Oral
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We support various oral dosage forms from pre-formulation to commercial manufacturing:
- Tablets including conventional, bilayer & mini tablets
- Capsules including conventional & multi-compartment capsules
- Lipid formulation including softgel and liquid filled hard capsules
- Powder and granule
- Liquid-in-bottle
With over one thoudand of formulators & analytical scientists, we work with thousands of clients every year to accelerate their projects for global patients:
- IEPP (IND Enabling Preformulation Package): 8-12 weeks for IND ready formulation
- F2CS (Fast to Clinic Supply): Formulation development and CTM supply both within 8 weeks
- F4CL (Fast for Commercial Launch): Technology transfer to release of PPQ completed in 6 months
Our oral solid R&D labs are at Shanghai Waigaoqiao site and Wuxi City site in China. Both of them, as well as Couvet site, in Switzerland have the oral solid manufacturing capability from preclinical scale to clinical supply and commercial production. The Middletown site in Delaware USA, currently under construction, will provide formulation development, drug product manufacturing and packaging, labeling and distribution services.
Modality
- Small molecule
- Peptide
Dose Forms
- Tablets
- Capsules
- Powders
- Liquid capsules
- Granules
- Liquid in bottle
Packaging and Labeling
- Bottle
- Blister
- Sachet
- Open labeling
- Double blind labeling
Various Products
- Intramuscular / subcutaneous
- Intravenous
- Intrathecal
- Inhalation
- Ophthalmic
One Stop Oral Solid Services
Enabling Technology Platform
High Potency Oral Drug
We have established high potency oral solid dosage manufacturing facilities in Wuxi City. Wuxi City site supports high potency oral drugs with formulation development services and drug product manufacturing services with our global high standards.
Our high potency oral drug manufacturing plants feature fully enclosed production system with automated equipment. Its Containment Performance Target (CPT) meets the control requirements of Occupational Exposure Limit (OEL) as low as 10 ng/m3. We offer multiple formulation processes, including wet and dry granulation, capsule filling, tablet compression, and coating. Our production capacity is 600 million doses every year.
Sublingual and Buccal Delivery
WuXi STA has exclusive access to apply Biolingus’ patented platform for stabilization and sublingual/buccal delivery of tablets and drops. This platform enables a convenient route of administration of peptides and small molecule based drugs that are not suitable candidates for traditional oral dosage forms (e.g. molecules that are not stable in the GI fluids, or metabolically unstable). The Biolingus platform, through a unique process and equipment, has demonstrated capabilities to enhance bioavailability, bioactivity and long shelf-life stability for certain challenging molecules.
Pediatric Formulation
Pediatric applications require flexible dosage form options to address special needs such as taste masking and differences in the ease, frequency, and safety of dosing regimen. WuXi STA established a pediatric formulation team to focus on customizing age-appropriate oral delivery options. Pediatric formulation platform includes oral solutions and suspension, mini tablets, pellets with taste masking and extended-release coating.
