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Verelan® PM

Case Study 2 – Once daily, night-time dosed, anti-hypertensive to minimise risk of early morning cardiovascular events

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

The Challenge
Elan Drug Technologies 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 Drug Technologies’ 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 where…..

• 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 as the drug beads disperse throughout the gastrointestinal tract
• maximum blood levels of drug achieved in the early morning, with bed-time dose, to offset the rapid surge in blood pressure
• therapeutic effect is maintained during wakening hours.          

Benefit to Marketer   
Elan Drug Technologies’ 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 at Elan Drug Technologies’ manufacturing site in Gainesville Georgia, U.S.

 

Our night-time once daily verapamil is available for licensing in all territories ex-North America.