excipients Flashcards

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

A

Filler

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

A

Lubricant

25
Q

Sodium stearyl fumarate

A

Lubricant

26
Q

Stearic acid

A

Lubricant

27
Q

Glidant

A

Used in tablet and capsule formulations to improve flow properties of the powder mixture

28
Q

Colloidal silica

A

Glidant

29
Q

Corn starch

A

Glidant

30
Q

Talcum powder

A

Gildant

31
Q

Coloring

A

Adds color

32
Q

FD&C Red No. 3 FD&C Red No. 20 FD&C Yellow No. 6 FD&C Blue No. 2 Caramel

A

Colors

33
Q

Ferric oxide

A

color

34
Q

Titanium dioxide

A

color

35
Q

Sweetners

A

Add sweetness to the formulation

36
Q

Aspartame
Dextrose
Glycerin
Mannitol
Saccharin sodium
Sorbitol
Sucrose

A

sweetener

37
Q

Preservative (Antioxidant)

A

Antioxidants are used to prevent the deterioration of preparations by oxidation.

38
Q

Ascorbic acid
Butylated hydroxyanisole Butylated hydroxytoluene
Propyl gallate
Sodium ascorbate
Sodium bisulfite
Sodium metabisulfite

A

Preservatives

39
Q

Preservative (Antimicrobial)

A

Used toprevent growth of microorganisms

40
Q

Benzalkonium chloride

A

preservative

41
Q

Preservative (Antifungal)

A

Used to prevent the growth of fungi

42
Q

Butylparaben
Ethylparaben
Methylparaben
Propylparaben
Benzoic acid
Sodium benzoate

A

Antifungal preservatives

43
Q

Suspending Agents

A

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
Q

examples of Suspending Agents

A

Carbomer (e.g., Carbopol)
Carboxymethylcellulose sodium Hydroxyethyl cellulose Hydroxypropyl cellulose Hydroxypropyl methylcellulose Methylcellulose
Bentonite Veegum

45
Q

Tablet Coating Agents

A

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
Q

Tablet Coating Agents categories

A

sugar coated, film coated, and enteric coated

47
Q

examples of film coating agents

A

Hydroxyethyl cellulose Hydroxypropyl cellulose
Hydroxypropyl methylcellulose Methylcellulose (e.g., Methocel) Ethylcellulose (e.g., Ethocel)

48
Q

examples of sugar coated agents

A

Liquid glucose, Sucrose

49
Q

examples of enteric coated

A

Hydroxypropyl methyl cellulose acetate succinate (HPMCAS)

50
Q

Flavoring Agents

A

Flavoring agents are used to impart a pleasant flavor and often odor to a preparation.

51
Q

Examples of flavoring agents

A

Anise oil
Cinnamon oil
Cocoa Menthol
Orange oil
Peppermint oil
Vanillin