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PHARM 124 > Capsules > Flashcards

Capsules Flashcards

1
Q

Define a solid dosage form

A

a drug substance is enclosed in either a hard or soft shell or container generally prepared from a suitable form of gelatin

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2
Q

What is the advantages of capsules?

A

mask the unpleasant taste, aroma or appearance of a drug
powder can be dispensed in an uncompressed form, allowing quicker dissolution and absorption of the drug

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3
Q

What a disadvantages of capsules?

A

they are easily tampered with
are subject to the effects of relative humidity
gelatin is relatively stable in air when dry, however, is subject to microbial decomposition when exposed to moisture
are difficult to swallow for some individuals

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4
Q

What is the composition of HGC shells

A

gelatin
plasticizer
colorant
water - 12 to 16 %

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5
Q

What is gelatin?

A

obtained by the hydrolysis of collagen

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6
Q

Types of Gelatin

A

Type A
Type B

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7
Q

What is type A gelatin?

A

pork skin gelatin
derived mainly from pork skins by acid hydrolysis
contributes plasticity and clarity

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8
Q

What is type B gelatin?

A

derived mainly from bones and animal skins by alkaline processing
contributes firmness

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9
Q

What is Plasticizer

A

used to reduce the rigidity of gelatin and to make it more pliable

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10
Q

What is the most common plasticizer?

A

glycerin

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11
Q

Hard Gelatin

A

if no or very little plasticizer is added, gelatin will be more brittle

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12
Q

Soft Gelatin

A

used primarily for liquids but recently employed for solids and solids dispersed in oil

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13
Q

Colorant

A

The coloring agent

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14
Q

functions of coloring agents

A

esthetic effects
identification
light protection

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15
Q

What is esthetic effects

A

marks variation in color of contents, raises confidence of users

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16
Q

The purpose of coloring for identification

A

color is the simplest and best method for quick identiifction

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17
Q

the purpose of coloring - identification

A

color is the simplest and best method for quick identification

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18
Q

Purpose of coloring in light protection

A

color reflects both the amount and wavelength of light passing through the gelatin layer

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19
Q

Composition of HGC shells (high humidity)

A

additional moisture is absorbed by the capsule
often packaged with a desiccant as a precaution against absorbing atmospheric moisture

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20
Q

Composition of HGC shells (low humidity)

A

some of the capsules moisture may be lost
may become brittle and crumble when handled

