Reimagining your Orally Dispersible Tablets Formulation Excipients, Introducing a New Lactose Product (SuperTab® 50ODT)

12:25 - 13:00

An orally disintegrating tablet or orally dissolving tablet (ODT) is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed as a whole. The regulatory condition for meeting the definition of an orally disintegrating tablet is that ODT drugs should disintegrate in less than 30 seconds for US ODT products and less than 3 minutes for European ODT products. ODT’s are a novel way for product line extensions and a new manner helping to deliver medication to pediatrics and geriatric patients, or to those who suffer from Dysphagia.

ODT manufacturing can be split into two distinct areas. The initial technology used involved  lyophilization. The first ODT form of a drug to get approval from the U.S. Food and Drug Administration (FDA) was a Zydis ODT formation of Claritin (loratadine) in December 1996. The second technology and most cost effective technology uses the standard tableting process equipment.

SuperTab® 50ODT is a specifically designed spray dried lactose which has characteristics that facilitate the production of ODT’s . Utilizing proprietary spray drying techniques a lactose monohydrate product has been developed with a typical porous nature due to which a fast disintegration time can be established in combination with a smooth tablet perception. The balance is to have a formulation that produces tablets with low friability, to aid packaging / transportation and the desired fast oral disintegration time coupled with a pleasant mouth feel and texture.

New in the development of excipients is the usage of large trained sensory tests panels evaluating product from prototypes to final products with CATA (Check All That Apply) and RATA (Rate All That Apply) testing protocols and use of MVA (Multi Variant Analysis) to monitor,  evaluate the sensory and physical behavior of tablets. The study shows that using  these CATA & RATA screening techniques the Organoleptic properties of commonly used pharmaceutical excipient such as lactose can be modified to suit ODT application.

Historically, these type of formulations have used polyols such as Mannitol etc. Unlike polyols, lactose does not decrease the small intestinal transit time[1].

[1] Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility, Drug Substances - 2018

Mara van Haandel, Innovation Manager , DFE Pharma