Reaction

A

can lead to ineffective drugs - A chemical reaction between amino acids and carbohydrates

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2
Q

Compendial

A

USP or NF standards

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3
Q

GRAS

A

only for food additives

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4
Q

How can we petition for new Food additives?

A

petition (21 CFR 171)

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5
Q

If an excipient is found to have another use, how can we apply for it to be used in that other way

A

in an NDA

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6
Q

Tablet Binders

A

Substances used to cause adhesion of powder particles in tablet granulations

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7
Q

Carboxymethylcellulose sodium (sodium CMC)

A

Tablet Binders

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8
Q

Ethylcellulose

A

Tablet Binders

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9
Q

Methylcellulose

A

Tablet Binders

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10
Q

PVP

A

Tablet Binders

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11
Q

Pregelatinized starch

A

Tablet Binders

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12
Q

Tablet Disintegrant

A

Substances used in solid form to promote the disruption of the mass into smaller particles that are more readily dispersed or dissolved include:

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13
Q

Cross-povidone (cross-linked PVP)

A

Tablet Disintegrant

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14
Q

Sodium starch glycolate

A

Tablet Disintegrant

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15
Q

Starch

A

Tablet Disintegrant

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16
Q

Tablet and Capsule Diluents (Fillers)

A

An inert filler is used to create the desired bulk, flow properties, and compression characteristics of tablets and capsules

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17
Q

Dibasic calcium phosphate

A

Filler

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18
Q

Lactose

A

Fillera

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19
Q

Mannitol

A

Filler

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20
Q

Microcrystalline cellulose

A

Filler

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21
Q

Powdered cellulose

22
Q

Starch

A

Also can be a filler

23
Q

Lubricant

A

Used in tablet formulations to reduce friction during tablet compression

24
Q

Magnesium stearate

25
Sodium stearyl fumarate
Lubricant
26
Stearic acid
Lubricant
27
Glidant
Used in tablet and capsule formulations to improve flow properties of the powder mixture
28
Colloidal silica
Glidant
29
Corn starch
Glidant
30
Talcum powder
Gildant
31
Coloring
Adds color
32
FD&C Red No. 3 FD&C Red No. 20 FD&C Yellow No. 6 FD&C Blue No. 2 Caramel
Colors
33
Ferric oxide
color
34
Titanium dioxide
color
35
Sweetners
Add sweetness to the formulation
36
Aspartame Dextrose Glycerin Mannitol Saccharin sodium Sorbitol Sucrose
sweetener
37
Preservative (Antioxidant)
Antioxidants are used to prevent the deterioration of preparations by oxidation.
38
Ascorbic acid Butylated hydroxyanisole Butylated hydroxytoluene Propyl gallate Sodium ascorbate Sodium bisulfite Sodium metabisulfite
Preservatives
39
Preservative (Antimicrobial)
Used toprevent growth of microorganisms
40
Benzalkonium chloride
preservative
41
Preservative (Antifungal)
Used to prevent the growth of fungi
42
Butylparaben Ethylparaben Methylparaben Propylparaben Benzoic acid Sodium benzoate
Antifungal preservatives
43
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
44
examples of Suspending Agents
Carbomer (e.g., Carbopol) Carboxymethylcellulose sodium Hydroxyethyl cellulose Hydroxypropyl cellulose Hydroxypropyl methylcellulose Methylcellulose Bentonite Veegum
45
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.
46
Tablet Coating Agents categories
sugar coated, film coated, and enteric coated
47
examples of film coating agents
Hydroxyethyl cellulose Hydroxypropyl cellulose Hydroxypropyl methylcellulose Methylcellulose (e.g., Methocel) Ethylcellulose (e.g., Ethocel)
48
examples of sugar coated agents
Liquid glucose, Sucrose
49
examples of enteric coated
Hydroxypropyl methyl cellulose acetate succinate (HPMCAS)
50
Flavoring Agents
Flavoring agents are used to impart a pleasant flavor and often odor to a preparation.
51
Examples of flavoring agents
Anise oil Cinnamon oil Cocoa Menthol Orange oil Peppermint oil Vanillin