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PHARM 124 > Capsules > Flashcards

Capsules Flashcards

1
Q

Define a solid dosage form

A

a drug substance is enclosed in either a hard or soft shell or container generally prepared from a suitable form of gelatin

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2
Q

What is the advantages of capsules?

A

mask the unpleasant taste, aroma or appearance of a drug
powder can be dispensed in an uncompressed form, allowing quicker dissolution and absorption of the drug

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3
Q

What a disadvantages of capsules?

A

they are easily tampered with
are subject to the effects of relative humidity
gelatin is relatively stable in air when dry, however, is subject to microbial decomposition when exposed to moisture
are difficult to swallow for some individuals

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4
Q

What is the composition of HGC shells

A

gelatin
plasticizer
colorant
water - 12 to 16 %

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5
Q

What is gelatin?

A

obtained by the hydrolysis of collagen

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6
Q

Types of Gelatin

A

Type A
Type B

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7
Q

What is type A gelatin?

A

pork skin gelatin
derived mainly from pork skins by acid hydrolysis
contributes plasticity and clarity

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8
Q

What is type B gelatin?

A

derived mainly from bones and animal skins by alkaline processing
contributes firmness

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9
Q

What is Plasticizer

A

used to reduce the rigidity of gelatin and to make it more pliable

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10
Q

What is the most common plasticizer?

A

glycerin

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11
Q

Hard Gelatin

A

if no or very little plasticizer is added, gelatin will be more brittle

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12
Q

Soft Gelatin

A

used primarily for liquids but recently employed for solids and solids dispersed in oil

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13
Q

Colorant

A

The coloring agent

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14
Q

functions of coloring agents

A

esthetic effects
identification
light protection

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15
Q

What is esthetic effects

A

marks variation in color of contents, raises confidence of users

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16
Q

The purpose of coloring for identification

A

color is the simplest and best method for quick identiifction

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17
Q

the purpose of coloring - identification

A

color is the simplest and best method for quick identification

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18
Q

Purpose of coloring in light protection

A

color reflects both the amount and wavelength of light passing through the gelatin layer

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19
Q

Composition of HGC shells (high humidity)

A

additional moisture is absorbed by the capsule
often packaged with a desiccant as a precaution against absorbing atmospheric moisture

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20
Q

Composition of HGC shells (low humidity)

A

some of the capsules moisture may be lost
may become brittle and crumble when handled

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21
Q

T or F
Light sensitive drugs can not be used in capsules

A

False - we can protect with color/opaquence of the drug

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22
Q

T or F
liquid drugs can not be used in capsules

A

False - we can in soft

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23
Q

T or F
major component of capsule shell are protein constituents

A

True - high % gelatin

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24
Q

T or F
capsules are easier to swallow compared to tablets

A

True - not as bitter, can control size, soft gels

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25
Q

Body of a shell

A

larger portion which is filled with medication

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26
Q

Cap of a shell

A

small portion which covers or slips over the body

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27
Q

Size of HGC

A

shells are produced in standard sizes
eight standard sizes are generally ised in human drug therapy
000-5

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28
Q

Most common capsule size

A

0-4

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29
Q

Shape of HGC

A

the basic shape is oblong
variations depend on the manufacturer

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30
Q

Closure of HGC

A

to prevent separation of the cap from the body
to provide evidence of tmapering

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31
Q

Methods used to assure that capsules do not come apart

A

spot welded
banded
locking device

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32
Q

What spot welded capsules means?

A

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

33
Q

What banded capsules means?

A

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

34
Q

What locking device means?

A

a pair of matched locking rings are formed in the cap and body portions of the capsule and engaged after filling

35
Q

What is the most common capsule diluents?

A

lactose
microcrystalline cellulose
starch

36
Q

Formulation of filling of hard gelatin capsules

A

diluent
disintegrants
lubricant and glidant
wetting agents

37
Q

Function of diluent

A

to increase bulk for the dosage form, act as a vehicle and improve content uniformity

38
Q

Function of disintegrants

A

serve assist in the break off the powder
mass/granules and help in distributing the drug throughout the stomach

39
Q

Examples of disintegrants

A

pre-gelanized starch
croscarmellose
sodium starch glycolate

40
Q

The purpose of lubricant and glidant

A

improve fluidity and flow of powders
decreases sticking of powders to metal surfaces
reduces friction on surfaces in contact with powder

41
Q

Examples of lubricant and glidant

A

calcium stearate
polyethylene glycol
talc

42
Q

Purpose of Wetting agents

A

surface active agent are often added to facilitate the wetting of the drug substance by the GI fluids thus enhancing dissolution

43
Q

Examples of wetting agents

A

alcohol
water

44
Q

Advantages of HGC

A

potential for rapid drug release
elegant, ide range of colors and possible opacity
often preferred by patients because their smooth, slippery, tasteless shell is easily swallowed
ease of use and portability

45
Q

Disadvantages of HGC

A

limited number of shell suppliers
generally more costly to produce than tablets
not to be used for extremely soluble drugs

46
Q

What are soft gelatin capsules?

