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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
true or false friability is related to capping and lamination
false - not related
26
what is the optimum moisture for granules? what happens if the granules are too dry?
optimum moisture is 4-6% if too dry, capping/lamination can occur
27
true or false lack of fines can result in capping/lamination of tablets
false - excess fines
28
entrapped air can be a cause of tablet capping and lamination what is a solution to this?
decrease the compression speed
29
define picking
the removal of material from the surface of the tablet and its adherence to the punch face
30
define sticking
the adherence of material to the die wall
31
true or false sticking is the removal of material from the surface of the tablet and its adherence to the punch face
FALSE - THIS IS PICKING sticking is the adherence of the material to the die wall
32
true or false picking and sticking have the same causes and remedies
true
33
name 2 causes of picking and sticking
excessive moisture in the granules not enough lubricant
34
true or false picking and sticking can be caused from granules that are too dry
false -- granules that are too moist too dry granules can cause capping and lamination
35
name 5 remedies to picking and sticking
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
36
define mottling
a tablet defect unequal or uneven distribution of COLOR on the surface of the tablet
37
true or false adding sugar coating could be a solution to mottling
true
38
name 5 causes of mottling of tablets
uneven mixing dye migration during drying color variation dye precipitation dye degrades while it's drying
39
name 4 remedies for hardness variation
change granule density and porosity change particle size and size distribution of granules change compression pressure change the nature of drug and excipients
40
true or false to fix poor compression and soft tablets, smaller granules should be used
FALSE - larger granules
41
true or false to fix poor compression and soft tablets, use less lubricant
true use 0.25-0.5%
42
true or false to fix poor compression and soft tablets, use more fines
false - fewer fines
43
true or false to fix poor compression, soft tablets, lower the bulk density
true
44
true or false to fix poor compression, soft tablets, decrease the granule porosity
false - increase
45
can changing the compression press fix poor compression, soft tablets?
yes - use precompression
46
give 4 reasons for tablet coating (general)
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
name 6 steps of sugar coating tablets
waterproofing and sealing subcoating smoothing and final rounding finishing and coloring imprinting polishding
48
in subcoating, the 2nd step of sugar coating tablets, what is added on?
syrup -- this is where the weight comes on
49
what are sugar coated tablets polished with
wax
50
name 3 advantages of sugar coated tablets
high glossy appearance elegant attrative
51
name 7 disadvantages of sugar coated tablets
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
which need to be sealed and why - sugar coating, film coating, or both?
sugar coating needs to be sealed bc it's water soluble film does not - advantage
53
true or false film coating and sugar coating are susceptible to microbial contamination
false - film coating is not
54
what weight does film coating add to the tablet?
only 10-20 micrograms - this is a major advantage
55
explain how the coat used in film coating is an advantage over sugar coating
it is noncaloric (sugar isnt's) and it's flexible
56
true or false applying film coating is not as complex as sugar coating
true
57
true or false applying film coating is not easily automated
false - it is
58
name 2 disadvantages of film coated tablets
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
in a nonaqueous film coating solution, name the 4 ingredients that are generally REQUIRED
a film former an alloying substance a plasticizer a surfactant
60
in a nonaqueous film coating solution, name 4 ingredients that are generally OPTIONAL
opaquants and colorants sweetners/flavors/aromas a glossant a volatile solvent
61
define what a film former is is it required in film coating solutions?
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
give an example of a film former
cellulose acetate phthalate (CAP)
63
true or false CAP is pH sensitive
TRUE it's very popular for enteric coating - won't dissolve in the stomach
64
what is an alloying substance?
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
true or false an alloying substance is not required for film coating solutions
false - it is
66
give a common example of an alloying substance used in film coating solutions
polyethylene glycol
67
what is a glossant? is it required?
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
give an example of a popular glossant
beeswax
69
what is the function of a plasticizer? give an example. is it requird for film coating solutions
yes, it's required a plasticizer provides durability by producing flexability and elasticity of the coating ex: castor oil
70
what is the function of a surfactant in film coating solutions? is it required? give an example of a popular one
a surfactant enhances the spreadability of the film when it is being applied to the tablet YES required ex: polyoxyethylene sorbitan derivatives (TWEEN)
71
what is the function of a volatile solvent in film coating solutions? is it required? give an example
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
what is the function of opaquants/colorants in film coating solutions? is it required? give examples
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
what is the function of sweeteners/flavors/aromas in film coating solutions? is it required? give examples
to enhance acceptability of the tab by the pt not required - optional sweeteners: saccharin flavors/aromas: vanillin
74
true or false vanillin is an example of a sweetner in film coating solutions
FALSE -- it is flavor/aroma ex of sweetner would be saccharin
75
normally, how many reagants are used in NONAQUEOUS film coating solutions and how many are actually required?
4 are actually required but 7 are normally used out of 8 possible
76
give the ingredients in a typical aqueous film coating formulation
film forming polymer plasticizer colorant and opacifier vehicle (water)
77
give 4 examples of film forming polymers commonly used in a typical aqueous film coating formulation
CAP cellulose ether polymers like: HPMC HPC MC
78
in an aqueous film coating formulation, what % of plasticizer is used? give 5 examples of plasticizers that are commonly used
0.5-2% (very small amt) glycerin propylene glycol polyethylene glycol diethyl phthalate dibutyl subacetate
79
what % of colorant and opacifier is typically used in an aqueous film coating solution? give exampkes of what is typcially used
2.5%-8% FD&C or D&C lakes iron oxide pigments
80
TRUE OR FALSE phthalates are not pH sensitive
FALSE - they are that's why CAP is used in enteric coating, and all phthalate groups in general
81
what is the function of enteric coating?
to pass through the stomach intact and disintegrate and release the drug content for absorption in the INTESTINES
82
some enteric coatings are designed to dissolve at what pH?
4.8 or greater
83
the design of the enteric coating may be based onw hat 2 things?
-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
how can enteric coating be applied?
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
true or false the coating system of enteric coating can only be aqueous based
FALSE - can be aqueous or organic solvent based, as long as the coating material RESISTS BREAKDOWN IN GASTRIC FLUID
86
name 5 enteric coating agents
pharmaceutical shellac HPMC phthalate PVA phthalate diethyl phthalate CAP
87
true or false high pH means high acidity
false - low pH means high acidity
88
besides tablets and capsules, name 5 other solid dosage forms for oral administration
lozenges (troches) lollipops pellets bolus tablets pills
89
explain what lozenges are. what is another name for them
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
true or false lozeneges give local action only
false - can give systemic too
91
give an example of a lollipop and what it's used for
Fentanyl Actiq (cephalon) - raspberry lollipop sugar-based lozenge on a stick containing fentanyl citrate 1st product designed to aid breakthrough cancer pain
92
explain what pellets are
sometimes called beads - small, solid particles of uniform shape that are nearly spherical can be administered orally or parenteraly
93
true or false it is a requirement for pellets to be spherical
FALSE - not a requirement, though they usually are nearly spherical
94
what are bolus tablets
large (usually elongated) tablets intended to be administered to large animals
95
what are pills
small, round solid oral dosage forms containing a medicianl agent to be administered orally
96

Pharmaceutics II FINAL (11 decks)

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