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Drug Delivery Exam IV
Packet 2
81
Other
Graduate
04/15/2010

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Term
The purpose of tablet coating is to protect the drug from the environment such as ___/___/___
Definition
air
moisture
light
Term
Coating can help mask unpleasant ___ or ___
Definition
taste
odor
Term
Coating can make it easier to ___
It can aid in product ___
Help to minimize cross contamination due to ___ generated during high-speed packaging operations
Definition
swallow
identify
powder dust
Term
Coating can help improve product ___
Can reduce incompatibility between other ___
Reduces ___ and attrition
Definition
appearance
drugs in the tablet
abrasion
Term
Coating can ___ drug release, such as enteric-coated products
Definition
modify
Term
___ is the most commonly used in the sugar coating process
Definition
sucrose
Term
Sucrose is one of the few materials that produce smooth, high quality coating that is basically ___ and ___-free at the completion of the coating process
Definition
dry
tack-free (sticky-free)
Term
popularity of sugar coating has declined, but it is still used. This is due to the needed skilled manpower and its protracted and ___
Definition
tedious
Term
There are SIX MAIN STEPS
Sealing
Subcoating
Smoothing
___
Polishing
Printing
Definition
color coating
Term
Sealing is to protect the drug and other ingredients from ___ (which is the main constituent of the coating formulation)
Definition
water
Term
Alcoholic solutions (10-30% solids) of resins such as ___, ___, and ___
Definition
shellac
zein
cellulose
Term
More than one ___ may be necessary for effective in sealing of the tablet
Definition
application
Term
SUBCOATING
Sugar coating often results in a ___ increase in weight. This occurs mainly in the subcoating STEP
Definition
50-100%
Term
A ___-based solution is applied to the sealed tablet cores, followed by a dusting powder application which reduces ___ and allows the tablet to build up
Definition
gum
stickiness
Term
In the subcoating process, a solution of ___, ___, and sucrose is mixed
Definition
gelatin
acacia
Term
The dusting powder consists of a mixture of ___, ___, ___, sucrose, and powdered acacia
Definition
calcium carbonate
titanium dioxide
talc
Term
The subcoat is formed from alternate layers of ___ and ___
Definition
gum
powder
Term
In the smoothing process the tablet must be smoothed out before the ___ is applied
Definition
color coating
Term
A solution containing ___ sugar solids and ___ titanium dioxide (which is used as an ___) is applied
Definition
60-70%
1-5%
opacifier
Term
___ is the most crucial step
Definition
color coating
Term
It involves multiple applications of a solution containing 60-70% of ___ and appropriate ___
Definition
sugar solids
colorants
Term
Color materials used in this step are either ___ dyes or ___ pigments
Definition
water-soluble
water-insoluble
Term
The water-soluble dye is dissolved in ___ and applied in small quantities to the tablets
Definition
syrup
Term
The tablets are allowed to ___ before the next application
Definition
dry slowly
Term
As many as ___ individual applications of the colored syrup may be necessary
Definition
60
Term
This process can take up to ___
Definition
25 hours
Term
When pigments are used, they are also dispersed in a ___
Definition
syrup
Term
If the pigment is ___ or combined with an opacifier, the desired color can develop more rapidly resulting in ___ coats that dry more rapidly; thus, shorter processing time
Definition
opaque
thinner
Term
Pigments used are either inorganic pigments (titanium dioxide, iron oxides) or ___
Definition
certified lakes
Term
Polishing: Sugar-coated tablets at this point are very ___, and polishing is needed to enhance elegance
Definition
dull
Term
Mixtures of waxes (___, ___, ___ or hard ___) in a polishing pan are applied to the tablets as powders or as ___ in organic solvents
Definition
beeswax
carnauba wax
candelila wax
paraffin
dispersions
Term
The printing process is for ___ purposes
Definition
identification
Term
Printing can be done before OR after ___
Definition
polishing
Term
The film coating process: A thin film is deposited onto the ___ of the substrate
Definition
surface
Term
This film coating in applicable to a variety of products such as tablets, capsules, ___, ___, and ___
Definition
powders
granules
nonpareils (?what?)
