SODAS® (Spheroidal Oral Drug Absorption System) is Elan’s multiparticulate drug delivery system. Based on the production of controlled release beads, the SODAS® technology is characterized by its inherent flexibility, enabling the production of customized dosage forms that respond directly to individual drug candidate needs.

Benefits offered by Elan’s SODAS® Technology include:

• Once daily dose resembling multiple daily doses by releasing drungs in discrete bursts
• Controlled absorption with resultant reduction in peak to trough ratios
• Targeted release of the drug to specific areas within the gastrointestinal tract
• Absorption independent of the feeding state
• Minimal potential for dose dumping
• Facility to produce combination dosage forms
• Sprinkle dosing by opening the capsule and swallowing the contents with food     

Elan can provide a number of tailored drug release profiles, including immediate release of drug followed by sustained release to give rise to a fast onset of action, which is maintained for 24 hours. Alternatively the opposite scenario can be achieved where drug release is delayed for a number of hours. An additional option is pulsatile release, where a once daily dosage form can resemble multiple daily doses by releasing drug in discrete bursts throughout the day.

Elan’s SODAS® Technology is based on the production of uniform spherical beads of 1-2 mm in diameter containing drug plus excipients and coated with product specific controlled release polymers.

As each candidate drug presents itself with different physicochemical properties, the composition of the polymer membrane will differ for each individual SODAS® formulation. Varying the nature and combination of polymers within a semi-permeable membrane enables Elan to achieve varying degrees of release profiles depending upon the required product profile.

Once produced, the beads are encapsulated into a hard gelatin capsule. Combining a number of different populations of beads with varying degrees of controlled release gives rise to tailored drug release profiles, making the SODAS® system highly flexible and predictable for oral delivery.

The SODAS® delivery system continues to be an accepted and approved system by regulatory authorities with three approvals by the US Food and Drug Administration received since 2002 with the launch of once daily oral dosage forms of Avinza®, Ritalin® LA and Focalin® XR. A number of other compounds are in late stage development utilizing Elan’s SODAS® Technology.

The SODAS® Technology is proprietary and is covered by patents in all major pharmaceutical markets. Products utilizing SODAS® Technology are approved and marketed throughout Europe, Japan and the United States.