Distinct PK/PD profile

Differences in pharmacology distinguish Adalat GITS from generic nifedipine

The release profile of Adalat GITS is ideal for a once-daily, sustained-release dosage form1.

The rate and extent of release of Adalat GITS remains consistent throughout the physiological range of pH values1.

At 24 hours, complete or near-complete release is achieved at all pH levels from 1 (0.1 M hydrochloric acid) to 8 (phosphate buffer)1.

The release of Adalat GITS is also unaffected by changes in other test conditions, including agitation, osmolarity and the presence of surfactants1.

Nifedipine SR (Coral)

An in vitro study of generic nifedipine SR (CORAL formulation) has demonstrated variable release curves across the physiological range of pH values1.
Drug release was slowest at pH 1, with 70% release at 24 hours1. Release profiles at pH 4.5 and pH 8.0 were similar to Adalat GITS, but drug release was more rapid, reaching a maximum (about 80%) at 14–16 hours1. Rate of drug release at pH 6.8 was markedly increased, reaching a maximum (about 80%) at approximately 4-6 hours1.
Total release at 24 hours was lower compared to Adalat GITS at all pH levels1.

   

Schug BS, et al. Eur J Clin Pharmacol. 2002;58:119-125.

Nifedipine SR (Osmotica)

Adalat GITS has a favourable release profile, compared with a generic nifedipine SR formulation (Osmotica)2.

  • Shorter lag time, i.e. earlier onset of release2
  • Higher terminal release, i.e. more drug released by the end of the 24-hour period2

References

  1. Schug BS, et al. Eur J Clin Pharmacol (2002) 58: 119-125.
  2. Anschutz M, et al. Int J Clin Pharmacol Ther 2010;48:158-70.