We know that the needs in early development are different from the needs in late development and we tailor our screening approach based on information from the client and our experience with a wide range of compounds. At Crystal Pharmatech, we utilize a unique screening approach that combines all of our experiences with direct input from our esteemed scientific advisory board. The screenings are performed in a tiered approach with information from each tier guiding the next tier.
We feel this approach is our competitive advantage as it offers maximum form screening space with limited material and turnaround time.
1. Polymorph/Salt/Cocrystal Screening
• Improving physical properties such as stability, hygroscopicity, and melting point
• Increasing bioavailability for weak acids and bases or neutral compounds
2. Amorphous Solid Dispersion Screening
• Improving the absorption of poorly soluble drugs by developing dispersion formulations
• Identifying key risks, such as chemical and physical stability of resulting dispersions
• Evaluating dispersions in early and late phase formulations
3. Chiral Salt Screening for enantiomeric enrichment
• Allowing enantiomeric enrichment by fractional crystallization finding the right salt formers.
Solid Form Screening - Resources
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Amorphous Materials and Dispersions in Pharmaceutical Development, Jun Huang, Crystal Pharmatech
Enabling Poorly Soluble Weak Bases for Improved Bioavailability: Why a Salt May Not be the Best Choice, Sheri Shamblin, Pfizer
Synthonic Engineering: Tools for the Rational Design of High Quality Pharmaceuticals, Kevin Roberts, University of Leeds
Engineering Cocrystal Solubility and Streamlining Cocrystal Early Development, Nair Rodriguez-Hornedo, University of Michigan.
Specialized Solid Form Screening Techniques. Org. Proc. Res. Dev. 2013, 17, 457-471 (free download)
Solid-State Pharmaceutical Development: Ensuring Stability Through Salt and Polymorph Screening in Pharmaceutical Stress Testing, Predicting Drug Degradation. Editors Baertschi, S.W., Alsante, K.M., Reed, R.A. (2011) 254-285.
Amorphous Solid Dispersion Screening in Pharmaceutical Amorphous Solid Dispersions. Editor A. Newman. (2015) 85-116.
Salt Cocrystal Form Selection. Chapter 14 in Preclinical Development Handbook. Editors S. Cox. (2008) 455-481.
X-ray Powder Diffraction in Solid Form Screening and Selection. Am. Pharm.l Rev.2011, Sept/Oct, 44-51 (free download)
A Solid-state Approach to Enable Early Development Compounds: Selection and Animal Bioavailability Studies of an Itraconazole Amorphous Solid Dispersion. J. Pharm. Sci. 2010, 99(9), 3901-3922.
Discovery of a Stable Molecular Complex of an API with HCl: A Long Journey to a Conventional Salt, J. Pharm. Sci. 2008, 97(9), 3721-3726.
Anhydrates and Hydrates of Olanzapine: Crystallization, Solid-State Characterization, and Structural Relationships. Cryst. Growth and Des. 2003, 3(6), 897-907.