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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
explain the composition of a empty hard gelatin capsule shell
gelatin sucrose sulfur dioxide water
25
why is sucrose 1 of the components in an empty hard capsule gelatin shell?
for shell hardness and rigidity
26
why is sulfur dioxide 1 of the components in an empty hard gelatin capsule shell?
for transparency
27
why are colorants added to hard gelatin capsule shells?
to make the capsule distinctive
28
what is added to make capsules opaque? (if desired)
titanium dioxide
29
name the 4 steps of the automated production mechanism of hard gelatin capsule shells
dipping drying trimming joining
30
name 3 components of coni-snap
tapered rims indentations grooves
31
what is the purpose of the tapered rims in the coni-snap capsule design?
to avoid telescoping (splitting)
32
what is the purpose of the indentations in coni-snap
to prevent premature opening -- don't want capsule and body to inadvertently separate
33
what is the purpose of the grooves in coni-snap capsule design
to lock the 2 capsule parts together
34
what is another variant of coni-snap design
coni-snap supro
35
capsule size ranges from...
000-5 human use -- 000 is too large so 00-5
36
true or false higher capsule number means a smalller amount can go in
true
37
how many mL can 000 hold? what about 00?
000 = 1.4 mL 00 = 0.95mL
38
how many mL can 0 hold? what about 1?
0 = 0.68 1 = 0.50
39
how many mL can 2 hold? what about 3?
0.37 0.30
40
how many mL can 4 hold? 5?
4 = 0.21mL 5 = 0.13mL
41
rank the following according to density: aspirin quinine sulfate sodium bicarbonate
most dense = sodium bicarbonate aspirin least dense = quinine sulfate
42
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
more mass is needed
43
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
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
how many grams of water can go into a size 2 capsule? (assuming nothing else was added)
0.37mL/0.37 grams bc density of water is 1, it will be exact amount that a size 2 capsule can hold
45
true or false only the density of the API is a concern when determining how much drug is needed to fill a capsule
FALSE density of diluents as well and other things are a concern
46
when possible, what size capsule should be used
the smallest size - size 5 not necessary but preferred
47
true or false the weight is constant but the volume varies for each capsule
FALSE VOLUME IS ALWAYS CONSTANT mass varies
48
how is the proper volume of a capsule maintained?
normally, the amt of API is constant. therefore, density is maintained by using DILUENT
49
for which is weight variation more significant -- using 65mg of API or using 130mg API?
weight variation is more significant for 65mg API
50
true or false if all of the powder formulation fits into a size 5 capsule, a size 5 capsule must be used
FALSE it is preferred but not necessary
51
name the 4 steps of preparing filled hard gelatin capsules
-develop and prepare the formulation and select capsule size -fill capsule shells -capsule sealing (optional) -cleaning and polishing the filled capsules
52
in the 1st step of preparing filled hard gelatin capsules, name 3 things to consider
1st step = develop and prepare formulation and select capsule size consider: -accurate dosage -good bioavailability -easy to fill the capsule during production
53
name 3 diluents commonly used in capsules to produce the proper capsule fill volume
lactose microcrystalline cellulose starch
54
name 2 reasons that companies might want to perform capsule sealing, even tho it is optional
when sealed, they will be tamper proof and leak proof
55
explain how cleaning and polishing process of the filled capsules is accomplished both in small scale and large scale
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
name 3 components in capsule formulation
API DILUENTS GLIDANTS (in manufacturing) others
57
name 6 diluents for the capsule dosage form
dicalcium phosphate kaolin lactose modified starch magnesium carbonate magnesium oxide
58
name disadvantages of using dicalcium phosphate as a diluent
it retards (slows) the dissolution rate and is incompatible with tetracyclines (forms a complex)
59
which capsule diluent(s) are good for eutectic mixtures?
kaolin magnesium carbonate magnesium oxide
60
which capsule diluent is incompatible with acidic drugs and why?
magnesium oxide bc it is alkaline in nature
61
WHY are kaolin, magnesium carbonate, and magnesium oxide good diluents for eutectic mixtures?
bc they absorb the formed liquid
62
which capsule diluent is incompatible with amines? give an example of a class of drug that are amines
lactose sulfa drugs
63
name 3 glidants that can be used in the capsule dosage form
silicone dioxide magnesium stearate talc
64
true or false glidants are really only needed in manufacturing and NOT in the small scale preparation of capsules
true -- needed for good flow into the die in manufacturing
65
explain the issue with using magnesium stearate as a glidant in capsule formulation
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
which glidant used in capsule formulation has water proofing characteristics?
magnesium stearate
67
true or false gelatin capsules are suitable for aqueous liquids
false -- unsuitable bc water softens gelatin and distorts the capsules, resulting in leakage of the contents.
68
true or false it is REQUIRED to reach the max volume of the capsule size chosen
true -- add diluents until max volume is reached
69
name methods of small scale filling hard capsule shells
hand operated capsule filling machine punching method
70
explain how the hand-operated capsule filling machines work
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
in small scale filling of hard capsule shells, what % error is allowed?
5%
72
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?
Osaka automatic capsule filler 165,000 capsules/hour
73
true or false automated capsule filling machines have their own content uniformity test
true
74
true or false soft gelatin capsules can be made both in manufacturing and in the pharmacy
FALSE -- can only be made in manufacturing and not in lab/pharmacy setting
75
TRUE OR FALSE soft gelatin capsules come in a VARIETY of shapes and sizes
true
76
soft gelatin capsules are most often used for what kind of drugs?
liquid or mixtures of liquid
77
what are the different routes of administration for soft gelatin capsules? routes are dependent on.....
routes are dependent on the shape of the capsules oral, rectal, vaginal, specialty for topical, ophthalmic, otic
78
besides being used for liquids/mixtures of liquids, what else can soft gelatin capsules be used for?
gels, pastes, powders, etc
79
further classify which liquids/mixtures of liquids that soft gelatin capsules can be used for
-water immiscible, volatile, and nonvolatile liquids (vegetable oils and aromatic oils) -water miscible and nonvolatile liquids (polyethylene glycols) -water miscible and relatively nonvolatile
80
the shells of soft gelatin capsules are made of....
gelatin + the addition of glycerin or polyhydric alcohol (sorbitol) -- gelatin elastic
81
do soft/hard gelatin capsules contain a preservative? why or why not?
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
name the typical preservatives for soft gelatin capsules
methyl and propyl parabens sorbic acid
83
what are the compendial requirements for the ADDED SUBSTANCES in capsules? (4)
-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
what are the compendial requirements for containers that are used to dispense capsules?
they must be: -tight -well closed -light resistant -and/or a combination of these
85
name 7 tests that are compendial requirements for capsules
disintegration test dissolution test weight variation content uniformity content labeling requirement stability testing moisture permeation test
86
explain what the disintegration test for capsules is. what else undergoes this test?
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
explain the weight variation test. is it form hard or soft capsules?
for both hard and soft capsules. they both have different procedures
88
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
9/10 must be within 85%-115% of labeled claim no unit can be outside of 75-125% of labeled claim
89
content uniformity is related to....
90

Pharmaceutics II FINAL (11 decks)

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