Osmotic Tablet Technologies
For clients whose projects require, or can benefit from zero-order or slow extended-release profiles, Capsugel uses two osmotic tablet technologies — osmotic asymmetric-membrane technology (AMT) and osmotic swellable-core technology (SCT). Both of these technologies provide steady-state, zero-order release drug release driven by osmotic/hydrostatic pressure.
Osmotic Asymmetric-Membrane Technology (AMT)
- Osmotic AMT tablets consist of a single-layer tablet coated with an insoluble, asymmetric microporous membrane produced by controlled phase separation. They are best suited to water-soluble drugs and accommodate low to high drug doses.
Osmotic Swellable Core Technology (SCT)
- Osmotic SCT tablets consist of a bi-layer tablet with an insoluble, semipermeable coating and a laser-drilled delivery orifice. This technology can be used with water-soluble, poorly water-soluble, or bioavailability-enhanced drug forms [e.g., spray-dried dispersions (SDDs)] and can accommodate low to moderate drug doses.
Release profiles are generally independent of pH and stirring rate. The attributes of these technologies minimize patient-to-patient variability and allow accurate prediction of in vivo performance from in vitro dissolution test results. A wide range of release rates is possible by varying the size of the laser-drilled hole, the coating application, and composition of the sweller layer, for instance.
Matrix bilayer tablets offer a viable alternative slow extended release approach to osmotic technology for some clients, especially for fixed-dose combinations.
Capsugel has techniques and experience in formulating and scaling technologies from feasibility scale (<10 tablets/batch), laboratory (0.1 to 4 kg), pilot (4 to 40 kg), and production scale (250 kg). We have in-house capabilities to manufacture clinical supplies for studies from Phase 1 through Phase 3 and have established partners for commercial-scale manufacture. We also offer a range of specially designed laser drills for osmotic tablets for development work, as well as for clinical trial manufacture using current Good Manufacturing Practice (cGMP) conditions.