Osmotic Tablet Technologies
Our osmotic tablet technologies are Osmotic Asymmetric-Membrane Technology (AMT) and Osmotic Swellable Core Technology (SCT) and are driven by osmotic/hydrostatic pressure that provides steady-state, zero-order release. Release profiles are generally independent of pH and stirring rate. These attributes 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.
Bend Research has techniques and experience in formulation and scaling technologies from feasibility scale (<10 tablets/batch), lab (0.1 – 4 kg), pilot (4 – 40kg), and production scale (250 kg); as well as in-house capability to manufacture clinical supplies for studies from Phase 1 through Phase 3.
Bend Research has designed, built and cGMP-qualified laser drills for laser drilling osmotic tablets. One design is used for development and small clinical trial material manufacture and consists of a semiautomated design whereby up to 256 tablets are laser-drilled in each iteration; this is typically used for batch sizes of 50 to 5000 tablets. The second design is for moderate to larger clinical trial material manufacture and consists of a fully automated, continuous design that has built in Quality Control cameras and other detectors. The throughput of this unit is up to 5000 tablets/hour.
Osmotic Asymmetric-Membrane Technology (AMT)
- A single-layer tablet coated with an insoluble, asymmetric microporous membrane produced by controlled phase separation
- Preferred drug substance and dose: water soluble, low to high dose
Osmotic Swellable Core Technology (SCT)
- A bi-layer tablet with an insoluble, semipermeable coating and a laser-drilled delivery orifice
- Preferred drug substance and dose: water soluble, poorly water soluble, or bioavailbility-enhanced forms, e.g., spray-dried dispersions (SDDs); low to moderate doses