Effective Pre-Formulation will help you produce an optimized product at a lower cost and with less rework.
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 physio-chemical 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 around 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
|Particle Size Distribution||Dissolution Rate||Solution Stability|
|Particle Shape/Image Analysis||pH Solubility Profile||Bulk Stability|
|Specific Surface Area and Porosity||Organic Solvent Solubility||Solid State Stability|
|Crystallinity & Polymorphism||Thermal Effects||Stability in Toxicology Formulations|
|Bulk/Tapped Density||Partition Coefficient||Crystallinity & Polymorphism|
|Dissociation Constant (pka)|