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Pharmacy Practice Lab II > Lab 10 > Flashcards

Lab 10 Flashcards

1
Q

define capsules

A

solid unit dose formulations in which the drug is enclosed in either a hard or soft soluble container - “shell”

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2
Q

the shells of capsules are usually made of ___ but they could be…

A

usually gelatin but could be made from starch, HPMC, or others

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3
Q

true or false

capsules may not be opened

A

false - they may be when intended to be used in patients with special needs OR when comparing extemporaneous preparations

however, the product info must be obtained to ensure there is no adverse effects when opening the capsule

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4
Q

capsules are the preferred dosage form when _____ is an issue.
why?

A

stability (issues w moisture and light) bc the powder can be incorporated into an opaque shell

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5
Q

how can capsules help to mask the taste of drugs

A

the shell masks the taste

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6
Q

name some disadvantages of capsules

A

they may be hard to swallow and are generally unsuitable for small children

also, some pts are concerned with the gelatin bc it’s made from animal tissue
(but non-animal gelatin shells are now available)

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7
Q

gelatin capsules are not suitable for….

A

aqueous liquids

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8
Q

true or false

the gelatin shell can be made of hard or soft gelatin

A

true

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9
Q

explain the components of a hard gelatin capsule.
where is the powder placed?

A

cap and body
powder is placed in the body

most shells for commercial use have locking groove to seal the capsule after it’s filled to prevent tampering

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10
Q

true or false

capsules should not be stored in humid conditions

A

true

the gelatin shell can often absorb moisture, soften, and lose its shape

but also shouldn’t be stored in very dry conditions bc the gelatin shell can lose moisture and crack

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11
Q

when is soft gelatin used?

A

to enclose oily liquids or semisolid pastes

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12
Q

hard gelatin capsule shells are used for…

A

powders

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13
Q

true or false

clear capsule shells are not available

A

false - they are

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14
Q

there is a wide variety of hard gelatin capsules available, from clear to opaque and colored.

what are they selected based on?

A

the stability of the drug
appearance
easy to identify

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15
Q

what is the range of capsule sizes available

A

000-5

000 is too large for human use, so 00 is the largest size in humans

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16
Q

which is a larger capsule size — 3 or 4

A

3 is larger

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17
Q

when is a 000 size capsule used

A

animals or when the capsule is not swallowed whole (used to pack divided powders or for rectal use)

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18
Q

what size capsules are preferred and most commonly selected for human use?

A

2 and 3

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19
Q

what is riboflavin

A

vitamin B2

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20
Q

in which solutions/drugs is riboflavin incompatible?

A

alkaline solutions and alkaline drugs

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21
Q

what is the appearance of riboflavin

A

yellow-orange crystalline powder with a slight odor

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22
Q

true or false

riboflavin is insoluble in water

A

false - very slightly soluble in water and alcohol

23
Q

how must riboflavin products be stored

A

riboflavin should be protected from air and light
at temp 15-30 degrees C (no less than 40)

24
Q

what is the recomended dose of riboflavin for daily supplementation

A

1-4mg

25
Q

how is riboflavin administered for riboflavin deficiency

A

5-30mg daily in divided doses

26
Q

what is the daily allowance (RDA) of riboflavin

A

1.2-1.7mg

27
Q

what is ascorbic acid?
is it water soluble?

A

water soluble vitamin C

28
Q

what happens to vitamin C when exposed to light?

A

it slowly darkens, but this doesn’t greatly influence the therapeutic effect

29
Q

in which solutions is ascorbic acid incompatible

A

alkaline media – it oxidizes rapidly

30
Q

why is a diluent used in capsules?

A

bc the usual dose of a drug is often too small to completely fill a capusle

diluents used as fillers to enhance the elegance and to ensure accurate dosing

a minor variation in powder content is less likely to cause harmful effects as compared to capsules filled with only drug powder

31
Q

the capsule diluent must be….

A

inert and should not have therapeutic and/or toxic effects.
should be compatible with drug and patient

32
Q

name 2 common diluents for internal use

A

lactose and starch

33
Q

when should lactose NOT be used as the diluent

A

in lactose intolerant ppl

34
Q

the quantity of diluent added in the formulation is based on what?

A

the potency and punching/filling properties of the API and capsule size used

35
Q

what is the consideration with potent drugs being incorporated into capsules

A

should be diluted so that weight variation will not cause harmful effects due to under or over dosing

36
Q

when are adsorbents used in capsules?

A

when a liquid drug is prepared as a capsule

37
Q

name 2 common adsorbents for capsules

A

kaolin and magnesium carbonate

38
Q

what is often used in large scale manufacture to improve flow properties and processability

A

lubricants/glidants

39
Q

why might disintegrants be used in capsules?

A

to ensure the complete disintegration of the capsule and its contents in vivo

40
Q

the amount of powder that can be filled in a shell depends on……

A

the density of the formulated powder

41
Q

name 2 methods used to estimate the weight of the powder to be filled into the shell

A
  1. rule of 6
  2. approximate weight based on the volume of the capsule
42
Q

explain the rule of 6

A

capsule size is substracted from 6 to give the capacity of the capsule in GRAINS

(1 grain = 65mg)

43
Q

convert grains to mg

A

1 grain - 65mg

44
Q

explain the approximate selection of capsule size method

A

requires trial and error. content filled varies with the substance

start with the SMALLER of the possible sizes. if doesn’t work, try the next higher or lower size

45
Q

small scale batches of capsules may be filled how?

A

punching method or capsule fillingmachine

46
Q

normally, it is recomended to prepare extra capsule powder.
why? what is an exception?

A

some is lost during filling and to ensure the last capsule is completely filled

exception = controlled substances of when use and quantity of the drug is restricted

47
Q

when the active ingredient is poorly compressible, what can be done?

A

the proportion of diluent can be adjusted to improve compressibility and filling

48
Q

according to the USP, the dosage units must demonstrate a degree of uniformity using what 2 things?

A

weight variation and content uniformity

49
Q

when is weight variation used?

A

when the drug substance in the capsule is 25mg or more and 25% or more (by weight) of the dosage unit

50
Q

how does weight variation work

A

the capsules are individually weighed and compared to the label claim using the assay values

51
Q

when is the content uniformity test used and not weight variation

A

when hard gelatin capsules contain less than 15mg/unit and less than 25% dose and ratio of drug substance

52
Q

explain how content uniformity test works

A

the capsules must be assayed individually and the assayed content must lie within the acceptance value (av)

53
Q
A

Pharmacy Practice Lab II (12 decks)

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