Clinical efficacy and bioavailability of a sustained release nifedipine formulation.
A new oral sustained release formulation containing 20 mg nifedipine (Coral retard) was administered twice daily to 30 patients suffering from coronary diseases and/or hypertension, in order to assess its clinical effectiveness. The controls of blood pressure and pain before, during and after 30 days of treatment revealed a significantly good therapeutic action of the new formulation, both as an antihypertensive and an antianginal remedy. Blood examinations exhibited an optimum tolerability of the test product. Moreover, in 8 additional subjects free of cardiovascular and other diseases, the formulation was compared to a commercial sustained release product in order to evaluate its bioavailability after a single 20 mg dose. The product under study showed a satisfactory bioavailability when compared to the reference product. It is concluded that the new formulation can be successfully applied to the treatment of hypertensive and/or coronary diseases with a considerable simplification of the dosing schedule and an improved patient compliance.
Piovella
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Ospedale di Lecco, Divisione di Medicina I, Como, Italy.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000378:metabolism; D001682:Biological Availability; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
D003692:Delayed-Action Preparations; D009543:Nifedipine