Crospovidon - A well-known super-disintegrant in the pharmaceutical industry

1. Chemical structure

Crospovidone is a cross-linked polymer of PVP, insoluble in water.

2. Pharmacopoeia nomenclature

Crospovidone (BP; JP; PhEur; USP-NF).

3. Trade name – Manufacturer (Distributor in Vietnam)

Tabdone – Blanver (Dang Hung), Polyplasdone – Ashland (DKSH), Kollidon CL-F – BASF (FD&C),..

4. General properties

Crospovidone swells without forming gel, making it useful for tablets where gelation affects solubility.
Crospovidone’s particle size significantly influences the rate of disintegration; larger particles promote a faster rate of disintegration in tablets.
Because of its non-ionic nature, the ability to disintegrate is not affected by pH.
The amount of residual peroxide in crospovidone can have an impact on the finished product’s stability.

5. Mechanism of action

Crospovidone’s two primary disintegration mechanisms are wicking and recovery. Although crospovidone is deformed when compressed in tablets, but it will recover to its normal size after being exposed to water via the capillary mechanism, releasing a significant amount of energy to break the tightly linked structure in the tablet.

6. Main application

Excipients that increase solubility in solid dosage forms such as tablets, capsules, and powdered granules are known as super-disintegrant excipients. In some circumstances, particularly in ODT and DT tablets, the ratio employed in the formula might be higher and typically ranges from 2 to 5%.

7. Personal experience

Crospovidone with big particle size normally disintegrates faster than crospovidone with finer particle size, however when exposed to the high humidity conditions, it could leave “roughness” on the tablet surface.
It is advised to use crospovidone with a low peroxide impurity level for APIs that are susceptible to oxidation (such as Polyplasdone Ultra ).
Because of its high water absorption capacity, it can readily cause the tablets to absorb moisture throughout accelerated stability testings.
Increasing the proportion of crospovidone in the formulation may increase tablet abrasion.

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