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83 Cards in this Set

  • Front
  • Back
What are tablets
solid preparations that contain a single dose of one or more active ingredients and is usually obtained by compressing uniform volume of particles
Excipients used in tablet making
⚫diluents
⚫binders
⚫glidants
⚫lubricants
⚫disintegrants
⚫sweetener
⚫pigments
Why is a coating applied to tablets
for easy swallowing, to control the release rate & improve stability, or to enhance appearance
Advantages of tablet dosage form
⚫stability
⚫accuracy of dosage
⚫portability which improve compliance with dosage schedule
⚫ease of shipping & transportation
⚫mass produced simply and quickly at relatively lower cost than most other dosage forms
Disadvantage of tablet dosage form
bioavailability of poorly water soluble drugs. such drugs may need to be given in very high doses or by injection
What are the processes of tableting
⚫die filling
⚫tablet formation
⚫tablet ejection
How are tablets manufactured
by powder compression
What is powder compression
the reduction in volume of a powder due to an applied force
What is compaction
the formation of a solid with defined geometry by the process of compression
Tablet presses commonly used in tableting
single-punch & rotary press
Tablet press used for small batches of tablets
single-punch press
Tablet press used for large scale manufacturing
rotary press
What are added to improve the compressibility for drug substances that are not suitable for compression in the simple form
excipients
What are the two properties of compressibility
⚫powder fluidity
⚫powder compressibility
Popular method for improving material compressibility
granulation
Quality attributes of tablets
⚫should include the correct dose of the drug
⚫should have elegant appearance, with consistent weight and size
⚫drug release from tablet should be controlled and reproducible
⚫tablet should be biocompatible
⚫mechanical strength should be sufficient to withstand fracture and erosion during handling
⚫should maintain physical, chemical and microbial activity throughout shelf life
⚫acceptable to patient
⚫packaging should be safe
Two methods of commercially manufacturing tablets
⚫Direct compression
⚫Granulation
Describe direct compression
powder mass is blended, the blend is then compressed to a finished product
Common excipients used in direct compression
anhydrous lactose, dicalcium phosphate, microcrystalline cellulose (avicel), starch, compressible sugar
What is granulation
this is the process by which powdered particles are made to adhere to each other in order to form larger particles known as granules
Types of granulation
wet & dry granulation
Range of size of granules for tablets and capsules
0.2-0.5mm
Another name for divided granules
effervescent granules
Another term for dry granulation
slugging
Describe the process of dry granulation
⚫slugging: the ingredients in the formulation are intimately mixed and precompressed on heavy duty tablet machines to form slugs
⚫roller compaction: the powdered ingredients may also be squeezed between two rollers to produce a sheet of material
the product formed is then broken up using a suitable mill to produce granular material that is sources to produce the desired size
What two process may be employed in dry granulation
slugging and roller compaction
When is dry granulation suitably used
for drugs that are sensitive to moisture and heat
Which method of granulation of more time consuming
wet granulation
Describe wet granulation
a liquid binder is added to the powder mass then screened to a suitable size and dried to form granules, which are then compressed
What characteristics should the granulation fluid used in wet granulation have
they should be volatile and easily removed by drying
Examples of granulating fluid used in wet granulation
water, ethanol, and isopropanol either alone or in combination
The most important technical problems during tableting
⚫high weight and dose variation of the tablets
⚫low mechanical strength of the tablets
⚫capping and lamination of the tablets
⚫sticking of powder material to punch tips
⚫high friction during tablet ejection
Ideal features of a filler
⚫chemically inert
⚫non-hydroscopic
⚫biocompatible
⚫possess good biopharmaceutical properties
⚫acceptable taste
⚫cheap
