Superior performance Primellose® can be used in wet granulation, dry granulation or direct compression in combination with nearly any type of API and excipient(s) (soluble or slightly soluble). Wicking is the most important factor in croscarmellose sodium performance, and it was found that the relatively large particle size distribution of Primellose® conferred superior performance compared to many other brands.
In wet granulation
We recommend that Primellose® is incorporated at least partly (50%w/w or more) during granulation. This is especially important when a high proportion of insoluble diluent is employed as shown in this example which uses Diclofenac Sodium as the API and dibasic calcium phosphate dihydrate as the main diluent.
In direct compression
The recommended starting point is 2%w/w to 6%w/w of Primellose®. Table 1 shows how the disintegration time of various placebo tablets (250 mg / 9 mm tablets containing 4%w/w Primellose® and 0.5%w/w magnesium stearate) is maintained after storage for 6 months at 40˚C / 75% RH in open containers. The disintegration of reference tablets stored for 6 months under ambient laboratory conditions is also shown. This data confirms that Primellose® remains an effective super-disintegrant, even under the most stressful stability storage conditions.
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