Lab 10

Question 1

define capsules

Answer 1

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

Question 2

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

Answer 2

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

Question 3

true or false

capsules may not be opened

Answer 3

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

Question 4

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

Answer 4

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

Question 5

how can capsules help to mask the taste of drugs

Answer 5

the shell masks the taste

Question 6

name some disadvantages of capsules

Answer 6

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)

Question 7

gelatin capsules are not suitable for….

Answer 7

aqueous liquids

Question 8

true or false

the gelatin shell can be made of hard or soft gelatin

Answer 8

true

Question 9

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

Answer 9

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

Question 10

true or false

capsules should not be stored in humid conditions

Answer 10

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

Question 11

when is soft gelatin used?

Answer 11

to enclose oily liquids or semisolid pastes

Question 12

hard gelatin capsule shells are used for…

Answer 12

powders

Question 13

true or false

clear capsule shells are not available

Answer 13

false - they are

Question 14

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

what are they selected based on?

Answer 14

the stability of the drug
appearance
easy to identify

Question 15

what is the range of capsule sizes available

Answer 15

000-5

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

Question 16

which is a larger capsule size — 3 or 4

Answer 16

3 is larger

Question 17

when is a 000 size capsule used

Answer 17

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

Question 18

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

Answer 18

2 and 3

Question 19

what is riboflavin

Answer 19

vitamin B2

Question 20

in which solutions/drugs is riboflavin incompatible?

Answer 20

alkaline solutions and alkaline drugs

Question 21

what is the appearance of riboflavin

Answer 21

yellow-orange crystalline powder with a slight odor

Question 22

true or false

riboflavin is insoluble in water

Answer 22

false - very slightly soluble in water and alcohol

Question 23

how must riboflavin products be stored

Answer 23

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

Question 24

what is the recomended dose of riboflavin for daily supplementation

Answer 24

1-4mg

Question 25

how is riboflavin administered for riboflavin deficiency

Answer 25

5-30mg daily in divided doses

Question 26

what is the daily allowance (RDA) of riboflavin

Answer 26

1.2-1.7mg

Question 27

what is ascorbic acid? is it water soluble?

Answer 27

water soluble vitamin C

Question 28

what happens to vitamin C when exposed to light?

Answer 28

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

Question 29

in which solutions is ascorbic acid incompatible

Answer 29

alkaline media -- it oxidizes rapidly

Question 30

why is a diluent used in capsules?

Answer 30

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

Question 31

the capsule diluent must be....

Answer 31

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

Question 32

name 2 common diluents for internal use

Answer 32

lactose and starch

Question 33

when should lactose NOT be used as the diluent

Answer 33

in lactose intolerant ppl

Question 34

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

Answer 34

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

Question 35

what is the consideration with potent drugs being incorporated into capsules

Answer 35

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

Question 36

when are adsorbents used in capsules?

Answer 36

when a liquid drug is prepared as a capsule

Question 37

name 2 common adsorbents for capsules

Answer 37

kaolin and magnesium carbonate

Question 38

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

Answer 38

lubricants/glidants

Question 39

why might disintegrants be used in capsules?

Answer 39

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

Question 40

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

Answer 40

the density of the formulated powder

Question 41

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

Answer 41

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

Question 42

explain the rule of 6

Answer 42

capsule size is substracted from 6 to give the capacity of the capsule in GRAINS (1 grain = 65mg)

Question 43

convert grains to mg

Answer 43

1 grain - 65mg

Question 44

explain the approximate selection of capsule size method

Answer 44

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

Question 45

small scale batches of capsules may be filled how?

Answer 45

punching method or capsule fillingmachine

Question 46

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

Answer 46

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

Question 47

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

Answer 47

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

Question 48

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

Answer 48

weight variation and content uniformity

Question 49

when is weight variation used?

Answer 49

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

Question 50

how does weight variation work

Answer 50

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

Question 51

when is the content uniformity test used and not weight variation

Answer 51

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

Question 52

explain how content uniformity test works

Answer 52

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