Fixed dose combinations (FDC), predetermined combinations of drugs and respective dosages, are popular for simplifying dosage regimens (reducing pill burden) and thereby improving patient compliance. This benefit can be especially advantageous in pediatric drug product development as well as geriatric applications where dose administration and compliance are especially challenging. An additional driver for FDC drug products include the potential ability to alter pharmacokinetics of the API interaction versus the individual API’s, e.g. offset adverse interactions.
Our product development teams utilize several several approaches to achieve dual release profiles for combination drugs or pulsatile drug release with a single API:
- Multiparticulate technologies – using either spray layered dispersion approaches with an inert core or matrix bead approaches used in combination with drug layering
- Bi- or tri-layered matrix tablets – use of multi-layered matrix technology using a combination of hydrophilic polymers
- Osmotic tablet technologies – use of more than one drug layer in combination with the push layer within an osmotic tablet design
- Capsule-in-capsule products – proprietary technology utilizing an inner drug containing capsule (solid, semi-solid or liquid) inside a liquid-filled hard capsule containing the second drug
These technologies are flexible in terms of their use for either crystalline and/or solubilized drug actives and to achieve combination delivery profiles, i.e. immediate, extended release, zero order, pulsatile or tailored drug release.
The choice of technology is dependent upon the APIs, API interaction, target product profile and commercial objectives specific to a customer’s drug program. We have the capabilities in place to support FDC development from concept through clinic, as well as small-scale commercial supply.