We can help you with most Preformulation testing.
Share with us all you already know about your new drug candidate. Have you already done a biopharmaceutical evaluation? Based on your biopharmaceutical evaluation, we can help with selecting the suitable excipients, the right composition, the correct processing steps, and appropriate packaging materials.
The preformulation package includes selecting the solid-state form of the new drug candidate for the future development of the potential drug product.
The Solid-form selection process contains the following stages:
- Solid-state form screening: search for possible salts, co-crystals, polymorphs, solvates, amorphous
- Solid-state form evaluation: a study of the solid-state properties (Link to the Solid State Analysis) of the found forms
- Selection of the best form for pharmaceutical development
Particle Analytical can offer an evaluation package for the selection of solid-state form:
- Crystallinity and polymorphism tendency
- Crystal structure and theoretical/true density
- Slurry studies and selection of the most stable form
- Solid-state stability
- Intrinsic dissolution
- pH solubility
- Particle size and morphology
- Specific surface area
- Thermal behaviour: melting point, volatiles, glass transition, sublimation tendency
- Batch-to-batch variation
Consult our Experts
Dr. Wenbo Wang
Dr. Anna Shevchenko
Balbach S, Korn C (2004) Pharmaceutical evaluation of early development candidates “the 100 mg-approach”. Int J Pharm 275(1-2):1-2.
Gibson, M. (2016). Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. CRC Press.
Taylor L, Braun D, and Steed J (2021) Crystals and Crystallisation in Drug Delivery Design. Mol Pharm Article ASAP DOI: 10.1021/acs 2nd Edition
The Compatibility studies are also part of the Preformulation process. Compatibility of the API with the excipients has crucial importance for the selection of appropriate excipients for the formulation. (Link to Compatibility section)