We utilize multiple approaches to achieving extended release (ER) drug delivery profiles in either multiparticulate or monolithic formats. For projects that require monolithic approaches and can benefit from zero order or slow ER delivery profiles, we utilize two osmotic tablet technologies. These technologies are highly flexible, can be used with both crystalline and amorphous drug substances, and utilize osmotic/hydrostatic pressure to provide consistent drug release without food effect.
This poster presents osmotic-rupturing multiparticulates with a time-dependent release profile as an attractive alternative to the common pH-dependent pulsatile-release profiles generated with enteric and reverse-enteric coatings.
Osmotic swellable core technology (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, such as spray-dried dispersions, and can accommodate low to
moderate drug doses.
Osmotic Asymmetric-Membrane Technology
Osmotic Asymmetric-Membrane Technology (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.
Matrix bilayer tablets offer a viable alternative slow extended release approach to osmotic technology for some clients, especially fixed-dose combinations.
We have experience in formulating and scaling SCT and AMT osmotic technologies from feasibility scale, laboratory scale, pilot scale and production scale (250 kg batches).