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Pharmaceutics II FINAL > Tablets Part 3 > Flashcards

Tablets Part 3 Flashcards

1
Q

name 2 methods for All-In-One Granulation

A

fluid bed process
microwave vacuum processing

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2
Q

the fluid bed process uses what equipment to perform all in one granulation?

A

the fluid bed granulator

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3
Q

explain the 3 steps of the fluid bed granulator in performing all in one granulation

A
  1. the formulation powder (drug+fillers+disintegrants) is preblended in a bed with fluidized air
  2. the mixture is granulated by spraying (onto the fluidized powder bed) a liquid binder. (ie: aqueous solution of acacia, HPC, or povidone
  3. The granulated product is dried to the desired moitsure content
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4
Q

name 2 advantages of the dry granulation method

A

useful for water and heat sensitive drugs (both used in wet granulation)

fewer steps than wet granulation

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5
Q

name a disadvantage of dry granulation

A

requires drugs or excipients that have cohesive properties (bc no liquid binder)

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6
Q

name 2 methods of dry granulation

A

slugging
roller compaction

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7
Q

in order to do the direct compression method of preparing compressed tablets, what must the properties of the drug be?

A

the drug must be free flowing and sufficiently cohesive

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8
Q

what is the LEAST EXPENSIVE method of preparing compressed tablets?

A

the direct compression method

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9
Q

name 2 binders that can be used in the direct compression method

A

starch
CMC

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10
Q

name 3 disadvantages of the direct compression method

A

-requires materials that can be directly compressed

-the drug /excipients must have good flow properties

-you can get non uniform tablets

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11
Q

true or false

an advantage of the direct compression method is that it is possible to prepare a tablets from a powdered mixture WITHOUT granulation

A

true

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12
Q

true or false

a disadvantage of the direct compression method is that it is slower than the other 2 methods

A

FALSE - it is faster

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13
Q

direct compression method is useful for drugs with what properties?
name 4

A

drugs that are moisture sensitive
drugs that are heat sensitive
large dose drugs
crystalline drugs

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14
Q

which normally has better bioavailability - tablets prepared by wet granulation, dry granulation, or the direct compression method?

A

direct compression method has optimal bioavailability bc there is a limited # of excipients (remember - useful for large dose drugs = less excipients used)

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15
Q

what is commonly used as a filler/diluent in the direct compression method?

in which other method is it commonly used?

A

ditab

also used in dry granulation

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16
Q

what is tablet dedusting?

A

removes traces of loose powder that adhere to the tablets following compression

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17
Q

what step immediately precedes dedusting?
what happens after dedusting?

A

tableting machine and then right to dedusting

after dedusting is when the compressed tablets may be coated if desired

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18
Q

true or false

dedusting happens immediately after tablet coating

A

false – happens right before coating

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19
Q

what are the types of tableting machines?

A

single punch
rotary punch

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20
Q

where in the tableting machines is the granulation fed into?

A

the die cavity

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21
Q

where in the tableting machine is the formed tablet ejected from?

A

the die

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22
Q

what is capping?

A

a tablet defect.

the partial or complete separation of the top or bottom from the main body of the tablet

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23
Q

what is lamination?

A

a tablet defect

the horizontal separation of the tablet into 2 or more distinct layers

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24
Q

capping and ______ have the same causes and remedies

A

lamination

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25
Q

true or false

friability is related to capping and lamination

A

false - not related

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26
Q

what is the optimum moisture for granules?
what happens if the granules are too dry?

A

optimum moisture is 4-6%

if too dry, capping/lamination can occur

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27
Q

true or false

lack of fines can result in capping/lamination of tablets

A

false - excess fines

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28
Q

entrapped air can be a cause of tablet capping and lamination

what is a solution to this?

A

decrease the compression speed

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29
Q

define picking

A

the removal of material from the surface of the tablet and its adherence to the punch face

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30
Q

define sticking

A

the adherence of material to the die wall

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31
Q

true or false

sticking is the removal of material from the surface of the tablet and its adherence to the punch face

A

FALSE - THIS IS PICKING

sticking is the adherence of the material to the die wall

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32
Q

true or false

picking and sticking have the same causes and remedies

A

true

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33
Q

name 2 causes of picking and sticking

A

excessive moisture in the granules

not enough lubricant

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34
Q

true or false

picking and sticking can be caused from granules that are too dry

A

false – granules that are too moist

too dry granules can cause capping and lamination

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35
Q

name 5 remedies to picking and sticking

A

clean and polish the tools

add silica gel or talc

use chromium plated punches

decrease the relative humidity in the compression area

use large lettering on the tools

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36
Q

define mottling

A

a tablet defect

unequal or uneven distribution of COLOR on the surface of the tablet

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37
Q

true or false

adding sugar coating could be a solution to mottling

A

true

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38
Q

name 5 causes of mottling of tablets

A

uneven mixing
dye migration during drying
color variation
dye precipitation
dye degrades while it’s drying

