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Once Daily, Novel Dual Release Morphine Sulphate using Elan’s proprietary SODAS® Technology
The Challenge
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
Solution Applied
Formulation and Process Approach
Elan’s 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
SODAS Multiparticulate formulation – non-pareil beads used as a carrier onto which a solution of active ingredient is applied, then rate controlling polymers are applied to produce desired profile.
Benefit to Patient
By applying our SODAS Technology, we developed a superior, unique, patented product …..
- 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
Benefit to Marketer
Elan’s once daily morphine product was launched in 2002 under the trade name Avinza® in the US by Ligand Pharmaceuticals Inc. Avinza is available in 30mg, 60mg, 90mg and 120mg capsule strength and is manufactured by Elan’s DEA approved manufacturing site in Gainesville Georgia, USA and currently marked by King Pharmaceuticals.
Unique features included
- Position itself as only true once daily product available in the US
- Eliminated fed fasted variations
- Patent protected
- Convenient administration
Avinza® Sales in US
Sales in $Millions
Source: IMS US Audited ex-factory sales