Effective pre-formulation services will help you produce an optimized product at a lower cost and with fewer reworks.

Drug pre-formulation and material characterization services are extremely important in the development of successful products. CritiTech’s material characterization testing capabilities can provide you with the most complete picture of the chemical and physical properties of your raw materials and active ingredients. Our expertise in pre-formulation for drug development can give you the solid foundation you need to produce the most effective pharmaceuticals.

In order to formulate a drug’s target product profile with the most suitable dosage, maintaining safety and encouraging good bioavailability, it needs to undergo an expert pre-formulation. Discerning the fundamental physiochemical properties of a new drug substance can require multiple methods of material characterization. 

CritiTech employs a variety of techniques to produce in-depth characterization of particles, which can assist in the understanding of API and drug product performance. Traditionally, particle characterization has focused on crystalline phase (XRD) and particle size distribution (PSD), in addition to these attributes, CritiTech evaluates specific surface area (SSA), bulk/tapped density (B/T), and shape/habit of particle using scanning electron microscopy (SEM). By adding SSA, B/T, and SEM to XRD and PSD, we can develop a more complete picture of your materials and make sense of other properties such as dissolution rate or mean median mass aerodynamic diameter. 

From achieving desired specifications with assays, impurities and dissolution rates, to patient compliance and promoting cost-effective manufacturing, CritiTech’s pre-formulation services will get your product ahead of the game. 

Pre-Formulation Material Characterization Areas

Why Choose CritiTech?

Choosing to work with us to provide pharmaceutical pre-formulation services means your company can have advanced techniques on its side. Our processes help us stand out from other providers because our pre-formulation development services are superior to the more-basic methods they use. With us serving as your partner, you can experience faster development, reduced costs and enhanced product quality. The expertise and experience we bring to your project can mean the difference between products that succeed and those that fail to rise above the competition. If you would like to learn more about everything we can do for you, take the next step and connect with one of our representatives today to discuss your needs.