Increase your speed to market with the fast-dissolve tablets patients prefer
Orally disintegrating tablets (ODTs) are solid dosage forms that disintegrate in the oral cavity, leaving an easy-to-swallow residue. Designed to disintegrate rapidly on contact with saliva and enable oral administration without water or chewing, these formulations offer increased convenience and ease of administration with the potential to improve compliance, especially when swallowing conventional solid oral-dosage forms presents difficulties for the patient.
Fast disintegration time is crucial to the process. A prolonged experience can result in failure to meet the defining performance characteristics of the ODT (or "fast dissolve tablet") dosage form. For instance, a fast dissolving tablet that fails to perform as expected might require water for administration or chewing to facilitate swallowing—resulting in an unsatisfactory patient experience and increased risk of noncompliance.
Even more significantly, if a patient or caregiver expects a tablet to rapidly disintegrate in the mouth, a tablet with a slower disintegration time could result in confusion and dissatisfaction, and may even present a dangerous choking hazard.
FDA recommendation for fast disintegration time
The US Food and Drug Administration (FDA) responded to this challenge with the 2008 publication of Guidance for Industry: Orally Disintegrating Tablets. In an effort to provide clear direction for pharmaceutical manufacturers of new and generic fast-disintegrating tablet products, the agency recommended that ODTs should have an in vitro disintegration time of approximately 30 seconds or less.
SPI Pharma's ODT platform can help ensure that your ODTs or fast-dissolve tablets perform effectively and meet patient expectations. We know the importance of creating a fast disintegrating tablet that’s hard enough to withstand the mechanics of production, storage, transportation, and being pushed out of a blister pack—yet sufficiently friable that it will dissolve entirely or disperse into small pieces that the patient can swallow comfortably.
We invite you to review our other resources on rapid disintegrating tablet technology and our innovative Pharmaburst® ODT platform. To learn more about our fast disintegrating tablet formulations, contact us today.