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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 Dosage Form Solutions 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.