Tablets Part 2 Flashcards by amanda kastel

what is another name for molded tablets

tablet triturates

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how are tablet triturates prepared? what is another name for them?

another name = molded tablets

prepared by molding rather than compression – minimum compression force

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molded tablets are usually ___ that contain ____

small, cylindrical tablets that usually contain potent drugs

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molded tablets/tablet triturates are designed to be….

readily and completely soluble in water

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what kind of excipients are AVOIDED in the preparation of molded tablets/tablet triturates?

any water insoluble excipient

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________ tablets are designed to disintegrate and release their medication with no special rate controlling features such as special coatings and other techniques

immediate release

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rapdily disintegration or dissolving tablets disintegrate or dissolve in the mouth when?

within 1 minute, and some are within 10 seconds

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what are the excipients used in rapidly disintegrating or dissolving tablets and why?

very water soluble excipients because they wick (absorb) water into the tablet for rapid disintegration or dissolution

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name 2 techniques used to prepare rapidly disintegrating or dissolving tablets

lypophilization or soft direct compression

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name 2 products that use the lyophilization method of preparing rapidly disintegrating or dissolving tablets

zydis and claritin

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name 2 tablets that use the soft direct compression method of preparing rapidly disintegrating or dissolving tablets

Dimetapp ND
Tempra Quicklets

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which technique of preparing rapdily disintegrating or dissolving tablets is “freeze drying” to increase porosity and allow for it to quickly dissolve

lyophilization

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true or false

the saliva from rapidly disintegrating or dissolving tablets can be swallowed

TRUE – it can. the dose is designed to go through the stomach

however, buccal and sublingual saliva should NOT be swallowed

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true or false

compressed tablets must be elegant in appearance

TRUE

if not, we have to apply sugar or film coating

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compressed tablets must be bioavailable.
this involves the tablet doing what?

undergoing disintegration and dissolution

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compressed tablets must have uniformity in what 3 things?

weight
thickness
drug contents

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true or false

it is not necessary for compressed tablets to be sufficiently strong to withstand pressures

false - it is

due to manufacturing, packaging, and shipping etc

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compressed tablets must retain all functional attributes throughout…..

this involves the drug’s ___ and ___

its shelf life

stability and efficacy

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the diameter and shape of compressed tablets depends on what?

the die and the punches used in compression

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the MORE CONCAVE the punches, the ____ convex the compressed tablet

more convex

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name 6 quality standards and compendial requirements for tablets

which of these are required for capsuels?

tablet weight and USP weight variation test
content uniformity
tablet thickness
tablet hardness and friability
tablet disintegration
tablet dissolution

only USP weight variation test and content uniformity is required for capsules

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true or false

the USP weight variation test is related to the amount of API contained in the tablet

FALSE – related to the total weight of the tablet

the content uniformity test is related to the amount of API

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explain how to perform tablet weight variation

if tablets are coated, weight 20 tablets individually (if uncoated, weight 10 tablets individuallt)

determine the average weight of the tablets

each INDIVIDUAL tablet should be within 10% of labeled claim. if greater than 10%, must be rejected

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tablet weight variation:

for the determination of dosage form uniformity by weight variation, select not _______ tablets

not less than 30 tablets

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true or false in tablet weight variation, 10 tablets should be weighted individually if they are coated

false -- 10 if uncoated 20 if coated

in the content uniformity test, how many tablets are sampled and how many are assayed?

30 tablets are sampled and 10 are assayed

in the 10 tablets assayed in the content uniformity test, explain the requirements in order to be accepted

the average content of each tablet should be within 85%-115% of the average potency (plus minus 15%) NONE should be outside of 75%-125% if any show potency OUTSIDE OF 85%-115%, assay 20 more tablets to pass this: -net content of all tablets within 75%-125% -and the net content of only 1 tablet can be outside 85-115% if there are more than 2 outside of the 15% range, reject whole batch

explain the tablet thickness test and requirements

the thickness and diameter of 20 tablets is measured for thickness, variation can't be more than 10% for diameter, variation can't be more than 2%

true or false the tablet thickness test measures both thickness and diameter

true

in the tablet thickness requirements, the diameter must be within 10% and the thickness must be within 2%. 20 tablets are measured TRUE OR FALSE

false 20 tablets are measures average variability: diameter must be within 2% thickness must be within 10%

in measuring tablet hardness, what is the normal minimum quantity of force to be applied? what is this test called?

about 4kg force applied and tablet does not break stress test

name the 2 tests for tablet hardness

stress test - force of 4kg is applied and tablet should not break friability (easily crumbled or broken) test - measures the tablet's durability. weight loss must be less than 1%. 20 rotations per minute (rpm) is applied

true or false the stress test in which 4kg is applied dto the tablet's is a measure of the tablet's friability

