We integrate knowledge of the complex interplay between in vitro and in vivo conditions into our formulation development and scintigraphic study designs to ensure success.
Conventional Oral Dosage Forms Development
BDD specializes in the development of conventional formulations including:
- Tablets (from immediate release to sustained, modified and pulsatile release)
- Tablet within a tablet (dry coated tablets)
- Capsules including powders and granules
- Granules for reconstitution
Our formulation design process encompasses the development of scalable, transferable formulations.
BDD’s development lab houses a STYL’One Evo tablet press, a state-of-the-art single station tablet press, which is capable of producing conventional monolithic, multilayer, and tablet-in-tablet formats at research scale. This press enables us to work with relatively small quantities of material in early-stage development projects where supplies may be limited.
The instrument also allows simulation of different production scale presses, allowing BDD to reduce risk at lab scale prior to downstream investment in scale up.
Hot Melt Extrusion capability
Using Hot Melt Extrusion (HME), BDD offers development solutions for your poorly soluble APIs (BCS class II):
- A solvent free alternative to spray dried solid dispersion
- Taste masking potential
- Intermediate product for your conventional formulation
- Twin screw granulation through HME process
Modified Release Formulations
With significant experience in the development of solid oral dosage forms, BDD are leaders in controlled release formulations, including:
- Time-delayed release
- Sustained release
- Multi-pulsed release
- Site-specific released
- Complex release
The development of your formulations is supported by in-house analytical testing. Our development team collaborate with our clients to identify the most successful approach to characterise your formulation and accelerate the development of your molecule to clinical evaluation. Our capabilities include:
- Loss on drying
- Disintegration and dissolution
- Flow / tap / bulk density
- Tablet hardness
For early formulation testing and characterisation of release profiles from complex formulations, BDD use a closed loop automated dissolution testing system with in-line UV spectrophotometer to enable multiple automated sample measurements at short intervals over long periods of time for in depth profile characterisation.