If you are looking for a job in the quality control or quality assurance department of pharmaceutical industries then you must have complete knowledge about different types of questions related to disintegration tests and basket rack assembly.
The preparation for disintegration related questions is very important because it is the most commonly and frequently performed test for oral solid dosage forms.
What is Disintegration?
The breakdown of solid dosage forms into small fragments is known as disintegration.
What is Disintegration time?
The time required for tablets or capsules to break down into small fragments is known as disintegration time.
What is a Disintegration Test?
Disintegration test is a physical test which is performed to check how much time is required for tablets or capsules to break down into small fragments which pass through sieve number 10 and no hard mass is left behind.
Which chapter of USP deals with Disintegration?
The chapter number… of USP describes the disintegration test.
For which dosage forms do we perform disintegrant tests?
We perform disintegration test for tablets, capsules and suppositories.
Name of disintegration test apparatus?
Most of the people working in pharmaceutical industries call it only disintegration apparatus but the technical term used to describe this apparatus is basket rack assembly.
Components of basket rack assembly?
A basket rack assembly has following components
- Basket
- Glass tubes
- SS wire mesh
- Disks
- Moving Shaft
- Glass beaker
- Water reservoir
- Water circulation pump
- Temperature sensor prob
- HMI
Types of basket rack assembly?
There are 2 types of basket rack assembly.One is type A apparatus and other one is type B apparatus.
Difference between type A & type B Apparatus?
Type A apparatus has 6 glass tubes and type B apparatus has 3 glass tubes.Type B apparatus is used for large tablets.The most commonly used apparatus in pharma is type A apparatus.
What is the length of glass tubes?
Each glass tube which is attached to the basket has a length of 75 to 80 mm.
Size of Wire mesh attached to the lower side of the basket?
A 10 number mesh is attached to the lower side of the bracket or it can be 2 ±0.2 mm, meaning 1.8 mm to 2.2 mm.
How many disks are used in basket rack assembly.
One disk is used for each glass tube so total 6 disks are used for type A basket rack assembly.
Why do we use disks in basket rack assembly?
Disks are used during disintegration test to prevent floating of dosage forms during disintegration test.
Glass beaker Specifications?
A low form beaker of 1000 ml capacity is used having 138 to 160 mm height.
Frequency of upward and downward stroke?
The basket moves up & down at the frequency of 29 to 30 strokes in a minute.
Number of holes in disk?
5 equally spaced holes are present in each disk in the basket rack assembly.
Number of tablets used for the Disintegration Test?
6 tablets are used to perform disintegration tests.
Acceptance criteria of disintegration test?
The disintegration test is performed with 6 tablets and the test is passed if all 6 tablets disintegrate in a specified time period.If one or 2 tablets do not disintegrate within time specified in monograph then repeat the test with additional 12 tablets.The test will be passed if 16 tablets out 18 disintegrate within specified time limits.
What is L1 and L2 in Disintegration?
The first stage of Disintegration where we take 6 tablets is known as L1 and the second stage of disintegration where we take further 12 tablets (if initial 6 tablets fail to disintegrate) is known as L2.
Temperature of medium during Disintegration?
The temperature of the medium inside beaker is kept at 37±2 except for dispersible & effervescent tablets.
Upward stroke specifications?
Upward stroke should be such that the basket mesh should immerse 15 mm beneath the level of fluid in break.
Downward stroke specifications?
In the downward stroke of the basket the mesh should descend NLT 25 mm from the breaker bottom.
Difference between Disintegration and dissolution?
In disintegration as we discussed previously the tablets or capsules break down into small fragments and it is a physical test where we only determine the time for which a dosage form must be disintegrated.
In dissolution the dosage forms are dissolved to form a solution and it is a chemical test where testing is performed to find out the amount of dissolved drug in a specific time period.
Factors affecting disintegration?
The factors which affect tablet disintegration are
- Quantity of disintegrants used in the formulation.
- Quantity of the binders used in formulation.
- Granules size
- Tablet hardness at which it is compressed.
What Is The Effect Of Binder Concentration On Disintegration?
The amount of binder has a direct impact on the disintegration time of dosage form.A very high concentration of binder will retard or prolong disintegration time.
Relation of Tablet hardness and Disintegration time?
If tablet hardness is high the tablet disintegration will be prolonged and if tablet hardness is low it disintegration will be rapid.
Disintegration time of tablets and capsules?
Core tablets should disintegrate in not more than 15 min.Film coated tablets should disintegrate in NMT 30 min & sugar coated tablets should disintegrate in NMT 60 min.The disintegration time for effervescent tablets is NMT 5 min and for dispersible tablets is NMT 3 minutes.Oro dispersible tablets should disintegrate in time not more than 30 seconds.
Enteric coated tablets should not disintegrate for 2 hrs in acidic media and disintegrate within 60 minutes in basic media.
Longest Disintegration Time?
Enteric coated dosage forms have the highest disintegration time.
Short Disintegration Time Tablet?
Orodispersible tablets have the shortest disintegration time.
For which tablets Disintegration Test is not performed?
For chewable tablets we do not perform disintegration test.
Examples of disintegrants
Disintegrants and super disintegrants are given as
- Starch
- Cross carmelose sodium
- Sodium starch glycolate.
Difference between disintegrants & super disintegrants?
Disintegrants are the conventional excipients which are required in higher quantities to give the required disintegrating effect and super disintegrants are modified excipients which give fast or rapid effect with less quantity.
Also Read