Compare different analytical techniques (ssNMR, XPRD, DSC) for detection and characterization of crystalline phase impurities in spray-dried dispersions (SDD) using the model compound Triamcinolone.

Amorphous solid dispersions combine the increased solubility of an amorphous material and the improved physical stability of more stable solid forms. Amorphous solid disperions can be used in early animal studies and in marketed products.

Batch-to-batch variability during the crystallization of active pharmaceutical ingredients (API) can have a profound impact on both safety and efficacy of the final drug formulation, and direct business and cost implications for both the API manufacturer and downstream drug-formulation partners.

A pharmaceutical co-crystal is a crystalline form that can be used to change pharmaceutical properties, such as solubility, dissolution, stability, hygroscopicity, or bioavailability. Co-crystals can be used in early development for animal pharmacokinetic studies, in human clinical trials, and in marketed products.

API phase and formulation should be able to reach desired exposures and have adequate chemical and physical stability for GLP toxicology and first in human (FIH) studies. Any changes to form or formulation will incur significant time and resource penalties.

Integrating the efforts of drug-discovery scientists, material scientists and formulation specialists earlier in the discovery process can reduce drug-development timelines, risk and overall costs and provide other competitive advantages.

A pharmaceutical salt is a crystalline form that is commonly used to change pharmaceutical properties, such as solubility, dissolution, stability, or bioavailability. Salts can be used in early development for animal pharmacokinetic studies, in human clinical trials, and in marketed products.

Solid form is a general term that refers to both crystalline and amorphous materials. The solid form will impact active pharmaceutical ingredient (API) development properties such as solubility, dissolution rate, stability, hygroscopicity, and bioavailability.