Tablets are manufactured by using different steps or stages and our ultimate goal is to produce tablets with good quality attributes.
To ensure tablets of good quality we adopt quality by design phenomenon and try to build quality in our product.
In QbD or quality by design our main focus is on the critical parameters like critical process parameters, critical quality attributes and critical material attributes.
Have you ever thought about what is a good tablet and what is a bad tablet or defective tablet?
First of all we will learn the definition of tablet, tablet is defined as the solid unit dosage form having active pharmaceutical ingredients and excipients compressed by using a tablet compression machine.
What is a Good Tablet
If a tablet meets the following requirements it is known as a good tablet.
- The correct amount of API
- The dissolution or drug release profile is as per specifications.
- Disintegration is as per the specification
- The tablet’s friability and hardness are within defined limits.
The correct amount of API
If a tablet has the correct amount of active pharmaceutical ingredients it is known as a good Tablet.
What is the meaning of the correct amount of API?
Active pharmaceutical ingredient is the material which is required for pharmacological effect & it is the main ingredient of the tablet.
Our tablet must have the claimed amount of active pharmaceutical ingredient e.g if the label claims that each tablet contains 50 mg of a specific API then all tablets must have the correct amount of API meaning 50 mg.
To ensure the correct amount of API in each tablet we critically monitor our critical process parameters like active pharmaceutical ingredient blending time to ensure the assay & content uniformity within ranges.
During the tablet compression process, we ensure that the weight of each tablet must be within defined limits to meet the API requirements.
When the whole tablet batch is compressed the quantity of active pharmaceutical ingredients is checked in the quality control lab by assay and content uniformity & if these are within range we can claim that there is the correct amount of drug in our batch and each tablet is a good tablet.
Drug Release Profile
A good tablet is a tablet whose drug release profile or dissolution values are as per specifications.
Suppose that for an immediate-release tablet, our dissolution specifications are not less than 80% after 1 hour, so if our tablet meets these specifications it is known as a good tablet.
Disintegration Time
A good tablet disintegrates within the recommended time period meaning if we are dealing with a core tablet and its integration time requirement is not more than 15 minutes then if the tablet disintegrates within 15 minutes it is known as a good tablet.
Hardness & Friability
A good tablet is a tablet
if its hardness values are as per the requirements.
A tablet which meets friability criteria means %age weight loss is not more than 1% it is known as a good tablet.
Bad Or Defective Tablet
In contrast to the good tablets we have the bad or detective tablets as well, so what are the bad or defective tablets?
If our tablet does not have the correct amount of active pharmaceutical ingredients and its content uniformity values are not within range, it is known as a bad tablet.
If the drug release profile of the tablet is not within the specifications it is known as a bad tablet.
If a tablet fails to meet disintegration specifications it is known as a bad tablet.
The tablets are known as bad or defective if there is any sticking, picking, capping or lamination.
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