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Disintegrants
1] A disintegrant is an excipient which is added to a tablet or capsule blend to aid in the break up of the compacted mass when it is put into a fluid environment. This is especially important for immediate release products where rapid release of drug substance is required. A disintegrant can be added to a powder blend for direct compression or encapsulation. It can also be used with products that are wet granulated. In wet granulation formulations, the disintegrant is normally effective when incorporated into the granule (intragranularly). However, it may be more effective if added 50% intragranularly, and 50% extra-granularly (i.e., in the final dry mixture). While there are some tablet fillers (e.g., starch and microcrystalline cellulose) which aid in disintegration, there are more effective agents referred to as superdisintegrants. Some superdisintegrants and their properties are listed below.
Completely insoluble in water. Rapidly disperses and swells in water, but does not gel even after prolonged exposure. Greatest rate of swelling compared to other disintegrants. Greater surface area to volume ratio than other disintegrants. Recommended concentration: 1 to 3%
Available in micronized grades if needed to improve uniform dispersion in the powder blend.
Insoluble in water. Rapidly swells in water. Grades LH-11 and LH-21 exhibit the greatest degree of swelling. Certain grades can also provide some binding properties while retaining disintegration capacity. Recommended concentration 1-5%.
Absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. Recommended concentration: 1.0 – 4.0% but may need to use up to 6.0%. Gels on prolonged exposure to water. High concentrations may cause gelling and loss of disintegration.
a consultant to the pharmaceutical industry with over 20 years
of pharmaceutical and nutraceutical research, development, formulation
and manufacturing experience.
