The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Novartis
Approval Status: Approved February 1997
Treatment for: hypertension
General Information
DynaCirc CR, a once-a-day calcium channel blocker, has been approved for the treatment of hypertension. Developed by Sandoz Research in collaboration with ALZA Corporation, DynaCirc CR is available in 5 mg and 10 mg controlled release tablets. The new formulation is Novartis’ first launch of a line extension and offers continuous reduction of blood pressure throughout a 24 hour period. DynaCirc CR has been demonstrated to be safe in a broad range of patients, including elderly, really impaired and diabetic patients, as well as patients with underlying cardiovascular conditions.
Mechanism of Action
Isradipine, the active ingredient in DynaCirc CR, is a potent intermediate-acting dihydropyridine calcium antagonist.
DynaCirc CR achieves its once-a-day dosing regimen through the use of osmotic controlled release technology developed by ALZA Corporation in Palo Alto, California. Known as OROS, OSMOTIC THERAPEUTIC SYSTEM, the system is based on a semipermeable membrane surrounding an osmotically active core. The core is composed of two layers, an active layer containing the drug and a pharmacologically inert, but osmotically active, push layer.
After ingestion, the tablet overcoating is quickly dissipated in the gastrointestinal tract allowing water to enter the tablet through the semipermeable membrane. The polyethylene oxide polymer swells in the osmotic push layer and expands against the active drug layer releasing an essentially constant dose of isradipine as a fine suspension.
Literature References
(1) Cohen JD, Carr AA, Blecker D, et al. DYNAMICS trial of isradipine in hypertension with and without coexisting diseases. Cline Geriatr. 1994;2:36-52.
(2) Marcus AO, Antihypertensive therapy with the calcium channel blocker isradipine; an appropriate choice for the diabetic patient with hypertension, Review. Curr Ther Res, 1993;54:763-778.
(3) Berg KJ, Holdaas H, Endresen L, et al. Effects of isradipine on renal function in cyclosporin-treated renal transplanted patients. Nephrol Dial Transplant. 1991;6:725-730.
(4) Francischetti EA, de Silva IB, Fagundes VG. Effects of long-term administration of isradipine on renal hemodynamics and sodium metabolism. J Cardiovasc Pharmacol. 1992;19 (supp 3):S90-92.
(5) Persson B, Andersson OK, Wysocki M, et al. Renal and hemodynamic effects of isradipine in essential hypertension. Am J Med, 1989;86 (supp 4A):60-64.
(6) Grossman E, Messerli FH, Oren S, et al. Cardiovascular effects of isradipine in essential hypertension. Am J. Cardiol. 1991;68:65-70 SOURCE Novartis Pharmaceuticals Corporation.