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21
Q

T or F
Light sensitive drugs can not be used in capsules

A

False - we can protect with color/opaquence of the drug

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22
Q

T or F
liquid drugs can not be used in capsules

A

False - we can in soft

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23
Q

T or F
major component of capsule shell are protein constituents

A

True - high % gelatin

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24
Q

T or F
capsules are easier to swallow compared to tablets

A

True - not as bitter, can control size, soft gels

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25
Body of a shell
larger portion which is filled with medication
26
Cap of a shell
small portion which covers or slips over the body
27
Size of HGC
shells are produced in standard sizes eight standard sizes are generally ised in human drug therapy 000-5
28
Most common capsule size
0-4
29
Shape of HGC
the basic shape is oblong variations depend on the manufacturer
30
Closure of HGC
to prevent separation of the cap from the body to provide evidence of tmapering
31
Methods used to assure that capsules do not come apart
spot welded banded locking device
32
What spot welded capsules means?
by means of a heated metal pin pressed against the cap, fusing it to the body
33
What banded capsules means?
colored molten gelatin is laid around the joint between the 2 capsules parts in a strip and dried
34
What locking device means?
a pair of matched locking rings are formed in the cap and body portions of the capsule and engaged after filling
35
What is the most common capsule diluents?
lactose microcrystalline cellulose starch
36
Formulation of filling of hard gelatin capsules
diluent disintegrants lubricant and glidant wetting agents
37
Function of diluent
to increase bulk for the dosage form, act as a vehicle and improve content uniformity
38
Function of disintegrants
serve assist in the break off the powder mass/granules and help in distributing the drug throughout the stomach
39
Examples of disintegrants
pre-gelanized starch croscarmellose sodium starch glycolate
40
The purpose of lubricant and glidant
improve fluidity and flow of powders decreases sticking of powders to metal surfaces reduces friction on surfaces in contact with powder
41
Examples of lubricant and glidant
calcium stearate polyethylene glycol talc
42
Purpose of Wetting agents
surface active agent are often added to facilitate the wetting of the drug substance by the GI fluids thus enhancing dissolution
43
Examples of wetting agents
alcohol water
44
Advantages of HGC
potential for rapid drug release elegant, ide range of colors and possible opacity often preferred by patients because their smooth, slippery, tasteless shell is easily swallowed ease of use and portability
45
Disadvantages of HGC
limited number of shell suppliers generally more costly to produce than tablets not to be used for extremely soluble drugs
46
What are soft gelatin capsules?
a continuous, soft, globular gelatin shell which surrounds a liquid fill material
47
Composition
Gelatin plasticizer colorant water preservative
48
What is the purpose of plasticizer?
added to render gelatin soft or plastic like
49
Examples of plasticizer
glycerol sorbitol propylene glycol
50
What is the purpose of preservation?
added due to the high water-content which makes them more susceptible to microbial growth
51
Examples of preservative
methylparaben propylparaben sorbic acid
52
What types of size and shapes do SGC?
varies considerably maybe round, oval, oblong tubes, etc.
53
What should the pH of a SGC?
liquid 2.5-7.5
54
If the SGC is too acidic
add hydrolyse gelatin
55
If the SGC is too basic
decrease gelatin solubility
56
Examples of SGC fill materials
pure liquid drugs vegetable oils mineral oils water miscible liquids some solids
57
Why is liquid filling soft gelatin capsules concerned the most accurate?
filled as a liquid homogeneous filled volumetrically with a syringe like apparatus
58
SGC Advantages
permits liquid drugs to become easily portable adaptable pt. preference accurate dosage form as volumetrically filling can be made opaque to prevent light penetration bioavailability product security
59
What bioavailability advantages does SGC have?
have faster dissolution rate than other solid dosage forms, including HGCs
60
What is the advantage of SGC for product security
nearly impossible because of complete sealing or tampering easy to identify
61
What are some hints for pt who have difficulty swallowing capsules?
try placing the capsule on the back of tongue before drinking place the capsule in warm water for a few seconds prior to taking --> makes it slide over more easily
62
Tips for dispensing Capsules
when dispensing SGCs, no cotton should be used in the vial. It is generally accepted to use with HGCs SGCs tend to adhere to one another --> store in a cool, dry place
63
Selecting a capsule size
the size selected for use is determined by the amount of material to be encapsulated capacity will vary depending on the density of the powdered drug material
64
The Rule of Sixes
Based on experimental observation that the bulk densities of many powders average about 0.6 mg/ml
65
Preparing the capsule formulation
if the dose is large enough, a capsule can be filled with just the drug to fill more adding bulk
66
Examples of Bulking
lactose microcrystalline cellulose starch
67
What is done to manage powders fluffiness?
a few drops of alcohol, water or mineral oil
68
Methods for extemporaneously filling HGCs
some powder will be lost during filling powder blending and sizing two methods of filling hard gelatin capsule shells
69
List two methods of filling hard gelatin capsule shells
punch method hand operated machines
70
How do you account for lost powder?
use 10% extra powder or 2 extra capsules
71
What is the punch method used for?
used to fill a relatively small number of capsules
72
How use the punch method?
place the powder on an ointment slab to prevent hand contact with powder place the exact number of empty capsules on the powder paper separate the capsule bodies and caps repeatedly push or "punch" the open end into the powder until the capsule is filled replace the cap on the body weight each filled capsule, add or remove power until the correct weight
73
What is a Hand operated machines
also called plate process special equipment capable of filling 30-300 capsules per cycle used in large pharmacies, hospitals and development laboratories
74
What is the finishing procedure for punching method?
sealing - use locking capsules or -wet the outer edge of the body with moist towel cleaning - rolling the capsule between the folds of a towel
75
What are the drug content uniformity tests?
Weight variation physical stability tests packaging
76
Explain weight variation
test performed by weight determination assesses uniformity of content without actually assaying each dosage unit normal within the range to 85% to 115%
77
Explain for physical stability tests
observe the capsules on a weekly basis for signs of discoloration record a description of the changes in appearance on a form, for future reference
78
packaging
capsule vials different sizes children resistant or non child resistant

PHARM 124 (14 decks)

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