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Oral Drug Product
Every oral dosage form, from the first developability question to commercial supply.
Dosage forms
- Tablets, including conventional, bilayer and mini tablets
- Capsules, including conventional and multi-compartment capsules
- Lipid formulations, including softgel and liquid-filled hard capsules
- Powders and granules
- Liquid in bottle
Modalities supported: small molecule and peptide.
Service packages
IEPP, the IND Enabling Pre-formulation Package: 8 to 12 weeks to an IND-ready formulation.
F2CS, Fast to Clinic Supply: formulation development and clinical trial material supply both within 8 weeks.
F4CL, Fast for Commercial Launch: technology transfer to release of PPQ completed in 6 months.
Sublingual and buccal delivery
WuXi STA has exclusive access to apply Biolingus’ patented platform for stabilization and sublingual or buccal delivery of tablets and drops.
The platform gives a route of administration for peptides and small molecules that are not suitable candidates for traditional oral dosage forms, such as molecules that are unstable in GI fluids or metabolically unstable. Through its process and equipment it has demonstrated enhanced bioavailability, bioactivity and long shelf-life stability for certain challenging molecules.
Pediatric formulation
Pediatric applications need flexible dosage form options for taste masking and for differences in the ease, frequency and safety of the dosing regimen.
A dedicated pediatric formulation team customizes age-appropriate oral delivery. The platform covers oral solutions and suspensions, mini tablets, and pellets with taste masking and extended-release coating.
Packaging and labeling
Bottle, blister and sachet, with open-label and double-blind labeling, run in the same operation as manufacture.
Where oral products are made
Oral solid R&D laboratories are at the Shanghai Waigaoqiao and Wuxi City sites in China. Both, and the Couvet site in Switzerland, manufacture oral solids from preclinical scale through clinical supply to commercial production. The Middletown site in Delaware, under construction, will provide formulation development, drug product manufacturing, and packaging, labeling and distribution.