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PHAR 124 > Pre-Midterm > Flashcards

Pre-Midterm Flashcards

1
Q

8 advantages of Solid Dosage Forms

A

Unit dose
Cost of shipping
No breakage or leakage
Masking taste less difficult
More portable
Require less space per dose
Good physical and chemical stability
Elegant distinctive appearance which has a high patient acceptability

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2
Q

Disadvantages of a solid dosage form

A

Potential bioavailability problems
Potential irritant effect on GI mucosa
Occasional difficulty in formulation
Manufacturing can be more technical or
specialized

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3
Q

What are the Physical Properties of Solids

A

a) Particle size
b) Mixing powders

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4
Q

What are the Types of compounded powders

A

Bulk powders for internal use
Other bulk powders

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5
Q

Dissolution rate:

A

the rate at which the particle dissolves.
By increasing the surface area, one may increase the bioavailability for some poorly soluble drugs, because there is often a direct relationship between dissolution rate and bioavailability and drug absorption.

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6
Q

Suspendability

A

the ability of particle to remain undissolved but uniformly dispersed in a liquid vehicle.

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7
Q

Accuracy of dosage form

A

there must be uniform distribution of drug substance in a powder mixture or dosage form, and to ensure batch-to-batch uniformity.

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8
Q

Penetrability

A

the ability of particle to reach their intended location, e.g. to be inhaled deep into the respiratory tract particles should be 1-5 μm.

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9
Q

Non-grittiness

A

do not want solid particle in dermal products to feel “gritty”. Finer particles allow for a smoother texture and better appearance and flow. This is also important for oral products such as chewable tablets.

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10
Q

Chemical stability

A

refers to degradation reactions (e.g. oxidation and hydrolysis). Smaller particles have an increased surface area, leaving them more exposed and vulnerable to reactions with oxygen, water and light.

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11
Q

Flowability

A

effect on flow properties of powders and mixing of powders and granules. This is important in the manufacturing of tablets and capsules.

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12
Q

Compressibility

A

effect on adhesion and “sticking” together when compressing granules into tablets. This is important in the manufacturing of tablets and capsules.

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13
Q

the larger the mesh#

A

the smaller the particles

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14
Q

Monodisperse powders

A

powders containing particles of uniform size, RARE

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15
Q

Polydisperse

A

particle size varies a great deal

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16
Q

Comminution

A

Comminution is the mechanical process of reducing particle size of a solid substance to a finer state of subdivision.

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17
Q

Small-scale comminution

A

Most commonly involves the use of a mortar and pestle and is done by
the pharmacist or technician.

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18
Q

trituration

A

the process of grinding a drug in a mortar to reduce its particle size

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19
Q

levigation

A

the process of mixing a powder with a liquid or semi-solid vehicle (the levigating agent), in which the powder is insoluble, to form a smooth paste

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20
Q

pulverization by intervention

A

particle size reduction with the aid of an additional material, which can be later, removed

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21
Q

lSpatulation

A

blending powders with a spatula on a tile or paper

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22
Q

Advantages (of powders as a dosage form)

A

Flexibility in compounding.

Suitable for infants and young children who cannot swallow tablets or capsules.

Rapid onset of drug action because disintegration is not required.

Can be applied to many body cavities such as ears, nose, tooth socket, and throat.

Relatively good chemical stability.

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23
Q

Disadvantages of powders

A

Potential for misunderstanding of the correct method of
use that can lead to inaccurate dosing.

Undesirable for bitter or unpleasant tasting drugs

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24
Q

Dentifrices

A

dental cleaning powders, denture powders

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25
Q

What types of substances that do not dissolve gelatin may be encapsulated in capsules.

A

Dry powders, semi-solids and liquids

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26
Q

Water content of HGC shells?

A

13-16

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27
Q

Spot-welded

A

by means of a heated metal pin pressed against the cap, fusing it to the body.

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28
Q

Banded

A

colored molten gelatin is laid around the joint between the 2 capsule parts in a strip and dried

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29
Q

Most common capsule diluents are

A

Lactose
Microcrystalline cellulose
Starch

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30
Q

Most common capsule disintegrants

A

Pre-gelatinized starch
croscarmellose
sodium starch glycolate

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31
Q

Disintegrants

A

Disintegrants serve assist in the break off the powder
Mass/granules and help in distributing the drug through-out the stomach.

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32
Q

Lubricant and Glidant

A

Improves fluidity and flow of powders
Decreases sticking of powders to metal surfaces

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33
Q

Wetting Agents

A

Surface active agent such as
sodium lauryl sulfate

are often added to facilitate the wetting of the drug substance by the GI fluids, thus enhancing dissolution.

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34
Q

What are the components of a tablet?

A

Diluent, Binders, Disintegrants, colorants, coatings

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35
Q

Examples of diluents for tablets

A

Lactose
Dextrose
Starch
MCC
Mannitol

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36
Q

What happens if you have to little binder?

