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Dissolution Test (1)

The document outlines the dissolution test, an in-vitro method to measure the time for a drug in a tablet to dissolve under specific conditions, which is essential for characterizing drug bioavailability. It details various dissolution apparatuses, media, and criteria for testing, including requirements for enteric-coated drugs and examples of test results. Additionally, it provides a formula for calculating the amount per tablet and the labeled claim percentage, along with a decision-making process based on test outcomes.

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Irene Trinidad
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3 views

Dissolution Test (1)

The document outlines the dissolution test, an in-vitro method to measure the time for a drug in a tablet to dissolve under specific conditions, which is essential for characterizing drug bioavailability. It details various dissolution apparatuses, media, and criteria for testing, including requirements for enteric-coated drugs and examples of test results. Additionally, it provides a formula for calculating the amount per tablet and the labeled claim percentage, along with a decision-making process based on test outcomes.

Uploaded by

Irene Trinidad
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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4.

DISSOLUTION TEST
An in-vitro test that measures the
amount of time required for a given
percentage of the drug substance in a
tablet to go into solution under
specified set of conditions.
DISSOLUTION TESTING

A requirement for characterizing the


bioavailability profile of a drug.

USP Specs: At least 80% of the drug


should be absorbed in its specified
dissolution media, for the specified
period of time (as stated in the
monograph).
DISSOLUTION APPARATUS
Apparatus # Name Applications

1 Rotating Basket Floating dosage forms

2 Rotating Paddle Non-floating dosage forms

3 Reciprocating cylinder Product development of MR products

4 Flow-through cell ER products, suppositories, pellets,


ointments, suspensions
5 Paddle over disk Small transdermal patches, NMT 90mm

6 Rotating Cylinder Big transdermal patches

7 Reciprocating Holder Small-volume option for transdermal


patches
8 Vertical Diffusion Cell Ointments, creams
DISSOLUTION MEDIA

• Distilled water
• Simulated gastric fluid TS
• Simulated intestinal fluid TS
DEGASSING / DEAERATION OF
DISSOLUTION MEDIA

A requirement to remove all dissolved


gases (which may interfere with the test
results). Methods are:

1. heating media to 45 C, followed by


membrane filtration (0.45 um filter)

2. Sonication

3. Helium sparging
CHOICE OF DISSOLUTION
MEDIA
The usual is carbon-dioxide free Distilled
Water ( previously deaerated / degassed).

For enteric-coated drugs, it requires 3 -


media changes;

1. Distilled water -for 5 minutes

2. Simulated gastric fluid - for 1 or 2 hours

3. Simulated intestinal fluid - for 1 hour


CRITERIA
Stages Samples Requirement

1 6 Each unit is NLT Q + 5%

2 6 Average of 12 units  Q,
No units is < Q -15%
3 12 Average of 24 units is  Q,
NMT 2 units are < Q – 15%,
No unit is < Q – 25%
EXAMPLE
Dissolution Test of Sample Abs Actual
Paracetamol 325 mg # weight
Tablets
Test solution: 1 0.178 505
Gastric fluid TS 2 0.275 500
Average weight of tablet 3 0.350 501
= 500mg
Tolerance (Q) = 90% 4 0.165 502
Concentration of 5 0.285 500
standard = 0.3 mg
Dilution factor = 2500 6 0.365 498
Standard 0.436
FORMULA
Amount/tab = Au/As x Cs x DF x average weight
Weight of tablet

% LC = Amount per tab x 100%


Labeled claim
QUESTIONS
Compute for the individual
amount per tablet.
Compute for the individual %
labeled claim.
What is the disposition?
SOLUTION/ANSWER
Sample # Abs Actual Amount % LC
weight Per tab
1 0.178 505 303 93
2 0.275 500 473 146
3 0.350 501 601 185
4 0.165 502 283 87
5 0.285 500 490 151
6 0.365 498 630 194
Standard 0.436
SOLUTION/ANSWER

Decision
• Based on S1, each unit should be
NLT Q + 5% which is 90% + 5% =
95%
• Two tablets failed to conform to the
requirement, so the decision is to
proceed to stage 2.

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