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39
Q

name 4 remedies for hardness variation

A

change granule density and porosity

change particle size and size distribution of granules

change compression pressure

change the nature of drug and excipients

40
Q

true or false

to fix poor compression and soft tablets, smaller granules should be used

A

FALSE - larger granules

41
Q

true or false

to fix poor compression and soft tablets, use less lubricant

A

true

use 0.25-0.5%

42
Q

true or false

to fix poor compression and soft tablets, use more fines

A

false - fewer fines

43
Q

true or false

to fix poor compression, soft tablets, lower the bulk density

A

true

44
Q

true or false

to fix poor compression, soft tablets, decrease the granule porosity

A

false - increase

45
Q

can changing the compression press fix poor compression, soft tablets?

A

yes - use precompression

46
Q

give 4 reasons for tablet coating (general)

A

enhance product acceptance and appearance

maintain physical or chemical drug integrity

control the site of drug release

provide controlled, continuous release, or reduce the frequency of dosing

47
Q

name 6 steps of sugar coating tablets

A

waterproofing and sealing

subcoating

smoothing and final rounding

finishing and coloring

imprinting

polishding

48
Q

in subcoating, the 2nd step of sugar coating tablets, what is added on?

A

syrup – this is where the weight comes on

49
Q

what are sugar coated tablets polished with

A

wax

50
Q

name 3 advantages of sugar coated tablets

A

high glossy appearance
elegant
attrative

51
Q

name 7 disadvantages of sugar coated tablets

A

children – candy (sugar)

hard to do - requires skill

takes 3-5 days per batch

high cost for space and equipment

microbial growth and contamination

hygroscopic

increases the tablet weight up to 50%

52
Q

which need to be sealed and why - sugar coating, film coating, or both?

A

sugar coating needs to be sealed bc it’s water soluble

film does not - advantage

53
Q

true or false

film coating and sugar coating are susceptible to microbial contamination

A

false - film coating is not

54
Q

what weight does film coating add to the tablet?

A

only 10-20 micrograms - this is a major advantage

55
Q

explain how the coat used in film coating is an advantage over sugar coating

A

it is noncaloric (sugar isnt’s) and it’s flexible

56
Q

true or false

applying film coating is not as complex as sugar coating

A

true

57
Q

true or false

applying film coating is not easily automated

A

false - it is

58
Q

name 2 disadvantages of film coated tablets

A

cannot hide the tablet appearance (like chipping) that sugar coating CAN hide

the use of solvents needed bc polymers may be water soluble, effect on worker safety and the environment

59
Q

in a nonaqueous film coating solution, name the 4 ingredients that are generally REQUIRED

A

a film former
an alloying substance
a plasticizer
a surfactant

60
Q

in a nonaqueous film coating solution, name 4 ingredients that are generally OPTIONAL

A

opaquants and colorants

sweetners/flavors/aromas

a glossant

a volatile solvent

61
Q

define what a film former is

is it required in film coating solutions?

A

yes it’s required

a film former is capable of producing a smooth, thin film that is reproducible and applicable to a VARIETY of tablet shapes

62
Q

give an example of a film former

A

cellulose acetate phthalate
(CAP)

63
Q

true or false

CAP is pH sensitive

A

TRUE

it’s very popular for enteric coating - won’t dissolve in the stomach

64
Q

what is an alloying substance?

A

it provides water solubility or permeability to the film coating to ensure that it will be penetrated by the body fluids and be therapeutically available

65
Q

true or false

an alloying substance is not required for film coating solutions

A

false - it is

66
Q

give a common example of an alloying substance used in film coating solutions

A

polyethylene glycol

67
Q

what is a glossant?
is it required?

