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Pharmaceutics II FINAL > Chapter 4 - Capsules > Flashcards

Chapter 4 - Capsules Flashcards

1
Q

which have a more predictable absorption mechanism and why - tablets or capsules

A

capsules bc they are already granules

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2
Q

give the definition of capsules

A

solid dosage forms in which 1 or more medicinal and/or inert substances are enclosed in a smell shell or container (generally prepared from a suitable form of gelatin)

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2
Q

true or false

an advantage to capsules is that they are tasteless

A

true – bc the material is enclosed within the shell and does not get in contact with the tongue

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3
Q

which are easier to compound - tablets or capsules

A

capsules

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4
Q

how is it that capsules are more easily administered than tablets?

A

because the powder is enclosed within the shell so you don’t have to worry about loose powder

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5
Q

TRUE OR FALSE

compared to other solid dosage forms, the bioavailability of capsules is generally worse

A

FALSE

generally better

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6
Q

how are capsules useful for clinical trials

A

to hide the placebo and actual drug – mask what is what

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7
Q

TRUE OR FALSE

capsules allow for physicians to prescribe drug combinations that fit individual requirements

A

true

ex - can put 5 drugs into 1 capsule

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8
Q

how do capsules offer protection from light?

A

if opaque – ie: titanium dioxide

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9
Q

name 5 scenarios in which the capsule dosage form is not suitable for the drug

A

drugs that are soluble salts
drugs that solubilize gelatin
hygroscopic drugs
deliquescent drugs
efflorescent drugs

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10
Q

potential for ________ is a disadvantage of the capsule dosage form

A

tampering

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11
Q

why are hygroscopic and deliquescent drugs not suitable for the capsule dosage form?

A

they will change the water content of gelatin

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12
Q

what are the 2 kinds of capsule shells

A

hard gelatin capsules
soft elastic capsules

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13
Q

between the 2 kinds of capsule shells, which can be made in compounding

A

hard gelatin can – soft elastic cant

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14
Q

soft elastic capsules normally contain what kind of drug

A

liquid drug

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15
Q

what are the components of a capsule shell

A

body (where powder is filled) and cap

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16
Q

the drug to be incorporated into capsules can be:

A

powder
granulation
liquid
semi-solid mass
pellet mixture
capsule
paste
tablet

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17
Q

HARD gelatin capsules contain how much moisture?

A

13-16% moisture

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18
Q

define gelatin

A

a heterogeneous proteinaceous (contains protein) material obtained from ANIMAL COLLAGEN by hydrolytic extraction

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19
Q

what is the significance of the fact that hard gelatin capsules contain 13-16% moisture

A

do not put hygroscopic materials inside bc it will absorb the water content and the capsule will break if the changes are significant

DO NOT STORE IN BATHROOM

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20
Q

What is the solubility of gelatin in water?

A

almost insoluble in cold water
soluble in hot water and in warm GI fluids

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21
Q

true or false

gelatin is stable in the air when dry

A

true

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22
Q

gelatin is prone to……

A

microbial decomposition when it becomes moist (free water)

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23
Q

TRUE OR FALSE

gelatin is digested and absorbed poorly

A

FALSE - digested and absorbed well

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24
Q

explain the composition of a empty hard gelatin capsule shell

A

gelatin
sucrose
sulfur dioxide
water

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25
Q

why is sucrose 1 of the components in an empty hard capsule gelatin shell?

A

for shell hardness and rigidity

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26
Q

why is sulfur dioxide 1 of the components in an empty hard gelatin capsule shell?

A

for transparency

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27
Q

why are colorants added to hard gelatin capsule shells?

A

to make the capsule distinctive

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28
Q

what is added to make capsules opaque? (if desired)

A

titanium dioxide

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29
Q

name the 4 steps of the automated production mechanism of hard gelatin capsule shells

A

dipping
drying
trimming
joining

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30
Q

name 3 components of coni-snap

A

tapered rims
indentations
grooves

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31
Q

what is the purpose of the tapered rims in the coni-snap capsule design?

A

to avoid telescoping (splitting)

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32
Q

what is the purpose of the indentations in coni-snap

A

to prevent premature opening – don’t want capsule and body to inadvertently separate

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33
Q

what is the purpose of the grooves in coni-snap capsule design

A

to lock the 2 capsule parts together

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34
Q

what is another variant of coni-snap design

A

coni-snap supro

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35
Q

capsule size ranges from…

A

000-5

human use – 000 is too large so 00-5

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36
Q

true or false

higher capsule number means a smalller amount can go in

A

true

37
Q

how many mL can 000 hold?
what about 00?

