DSM Pharmaceuticals, Inc., Formulation Development and CTM Manufactur¬ing
services have offerings to include Formulation Development and Clinical Trial
Manufacturing for solid dosage form products. Averaging over 20 product
launch¬es per year, DSM has a 37 year history of successfully manufacturing
complex solid dosage forms for the commercial pharmaceutical market. These
services have significant value-added benefits to our customers in terms of
reducing cost and accelerating time to market. They will be able to avoid the
high cost of tech transfers leading to launch and commercial supply. Our
services are supported by a staff of Scientists and Project Managers dedicated
exclusively to these services.
Innovative Development Solutions
• Preformulation studies
• Formulation development
• CTM manufacturing
• Stability studies
•
Evaluation of new delivery technologies
• Formula and process
optimization through DOE
Preformulation Services
• Physico-chemical characterization of drug substance
•
Polymorphism studies
• Powder X-ray diffraction
•
Qualitative and quantitative thermal analysis
• Solubility and
partitioning studies
• Salt form selection
•
Excipient compatibility studies
• Packaging compatibility and
extractability studies
• Forced degradation studies
Formulation Services
• Tablets, capsules, liquids,
suspensions and semi-solids
• Reformulations and line extensions
• Modified and controlled release tablets and capsules
•
Controlled substance (Schedule I-III)
• Evaluation of packaging
presentations based on formulation requirements
• Bottle, blister,
sachet and tube packaging
• Clinical supply and placebo manufacture
Phase I-III
• Review of batch documentation by Quality Assurance team
Analytical Research Support
• Method development and validation for Phase I-III
•
Process development support and release testing
• Cleaning
validations for manufacturing equipment
• Non-compendial method
development and validation
• Drug substance impurity profiling (HPLC)
• Dissolution studies (ICH guidelines and customer design)
- Validated environmental chambers
- 25C/60%RH, 30C/65%RH
- 40C/75%RH, 25C/40%RH
- 40C/25%RH, 5C, photostability
• Microbiological methods validation and testing method development and
testing
• Stability
Modern Laboratory
Facilities
• Formulation development 3,000 sq. ft.
• Analytical development of 27,000 sq. ft.
• Process
development and CTM manufacturing 30,000 sq. ft.
