Physical-chemical evaluation of selected chemical leads to enable the selection of optimal development candidates;
Microscale drug characterization and evaluation;
Exposure-enhancing formulations for activity/efficacy, pharmacokinetics and toxicology evaluations;
Drug developability assessment.

Preformulation study

Physical pharmacy profiling: pH-solubility, pH-stability, solubility in lipids, surfactants/polymers, partition coefficient (logP, logD), solid state characterization, solid state stability, solution stability;
Dissolution and intrinsic dissolution rate;
Polymorph form screening and selection;
Salt form screening and selection;
Early formulations for PK, PD and toxicological evaluation;
Powder characterization: compactability, process induced form conversion, flow, particle size evaluation and specification recommendation;
Drug excipient compatibility.

Formulation and product development

Formulation screening using stability, dissolution and animal PK;
Process selection based on physicochemical and physical properties of the drug candidate;
Scale up process design and optimization;
Establish product specifications based on pre-formulation and formulation data;
Multimedia dissolution testing and dissolution method development;
Packaging, storage and shipping conditions evaluation and selection;
Technology transfer of formulation and manufacturing process to clinical supply manufacturing sites;
CMC package for IND/NDA/ANDA filing documents;

Clinical trial material manufacturing

Capsules, tablets and oral liquids formulations to support up to phase 2 in cGMP compliant facility;
Clinical support material: powder in bottle (PIB), powder in capsule (PIC);
Supporting documentation, including detailed formulation development, stability reports, specification document;
Global filing documents for phase II trials

Instrument and equipment highlights

Rotary tablet press (19 stations)
Bilayer rotary tablet press (14 stations, B/D turret)
High shear vertical granulators (1L ~ 25L)
Fluid bed granulator, dryer and granulator (1L ~ 10L)
Extruder and spheronizor
Roller compactor
Quadro Comil
Perforated pan coater (1.5L ~ 8L)
Automatic capsule filler (for solids, liquids and semi-solids) and capsule sealer
Powder X-Ray diffraction (Powder XRD)
Differential Scanning Calorimetry (DSC)
Thermal Gravimetric Analysis (TGA)
Dynamic moisture vapor sorption (DVS)
Dissolution stations with online UV detector, auto-sampler