Controlled release for 24-hour blood pressure control
The Adalat® Gastro-Intestinal-Therapeutic-System (GITS) is a highly sophisticated system for prolonged drug release over 24 hours and shows superior features when compared to generic nifedipine formulations.
Large-scale, randomised, clinical trials such as INSIGHT and ACTION, which have been conducted with Adalat® (nifedipine GITS), demonstrate that this formulation provides a controlled onset of action and has a significant lower incidence of side effects compared with the short-acting formulations.
Composition1
- A two-layer tablet is pressed from the active substance (Nifedipine) and osmotically active granules.
- This is provided with a semi-permeable coating, which is not soluble in water.
- A laser beam is then used to drill a 0.6 mm hole through the coating, down to the layer of active substance underneath.
Inside the body1
- Water penetrates through the semi-permeable coating layer, which is water-permeable but nor water-soluble.
- The active substance inside liquefies and the osmotically active layer swells up.
- The active substance is administered evenly over a 24-hour period through the hole.
Advantages
- The level of active substance in the blood plasma remains constant.
- Peaks and troughs are avoided.
- Significant lower incidence of side effects compared with the short-acting formulations.
- Effective and convenient once-daily formulation improves patient compliance.
- Effective in combination with other antihypertensive drugs.
- In contrast to other Adalat formulations Nifedipine GITS tablets have constant dissolution properties.
See graphic below.2
Superior to generics
- Generic drugs are not subject to the same rigorous clinical testing as novel drugs.
- The unpredictable pharmacokinetics and pharmacodynamics of controlled-release generic nifedipines may result in different clinical effects and safety profiles compared with once-daily Adalat and might put patients at risk.
- Adalat is constantly released before and after food consumption.
- The once-daily Adalat formulation has unique pharmacokinetics and pharmacodynamics that cannot be transferred to any other controlled-release nifedipine formulations.
- Download our full detail aid: Protecting your patients against generic nifedipines
See graphic below.3
1. Grundy JS, Foster RT. The nifedipine gastrointestinal therapeutic system (GITS). Evaluation of pharmaceutical, pharmacokinetic and pharmacological properties. Clin Pharmacokinet 1996;30:28–51.
2. Meredith PA, Elliott HL. Dihydropyridine calcium channel blockers: basic pharmacological similarities but fundamental therapeutic Differences. J Hypertens 2004;22:1641–8.
3. Adapted from Schug BS, et al. Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union. Eur J Pharm Sci 2002;15:279−85;
Schug BS, et al. The effect of food on the pharmacokinetics of nifedipine in two slow release formulations: pronounced lag-time after a high fat breakfast. Br J Clin Pharmacol 2002;53:582–8.
