Melt-in-the-mouth ODTs

Published: 8-Feb-2010

Orodispersible tablets (ODT) cater for a growing market in which convenience, mouthfeel and taste are key. Cecile Dusautois, Roquette Research Innovation & Development, France, looks at requirements for successful ODT formulations and introduces a new ingredient for ODT

Orodispersible tablets, otherwise known as orally disintegrating tablets (ODT), are modern medication delivery systems that can improve patient compliance through an attractive mouthfeel. For successful market application, ODTs need to be simple to produce using suitably robust ingredients. To meet these requirements, food and pharmaceutical ingredient supplier Roquette has developed an enabling technology for such successful ODTs.

Pearlitol Flash is a simple compound of mannitol and starch - two established ingredients of natural origin. Both ingredients comply with pharmaceutical and food regulations, and thus broaden the material's application to include pharmaceutical, otc, nutraceutical and food products.

Designed for direct compression processes, the new ingredient has excellent flow properties and a good compactibility. For example, a 15kN compression force is sufficient to obtain tablets with suitable hardness, friability and disintegration time characteristics (Fig. 1).

For ODT consumers, mouthfeel is a key criterion as the tablet remains on the tongue for about 30 seconds. Taste and texture need to be exceptional to ensure patient compliance. The new ingredient satisfies these criteria thanks to its nature, its self-disintegrating property and the low lubricant level required.

Mannitol is already known in the pharma and food industry for having a pleasant and mild sweet taste. With the new compound, orodispersible tablets melt in the mouth with a creamy, smooth texture, providing a pleasing taste experience.

Some orodispersible tablets require the addition of a super-disintegrant, which can impair the taste. However, as Pearlitol Flash is a self-disintegrating compound for which no super-disintegrant is required, the taste is unaffected.

When using the mannitol-based compound, 0.4% lubricant is sufficient to ensure a correct direct compression process. This also contributes to a better tasting tablet, as a high level of lubricant can produce a taste that many consumers find unpleasant.

For ODT producers, robustness of a formulation is a key criterion as it gives greater production flexibility. With the new ingredient the disintegration time is not significantly influenced by the tablet hardness (Fig. 2) or the speed of the tabletting machine (Fig. 3), which gives manufacturers tremendous flexibility in production.

Fast dispersion is a key parameter for orodispersible tablets. Consumers expect a complete disintegration in about 30-40 seconds. In tests, Pearlitol Flash had an in vivo disintegration time that measured below one minute and the in vitro Pharmacopoeial disintegration time was measured at below three minutes (Table 1).

An advantage of the new ingredient is that only a small number of excipients are necessary for an ODT formulation, as shown by the example formulae in Table 1.

In summary, the technology facilitates innovation in the formulation of ODTs that are attractive and quick to dissolve (increasing patient compliance) and that are robust to ensure production flexibility. Because all of the tablet requirements are gathered into a simple formulation, this binary compound ensures that formulating ODTs has never be so simple.

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