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