Capsules Flashcards

1
Q

What are capsules?

A

solid dosage in which a drug substance is encapsulated in either a hard or soft shell or container generally prepared from a suitable form of gelatin

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2
Q

What can be encapsulated in capsules?

A

dry powders
semi-solids
liquids
assuming they do not dissolve gelatin

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3
Q

True or false: capsules are only administered orally

A

false
can be used rectally and vaginally

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4
Q

What are the advantages of capsules?

A

masks unpleasant taste or aroma of a drug
quicker dissolution and absorption
variety of administration routes
made quickly and inexpensively
can combine drugs into one capsule
easier to swallow than tablets
alter release rate of drug

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5
Q

What are the disadvantages of capsules?

A

easily tampered
subject to humidity
difficult to swallow for some individuals

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6
Q

What is the composition of HGC shells?

A

gelatin
plasticizer
colorant
water (12-16%)

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7
Q

How is gelatin obtained?

A

hydrolysis of collagen

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8
Q

What are the two types of gelatin?

A

type A (pork skin gelatin)
-derived from pork skins by acid hydrolysis
-contributes plasticity and clarity
type B (bone gelatin)
-derived from bones and animal skin by alkaline processing
-contributes firmness

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9
Q

How is gelatin digested?

A

proteolytic enzymes
-gelatin is a protein

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10
Q

Why is plasticizer used in HGC?

A

reduce rigidity of gelatin and make it more pliable
plasticizer <5% by weight in HGC

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11
Q

What is the most common plasticizer used in HGC?

A

glycerin

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12
Q

What is the difference between hard gelatin and soft gelatin?

A

hard:
-no or very little plasticizer, gelatin will be more brittle
-<5% plasticizer
-used for powders, granules, or pellets
soft:
-primarily for liquids but recently employed for solids and
solids dispersed in oils

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13
Q

What are the functions of coloring agents in HGC?

A

esthetics
identification
light protection

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14
Q

What would happen to a HGC in high humidity? What about low humidity?

A

moisture absorbed by the capsule
may become brittle and crumble

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15
Q

What are capsules often packaged with?

A

desiccant
-precaution against moisture

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16
Q

Where should capsules be stored?

A

areas of low humidity
-not the bathroom

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17
Q

What are the two sections of HGC?

A

body: larger portion which is filled with medication
cap: small portion which covers or slips over the body

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18
Q

How many sizes of capsules exist?

A

eight
-#5 (smallest) to #000 (largest)

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19
Q

What are the most popular size of capsules?

A

0 to #4

-#0 and #1 are the most commonly used

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20
Q

True or false: shape variation is more common with HGC than SGC

A

false
more common with SGC

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21
Q

What is the basic shape of a HGC?

A

oblong

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22
Q

What is the purpose of HGC closure?

A

prevent separation of cap from body
provide evidence of tampering

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23
Q

What are the methods used to assure that capsules will not come apart?

A

spot-welded: heated metal pin pressed against cap, fusing it to
body
banded: colored molten gelatin is laid around joint between
the capsule parts in a strip and dried
locking device: matched locking rings are formed in the cap
and body portions of the capsule and engaged
after filling

24
Q

What are the advantages of the banded method?

A

distinctive
tamper-proof
leak-proof

25
Q

What is the function of diluents in HGC?

A

increase bulk for the dosage form
act as a vehicle
improved content uniformity
assist transferring powder blend to the capsule bodies

26
Q

What are the most common capsule diluents?

A

lactose
microcrystalline cellulose
starch

27
Q

What is the function of disintegrants in HGC?

A

assist in the break off the powder
distributing the drug throughout the stomach

28
Q

What are the common capsule disintegrants?

A

pre-gelatinized starch
croscarmellose
sodium starch glycolate

29
Q

What is the function of lubricant and glidant in HGC?

A

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

30
Q

What are the common lubricants and glidants used in HGC?

A

calcium stearate
polyethylene glycol
talc

31
Q

What is the function of wetting agents in HGC?

