SODAS®
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. 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. Pulsatile release, where a once daily dosage form can resemble multiple daily doses by releasing drug in discrete bursts throughout the day, is an additional option.
SODAS 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. Each bead begins as an inert core onto which drug is applied, followed by a number of layers or coatings of an appropriate mix of controlled release polymers. These polymers (water soluble and insoluble, pH dependent/independent etc.) form a rate controlling membrane around each bead. Utilizing the core plus drug without the addition of a rate limiting polymer coat produces immediate release beads.
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 sustained release depending upon the required product profile. Controlled release is produced when the soluble polymers dissolve, leaving pores within the outer membrane. Fluid then enters the core of the beads and dissolves the drug. The resultant solution diffuses out in a controlled, pre-determined manner allowing for prolongation of the in-vivo dissolution phase. Controlled release may also be as a result of the use of pH dependent coatings or a single polymer system. During the development phase, the optimum formulation will be identified through the use of in vitro dissolution screening.
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 SODAS a highly flexible and predictable oral drug delivery system. The unique nature of the SODAS technology gives rise to a number of attributes that directly benefit individual drugs : |  |
- Controlled absorption with resultant reduction in peak to trough ratios
- Targeted release of the drug to specific areas within the gastrointestinaltract
- 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 possesses a great deal of experience and expertise with respect to optimum selection of polymers and excipients, manufacturing method, validation and all the necessary components required to achieve product approval. Elan has achieved a number of innovative release profiles employing the SODAS technology. The first product developed by Elan was a controlled release tetracycline, which employed the SODAS technology.
Typical equipment critical to the SODAS process includes layering/coating using Glatt fluid bed and/or CF granulator and capsule filling.
SODAS continues to be an accepted and approved system by regulatory authorities with the most recent regulatory approvals for a SODAS based system occurring since US in 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.