Once daily, night-time dosed antihypertensive to minimize risk of early morning cardiovascular events. 

The Challenge
Elan wanted to develop an anti-hypertensive product that would overcome problems associated with increased blood pressure surge in early morning waking hours of hypertensive patients. 

The challenge was to develop a product that:

• would provide optimum concentrations when most needed – at early morning waking hours
• allowed timing of drug release / absorption for reduction in effective daily dose and drug exposure
• reduced dosage form dependence on gastric motility, posture and food          

Solution Applied
CODAS™, Chronotherapeutic Oral Drug Absorption System, is one of Elan’s multiparticulate drug delivery systems. The extended-release, controlled-onset properties of the CODAS™ Technology is designed to allow a four-to-five hour delay of onset following administration of drug. This delay in release is introduced by the level of release controlling polymer applied to the drug loaded beads.  The release-controlling polymer is a combination of water-soluble and water insoluble polymers.  As water from the gastrointestinal tract comes in contact with the polymer coat beads, the water-soluble polymer slowly dissolves and the drug diffuses through the resulting pores in the coating.  The water insoluble polymer continues to act as a barrier, maintaining the controlled release of the drug.

Applying the CODAS™ Technology to Verapamil Hydrochloride, complimented the circadian pattern of hypertension and provided 

• a controlled onset, extended release delivery system
• a rate of release essentially independent of pH, posture and food
• “sprinkle” dosing by opening the capsule and sprinkling the contents on food          

Benefit to Patient 
By applying our CODAS™ Technology, we developed a superior, unique, patented  product …..

• Controlled release of the drug, manipulated such that maximum blood levels of the antihypertensive are provided at appropriate times throughout the day
• Night-time dosing where the drug beads disperse throughout the gastrointestinal tract
• Maximum blood levels of drug in the early morning, to offset the rapid surge in blood pressure
• Therapeutic effect is maintained during wakening hours.          

Benefit to Marketer   
Elan’s Verelan® PM was launched in 1998 in the US by Schwarz Pharma Inc. Verelan® PM is available in 100mg, 200mg and 300mg capsule strength and is manufactured by Elan’s manufacturing site in Gainesville Georgia, USA. 

Verelan is a registered trademark of Elan Corporation plc