A

facilitate wetting of drug substance by GI fluids, enhances dissolution
handling fluffy and light powders

32
Q

What are the common wetting agents used in HGC?

A

alcohol
water

33
Q

What are the advantages of HGC?

A

rapid drug release
elegant, wide range of colours and opacity
preferred by patients cause of their smooth, slippery, tasteless shell is easily swallowed
readily compounded
ease of use and portability

34
Q

What are the disadvantages of HGC?

A

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

35
Q

Why are extremely soluble drugs not to be formulated as HGC?

A

fluid penetrating the capsule rapidly dissolves the salts, burst release can cause GI irritation

36
Q

What is a SGC?

A

a continuous, soft, globular gelatin shell which surrounds a liquid fill material
-may also contain suspensions, pasty materials, or dry
powders

37
Q

How many operations does it take to form SGC?

A

all done in one operation

38
Q

What is the composition of SGC?

A

gelatin: 35-50%
plasticizer: 15-30%
colorant
water: 30-40%
preservative

39
Q

Why do SGC contain more plasticizer than HGC?

A

added to render gelatin soft or plastic-like

40
Q

What is the role of preservative in SGC?

A

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

41
Q

What are the common preservatives used in SGC?

A

methylparaben
propylparaben
sorbic acid

42
Q

What is the size and shape of SGC?

A

varies considerably
round, oval, oblong, tubes, etc

43
Q

What kind of liquids should be avoided in SGC?

A

those with adverse effects on the gelatin
liquids which easily migrate through a capsule

44
Q

What should the pH be of a liquid in a SGC?

A

2.5-7.5
too acidic: hydrolyse gelatin
too basic: decrease gelatin solubility

45
Q

What are some of the SGC fill materials?

A

pure liquid drugs
solid drug dissolved or dispersed in vehicles
some solids (dry powders, granules, pelletized material)

46
Q

As a dosage form, liquid-filled SGC are considered the most accurate and most uniform with respect to content for 2 main reasons, what are these reasons?

A

filled as liquid which is homogenous
filled volumetrically with a syringe-like apparatus

47
Q

What are the advantages of SGC?

A

permits liquid drugs to become portable
adaptable
patients preference (potential for increased compliance)
accurate dosage form as volumetrically filled
can be made opaque for light protection
faster dissolution rate than other solid dosage forms
product security

48
Q

What are some tips for dispensing SGCs?

A

when dispensing SGC, dont put cotton in vial
SGCs adhere to eachother=store in cool, dry place
patients who have difficulty swallowing:
-place capsule on back of tongue before drinking liquid
-place capsule in warm water, easier to slide

49
Q

When do we need fillers for compounded capsules? When do we not need fillers?

A

need filler: dose is too small, filler increases uniformity
dont need filler: dose is large enough

50
Q

How much extra powder should be used when compounding capsules?

A

10%
or use enough extra powder for 2 extra capsules

51
Q

What are the two methods of filling HGC?

A

punch method
hand operated machines

52
Q

What are the methods for powder blending and sizing capsules?

A

triturate in a mortar with a pestle
pass the powder blend through a 60-100 mesh sieve before beginning filling process

53
Q

Explain the punch method.

A
  1. place powder on ointment slab, to a heigh of 1/3 to 1/2 of
    the length of the capsule body
  2. prevent hand contact with powder by wearing gloves
  3. place the exact number of empty capsules on the powder
    paper, separate the capsule bodies and caps
  4. repeatedly punch the open end into the powder until the
    capsule is filled
  5. replace the cap on the body
  6. weigh each filled capsule, add or remove powder as needed
54
Q

Explain hand operated machines for filling capsules.

A

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

55
Q

What is the finishing procedure for compounding capsules?

A

sealing
-use locking capsules OR wet outer edge of body with moist
towel to soften the gelatin
-use cotton swab dipped in warm water to rub around the
inner edge of the cap
cleaning
-roll capsules between folds of a towel OR place in container
with sodium carbonate, sodium chloride, and gently roll in
container

56
Q

What is the formulation of the filling material in HGCs?

A

diluent
disintegrant
lubricant and glidant
wetting agents