A

fragile tablets

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37
Q

What happens if you have too much binder?

A

Excessive hardness

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38
Q

Example of disintegrants

A

Corn Starch

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39
Q

Potential Problems with Sugar Coating

A

Many steps of this process involve tumbling – tablets must be hard enough to withstand it

Sugar coating pans must mix uniformly or coating goes on unevenly resulting in tablets of different sizes and weights

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40
Q

Most common tablet coating

A

Film Coating

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41
Q

What can aqueous tablet coating lead to?

A

Orange peel effect where the surface due ot failure of spray droplets

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42
Q

What is Enteric Coating?

A

Allows for disintegration in the intestine rather than the stomach.

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43
Q

WHat are the physical feautres of a tablet?

A

Appearance
Size
Shape
Organoleptic Properties

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44
Q

Friability test

A

Ability of tablet to withstand abrasion in packaging, shipping and handling; in other words, its tendency to crumble).

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45
Q

What is an acceptable amount of loss during the friability test? %

A

Usually acceptable value is <1% loss

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46
Q

Drug Content Uniformity

A

Two tests can be used to evaluate whether the amount of drug is uniform from one tablet to another one:

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47
Q

Weight Variation

A

Relies on tablet weight to assess the amount of drug in each unit

The greater the amount of drug, the more accurate the method is

48
Q

Content Uniformity

A

May be applied in all cases (items listed under weight variation)

Assesses uniformity of content by assaying each dosage unit.

49
Q

Disintegration

A

Tablets (or other solid dosage forms) must disintegrate within a specified time period

50
Q

What is the most important test?

A

Dissolution

51
Q

What is the Dissolution test?

A

dissolution test measures the amount of time required for a certain % of the drug substance to dissolve under specified conditions (which resemble physiological conditions).

52
Q

What are Molded Tablets?

A

Prepared by molding rather than by compression

53
Q

What are Molded tablets not appropriate for?

A

Not appropriate for potent drugs due to difficulties with content uniformity

54
Q

limitations of chewable tablets?

A

Drug material is bitter and flavouring is important and often5 difficult.

55
Q

What is Mannitol?

A

Adds sweetness and a cool tase

~50% of formulation in chewable tablets.

56
Q

Effervescent Tablets

A

Large wafer-like tablets which dissolve rapidly in water

Tablet breakup is facilitated by the release of carbon dioxide (CO2) generated from sodium bicarbonate and citric or tartaric acid

57
Q

Where are buccal tablets placed?

A

Side of cheek

58
Q

What does gelatin do to a tablet?

A

Makes it soft hence usually a soft chewable

59
Q

What does corn syrup do to a tablet?

A

Make it hard hence hard lozenge

60
Q

What does polyethylene glycol do?

A

Make it soft so more likely a soft lozenge

61
Q

Capping

A

the partial or complete separation of the top or bottom
crowns of a tablet from the main body of the tablet.

62
Q

Lamination

A

the separation of a tablet into 2 or more distinct layers,
i.e. transverse cracking and separation of tablet.

63
Q

Causes of Lamination / Capping

A

Air entrapment in light and fluffy powders
Excessive “fines”
Too little moisture in granulation
Weak granules or too weak a binder
Improper adjustment of machinery

64
Q

Picking

A

the surface material from a tablet that is sticking and being removed from the tablet surface by a punch. Usually associated with letters such as “A”, “B”, “O” and “P”, etc from logos and lettering in the punch surface.

65
Q

Sticking

A

tablet material adhering to the die wall.

66
Q

Causes of Picking/Sticking

A

Inadequate lubrication (adhesive components may be present)
Insufficiently dried wet granulation
Poor finish on punch surfaces

67
Q

What is Whiskering?

A

fine edge attached but not broken off tablet. End up with high friability values since “whiskers” are removed in friability testing.

68
Q

Causes of Whiskering

A

Especially deep concave punches
Punches worn and in poor condition

69
Q

Friability

A

It refers to the ability of the compressed tablet to withstand abrasion or crumbling in packaging, handling and shipping.

70
Q

Causes of Poor Disintegration

A

Tablet hardness too high
Low amount of disintegrant. May require better disintegrant
Too much binder
Over lubrication causing “waterproofing”

71
Q

Mottling

A

an unequal or uneven distribution of colour on or in a tablet.

72
Q

Low Hardness

A

Low hardness can lead to rapid release of drug from dosage form or tablet will be too fragile for shipping and handling.

73
Q

Dissolution

A

The transfer of molecules and ions from a solid phase into a solution

74
Q

Factors affecting solubility

A

Molecular weight, volume.
Presence of functional groups and their position.
Acids or bases (pH dependent solubility – ionized form more soluble).