A

000 = 1.4 mL

00 = 0.95mL

38
Q

how many mL can 0 hold?
what about 1?

A

0 = 0.68
1 = 0.50

39
Q

how many mL can 2 hold?
what about 3?

A

0.37
0.30

40
Q

how many mL can 4 hold?
5?

A

4 = 0.21mL
5 = 0.13mL

41
Q

rank the following according to density:

aspirin
quinine sulfate
sodium bicarbonate

A

most dense = sodium bicarbonate
aspirin
least dense = quinine sulfate

42
Q

as mentioned, between aspirin, sodium bicarbonate, and quinine sulfate, sodium bicarbonate is the MOST DENSE

therefore, _____ mass is needed for sodium bicarbonate to entirely fill the volume of a capsule than for the other 2 drugs

A

more mass is needed

43
Q

TRUE OR FALSE

there are 3 size 5 capsules, each containing different drugs in different amounts.

Drug A - 65mg
Drug B - 130mg
Drug C - 97mg

true or false… the volume of each capsule will be different, with the capsule containing Drug B having the most volume

A

FALSE

ALL CAPSULES WILL HAVE 0.13mL volume bc all size 5

varying mass numbers are simply due to varying densities.
Drug B is the most dense

44
Q

how many grams of water can go into a size 2 capsule? (assuming nothing else was added)

A

0.37mL/0.37 grams

bc density of water is 1, it will be exact amount that a size 2 capsule can hold

45
Q

true or false

only the density of the API is a concern when determining how much drug is needed to fill a capsule

A

FALSE

density of diluents as well and other things are a concern

46
Q

when possible, what size capsule should be used

A

the smallest size - size 5
not necessary but preferred

47
Q

true or false

the weight is constant but the volume varies for each capsule

A

FALSE

VOLUME IS ALWAYS CONSTANT
mass varies

48
Q

how is the proper volume of a capsule maintained?

A

normally, the amt of API is constant.
therefore, density is maintained by using DILUENT

49
Q

for which is weight variation more significant – using 65mg of API or using 130mg API?

A

weight variation is more significant for 65mg API

50
Q

true or false

if all of the powder formulation fits into a size 5 capsule, a size 5 capsule must be used

A

FALSE

it is preferred but not necessary

51
Q

name the 4 steps of preparing filled hard gelatin capsules

A

-develop and prepare the formulation and select capsule size

-fill capsule shells

-capsule sealing (optional)

-cleaning and polishing the filled capsules

52
Q

in the 1st step of preparing filled hard gelatin capsules, name 3 things to consider

A

1st step = develop and prepare formulation and select capsule size

consider:

-accurate dosage
-good bioavailability
-easy to fill the capsule during production

53
Q

name 3 diluents commonly used in capsules to produce the proper capsule fill volume

A

lactose
microcrystalline cellulose
starch

54
Q

name 2 reasons that companies might want to perform capsule sealing, even tho it is optional

A

when sealed, they will be tamper proof and leak proof

55
Q

explain how cleaning and polishing process of the filled capsules is accomplished both in small scale and large scale

A

small scale - cleaned individually in small numbers by rubbing them with clean gauze or cloth, OR mix with salt or sugar or anything that can create friction

large scale - many capsule filling machines affixed with a cleaning vacuum. this removes any extraneous material from the capsules as they leave this equipment

56
Q

name 3 components in capsule formulation

A

API
DILUENTS
GLIDANTS (in manufacturing)
others

57
Q

name 6 diluents for the capsule dosage form

A

dicalcium phosphate
kaolin
lactose
modified starch
magnesium carbonate
magnesium oxide

58
Q

name disadvantages of using dicalcium phosphate as a diluent

A

it retards (slows) the dissolution rate and is incompatible with tetracyclines (forms a complex)

59
Q

which capsule diluent(s) are good for eutectic mixtures?

A

kaolin
magnesium carbonate
magnesium oxide

60
Q

which capsule diluent is incompatible with acidic drugs and why?

A

magnesium oxide bc it is alkaline in nature

61
Q

WHY are kaolin, magnesium carbonate, and magnesium oxide good diluents for eutectic mixtures?