A

function is to provide luster ti the tablets without requiring a whole separate polishing operation

NOT required for film coating solutions - it depends on the need

68
Q

give an example of a popular glossant

A

beeswax

69
Q

what is the function of a plasticizer?
give an example.
is it requird for film coating solutions

A

yes, it’s required

a plasticizer provides durability by producing flexability and elasticity of the coating

ex: castor oil

70
Q

what is the function of a surfactant in film coating solutions?
is it required?
give an example of a popular one

A

a surfactant enhances the spreadability of the film when it is being applied to the tablet

YES required

ex: polyoxyethylene sorbitan derivatives (TWEEN)

71
Q

what is the function of a volatile solvent in film coating solutions?
is it required?
give an example

A

function is to allow the spread of other components over the tablets while allowing rapid evaporation. this gives an effective yet speedy operation

not required - depends on the need

ex: alcohol mixed with acetone

72
Q

what is the function of opaquants/colorants in film coating solutions?

is it required?

give examples

A

not required - optional

to make the appearance of the coated tablets handsome and distinctive

opaquant: titanium dioxide
colorant: FD&C or D&C dyes

73
Q

what is the function of sweeteners/flavors/aromas in film coating solutions?

is it required?

give examples

A

to enhance acceptability of the tab by the pt

not required - optional

sweeteners: saccharin
flavors/aromas: vanillin

74
Q

true or false

vanillin is an example of a sweetner in film coating solutions

A

FALSE – it is flavor/aroma

ex of sweetner would be saccharin

75
Q

normally, how many reagants are used in NONAQUEOUS film coating solutions and how many are actually required?

A

4 are actually required but 7 are normally used out of 8 possible

76
Q

give the ingredients in a typical aqueous film coating formulation

A

film forming polymer
plasticizer
colorant and opacifier
vehicle (water)

77
Q

give 4 examples of film forming polymers commonly used in a typical aqueous film coating formulation

A

CAP

cellulose ether polymers like:
HPMC
HPC
MC

78
Q

in an aqueous film coating formulation, what % of plasticizer is used?

give 5 examples of plasticizers that are commonly used

A

0.5-2% (very small amt)

glycerin
propylene glycol
polyethylene glycol
diethyl phthalate
dibutyl subacetate

79
Q

what % of colorant and opacifier is typically used in an aqueous film coating solution?

give exampkes of what is typcially used

A

2.5%-8%

FD&C or D&C lakes
iron oxide pigments

80
Q

TRUE OR FALSE

phthalates are not pH sensitive

A

FALSE - they are

that’s why CAP is used in enteric coating, and all phthalate groups in general

81
Q

what is the function of enteric coating?

A

to pass through the stomach intact and disintegrate and release the drug content for absorption in the INTESTINES

82
Q

some enteric coatings are designed to dissolve at what pH?

A

4.8 or greater

83
Q

the design of the enteric coating may be based onw hat 2 things?

A

-the transit time required for passage to the intestines - change coating thickness based on this

-based on factors of pH - resist dissolution in highly acidic environment of the stomach

84
Q

how can enteric coating be applied?

A

either to whole compressed tablets OR to drug particles or granules that are used in the making of tablets or capsules

applied in MULTIPLE PORTIONS to build either a thick coating or a thin film coat

85
Q

true or false

the coating system of enteric coating can only be aqueous based

A

FALSE - can be aqueous or organic solvent based, as long as the coating material RESISTS BREAKDOWN IN GASTRIC FLUID

86
Q

name 5 enteric coating agents

A

pharmaceutical shellac
HPMC phthalate
PVA phthalate
diethyl phthalate
CAP

87
Q

true or false

high pH means high acidity

A

false - low pH means high acidity

88
Q

besides tablets and capsules, name 5 other solid dosage forms for oral administration

A

lozenges (troches)

lollipops

pellets

bolus tablets

pills

89
Q

explain what lozenges are.

what is another name for them

A

another name = troches

solid oral dosage forms that dissolve or disintegrate slowly in the mouth. contains 1 or more active drugs that are slowly releeased from the flavored and sweetened base

90
Q

true or false

lozeneges give local action only

A

false - can give systemic too

91
Q

give an example of a lollipop and what it’s used for

A

Fentanyl Actiq (cephalon) - raspberry lollipop

sugar-based lozenge on a stick containing fentanyl citrate
1st product designed to aid breakthrough cancer pain

92
Q

explain what pellets are

A

sometimes called beads - small, solid particles of uniform shape that are nearly spherical

can be administered orally or parenteraly

93
Q

true or false

it is a requirement for pellets to be spherical

A

FALSE - not a requirement, though they usually are nearly spherical

94
Q

what are bolus tablets

A

large (usually elongated) tablets intended to be administered to large animals

95
Q

what are pills

A

small, round solid oral dosage forms containing a medicianl agent to be administered orally

96
Q
A

Pharmaceutics II FINAL (11 decks)

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