Formulation Development

From early-stage development to formulation optimisation, our design strategies are based on a science led approach and underpinned by our knowledge of biopharmaceutics gained through years of clinical visualisation and testing of formulations in man.

The gastrointestinal tract is a dynamic environment, and the physiology of the human population can be variable within that, making it crucial to account for this in formulation design. BDD Pharma can provide insight on the myriad of factors that might influence performance of your dosage form in vivo, from the effects of food in the stomach, the local changes in pH, motility, absorption and hydrodynamics to the physicochemical properties of the active pharmaceutical ingredient (API) and help develop formulation strategies to maximise the potential for achieving therapeutic aims.

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
Gastro-retention
Complex release

We factor in practicality, cost, and reliability to all our development projects to facilitate commercial success.

BDD can also achieve a variety of modified and controlled release profiles using our OralogiK™ platform technology which uses an excipient erosion-based system to delay the release of API to a pre-determined time. We also have extensive knowledge of other modified release techniques which include polymer coatings.

Interested in applying modified release options to your drugs – chat to us and we can help evaluate your options.

Targeted Drug Delivery to the Gastrointestinal (GI) tract

We have capabilities in conventional coating as well as press coating to develop:

Formulations targeted to upper and lower GI tract
Colon targeted formulations
Gastro retentive formulations
Enteric coated formulations

Characterisation Tools

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:

HPLC
Loss on drying
Disintegration and dissolution
Friability
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.