Capsugel is well versed in using drug layering and modified-release coat layering to achieve a range of dissolution profiles in multiparticulate format. These formulations consist of spherical 100- to 1,500-µm multiparticulates with one or more coating layers applied by fluidized-bed coating technology. Sucrose or microcrystalline substrates are typically utilized with the coat layers containing one or more drug substances. Extruded beads or lipid multiparticulates can also be spray-layered coated for further functionality.
Proven applications for this versatile technology include delayed release, extended release, pulsatile release, and fixed dose combinations. We also utilize spray-layered multiparticulates, and other modified release technologies, in conjunction with bioavailability enhancement technologies to optimize overall drug availability.
We use an array of fluid bed equipment to produce high-yield, high-quality coatings and can produce spray-layered multiparticulates at the feasibility, laboratory, clinical and small commercial scales at batch sizes as small as 2g. Fluid bed coaters, dryers and granulators at a range of scales enable clinical trial supply for phase I-III.
Capsugel has also developed osmotic-bursting multiparticulates with a barrier-coating option to approximate zero-order release.
Drug release is controlled primarily by manipulating coating type and weight. Advantages of this approach include:
- tunable release lag based on barrier coating weight, followed by pulsatile to short controlled-release durations;
- relative insensitivity to environmental pH; and
- relative insensitivity to sweller-layer thickness or drug properties.