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Modified Release

Modified Release Delivery Systems

Metrics Contract Services offers proprietary pellet technologies enabling controlled release of active pharmaceutical ingredients (API). Metrics Contract Services’ advanced drug delivery technology supports the therapeutic effectiveness of API by tailoring drug release to the specific application and desired end-point.

Possible Benefits of Customized Controlled Release

  • Decreased dosing frequency
  • Reduced peak-to-trough ratio of drug in systemic circulation
  • Reduced rate of rise of drug concentration in blood
  • Sustained and consistent blood levels within the therapeutic window
  • Increased patient compliance
  • Reduced side effects

Advanced Pellet Release Profiles

  • Pulsed release – pulses of API concentrations over 12-24 hours following a single dose.
  • Sustained release – delivering steady levels of API over 12-24 hours following a single dose.
  • Modified release – immediate release of some API and delayed release of the remainder.
  • Delayed release – allowing API to pass through the stomach undigested so that it can be absorbed in the small intestine.

Pellet Technology and Process Capabilities

Pellet (or bead) technology allows a variety of different drug delivery profiles to be achieved by coating a ‘core’ of drug and excipient with various polymers. The drug cores are generally spheroidal in shape and have a diameter in the range of 300 to 1,700 µm. In order to generate the spheroidal particles, there are two main types of processes used:

  • The first, extrusion granulation, granulates API with excipients, which is extruded to form a core then coated by polymers. This process allows drug potencies up to 90%.
  • The second process is known as spheronization, where drug particles are fixed to the outside of a seed core – typically sugar – with the aid of a binder. The core is coated with a polymer. This process provides a very tight size distribution of pellets. Drug potencies up to 60% are possible.

The drug delivery system is then achieved by coating these particles with a polymer coat. Depending on the type of polymers used various release profiles can be achieved such as sustained, targeted or pulsed release.

Pellet technology has successfully been applied to a number of proprietary pharmaceuticals with modified release profiles. These include:

  • Eryc™ (delayed release erythromycin)
  • Doryx™ (delayed release doxycycline)
  • Kadian™ (extended release morphine)
  • Astrix™ (delayed release low-dose aspirin)
  • Pulsed release diltiazem