75
Q

Increase temperature ___ solubility

A

decreases

76
Q

Increasing pressure ___ solubility

A

Increases

77
Q

Miscibility

A

expresses the mutual solubility of components in a liquid-liquid system (mixes without separating)

78
Q

In an Endothermic solution Solubility ___ with increase temperature

A

increases increases

79
Q

In an exothermic solution solubility ___ with increased temperature

A

decrease

80
Q

Primary solvent for many organic compounds

A

◼ alcohol
◼ isopropyl alcohol
◼ glycerin
◼ propylene glycol
◼ polyethylene glycol 400

81
Q

What is the most common solvent?

A

Alcohol

82
Q

Advantages of semi-polar solvents?

A

◼ Better solubility for many compounds
◼ Can be used as co solvent
◼ Better stability for the drug:
◼ Hydrolysis
◼ Bacterial growth
◼ 70% is used as a skin antiseptic or for sterilizing work surfaces (BSC)

83
Q

Limits for Alcohol in OTC products:
Children <6
Children 6-12
Adults

A

0.5
5
10

84
Q

Denatured alcohol

A

Has additives (ketones or kerosene) to render it more poisonous and unfit for internal use

85
Q

Absolute alcohol (100%)

A

Essentially water-free ethanol

86
Q

Diluted Alcohol NF

A

prepared by diluting Alcohol USP with an equal volume of Purified Water USP

87
Q

Rubbing Alcohol:

A

◼ Around 70% by volume.
◼ Effective antiseptic-disinfectant
◼ For external use only (dye can be added)

88
Q

Miscible Solvents

A

a solute may be more soluble in a mixture of solvents than in one solvent = co-solvent effect

89
Q

If there are two or more solvents and two or more solutes in a formulation,

A

each solute should be dissolved in the solvent in which it is most soluble before mixing with other liquids in the preparation.

90
Q

Complexes are

A

loose molecular associations that can either increase/decrease solubility.

91
Q

Solutions for oral administration often include additives WHY?

A

Storage stability, enhance solubility, taste etc.

92
Q

What are the 4 primary tastes

A

Sweet, Sour, Bitter, Salty

93
Q

What is the Flavouring techniques Physiological

A

anesthetize the taste buds/receptors

94
Q

What is the Flavouring techniques Physical

A

◼ Prevent dissolution of drug (prevent it from coming in contact with taste buds)

95
Q

What is the Flavouring techniques for Overshadowing

A

Addition of a flavour whose intensity is longer and stronger than the taste of the drug (e.g. Methyl salicylate)

96
Q

What is the Flavouring techniques for Blending

A

add flavours which compliment the taste and modify the flavour
perception (e.g. Vanillin, benzaldehyde)
◼ sourtaste–blended with fruit flavours
◼ bitter taste – adding salty, sweet and sour flavour

97
Q

Chemical

A

Drug can be complexed or a prodrug can be made

Used in drug product manufacturing

98
Q

Other factors besides taste:

A

Aroma
Texture
Viscosity

99
Q

2 categories of sweeteners

A

Natural sweeteners that include
sugars and polyols such as sucrose,

Artificial sweeteners

100
Q

What are the sweeteners-Sugars

A

Sucrose
Lactose
Dextrose

101
Q

What are the Natural Polyols? (Sugar free)

A

Sorbitol
Mannitol
Xylitol

102
Q

Artificial sweeteners

A

Saccharin
Cyclamate
Aspartame
Sucralose
Stevia

103
Q

What is the issue with Aspartame?

A

Aspartame degrades into diketopiperazine when
exposed to high temperatures (180C)

Intolerance in patients

PKU incidence 1 in 20 000

104
Q

No colour is certified for use in the?

A

Eye

105
Q

What concentration of dye colour do we usually use?

A

0.0005-0.001%

106
Q

When should preservatives/antimicrobials not be used?

A

Formulation used immediately
No water is present
PH is less than 3 or greater then 9

107
Q

Where are preservatives CI?

A

Neonates
Ophthalmics
Volumes greater than 30

108
Q

What are the 2 aqueous solutions?

A

Syrups and Aromatic waters

109
Q

What are the non-Aqueous Solutions?

A

Elixirs, Spirits, tinctures

110
Q

What concentration of alcohol is usually in syrups?

A

up to 10%

111
Q

What are the non medical ingredients in Syrups that we should know? (4)

A

Glycerin, Propylene glycol, sorbitol, sucralose

112
Q

What % of sucrose should be in syrups before not having to add antimicrobrials

A

<80%

113
Q

What is simple syrup?

A

Concentrated with sucrose and has self preservative properties

114
Q

What is the alcohol content of a spirit?

A

62-85%

115
Q

What is the alcohol concentration oin tinctures?

A

15-80%

116
Q

What is the concentration of alcohol in elixirs?

A

3-44%

PHAR 124 (6 decks)

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