Troubleshooting and FAQs for PEARLITOL® Flash Mannitol

Orally disintegrating tablets must disintegrate within 3 minutes, according to European Pharmacopoeia disintegration test conditions. Consumers typically expect complete disintegration in 30-40 seconds.

PEARLITOL® Flash is a self-disintegrating mannitol compound, so superdisintegrants may not be required in the formulation of orally disintegrating tablets. In challenging formulations (e.g. high drug load), some superdisintegrants may be added to complement the effect of PEARLITOL® Flash.

PEARLITOL® Flash is compliant with EP, USP-NF and JP regulations. For more information, you may refer to its product profile page.

Using PEARLITOL® Flash, 0.4% lubricant can be sufficient to ensure a direct compression process.

Tablet hardness is affected by the tabletability of other components in the formulation, including the active pharmaceutical ingredient. Hence, addition of a suitable excipient (e.g., PEARLITOL® 100 SD mannitol or MICROCEL™ microcrystalline cellulose) can be complementary to improve the tablet hardness.

Depending on the reason for the bad taste, different formulation strategies may be employed. If the active pharmaceutical ingredient has a bad taste, taste-masking strategies (e.g., molecular encapsulation or powder coating, etc.) could be useful. Selection of the matrix excipient is also important as it is the major component of the tablet and consequently, impacts its taste. PEARLITOL® Flash Mannitol has a pleasant, mild sweet taste and creamy smooth texture which makes it a superior matrix excipient for ODTs.