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.
We have in-house capabilities to design, develop and manufacture specialized drug products based on osmotic technologies.
Osmotic swellable core technology
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).
We utilize four multiparticulate technologies for meeting target product profiles,with the choice being dependent upon API parameters, formulation requirements and commercial objectives.
We combine our expertise in encapsulation and targeted delivery to the gastro-intestinal track to achieve effective colonic delivery.
Taste and Odor Masking
Effective taste and odor masking has been shown to have a marked effect on patient compliance, especially for specialized patient populations such as pediatrics and geriatrics.
The depth of our bioavailability enhancement offering makes us a leader in addressing drug solubility and dissolution rate issues.