Innopran XL
Project: A delayed-release formulation of propranolol
Technology: Diffucaps
Challenges: To develop a unique drug release profile for a chronically administered drug to provide PM dosing with AM plasma peak levels and maintenance of adequate drug plasma levels during the day
Optimal treatment of diseases whose incidence or severity has a link with the biorhythms of the body, e.g. hypertension, can require that drug release profile be designed to provide appropriate plasma drug concentrations during the day. For hypertension, it could be desirable to have elevating plasma concentrations of the drug in the early hours of the morning as systolic blood pressure increases. Adequate levels of the drug should then be maintained during the remainder of the day as blood pressure is generally lower at these times. Dosing at bedtime with a delayed release of the product can facilitate this profile in a once-a-day dosage form.
To achieve this therapeutic profile, Eurand used its Diffucaps technology to develop a timed and sustained release dosage form of the beta-blocker propranolol. The product was developed using a combination of controlled and delayed release membrane system and the use of multiple-release profile beads-in-a-capsule system. This formulation was developed for Reliant Pharmaceuticals, and the product is currently marketed in the United States as Innopran XL®.
Chart: Plasma levels of Propranolol for the Innopran XL® product
