Pre-Formulation and Formulation Development Services

Pre-Formulation Development: These studies are required to establish comprehensive insight into a product. This work encompasses evaluation of the physiochemical properties of a molecule. Services that we can 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 and also to prepare different dosage forms. We conduct studies to evaluate product formulations by screening inactive 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
pH Optimization
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. These are generally filled/finished at a sterile facility but the development work can be completed 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, hold times)

Celsis is a world leading

provider of value enhancing

products and services