Preformulation/Formulation services brochure
Celsis Development Services provides the following preformulation and formulation development services to establish comprehensive insight into your product.
Preformulation Development
This work encompasses evaluation of the physiochemical properties of a molecule. Services that we provide are:
- Evaluation of solubility in water or other solvent systems
- Determination of pH solubility and stability
- Determination of pKa and partition coefficient
- Osmolality optimization for IV formulations
- Excipient compatibility and selection
- Stability indicating analytical methods development
Formulation Development
A product is the combination of an active ingredient and one or more excipients (inactive ingredients). A good product should be formulated to be stable when exposed to conditions such as time, temperature, light and humidity. We conduct studies to evaluate product formulations by screening excipients in the presence of the active ingredient and analyze using stability indicating methods. The services we provide are for:
- Parenterals
- Topicals
- Solid dosage forms
Services we provide include:
- Evaluation of buffers
- Screening of excipients
- Antioxidants, bulking agents, surfactants and antimicrobials
- Evaluation of liquid and lyophilized formulations
- Stability studies
Forced Degradation Studies
These studies are needed for product evaluation under stressed conditions in order to define and understand degradation pathways. The product is stressed under the conditions described below and analyzed using stability indicating methods:
- Accelerated thermal conditions
- Induced oxidation conditions
- Acidic and basic conditions
- Others as needed
Fill/Finish Optimization
This is principally relevant to liquid dosage forms. Fill/finish processing is completed at a sponsordesignated sterile facility but the development and optimization work can be conducted in our laboratory. The services we provide are:
- Evaluating the container/closure
- Compounding of formulation buffers
- Compounding of bulk
- Sterile filtration process
- Compatibility with filters, flow rate, filling speed and hold times
