Elan Drug Technologies

SODAS^® (Spheroidal Oral Drug Absorption System) is Elan Drug Technologies' multiparticulate drug delivery system.

Based on the production of controlled release beads, the SODAS^® technology is characterised by its inherent flexibility, enabling the production of customised dosage forms that respond directly to individual drug candidate needs.


Benefits offered by the SODAS^® technology include:

• 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
• suitability for use with one or more active drug candidate
• facility to produce combination dosage forms
• “sprinkle dosing” by administrating the capsule contents with soft food
• once or twice  daily dose resembling multiple daily dose profiles

Elan Drug Technologies 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 Drug Technologies’ 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 Drug Technologies to achieve varying degrees of release profiles to achieve the required target 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 five products approved and launched in the U.S. since 2002 including once daily oral dosage forms of Avinza^®, Ritalin^® LA, Focalin^® XR and Luvox^® CR. A number of other compounds are in late stage development utilising Elan Drug Technologies’ SODAS^® technology.


Products marketed using the SODAS^® Technology

SODAS^® technology is a proven system approved by regulatory authorities. The most recent U.S. regulatory approvals for SODAS^® based drugs include a differentiated once daily morphine product (Avinza^®), an extended release formulation of methylphenidate with a bi-modal release profile (Ritalin^® LA), an extended release formulation of dexmethylphenidate hydrochloride also with a bimodal release profile (Focalin^® XR) and a once daily fluvoxamine maleate extended release capsule (Luvox^® CR). In addition to the U.S. FDA regulatory approvals, many products have been approved by the European EMEA and the Japanese health authorities using the SODAS^®  technology.


Diltiazem Once and Twice Daily
Both Elan Drug Technologies’ Once and Twice daily dosage forms were developed for the treatment of hypertension using the proprietary SODAS^® technology. Diltiazem has a short half and was originally administered three or four times daily. The twice daily product was first launched in the US in 1986, followed by the once daily product in 1991. Elan Drug Technologies’ diltiazem is now marketed in many international markets including the U.S., Europe and Asia.


Verapamil Once Daily
Verapamil, a calcium channel blocker, indicated for the treatment of hypertension was originally administered three times daily. Elan Drug Technologies developed a once daily formulation of verapamil using its SODAS^® technology. Elan Drug Technologies’ SODAS^® formulation was unique in that it represented the first verapamil controlled release formulation in which the extent or rate of absorption was not affected by food intake. In addition, the capsule could be opened and the beads sprinkled on soft food for those patients unable to swallow traditional dosage forms. This verapamil is now marketed in many international markets including the U.S. and Europe.


Sustained Release
The most conventional release profile is the sustained release of drug over 24 hours

Elan Drug Technologies’ controlled release morphine product, Morphelan^® /Avinza^®  


Mean Steady State Plasma Morphine Concentrations
The above graph illustrates how Elan Drug Technologies’ SODAS® technology can achieve sustained release over 24 hours. In this case study, the superior nature of the SODAS® controlled release technology is illustrated through the comparison of once daily Avinza® versus an immediate release morphine solution.


Pulsatile Release
Perhaps the most complex controlled-release profile is the pulsatile profile. Pulsatile release may be desirable where tolerance to a drug is likely to develop, or where the drug is administered to mimic natural secretion within the body. In cases such as these, drug delivery technologies can imitate the effect of administering the drug at discrete intervals throughout the day, without inconvenience to the patient because of a cumbersome dosage regime.

SODAS^® technology is a proprietary technology platform, aspects of which are covered by patents in all major pharmaceutical markets. Products utilising SODAS^® technology are approved and marketed throughout Europe, Japan and the U.S.