PEARLITOL® Flash, mannitol and starch compound, offers inert stability, fast disintegration and superior organoleptic properties, allowing complex ODT formulations to become simple. PEARLITOL® Flash shows beneficial stability and patient compliance characteristics when compared to other inert natural formulations.

Situation

Orally disintegrating tablets (ODT) are solid dosage forms which disintegrate/melt rapidly when placed on the tongue and do not require water for swallowing. ODT formulation was introduced to the market with the goal of better patient compliance, further gaining popularity as an alternative Rx and over-the-counter (OTC) oral dosage forms, as well as nutraceuticals. ODTs are particularly suitable for consumers with dysphagia (difficulty in swallowing), specifically pediatric and geriatric populations, or for cases when compliance is a known issue, such as mentally disabled patients. ODTs are also intended for convenience as an “on-thego” medication when water is not available or when consumption of water/liquid is not desired, for example persistent nausea. ODTs are preferred over chewable tablets in certain situations such as when chewing is difficult or painful. Improved bioavailability of active ingredients in orodispersible formulations is possible due to pre-gastric absorption, reducing first-pass liver and gastric metabolism, which is beneficial when faster onset of action is required, e.g. emergency or pain medications, or for drugs that degrade or metabolize intensively when digested...

Challenge

Simple inert direct compression platform for Orally Disintegrating Tablet (ODT) formulations is in demand for development and re-formulation of pharmaceutical and nutraceutical products.

Solution

PEARLITOL® Flash is a platform composed of only two long-established ingredients of natural origin – mannitol and maize starch, enabling production of high quality ODT by direct compression.