A

bc they absorb the formed liquid

62
Q

which capsule diluent is incompatible with amines?
give an example of a class of drug that are amines

A

lactose
sulfa drugs

63
Q

name 3 glidants that can be used in the capsule dosage form

A

silicone dioxide
magnesium stearate
talc

64
Q

true or false

glidants are really only needed in manufacturing and NOT in the small scale preparation of capsules

A

true – needed for good flow into the die in manufacturing

65
Q

explain the issue with using magnesium stearate as a glidant in capsule formulation

A

it has water proofing characteristics which slows the penetration by GI fluids – this delays drug dissolution and absorption

to solve this issue, a surfactant like SLS is added as a wetting agent to facilitate wetting by the GI fluids to overcome the water proofing issue

66
Q

which glidant used in capsule formulation has water proofing characteristics?

A

magnesium stearate

67
Q

true or false

gelatin capsules are suitable for aqueous liquids

A

false – unsuitable bc water softens gelatin and distorts the capsules, resulting in leakage of the contents.

68
Q

true or false

it is REQUIRED to reach the max volume of the capsule size chosen

A

true – add diluents until max volume is reached

69
Q

name methods of small scale filling hard capsule shells

A

hand operated capsule filling machine

punching method

70
Q

explain how the hand-operated capsule filling machines work

A

empty capsules in the loader tray and place on top of the filler unit

insert the capsules into the filling unit and remove. lift the top plate to separate the caps and bodies

place powder on the unit and fill the capsule bodies

return top plate to the unit and place the caps on the filled bodies

71
Q

in small scale filling of hard capsule shells, what % error is allowed?

A

5%

72
Q

what is the name of the equipment used to fill hard capsule shells in large scale?
how many capsules can be filled in x amount of time?

A

Osaka automatic capsule filler

165,000 capsules/hour

73
Q

true or false

automated capsule filling machines have their own content uniformity test

A

true

74
Q

true or false

soft gelatin capsules can be made both in manufacturing and in the pharmacy

A

FALSE – can only be made in manufacturing and not in lab/pharmacy setting

75
Q

TRUE OR FALSE

soft gelatin capsules come in a VARIETY of shapes and sizes

A

true

76
Q

soft gelatin capsules are most often used for what kind of drugs?

A

liquid or mixtures of liquid

77
Q

what are the different routes of administration for soft gelatin capsules?
routes are dependent on…..

A

routes are dependent on the shape of the capsules

oral, rectal, vaginal, specialty for topical, ophthalmic, otic

78
Q

besides being used for liquids/mixtures of liquids, what else can soft gelatin capsules be used for?

A

gels, pastes, powders, etc

79
Q

further classify which liquids/mixtures of liquids that soft gelatin capsules can be used for

A

-water immiscible, volatile, and nonvolatile liquids (vegetable oils and aromatic oils)

-water miscible and nonvolatile liquids (polyethylene glycols)

-water miscible and relatively nonvolatile

80
Q

the shells of soft gelatin capsules are made of….

A

gelatin + the addition of glycerin or polyhydric alcohol (sorbitol) – gelatin elastic

81
Q

do soft/hard gelatin capsules contain a preservative?
why or why not?

A

soft gelatin capsules contain a preservative and hard gelatin capsules do not because soft gelatin capsules contain slightly higher moisture content than hard shell capsules

82
Q

name the typical preservatives for soft gelatin capsules

A

methyl and propyl parabens
sorbic acid

83
Q

what are the compendial requirements for the ADDED SUBSTANCES in capsules? (4)

A

-harmless in the quantities used
-do not exceed min. amounts required to produce their intended effect

-do not impair bioavailability of the product, the therapeutic efficacy, or safety

-do not interfere with required (requisite) compendial tests and assays

84
Q

what are the compendial requirements for containers that are used to dispense capsules?

A

they must be:

-tight
-well closed
-light resistant
-and/or a combination of these

85
Q

name 7 tests that are compendial requirements for capsules

A

disintegration test
dissolution test
weight variation
content uniformity
content labeling requirement
stability testing
moisture permeation test

86
Q

explain what the disintegration test for capsules is.
what else undergoes this test?

A

uncoated tablets also undergo this test

capsules are placed in a basket rack and immersed 30 times/min into a 37 degree celsius thermostatically controlled fluid.

the capsules must disintegrate completely into soft mass with no firm core and only contain some fragments of the gelatin shell

87
Q

explain the weight variation test.

is it form hard or soft capsules?

A

for both hard and soft capsules. they both have different procedures

88
Q

in the content uniformity test for capsules, the capsules must be in _______ range of the labeled claim for 9/10 dosage units, with NO UNIT outside the range of ________ of the labeled claim

A

9/10 must be within 85%-115% of labeled claim

no unit can be outside of 75-125% of labeled claim

89
Q

content uniformity is related to….

A
90
Q
A

Pharmaceutics II FINAL (11 decks)

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