Triclinic Labs, Inc.

Triclinic Labs, Inc. and ELDICO Scientific Announce Microcrystal Electron Diffraction Services Partnership. Today, the two companies announced an exclusive strategic collaboration to introduce Microcrystal Electron Diffraction services and instruments to the North American market. Microcrystal Electron Diffraction (microED, also called 3D ED) has emerged as a way to bridge the deficiencies between single-crystal X-ray diffraction (SCXRD) and powder X-ray diffraction (PXRD). Since the interaction of electrons with materials is much stronger than for X-rays, much less material is needed to obtain sufficient diffraction. Therefore, MicroED can be utilized for crystals that are orders of magnitude smaller than required for SCXRD and with much smaller sample amounts than required for PXRD. Under the terms of the agreement, Triclinic Labs has installed ELDICO’s innovative MicroED instrument, the ED-1, at its labs in Indiana. Using the ED-1 and software, Triclinic’s crystallography group will offer crystal structure determination from nanocrystalline powders, absolute configuration determination, micro-crystallinity analysis in amorphous solid dispersions, and phase analysis of crystals in mixtures. ELDICO will be able to offer prospective customers access to domestic instrument demonstrations and priority MicroED analysis services at Triclinic, the only contract research provider in North America to offer MicroED analysis using the system. “We’re incredibly excited to add ELDICO’s instrument and software to our powder and single crystal diffraction capabilities. It bridges a huge gap in the pharmaceutical and specialty chemical industries,” said Dr. Steef Boerrigter, Triclinic’s Head of Materials Modeling. “The ED-1 system bypasses one of the main limitations of crystallography, namely – growing crystals of suitable size. The ED-1 system also overcomes the limitations of older Cryo-TEM systems,” he added. “We are thrilled to bring our innovative microED instrument to the North American market for mainstream application,” said Danny Stam, Sales Manager at ELDICO Scientific. “Our potential clients have indicated a US laboratory with Triclinic’s reputation and proximity will allow the technique to be more quickly adopted in research and patent projects. This collaboration will demonstrate the utility and ease of use of the ED-1, which can be used as a new crystallography tool during chemical and intellectual property development,” Stam added. For more information on Triclinic's Micro Electron Diffraction services, please contact: Triclinic Labs: Steef Boerrigter, Ph.D. Triclinic Labs, Inc. [email protected] For more information on the ED-1 instrument and a demonstration, please contact: ELDICO: Danny Stam, ELDICO Scientific., [email protected]

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Rapid Lab Scale Spray Drying and Amorphous Solid Dispersion Development. Amorphous solid dispersions are a proven approach to alter the properties of active pharmaceutical ingredients (API) for improved dissolution rate, solubility and overall bioavailability, and produce added intellectual property. Triclinic offers amorphous solid dispersion (ASD) development as part of our solid form screening and development services. Polymers are utilized in spray drying and hot-melt extrusion to improve the solid-state stability of amorphous solid dispersions. Feasibility studies allow us to quickly and cost effectively determine if the formulation will lead to improved properties. The lab scale process can be scaled up to meet clinical and production needs. We have numerous case studies that demonstrate these techniques are viable approaches for molecules with both solubility and stability issues. At Triclinic, the following considerations are evaluated in ASD development: ·???????API: Is the API a fast or slow crystallizer? What is the solubility advantage of the amorphous form? ·???????ASD: Which polymer from a toolbox of 8-12 proven additives, is best? What is the best drug loading (%w/w)? ·???????Processing: Should the ASD be generated via solvent- or melt-based approach? ·???????Stability: What are the recommended storage conditions? How does temperature and humidity affect stability? ·???????Performance: Does the ASD show superior performance during in vitro dissolution compared to its crystalline counterpart? Triclinic Labs is equipped with a ProCept R&D spray dryer and a MiniCTW hot melt extruder. The entire ASD development can be performed with as low as 500 mg material. In addition, Triclinic Labs is equipped with complete thermal, microscopy, and spectroscopy techniques sensitive for crystallization detection needed in an ASD development. Contact us today for more information or click here to learn more: https://lnkd.in/eE28DW4F