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 Corporation 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.
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
Products marketed using the SODAS® Technology : SODAS®technology is a proven system approved by regulatory authorities. The most recent US 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)
A once-daily fluvoxamine maleate extended-release capsule (Luvox® CR) is taken at bedtime for the treatment of Obsessive Compulsive Disorder or OCD, as defined in the DSM-IV.
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. The most conventional release profile is the sustained release of drug over 24 hours Avinza® Once Daily Morphine, while a well-known and trusted analgesic….
- has a short half-life
- break-though pain is a significant problem
- no product offered true once daily dosing
- fed fasted variability
- not suitable for monotherapy – did not have a fast onset of action coupled with full day relief
Elan Drug Technologies’ unique solution was its SODAS® technology. A novel dual release formulation of the narcotic analgesic morphine was developed which differed from other currently marketed formulations because of two unique properties:
- True once daily controlled release achieved, therapeutic plasma levels maintained for 24 hours
- An immediate release component enabled a fast onset of action, suitable for monotherapy, thus eliminating the need for fast acting products
Mean Steady State Plasma Morphine Concentrations This 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.
Benefit to Patient By applying SODAS® technology, drug release technologists developed a superior, unique, patented product with
- fast onset
- 24 hour sustained pain control in a single daily dose
- steady around the clock analgesia
- ability to titrate with other strengths
- ability to sprinkle on food for easier administration
Marketing Advantages Elan Drug Technologies’ once daily morphine product was launched in 2002 under the trade name Avinza® in the U.S. Avinza® is available in 30mg, 45mg, 60mg, 75mg, 90mg and 120mg capsule strengths and is manufactured in Elan Drug Technologies’ DEA approved manufacturing site in Gainesville Georgia, USA. Avinza® is currently marketed by Pfizer Inc. 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. In addition to the US FDA regulatory approvals, many products have been approved by the European EMEA and the Japanese health authorities using the SODAS® technology.