Wednesday, December 15, 2010

Formulation and Development

A formulation is a mixture that is prepared according to a specific procedure (called a “formula”). Formulations are made for particular applications and normally are more effective than their individual components when these are used singly.
Formulations are commercially produced for drugs, cosmetics, foods, paints, coatings, cleaning agents, and many other things.

Innovative Development
• Preformulation studies
• Formulation development
• CTM manufacturing
• Stability studies
• Evaluation of new delivery technologies
• Formula and process optimization through DOE

•  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

•  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
•  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

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