Solid NanoCrystalline Dispersions, or SNCDs, consisting of drug crystals embedded in a polymer-rich matrix, are the purposeful formation of sub-micron, high-energy crystals from amorphous dispersions. They can be formed through crystallization of the drug in a spray-dried dispersion (SDD) under controlled temperature and relative humidity conditions that favor high nucleation rates over crystal growth.
SNCDs have two important properties: (1) the high-energy nature of the drug nanocrystals enhances dissolution performance, and (2) the crystalline nature stabilizes the drug form and allows higher drug-loadings. Thus, it is possible to attain both good performance and good stability with SNCDs.
Process of forming an SNCD
Transmission Electron Microscopy (TEM) analysis of an SNCD
SNCDs are best used in cases where any of the following apply:
- Additional stability relative to an amorphous form is needed because a high drug-loading is required or amorphous drug has a low glass-transition-temperature (Tg).
- Improved chemical stability relative to an amorphous drug form is needed.
- Small crystals with rapid dissolution rates are sufficient to meet pharmacokinetic targets.
Through our SNCD work, we have demonstrated the following:
- Formulations based on neutral and anionic polymers.
- Manufacture at kilogram scales under GMP protocols is possible.
- Improved performance over crystals, in some cases equal to SDDs.
- Excellent chemical and physical stability.
- Flexible use in dosage forms, including osmotic tablets, matrix tablets, granulated formulations and on multiparticulate beads for human and animal studies.
Contact us to discuss how SNCD technology can help to advance your drug candidates.