FALSE - measure of the tablet's hardness friability test is when it undergoes 20rpm and less than 1% of the weight can be lost to be accepted

why must a tablet be able to disintegrate?

for the medicinal agent in the tablet to be fully available for absorption, it must fully disintegrate and release the drug to the body fluids to then undergo DISSOLUTION if the site of action is the GI tract, the tablet must disintegrate in order to increase the surface area for activity within the GI tract

the tablet disintegration test determines what?

the disintegration time of 12 tablets 6 used for every test -- so 2 tests are done for a total of 12 tabs

in the tablet disintegration test, state the amount of time allowed for the full disintegration of these tablets: uncoated coated buccal sublingal enteric coated

uncoated: no more than 15-30 minutes (30 minutes = compressed tabs) coated - up to 2 hours buccal - all tablets within 4 hours sublingual - 30 seconds - 3 minutes MAX (1 min is goal) enteric coated - stimulates gastric fluid (WATER NOT USED) for 1 hour -- NO cracking or disintegration or anything can be observed after this 1 hour

time used for disintegration test for buccal tablets

all tablets must disintegrate within 4 hours

time required for disintegration test for most uncoated tablets. what is time for compressed tablets?

most uncoated tablets = 15-30 minutes for compressed - more like 30 mins

time required for disintegration test for coated tablets

up to 2 hours

what is the mesh used in the tablet disintegration test? how many cycles per minute? which fluid is used?

10 mesh 30 cycles/min water is used for all tablets EXCEPT enteric coated for enteric coated, a fluid with a pH of 1 is used to represent the stomach. NO disintegration of cracking or softening can be seen after the 1 hours (bc the whole point of enteric coating is for it not to be absorbed in the stomach, but in the small intestine)

what is the rate limiting step for WATER SOLUBLE tablets to provide therapeutic effect?

tablet disintegration dissolution is not a problem for a water soluble drug

an indicator of the bioavailability of the drug from the solid dosage form is......

tablet dissolution

what is tablet dissolution?

an indicator of the bioavailability of the drug from the solid dosage form

true or false for a water insoluble drug, disintegration is the rate determining step

FALSE - DISSOLUTION

what is the criteria for a drug to be water soluble

solubility is greater than 10mg/mL at room temp

what is the criteria for a drug to be water insoluble

solubility is less than 1mg/mL

water soluble drug: solubility greater than 10mg/mL water insoluble drug: solubility less than 1mg/mL what about drugs whos solubility is between 1mg/mL - 10mg/mL?? what is the rate limiting step?

both disintegration AND dissolution are important for these drugs

is there an issue? solubility of drug: 20mg/mL dose: 50mg

yes there is a solubility issue.

what does IVIVC stand for what is it related to?

in vivo in vitro correlation related to tablet dissolution tests

what is the approximate amount of fluids that should be taken with a drug

250mL

name 3 methods of the manufacture of compressed tablets

wet granulation method dry granulation method direct compression tableting

name 3 common steps for the manufacture of compressed tablets

grinding the drug or powder blending the powders adding the lubricant

what is granulation?

process in which a powder mixture is converted to free flowing particles

name 3 benefits of performing granulation

you can get: -desired size/distribution -desired granule shape -desired granule hardness and density

what is one of the most demanding processes in tablet preparation?

granulation

what is another word for dry granulation?

slugging

which method of manufacturing compressed tablets is generally used first?

wet granulation

true or false there is NO granulation involved in the direct compression method of manufacturing compressed tablets

true

in dry granulation, a tablet mixture is prepared without....

a wet binder or moisture (liquid)

in which method of preparing compressed tablets is a slug formed and then compressed?

in dry granulation/slugging

why is DIRECT COMPRESSION becoming a more desired method of manufacturing compressed tablets?

because of the availability of the excipients needed in this method

what is the most widely used and most general method of tablet preparation?

wet granulation

what is the most expensive method of preparing compressed tablets?

wet granulation

name 2 advantages of the wet granulation method

most reliable method has the highest probability of meeting the requirements to make a successful tablet

name 4 disadvantages of wet granulation

-labor intensive -time consuming -CANNOT be used for water sensitive drugs -a uniform granulation needs to be prepared

for wet granulation, the drug cannot be....

MOISTURE SENSITIVE

"the granulation will meet all the physical requirements for the compression of good tablets"

wet granulation

in wet granulation, how many times is the preparation screened? explain

screened twice 1st time - after damp mass is prepared. no 6 or 8 mesh screen after drying -- screened again 12-20 mesh size (SMALLER)

Name 4 uses of lubricant in tablet preparation

improves flow from the hopper to the die prevents adhesion to punches and dies during compression gives sheen to the finished tablet reduces friction between tablet and die wall during ejection

in wet granulation, how is the granulation dried?

by thermostatically controlled ovens that constantly record the time temp and humidty