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23 Cards in this Set
- Front
- Back
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What BP quality control tests are in place for tablets? |
-Uniformity of weight -Uniformity of content -Disintegration test -Dissolution test -Resistance to crushing of tablets (compression) -Friability |
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How much from the mean can one tablet deviate during uniformity of weight testing for tablets weighing >250mg? |
Up to 10% from the mean (2 can deviate by 5%) |
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How many tablets are allowed to deviate from the average weight in uniformity of weight testing? |
No more than two
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How much from the mean can one tablet deviate during uniformity of weight testing for tablets weighing 80-250mg? |
15% (2 can deviate by 7.5%) |
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How much from the mean can one tablet deviate during uniformity of weight testing for tablets weighing <80mg? |
20% (2 can deviate by 10%) |
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What percentage weight range must all tablets fall in during uniformity of content testing? |
85-115% (One is allowed out of this range, but must be in the 75-125% range to pass) |
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What is the definition of the disintegration of tablets? |
The physical dosage form will degarde and, in the case of a tablet, break into smaller parts |
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What is the definition of the dissolution of tablets? |
The act of material passing into solution- the solid drug dissolving in the dissolution media |
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How many tablets are tested during disintegration testing? |
18, done as 3 tests of 6 tablets |
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What temperature should disintegration tests be carried out at? |
37oC |
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What conditions should uncoated and coated tablets be disintegration tested in? |
Water |
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What conditions should enteric-coated tablets be disintegrated tested in? |
0.1M HCl. pH 6.8 phosphate buffer if no disintegration occurs |
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What conditions should effervescent tablets be disintegration tested in? |
200mL water at 20 degrees Celcius |
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What conditions should soluble tablets be disintegration tested in? |
Water at 20 degrees Celcius |
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What conditions should dispersible tablets be disintegration tested in? |
100mL water at 20 degrees C, stir until completely dispersed. |
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When can you tell that a smooth dispersion has been produced? |
When the dispersion mixture passes through a 710micrometre sieve. (screen 22) |
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What are the steps for dissolution testing? |
-Place 3-6 tablets into dissolution vessel of 900mL water (at 36.5-37.5 degrees C) -Set paddles rotating -Withdraw samples at 45 minutes -Determine amount of AI in sample. Pass if >70% had dissolved by 45mins. -Fail> test 6 more tablets- all 6 must pass to pass overall |
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What is the definition of crushing strength? |
The minimum diametric compressional force which fractures a tablet |
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What is the equation for tensile strength? |
Where sigma= tensile strength 9N/m^2) P= crushing strength (N) D= diameter (m) H= tablet thickness (m) |
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What are the steps for measuring crushing strength? |
-Select 10 tablets at random and place in instrument -Apply pressure and measure the force at which the tablets break -Express results in Newtons -Calculate tensile strength of each tablet, and the mean standard deviations (+/-) |
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What is the percentage friability defined as? |
The percentage of weight loss resulting from chipping, abrasion, and erosion of the tablets under stress conditions. |
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What are the steps for friability testing? |
1. If a single tablet weighs < 0.65 g, select 20 tablets at random. If a single tablet weighs > 0.65 g, select 10 tablets at random.2. Tablets are de-dusted, weighed [W0], placed in a drum and rotated 100 times.3. After de-dusting they are reweighed [W].4. PASS if <1% friability (<0.1% is a realistic goal in development). If >1%,repeat twice. The mean weight loss of all three must be <1% to PASS. |
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What is the equation for Friability, F? |
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