A

a continuous, soft, globular gelatin shell which surrounds a liquid fill material

47
Q

Composition

A

Gelatin
plasticizer
colorant
water
preservative

48
Q

What is the purpose of plasticizer?

A

added to render gelatin soft or plastic like

49
Q

Examples of plasticizer

A

glycerol
sorbitol
propylene glycol

50
Q

What is the purpose of preservation?

A

added due to the high water-content which makes them more susceptible to microbial growth

51
Q

Examples of preservative

A

methylparaben
propylparaben
sorbic acid

52
Q

What types of size and shapes do SGC?

A

varies considerably
maybe round, oval, oblong tubes, etc.

53
Q

What should the pH of a SGC?

A

liquid 2.5-7.5

54
Q

If the SGC is too acidic

A

add hydrolyse gelatin

55
Q

If the SGC is too basic

A

decrease gelatin solubility

56
Q

Examples of SGC fill materials

A

pure liquid drugs
vegetable oils
mineral oils
water miscible liquids
some solids

57
Q

Why is liquid filling soft gelatin capsules concerned the most accurate?

A

filled as a liquid homogeneous
filled volumetrically with a syringe like apparatus

58
Q

SGC Advantages

A

permits liquid drugs to become easily portable
adaptable
pt. preference
accurate dosage form as volumetrically filling
can be made opaque to prevent light penetration
bioavailability
product security

59
Q

What bioavailability advantages does SGC have?

A

have faster dissolution rate than other solid dosage forms, including HGCs

60
Q

What is the advantage of SGC for product security

A

nearly impossible because of complete sealing or tampering easy to identify

61
Q

What are some hints for pt who have difficulty swallowing capsules?

A

try placing the capsule on the back of tongue before drinking
place the capsule in warm water for a few seconds prior to taking –> makes it slide over more easily

62
Q

Tips for dispensing Capsules

A

when dispensing SGCs, no cotton should be used in the vial. It is generally accepted to use with HGCs
SGCs tend to adhere to one another –> store in a cool, dry place

63
Q

Selecting a capsule size

A

the size selected for use is determined by the amount of material to be encapsulated
capacity will vary depending on the density of the powdered drug material

64
Q

The Rule of Sixes

A

Based on experimental observation that the bulk densities of many powders average about 0.6 mg/ml

65
Q

Preparing the capsule formulation

A

if the dose is large enough, a capsule can be filled with just the drug
to fill more adding bulk

66
Q

Examples of Bulking

A

lactose
microcrystalline cellulose
starch

67
Q

What is done to manage powders fluffiness?

A

a few drops of alcohol, water or mineral oil

68
Q

Methods for extemporaneously filling HGCs

A

some powder will be lost during filling
powder blending and sizing
two methods of filling hard gelatin capsule shells

69
Q

List two methods of filling hard gelatin capsule shells

A

punch method
hand operated machines

70
Q

How do you account for lost powder?

A

use 10% extra powder
or 2 extra capsules

71
Q

What is the punch method used for?

A

used to fill a relatively small number of capsules

72
Q

How use the punch method?

A

place the powder on an ointment slab
to prevent hand contact with powder
place the exact number of empty capsules on the powder paper
separate the capsule bodies and caps
repeatedly push or “punch” the open end into the powder until the capsule is filled
replace the cap on the body
weight each filled capsule, add or remove power until the correct weight

73
Q

What is a Hand operated machines

A

also called plate process
special equipment capable of filling 30-300 capsules per cycle
used in large pharmacies, hospitals and development laboratories

74
Q

What is the finishing procedure for punching method?

A

sealing
- use locking capsules
or
-wet the outer edge of the body with moist towel
cleaning
- rolling the capsule between the folds of a towel

75
Q

What are the drug content uniformity tests?

A

Weight variation
physical stability tests
packaging

76
Q

Explain weight variation

A

test performed by weight determination
assesses uniformity of content without actually assaying each dosage unit
normal within the range to 85% to 115%

77
Q

Explain for physical stability tests

A

observe the capsules on a weekly basis for signs of discoloration
record a description of the changes in appearance on a form, for future reference

78
Q

packaging

A

capsule vials
different sizes
children resistant or non child resistant

PHARM 124 (14 decks)

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