Generic pharmaceutical drug development

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tablets for dissolution and absorption
Anti-adherent which works as a lubricant
A lubricant prevents the powders from sticking to the equipment
used to compress tablets.
There are some other ingredients as well;
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Dyes which impart a color to the tablet
Sweetening agents which add flavors
Wetting agents to enhance the solubility of the drug substance
Acidifying agents and buffers which provide a more stable
environment to the drug product.
After pre-formulation work and development are completed, small scale
trials are performed. During the trials, the drug substance is processed
with the excipients to produce a dired strength and appearance dosage.
The dosage is then physically and chemically evaluated. This
determines its acceptability.
Some of the common types of testing performed on the tablets and
capsules are:
- Physical testing like appearance, weight variation, time of
disintegration, etc.
- Chemical testing like chemical identification, dissolution profiles
vs. reference product, etc.
If the product retains good physical and chemical properties, it is sent
for the test of “in-vivo bioequivalency” vs. reference product. If it proves
to be bioequivalent to the reference product, a package is assembled