Term
Films are typically applied ___ by spraying the coating liquid onto a moving mass of product
Definition
continuously
Term
The technique was introduced in the 1950s because of the shortcomings of the ___ process was predominantly used
Definition
sugar coating
Term
Advantages of film coating have minimal weight increase (usually ___ of the tablet core weight)
Definition
2-3%
Term
There is a much shorter ___
There is increased process efficiency and ___
there is increased ___ in formulation
Improved resistance to ___ of the coat
Definition
processing time
output
flexibility
chipping
Term
In the early years of film coating, ___ solvents were used to enhance evaporation and decrease processing time
Definition
volatile organic
Term
Due to significant improvements in the equipment technology, ___ coating liquids are used nowadays
Definition
water-based
Term
___ pans and ___ equipment have replaced conventional pans for faster drying
Definition
side-vented
fluid-bed
Term
The materials used in film coating are ___, ___, colorant, and a vehicle
Definition
Polymers
Plasticizers
Term
Each white to white off, oval, film-coated ___ tablet has breaklines and ___ debossed on both faces and contains ___ equivalent to 320mg of gemifloxacin
Definition
factive
GE 320
gemifloxacin mesylate
Term
The inactive ingredients are crospovidone, ___, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and ___
Definition
hydroxypropyl methylcellulose
titanium dioxide
Term
The polymer should be soluble in a variety of solvents and be capable of forming ___ with suitable mechanical properties
Definition
coatings
Term
Another important prerequisite is that the polymer must dissolve in the ___ to allow release of the drug
Definition
GI fluids
Term
___, especially hydroxypropyl methylcellulose are preferred in film coating
Definition
cellulose ethers
Term
Other cellulosic polymers include ___ and ___
Definition
hydroxypropyl cellulose
methylcellulose
Term
Alternatives to cellulose ethers are ___ copolymers and ___ polymers (such as polyvinyl alcohol)
Definition
acrylic
vinyl
Term
The polymers are applied as ___ in water and organic solvents
Definition
solutions
Term
A plasticizer is included in the coating formulation to improve ___ of the film and its adhesion to the substrate
Definition
flexibility
Term
Typical plasticizers include ___, ___ glycol, ___ glycols, ___ esters, or ___ esters
Definition
glycerin
propylene
polyethylene
citrate
phthalate
Term
Colorants are used to to improve appearance and help ___ of the product
Definition
identification
Term
Colorants can be can be ___ dyes (not used in organic solvents), or certified lakes, particularly ___
Definition
water-soluble
aluminum lakes
Term
Typical film-coating formulations contain ___ coating solids in the requisite vehicle (the higher concentration is preferred is the case of aqueous formulations)
Definition
5-20% w/w
Term
___ of the total solids is polymer, ___ is plasticizer, and ___ is pigment
Definition
60-70%
6-7%
20-30%
Term
Enteric coating is a form of delayed release, the coating remains intact in the ___ but it dissolves and its contents are released once the dosage form reaches the ___
Definition
stomach
intestine
Term
This type of dosage form is used when the drug is inactivated by the stomach contents, example ___, ___, ___ or it may cause nausea or bleeding by irritating the gastric mucosa, such as ___/___
Definition
pancreatin
erythromycin
proton pump inhibitors
aspirin
steroids
Term
One variation of enteric coating is to make a product with a ___ effect
Definition
repeat-action
Term
An additional amount of drug is applied over the ___
Definition
enteric coat
Term
It is released in the ___ and the remainder is released in the intestine
Definition
stomach
Term
Most currently used enteric coatings are ___ because they are undissociated in the stomach, but readily ionize when pH is above ___ (___)
Definition
weak acids
5 (intestine soluble)
Term
Polymers used include ___, ___, and ___
Definition
-PHTHALATES
*such as cellulose acetate pht, polyvinyl acetate pht
-carboxymethyl ethylcellulose
-acrylic copolymers
Term
Sustained-release coatings control the release of the drug from the dosage unit in such that it is made available to the body over a ___, the release is sustained
Definition
prolonged period of time
Term
Materials for sustained release are ___ such as waxes with fatty acids, fatty alcohols, and monoglycerides. Also made of ___ and ___
Definition
fats
shellacin
ze
Term
___ provides a membrane around the tablet that remains intact throughout the GIT
Definition
ethylcellulose
Term
___ behave similarly to ethylcellulose
Definition
acrylic polymers
Term
Like enteric coatings, many of the synthetic polymers are commercially available as aqueous dispersions called ___ or ___
Definition
latexes
pseudolatexes
Term
What is being coated to have a sustained-release effect?
Dried ___
Drug loaded ___
Drug ___
Drug ion-exchange resin complexes
Tablets
Definition
granules
beads (AKA nonpareils)
crystals
Term
The coated particles in the first four cases above can either be filled into a two-piece hard ___ or ___ into tablets
Definition
gelatin capsules
compressed
Term
Another variation of sustained release coating is exhibited by coated tablets in which the film is pierced with a ___ to create a delivery orifice
Definition
laser
Term
The osmotic pressure created by the influx of water across the semi-permeable membrane pumps the drug through the orifice; known as an ___
Definition
osmotic pump
Term
The coating fluid is ladled onto a bed of tablets in a rotating ___
Definition
coating pan
Term
The tablets are stirred ___ to facilitate the dispersion of the liquid throughout the batch
Definition
by hand
Term
The tablet bed is then dried by ___
Definition
blowing air
Term
The pan is also fitted with an exhaust to allow ___ and ___ to be removed
Definition
moisture
dust
Term
These consecutive cycles of liquid application, stirring, and drying are repeated ___
Definition
as many times as needed
Term
The polishing step is performed in a ___ pan
Definition
cloth-lined
Term
Film coating of sustained release; The coating liquid is sprayed in the form of ___ over the moving tablet mass in the coating pan in a manner that ensures uniform coverage of the surface of the tablets
Definition
finely atomized droplets
Term
IMPORTANT DIAGRAMS on last pg (41)
skipped the last page
ITS crazy
Definition
BLA
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