⚫possess good technical properties such as compatibility and dilution capacity
Fillers
added to raise the bulk size of the tablet and make it easy to handle
Examples of fillers
lacrosse, mannitol, microcrystalline cellulose (Avicel®)
Disintegrant
ensures that the tablet breaks up in small fragments when it comes in contact with a liquid
Two steps of the disintegration process
⚫liquid wets solid and penetrates pores of tablet
⚫tablet breaks up into smaller fragments
Two classifications of disintegrants
⚫disintegrants that facilitate water uptake
⚫disintegrants that rupture the tablet
Traditional Disintegrant
starch
Other examples of disintegrants
microcrystalline cellulose (MCC), hydroxypropyl methylcelluose (HPMC)
Binders
ensure granules are formed with the required mechanical strength. they improve flowability and compressibility of powders
Examples of binders
starch, acacia, methylcellulose
Glidant
improves flowability of the powder
Example of glidant
talc, colloidal silica
Lubricant
used to ensure that tablet formation and ejection can occur with low friction between the solid and the die wall
Most widely used lubricant
magnesium stearate
Antiadherent
used to reduce adhesion between powder and the punch faces preventing sticking to the punches
Examples of Antiadherent
talc, starch
Sorbent
functions by sorbing quantities of fluids in an apparently dry state
Examples of sorbing substances
microcrystalline cellulose, silica
Flavors
give pleasant taste or mask impeccant ones
Examples of flavors
strawberry tincture, vanillin
Colorant
aids in identification of the formulation and patient compliance
How is coloring accomplished
during coating or added in formulation prior to compaction
Types of tablets
⚫disintegrating
⚫chewable
⚫effervescent
⚫sublingual
⚫buccal
Visual defects of tablets occur as a result of
⚫tableting process
⚫excipient
⚫machine
Visual defects related to tablet processing
⚫capping
⚫lamination
⚫cracking
Capping
partial or complete separation of the top or bottom of tablet due to air-entrapment in the granular material
Lamination
separation of a tablet into two or more layers due to air-entrapment in the granular material
Cracking
due to rapid expansion of tablets when deep concave punches are used
Visual defects related to excipients
⚫chipping
⚫sticking
⚫picking
⚫binding
Visual defects related to machine
double impression
Other related factors of visual defects to tablets
mottling: unequal distribution of color on a tablet
Tablet tests not found in the pharmacopeia
noon-compendial methods
Tests used in evaluating quality of tablet dosage form
⚫uniformity of content of active ingredient
⚫disintegration
⚫dissolution
⚫mechanical strength
⚫attrition resistance method
⚫fracture resistance methods
Uniformity of content of active ingredients
Disintegration
Dissolution
Mechanical Strength
Attrition resistance methods
Fracture resistance methods
What is coating
the process by which a dry outer layer of coating material is applied to the surface of a dosage form for varying benefits
Reasons for coating
⚫making taste of unpleasant drugs
⚫allow easy swallowing of large tablets
⚫improve product stability
⚫improve product appearance
⚫facilitate rapid identification of product by manufacturer, dispensing pharmacist and patient
⚫allow for easy handling during high-speed automatic filling and packaging
⚫allows for modified release characteristics to be imparted to the tablet
Types of coating processes
⚫film coating
⚫sugar coating
⚫compression coating
Film coating is often applied using what method
spraying method
Coating of choice for most newly launched products
film coating
Film coating may be designed as either
immediate-release film coating, modified-release film coating
'Non-functional' coating
immediate-release film coating
'Functional' coating
modified-release film coating
Also called enteric coating
modified-release film coating
Typical ingredients used in film coating
⚫polymers e.g. hydroxypropyl methylcellulose (HPMC)
⚫plasticizer e.g. polyethylene glycol
⚫colorants e.g. iron oxide, titanium dioxide
⚫solvent/vehicle e.g. organic solvents such as ethanol
Disadvantage of sugar coating
time and expertise required in coating process
Five separate operations of sugar coating
⚫sealing/ waterproofing
⚫subcoating
⚫grossing/smoothing
⚫coloring
⚫polishing